Patent Application
20200375849
The present description is directed to devices and methods for providing medication, more specifically, the present description is directed to transfer of medication for preparation of an administration dosage.
Prescription medication is typically dispensed by a pharmacy. At the pharmacy, patients may receive instructions regarding preparation and administration. For example, patients may be instructed to prepare a dosage amount such as a specified number of pills or a volume of solution to ingest or apply.
It is often difficult or inconvenient for patients to visit a pharmacy to obtain prescription medication. Mail order dispensing has gained popularity. However, with mail order dispensing of medication, patients may not receive sufficient guidance with respect to preparation and administration of the medication. Measuring dosages can also be complex and difficult even with proper instruction for patients that lack the proper measurement devices, coordination, or mobility. Whether mail order or obtained at a pharmacy, stability of medications and protecting children for accessing the medication are also concerns. The above concerns also apply to over-the-counter medications. What is need are improved methods for preparing medication dosages.
In one aspect, a method of supplying a medication for use with a medication transfer system includes supplying a liquid medication into an interior volume of a drug chamber and dispensing the drug chamber to a patient or caregiver. The drug chamber may include a fitting for coupling to a corresponding fitting of a transfer module. The drug chamber may also include a drug port. The transfer module may also include a transfer port configured to align with the drug port when the drug chamber and transfer module are coupled at their fittings. The transfer module may be operable to open the drug port to allow transfer a portion of the liquid medication through the transfer port into a separate dose chamber.
The liquid medication may comprise a prescription medication selected from an anti-infective and/or corticosteroid. In one example, the liquid medication comprises levofloxacin or itraconazole. In a further example, the liquid medication comprises levofloxacin 25 mg/mL oral solution. In one example, the liquid medication comprises itraconazole 10 mg/mL oral solution.
The drug chamber may include a hose that extends from within its interior volume to the drug port.
In another aspect, a method of preparing a measured medication dosage includes transferring a transfer volume of liquid medication from a drug chamber through a transfer port and into a dose chamber. A transfer module may be positioned to at least partially control transfer of the liquid medication through the transfer port. The transfer volume may be less than the volume of liquid medication within the drug chamber when transfer begins.
The dose chamber may be configured for measurement of the transfer volume. In one example, the dose chamber includes measurement markings corresponding to the transfer volume.
The transfer module may be configured for measurement of the volume of transferred medication. In one example, the transfer module includes a user interface including a control actuator and transferring the liquid medication includes actuating the control actuator to initiate the transfer of the liquid medication. The drug chamber may be child-resistant.
The liquid medication is a prescription medication comprising an anti-infective and/or corticosteroid. In one example, the liquid medication comprises levofloxacin 25 mg/mL oral solution, itraconazole 10 mg/mL oral solution, or both.
In still another aspect, a method includes supplying a medication together with a medication transfer system including dispensing a medication transfer device. The medication transfer device includes a drug chamber having an interior volume, a dose chamber having an interior volume, and a transfer module including a transfer port between the interior volumes of the drug chamber and the dose chamber. The method may further include dispensing liquid medication within the interior volume of the drug chamber when dispensing the drug chamber. The liquid medication may be selectively transferable from the interior volume of the drug chamber to the interior volume of the dose chamber. The medication transfer device may be configured for measurement of a volume of the transferred liquid medication.
In one configuration, the medication transfer device comprises a bag that is partitioned to define the drug chamber and dose chamber. The medication transfer device may comprises a child-resistant device. In one example, the medication transfer device comprises a child-resistant bottle or child-resistant bag.
In one example method, the liquid medication is a prescription medication comprising an anti-infective and/or corticosteroid. The liquid medication may be levofloxacin 25 mg/mL oral solution, itraconazole 10 mg/mL oral solution, or both.
The novel features of the described embodiments are set forth with particularity in the appended claims. The described embodiments, however, both as to organization and manner of operation, may be best understood by reference to the following description, taken in conjunction with the accompanying drawings in which:
The medication delivery system may comprise a medication transfer device including a drug chamber for containing medication and a dose chamber for receiving a dose, which may be a full or partial dose, of the medication. The medication transfer device may also include a transfer module for transferring medication from the drug chamber to the dose chamber. The transfer module may be operable to transfer or enable transfer of a transfer volume of medication. One or more transfer volumes will typically provide a dosage volume suitable for administration to a patient. The medication transfer device may be configured to contain multiple dosages of medication within the drug chamber and be operable to transfer a predetermined and/or customized transfer volume of the medication into the interior volume of the dose chamber. Various transfer mechanisms, metering mechanisms, or combinations thereof may be used. In some embodiments, one or more transfer volumes or dosage volumes correspond to the interior volume of the dose chamber. The dose chamber may also include measurement markings from which desired transfer volumes may be determined.
The medication transfer device may include various configurations such as a bag, bottle, jar, vial, or pouch. The medication transfer device or chambers thereof may be formed from generally liquid impermeable material such as glass; plastic such as PVC, vinyl, polypropylenes (PP), polyethylenes (PE), polyethylene terephthalates (PET) such as boPET, or other plastics; ceramic; metal; or combinations thereof.
The medication transfer device may also include various child-resistant features. For example, access to the drug chamber, dose chamber, and/or operations of the transfer module may be equipped with child-resistant features that are resistant to child usage, e.g., in compliance with the Poison Prevention Packaging Act or as otherwise with the Federal Drug Administration or U.S. Consumer Product Safety Commission. Examples may include caps, lids, or over caps utilizing local squeeze force applied while turning for removal or operation, continuous threads, hold fitment while turning, push down while turning, push down into limited fitment gap followed by turn to secondary fitment gap for access to removal or operation functions, lug finish closures, align cap and ring followed by pushing cap toward ring and turning, localized push up to remove, localized press down then pull up at arrow, turn cap to stop and then lift and continue opening, localized push in while turning where force must be applied to designated place on closure, or other child-resistance mechanisms, which may include others described herein. Additional child-resistant features may include trigger pumps (press down on a point to release lock and rotate orifice to spray position to squeeze trigger), finger pumps (push tab while rotating to spray position, zipper or seal locks).
In various embodiments, a method of providing a medication comprises providing the medication delivery system, medication transfer device, or a component thereof. In one example, the method comprises providing a drug chamber, containing medication and configured for coupling with the transfer module and dose chamber. In another example, the method includes providing a refill container for charging the drug chamber with medication. In one example, the method includes providing a transfer module operable to provide a desired transfer volume when coupled between the drug chamber and the dose chamber. In some embodiments, the method includes providing a drug chamber containing medication and an attached or attachable transfer module for coupling with a dose chamber. The transfer module may be configured to provide a suitable transfer volume or may be configured to allow a user to select a transfer volume, which may comprise multiple transfer volumes. In one embodiment, multiple interchangeable transfer modules may be provided, each configured for use in transferring a different transfer volume.
The medication transfer device 20 may be configured to contain multiple dosages of medication within the drug chamber 30 and is operable to transfer a volume of the medication into the interior volume 41 of the dose chamber 40. The interior volume 41 of the dose chamber 40 may define a desired dosage such that transferring an amount of medication, e.g., one or more transfer volumes, to fill the dose chamber 40 provides the desired measured dosage volume. In some such embodiments, a medication delivery system 10 may comprise a plurality of medication transfer devices 20 having different sized dose chambers 40 for providing different dosage volumes. In some embodiments, as described in more detail below, a medication transfer device 20 may include multiple dose chambers 40, each in fluid communication or selectively in fluid communication with one or more drug chambers 30. For example, multiple dose chambers 40 having the same or different interior volumes 41 may be used. Multiple drug chambers 30 may be provided to supply the same or different medications to one or more dose chambers 40. For example, a medication transfer device 20 may include a first drug chamber 30 for holding a first medication transferable to a dose chamber 40 or intermediate chamber and a second drug chamber 30 for holding a second medication transferable to the dose chamber 40, a different dose chamber 40, or the intermediate chamber. The intermediate chamber may be used for mixing before transfer to a dose chamber 40, which may include mixing additional medication before or after transfer.
It is contemplated that any of the various features described with respect to drawings may be utilized in combination with other described features describes with respect to other embodiments. However, various features are described separately for ease of understanding. Furthermore, while certain features are described with respect to a bag, bottle, or container configuration, those having skill in the art will appreciate that these features may find use in other device configurations, such as those described herein, and their use in such other device configurations is contemplated herein.
With particular reference to
The medication transfer device 20 is configured to contain multiple dosages of medication within the drug chamber 30 and is operable to transfer a transfer volume of the medication into the interior volume 41 of the dose chamber 40. The transfer volume may be a predetermined, selectable, or customizable volume of medication according to a configuration of the transfer module 50 or device configuration, as described in more detail elsewhere herein. In various embodiments, the medication transfer device 20 may include a user interface 25 for interfacing the user with operations of the device.
The medication transfer device 20 may comprise various shapes, such a square, rectangular, polygonal, round, or freeform, for example. The dose chamber 40 and the drug chamber 30 may be comprise various relative dimensions and be located at various relative positions. For example, in
The medication delivery system 10 including a medication transfer device 20 comprising a bag configuration may also include multiple dose chambers 30 and/or multiple drug chambers 40.
Other configurations of multiple drug chambers 30, dose chambers 40, and/or transfer modules are also contemplated, for example, a medication delivery system 10 may include a medication transfer device 20 having multiple sets of drug chambers 30, dose chambers 40, and transfer modules 50. The multiple sets may be used to provide different volumes of the same or different medications to be administered together or separate in time and/or location of administration. While multiple user interfaces 25a, 25b are identified in
The dose chamber 40 will typically be configured with a dose release port to allow removal of a transfer volume. A dose release port may be configured to be resealable and may include various child-resistant features as described elsewhere herein.
The device 20 shown in
The device 20 shown in
The device 20 shown in
In some embodiments, an administration mechanism is provided at the dose release port 43. For example, a nozzle for extruding, spraying, sucking, or pouring the transfer volume from the dose release port 43 may be provided.
In various embodiments, the interior volume 31 of the drug chamber 30 is permanently sealed, other than at one or more transfer ports, after medication is received therein to prevent tampering and access.
With particular reference to
In various embodiments, the medication delivery system 10 may include an initial fill or refill container for supplying initial or additional medication into the drug chamber 30. For example, such a container may include a fitting for coupling to the fill port 33 to charge or recharge the drug chamber 30. Fittings may include or couple to a transfer hose. A pump, such as a hand pump may be coupled with the transfer hose. In some embodiments, the container may be flexible for squeezing to generate pressure to drive transfer of medication into the drug chamber 30. In one embodiment, the fill port 33 comprises a Schrader valve and the hose comprises a suitable Schrader valve fitting.
As introduced above, the medication delivery system 10 may include a transfer module 50 for controlling transfer from the drug chamber 30 to the dose chamber 40. The transfer via the transfer module 50 may utilize a variety of transfer mechanisms. For example, transfer valves may be used to control flow, pumps may be utilized to pump fluid, or one or more chambers 30, 40 may be flexible to allow relative pressure to be modulated to drive transfer. In some embodiments, the transfer module 50 may include or utilize a transfer mechanism configured to allow or prevent fluid communication between the interior volumes 31, 41 of the drug chamber 30 and the dose chamber 40. With general reference again to
In some embodiments, a mechanism for selectively opening or closing the transfer port includes a check-valve allowing one-way flow. Check-valves may include a stop check-valve for selectively preventing flow. For example, an actuator may be provided at a user interface 25 to allow a user to manually or via motor assistance engage or disengage the stop function of a stop check-valve.
An actuator with respect to a valve, e.g., shutoff valve or stop check-valve, may comprise a switch, push button, knob, or a touch screen button of a user interface, for example. The pushing, pulling, twisting, sliding, switching, or otherwise actuating the actuator may cause opening or closing of the transfer port 51. Actuation may cause a physical barrier to obstruct or reveal the transfer port 51. In some embodiments, actuation may initiate or drive transfer of medication from the drug chamber 30 to the dose chamber 40 through the transfer port 51. In one embodiment, actuation may cause a measurement component of the transfer module 50 to pump in or receive medication from the interior volume 31 of the drug chamber 30 and/or to pump out or release medication into the interior volume 41 of the dose chamber 40, which may comprise a measured portion of medication.
As introduced above, a mechanism for selectively opening and closing the transfer port 51, or allowing or preventing transfer, may be operated manually, electronically, and/or via motor assistance, which may be automated, e.g., operation of an switch, button, or actuator corresponding to initiation of medication transfer, or otherwise selectable by a user, e.g., operation of a switch, button, or actuator corresponding to powering a motor configured to open or close a transfer valve or manipulate a barrier or structure to open or close the transfer port 51.
In some embodiments, the actuator 52 may be pressed to open and close the transfer valve, which may comprise a stop check-valve, and further rotated to initiate or drive transfer of medication. In one embodiment, the actuator 52 may be rotated to open and close the valve and pressed to initiate or drive transfer of medication. In one embodiment, actuating the actuator 52 drives or initiates rotation or movement of a metering wheel, movement of a plunger, and/or movement of a transfer chamber. For example, the actuator 52 may be rotated to a position corresponding to a desired predetermined transfer volume. Rotation may cause a corresponding rotation of a metering wheel. The degree of rotation may or may not correspond to a degree of rotation of the actuator. For example, rotation may initiate a motor for providing a particular number of rotations of the metering wheel or may actuate a biasing structure such as a spring configured to cause a desired number of rotations of the metering wheel. It is noted that other metering structures may be used and need not have a ball or wheel shape. For example, actuation may cause movement of a transfer chamber or a plunger within a transfer chamber or in fluid communication therewith.
In one embodiment, the actuator 52 may be rotated or pulled outwardly to actuate a plunger to fill a transfer chamber (not shown) with medication from the interior volume 31 of the drug chamber 30 and then rotated or pushed in to pump the medication from the transfer chamber into the interior volume 41 of the dose chamber 40, which may include driving the plunger back through the transfer chamber. In one such example, actuation causing movement of the plunger also causes sequenced opening of the transfer port, which may comprise multiple transfer ports, in communication with the transfer chamber. In some embodiments, the transfer chamber includes a transfer valve arrangement similar to that described with respect to
As introduced above, the transfer mechanism may include increasing pressure within the interior volume 31 of the drug chamber 30. For example,
In some embodiments, the transfer mechanism includes a movable partition. For example,
In one embodiment, the transfer chamber 60 comprises a volume that may be decreased and subsequently returned to a previous volume. For example, the transfer chamber 60 may include one or more flexible walls that may be flexed to decrease the volume of the transfer chamber 60. The transfer chamber 60 may include a movable partition for drawing in and pushing out medication. In one embodiment, the transfer chamber 60 includes a flexible bladder (e.g., a balloon). The bladder may be compressed by manipulation, e.g., utilizing an actuator or directly with the hand of a user. Depressing a side of the bladder drives a reduction in volume within the transfer chamber 60. As the transfer chamber 60 returns to a pre-compressed volume, medication is drawn into the transfer chamber 60. Subsequent compression of the volume may drive delivery of the medication from the transfer chamber 60 into the interior volume 41 of the drug chamber. Thus, in such a configuration, a predetermined amount of medication transferred may be associated with each actuation or depression, e.g., pump, of the bladder and the number of pumps may be used to determine the appropriate transfer volume. While the transfer chamber is illustrated as having a round cross-section, in various embodiments, the transfer chamber 60 may comprise a different cross-section such as oblong, square, triangular, rectangular, polygonal, or freeform.
In one embodiment, the transfer mechanism includes an actuator, which may be similar to that shown in
In one embodiment, the transfer chamber 60 comprises a volume that may be decreased and subsequently returned to a previous volume. For example, the transfer chamber 60 may include one or more flexible walls that may be flexed to decrease the volume of the transfer chamber 60. The transfer chamber 60 may include a movable partition for drawing in and pushing out medication. In one embodiment, the transfer chamber 60 includes a flexible bladder (e.g., a balloon). The bladder may be compressed by manipulation, e.g., utilizing an actuator or directly with the hand of a user. Depressing a side of the bladder drives a reduction in volume within the transfer chamber 60. As the transfer chamber 60 returns to a pre-compressed volume, medication into taken into the transfer chamber 60 (
In one embodiment, the transfer mechanism includes an actuator, which may be similar to that shown in
In one embodiment, the transfer chamber 60 comprises a volume that may be decreased and subsequently returned to a previous volume. For example, the transfer chamber 60 may include one or more flexible walls that may be flexed to decrease the volume of the transfer chamber 60. The transfer chamber 60 may include a movable partition for drawing in and pushing out medication. In one embodiment, the transfer chamber 60 includes a flexible bladder (e.g., a balloon). The bladder may be compressed by manipulation, e.g., utilizing an actuator or directly with the hand of a user. Depressing a side of the bladder drives a reduction in volume within the transfer chamber 60. As the transfer chamber 60 returns to a pre-compressed volume, medication is drawn into the transfer chamber 60 (
In one embodiment, the transfer mechanism includes an actuator, which may be similar to that shown in
While the features of the medication delivery system 10 described with respect to
The medication transfer device 20 is configured to contain multiple dosages of medication within the drug chamber 30 and is operable to transfer a transfer volume of the medication into the interior volume 41 of the dose chamber 40. The transfer volume may be a predetermined, selectable, or customizable volume of medication according to a configuration of the transfer module 50 or device configuration, as described in more detail elsewhere herein. In various embodiments, the transfer module 50 may include a transfer valve (not shown) that may be selectively opened and closed, e.g., via user interaction with a user interface 25 or by assembling the device 20. In a further example, the transfer module 50 includes a gate valve. Control of the transfer valve may be used to prevent unwanted initiation of the transfer mechanism leading to unwanted transfer of medication and tampering by children. The medication transfer device 20 may be configured to utilize any suitable transfer mechanism, such as those described herein. The transfer module 50 may comprise a manual pump or a pump that couples to the output of a motor configured for assisted or automated pumping. In various embodiments, the transfer module 50 includes a valve configuration, bladder, and/or transfer chamber as described above with respect to
The transfer module 50 may include a valve such as a shutoff valve or stop check-valve. In some embodiments, users may interface with operations of the valve at a user interface 25. The user interface 25 may comprise one or more switches, push buttons, knobs, or soft buttons, for example. The user interface 25 may include or operatively couple with, e.g., be operable to control, an actuator for opening and/or closing the valve. In one embodiment, the user interface 25 includes a control component that may be pushed, pulled, rotated, slid, switched, or otherwise actuated to cause opening or closing of the transfer port 51 (see
With reference to
As introduced above, a mechanism for selectively opening and closing the transfer port 51, or allowing or preventing transfer, may be operated manually, electronically, and/or via motor assistance, which may be automated, e.g., operation of an switch, button, or actuator corresponding to initiation of medication transfer, or otherwise selectable operation by a user, e.g., operation of a switch, button, or actuator corresponding to powering a motor configured to open or close a valve or manipulate a barrier or structure to open or close the transfer port.
In various embodiments, the transfer module 50 comprises a control system including a processor configured to execute pumping operations to provide precise transfer and/or dosage volumes. For example, the control system may include a user interface 25 comprising a touch screen, one or more hard or soft buttons, knobs, switches, or other control components, which may comprise actuators 26 as noted above. The control system may include computer readable memory storing instructions that when executed by the processor execute operations of the control system. The control system may be operable to control operations of a motor and pump for pumping medication into the dose chamber 40. In one embodiment, the control system includes one or more sensors such as depth sensors, flow rate sensors, pressure sensors, weight sensors, optical sensors, or other sensors configured for determining a transfer volume. A user may enter a desired transfer or dosage volume into the user interface. The control system may then control operations of the pump to provide the entered volume.
One or more components of the medication delivery system 10 may comprise modular and/or interchangeable components. With reference to
The medication transfer device 20 is configured to contain multiple dosages of medication within the drug chamber 30 and is operable to transfer a transfer volume of the medication into the interior volume 41 of the dose chamber 40. The transfer volume may be a predetermined, selectable, or customizable volume of medication according to a configuration of the transfer module 50 or device configuration, as described in more detail elsewhere herein. In various embodiments, the transfer module 50 may include a transfer valve (not shown) that may be selectively opened and closed, e.g., via user interaction with a user interface 25 or by assembling the device 20. In a further example, the transfer module 50 includes a gate valve. Control of the transfer valve may be used to prevent unwanted initiation of the transfer mechanism leading to unwanted transfer of medication and tampering by children. The medication transfer device 20 may be configured to utilize any suitable transfer mechanism, such as those described herein. The transfer module 50 may comprise a manual pump or a pump that couples to the output of a motor configured for assisted or automated pumping. In various embodiments, the transfer module 50 includes a valve configuration, bladder, and/or transfer chamber as described above with respect to
The transfer module 50 may include a shutoff valve or stop check-valve. In some embodiments, users may interface with operations of the valve at a user interface 25. The user interface 25 may comprise one or more switches, push buttons, knobs, or soft buttons, for example. The user interface 25 may include or operatively couple with, e.g., be operable to control, an actuator for opening and/or closing the valve. In one embodiment, the user interface 25 includes a control component that may be pushed, pulled, rotated, slid, switched, or otherwise actuated to cause opening or closing of the transfer port 51 (see
With continued reference to
As introduced above, a mechanism for selectively opening and closing the transfer port 51, or allowing or preventing transfer, may be operated manually, electronically, and/or via motor assistance, which may be automated, e.g., operation of an switch, button, or actuator corresponding to initiation of medication transfer, or otherwise selectable operation by a user, e.g., operation of a switch, button, or actuator corresponding to powering a motor configured to open or close a valve or manipulate a barrier or structure to open or close the transfer port.
In various embodiments, the transfer module 50 comprises a control system including a processor configured to execute pumping operations to provide precise transfer and/or dosage volumes. For example, the control system may include a user interface 25 comprising a touch screen, one or more hard or soft buttons, knobs, switches, or other control components, which may comprise actuators 26 as noted above. The control system may include computer readable memory storing instructions that when executed by the processor execute operations of the control system. The control system may be operable to control operations of a motor and pump for pumping medication into the dose chamber 40. In one embodiment, the control system includes one or more sensors such as depth sensors, flow rate sensors, pressure sensors, weight sensors, optical sensors, or other sensors configured for determining a transfer volume. A user may enter a desired transfer or dosage volume into the user interface. The control system may then control operations of the pump to provide the entered volume.
As introduced above, one or more components of the medication delivery system 10 may comprise modular and/or interchangeable components. With reference to
Users may be provided one or more suitable transfer modules 50a, 50b for the transfer volume needed. In some embodiments, a method of providing a medication treatment comprises providing a transfer module 50a, 50b configured to provide an appropriate transfer volume for a prescribed dosage. In this or another embodiment, a method of providing a medication treatment may comprise providing a drug chamber 30 as described herein containing multiple dosages of a prescribed medication treatment. The drug chamber 30 may be sealed as to not spill or become contaminated during shipping or delivery. The drug chamber 30 may include a fitting 85 configured to couple to a corresponding fitting 86a, 86b of a transfer module 50a, 50b, which may include fittings disposed on a plurality of interchangeable transfer modules 50a, 50b. A drug port 28 may be positioned near fitting 85, around the area of coupling, for alignment and coupling with the transfer port 51. In some embodiments, the hose 80 couples to a closure valve 27 at or around the drug port 28. The drug port 28 and transfer port 51 may align when coupled. The fitting 86a, 86b of the transfer module 50a, 50b may engage or associate with the closure valve 27, hose 80, or extension thereof. In some embodiments, the engagement or association may result in providing control of the operation of closure valve 27 to the transfer module 50a, 50b, e.g., via an operation provided at user interface 25 utilizing an interface component such as actuator 26a, 26b. In the illustrated embodiment, coupling the fitting 85 to fitting 86a, 86b does not open the closure valve 27; however, in other embodiments, coupling the fittings 85, 86a, 86b opens the closure valve 27. In one embodiment, compressing the drug chamber 30 fitting 85 and the transfer module 50 fitting 86a together or relatively rotating the fittings 85, 86a may initiate opening or the ability to open the closure valve 27, e.g., via user interface. In one such example, the transfer module 50a, 50b seals or blocks the transfer port utilizing a valve, e.g., as described herein, to prevent undesirable transfer of medication until initiation of transfer. Dose chamber 40 may include a fitting 88 configured to couple to a complementary fitting 87a, 87b of the transfer module 50a, 50b, which may include fittings disposed on a plurality of interchangeable transfer modules 50a, 50b. Coupling the dose chamber 40 and transfer module 50a, 50b may align a port defined in the fitting 88 of the dose chamber 40 with the transfer port extending through the transfer module 50a, 50b. In various embodiments, the transfer module 50a, 50b is prevented for opening the transfer port or closure valve 27 unless properly coupled to the drug chamber 30, dose chamber 40, or both. Thus, in one example, operation of a transfer actuator or otherwise initiating transfer operations at the user interface 25 may be prevented if the transfer module 50a, 50b is coupled to the drug chamber 30 but not properly coupled to the dose chamber 40.
The embodiment illustrated in
The medication delivery system may be utilized through the mail wherein a component such as a drug chamber containing medication is sent by a pharmacy, health provider, drug store or retailer to a caregiver or patient. The drug chamber may be protected during shipping from tampering herein and may further comprise child-resistant packaging as described herein. Access to or transfer of medication contained in the drug chamber may only be reasonably accessed by utilization of the system. Users may be sent transfer modules together with or separately of drug chambers. The transfer modules may be configured for use to transfer a prescribed dosage. In some embodiments, users may utilize any of a number of interchangeable transfer modules that may be configured to transfer different volumes of medication. In one embodiment, the medication delivery system includes a refill container. A refill container may include a bag, bottle, jar, pouch, or other container for containing medication. Refill containers may be mailed or otherwise provided to users for charging or refilling a drug chamber. In some embodiments, the refill container may be configured to transfer all or a portion of its medication contents into a drug chamber. The refill container may be opened to release medication for delivery into the drug chamber, e.g., through a fill port. In some embodiments, a refill container may be configured to couple to a transfer mechanism component. For example, a hose or fitting may be coupled between the drug chamber and the refill container. A electrically powered or hand pump may be used to assist in transfer. In another example, a transfer mechanism may include the transfer mechanism of the medication transfer device. That is, is one example, the refill container may comprise a modular drug chamber for coupling to the transfer mechanism to selectively transfer medication into the dose chamber as described herein.
In various embodiments, the medication may be transferred without utilization of outside measuring devices such as spoons or measuring cups. In one embodiment, a method of dispensing medication to a patient includes dispensing the medication in a liquid contained in the drug chamber. The method may also include dispensing the dose chamber and/or the transfer module providing the capacity to transfer the liquid medication. The does device may comprise a child resistant container such as a child-resistant bag, child-resistant bottle, or other device that meets or exceeds the industry accepted definition of child-resistant or child-proof.
In various embodiments, the dose chamber may be configured for administration and include an extrusion nozzle, applicator, spout, or spray nozzle.
The medication transfer device may be dispensed for use with various medications. For example, the medications may comprise liquid, cream, lotion, or gel formats. Medications may be include or be dispensed for formulation of compounded compositions for topical administration.
In various embodiments, the medication comprises or is dispensed for combination and topical administration to an external surface of a mammal, such as a human. In some embodiments, the topical composition may be formulated to treat infections or suspected infections of tissues and may be topically administered to surface tissues comprising or adjacent tissues thereof, which may include nails, wounded tissue, mucosal surfaces of the vagina or anus, skin such as on hands, feet, scalp, torso, arms, legs, or other surface. Embodiments of the composition may also be formulated to be applied to nails, a vaginal orifice, or anal orifice. In various embodiments, such a composition or component thereof may be supplied in the drug chamber and may be referred to herein as a topical composition.
The topical composition may generally include an antimicrobial agent, e.g., antibacterial, antifungal, or antiviral, comprising one or more pharmaceuticals drugs. However, the topical composition or medication may alternately or additional include other or different classes of pharmaceuticals drugs such as corticosteroids. Some embodiments may include combinations of active agents described herein without the antimicrobial agent. The topical composition may include a carrier comprising one or more carrier components. Unless stated otherwise, carrier is intended to include carrier component such that use of the term carrier may refer to a component of the carrier and is not restrictive in that other carrier components may be included and the carrier component referred to as the carrier need not form a complete carrier. Indeed, a carrier may include a thickening agent added to a commercially available medicated carrier solution, lotion, or cream, alone or together with other carriers, to formulate a carrier with respect to the topical composition. Carrier may also be used interchangeably with the term base. The carrier may be liquid, semi-liquid, or solid. For example, the carrier may include an aqueous, organic, or inorganic solution, which may include a dispersion or suspension, cream, gel, ointment, lotion, emulsion, powder, or paste. The topical composition may be formulated to treat microbial infections, such as infections of the skin, nails, mucosal surfaces, and potentially internalized infections, e.g., via transdermal administration of antimicrobial agents.
Embodiments of the topical composition may include an antimicrobial agent selected from an antibacterial component, antifungal component, or both. In one embodiment, the antibacterial component may include an antiviral agent. As introduced above, the topical composition may comprise the antimicrobial agent alone or in combination with one or more additional active agents selected from antibacterial component, antifungal component, an anti-inflammatory agent, a steroid, an anti-allergic agent, an antimicrobial agent, an anti-depressant agent, a stimulant agent, a disinfectant agent, an anticonvulsant agent, a local anesthetic agent, or combinations thereof. In one embodiment, the topical composition includes additional active agents selected from one or more anticonvulsants, nerve depressants, muscle relaxants, NMDA (N-Methyl-D-aspartate) receptor antagonists, opiate or opioid agonists, antidepressants, and/or other active agents. In some embodiments, the topical composition may comprise the antimicrobial agent including an antifungal component, antibacterial component, or both alone or in combination with a steroid agent, antiviral agent, NSAID agent, antidepressant agent, anticonvulsant agent, analgesic agent, opiate or opioid agonist agent, keratolytic agent, or combination thereof.
It is to be appreciated that recitations herein of a particular active pharmaceuticals include pharmaceutically acceptable salts thereof whether or not specifically recited as such. Similarly, recitation of a particular active pharmaceutical salt may also include other pharmaceutically acceptable salts thereof whether or not specifically recited as such.
In various embodiments, the antimicrobial agent comprises an antifungal component, alone or in combination with an antibacterial components, wherein the an antifungal component includes one or more antifungal pharmaceutical drugs selected from one or more categories of antifungal components including azoles (imidazoles), antimetabolites, allylamines, morpholine, glucan synthesis inhibitors (echinocandins), polyenes, benoxaaborale; other antifungal/onychomycosis agents, and new classes of antifungal/onychomycosis agents. For example, the antifungal component may comprise one or more antifungals selected from abafungin, albaconazole, amorolfin, amphotericin b, anidulafungin, bifonazole, butenafine, butoconazole, candicidin, caspofungin, ciclopirox, clotrimazole, econazole, fenticonazole, filipin, fluconazole, flucytosine, griseofulvin, haloprogin, hamycin, isavuconazole, isoconazole, itraconazole, ketoconazole, micafungin, miconazole, naftifine, natamycin, nystatin, omoconazole, oxiconazole, polygodial, posaconazole, ravuconazole, rimocidin, sertaconazole, sulconazole, terbinafine, terconazole, tioconazole, tolnaftate, undecylenic acid, voriconazole, or a combination thereof. In some embodiments, the antibacterial component is selected from one or more azoles. In one example, the antifungal component is selected from itraconazole, voriconazole, or combination thereof. In various embodiments, the antimicrobial agent comprises an antifungal component selected from one or more antifungals comprising fluconazole, itraconazole, voriconazole, amphotericin, nystatin, clotrimazole, econazole, or ketoconazole.
In various embodiments, the topical composition may comprise between approximately 0.01% and approximately 20% by weight antifungal component, such as between approximately 0.01% and approximately 5%, approximately 0.01% and approximately 3%, approximately 0.01% and approximately 1%, approximately 0.01% and approximately 0.25%, approximately 0.01% and approximately 0.15%, approximately 0.05% and approximately 0.15%, between 0.1% and 10%, approximately 0.1% and approximately 0.5%, approximately 0.1% and approximately 0.2%, approximately 0.2% and approximately 0.8%, approximately 0.2% and approximately 0.6%, approximately 0.2% and approximately 0.4%, approximately 0.3% and approximately 1%, approximately 0.3% and approximately 0.8%, approximately 0.3% and approximately 0.6%, approximately 0.4% and approximately 1%, approximately 0.5% and approximately 1%, approximately 0.5% and approximately 8%, approximately 0.6% and approximately 1%, approximately 0.6% and approximately 0.8%, approximately 0.8% and approximately 1%, approximately 1% and approximately 3%, approximately 1% and approximately 10%, approximately 1% and approximately 8%, approximately 1% and approximately 5%, approximately 1% and approximately 3%, approximately 3% and approximately 10%, approximately 3% and approximately 8%, approximately 3% and approximately 5%, between 5% and 10%, approximately 5% and approximately 8%, approximately 6% and approximately 10%, approximately 6% and approximately 8%, approximately 7% and approximately 10%, approximately 8% and approximately 10%, approximately 10% and approximately 20%, approximately 10% and approximately 15%, approximately 10% and approximately 12%, approximately 12% and approximately 15%, or between approximately 15% and approximately 20% antifungal component by weight. In some embodiments, the amount of antifungal component by weight may be approximately 0.01%, approximately 0.05%, approximately 0.1%, approximately 0.5%, approximately 1%, approximately 1.5%, approximately 2%, approximately 2.5%, approximately 3%, approximately 3.5%, approximately 4%, approximately 4.5%, approximately 5%, approximately 5.5%, approximately 6%, approximately 6.5%, approximately 7%, approximately 7.5%, approximately 8%, approximately 8.5%, approximately 9%, approximately 9.5%, approximately 10%, approximately 11%, approximately 12%, approximately 13%, approximately 14%, approximately 15%, approximately 17%, approximately 19%, approximately 20%, or any other percentage between approximately 0.01% and 20% by weight of the topical composition.
It is to be appreciated that the amount of medication initially supplied in the drug chamber is preferably greater than that transferred to the dose chamber in a transfer or dose volume.
In various embodiments, the topical composition comprises an antimicrobial agent including an antifungal component alone or in combination with an anti-inflammatory agent, an non-steroidal anti-inflammatory (NSAID) agent, an anti-allergic agent, an antimicrobial agent, an anti-depressant agent, a stimulant agent, a disinfectant agent, an anticonvulsant agent, a local anesthetic agent, or combination thereof, which may include one or more active pharmaceutical drugs of selected components or agents. In one embodiment, the topical composition includes one or more additional active agents selected from one or more anticonvulsants, nerve depressants, muscle relaxants, NMDA (N-Methyl-D-aspartate) receptor antagonists, opiate or opioid agonists, antidepressants, and/or other actives. In some embodiments, the topical composition comprises an antifungal component alone or in combination with an antibacterial component, antiviral component, steroid agent, NSAID agent, antidepressant agent, anticonvulsant agent, analgesic agent, opioid agent, keratolytic agent, or combination thereof, which may include one or more active pharmaceutical drugs of selected components or agents. In an above or another embodiment, the antimicrobial agent may further comprise an antibacterial component comprising one or more antibacterial pharmaceutical drugs, such as those identified herein.
The antimicrobial agent may comprise an antibacterial component alone or in combination with an antifungal component. In some embodiments, the antibacterial component comprises one or more enicillins, cephalosporins, fluoroquinolones, aminoglycosides, monobactams, carbapenems, macrolides, other antibacterial, or combination thereof. For example, the antibacterial component may include one or more antibacterial pharmaceutical drugs selected from afenide, amikacin, amoxicillin, ampicillin, arsphenamine, azithromycin, azlocillin, aztreonam, bacampicillin, bacitracin, carbacephem (loracarbef), carbenicillin, cefaclor, cefadroxil, cefalotin, cefamandole, cefazolin, cefdinir, cefditoren, cefepime, cefixime, cefoperazone, cefotaxime, cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, ceftizoxime, ceftobiprole, ceftriaxone, cefuroxime, cephalexin, chloramphenicol, chlorhexidine, ciprofloxacin, clarithromycin, clavulanic acid, clindamycin, cloxacillin, colimycin, colistimethate teicoplanin, colistin, demeclocycline, dicloxacillin, dirithromycin, doripenem, doxycycline, efprozil, enoxacin, ertapenem, erythromycin, ethambutol, flucloxacillin, fosfomycin, furazolidone, gatifloxacin, geldanamycin, gentamicin, grepafloxacin, herbimycin, imipenem, isoniazid, kanamycin, levofloxacin, lincomycin, linezolid, lomefloxacin, meropenem, methicillin, meticillin, mezlocillin, minocycline, mitomycin, moxifloxacin, mupirocin, nafcillin, neomycin, netilmicin, nitrofurantoin, norfloxacin, ofloxacin, oxacillin, oxytetracycline, paromomycin, penicillin G, penicillin V, piperacillin, pivmecillinam, platensimycin, polymyxin B, prontosil, pvampicillin, pyrazinamide, quinupristin/dalfopristin, rifampicin, rifampin, roxithromycin, sparfloxacin, spectinomycin, spiramycin, sulbactam, sulfacetamide, sulfamethizole, sulfamethoxazole, sulfanilamide, sulfanilimide, sulfisoxazole, sulphonamides, sultamicillin, telithromycin, tetracycline, thiamphenicol, ticarcillin, tobramycin, trimethoprim, trimethoprim-sulfamethoxazole, troleandomycin, trovafloxacin, or a combination thereof. In some embodiments, the antibacterial component is selected from mupirocin, gentamycin, tobramycin, or combinations thereof. In one embodiment, the antibacterial component includes an aminoglycoside.
In various embodiments, the one or more antimicrobial agents comprises an antibacterial component selected from one or more antibacterials comprising vancomycin, ciprofloxacin, levofloxacin, azithromycin, clindamycin, doxycycline, mupirocin, ceftriaxone, colistimethate, tobramycin, cefepime, gentamicin, streptomycin, sulfamethoxazole/trimethoprim. In one example, the topical composition comprises linezolid, levofloxacin, ciprofloxacin, or combination thereof.
In various embodiments, the topical composition may comprise between approximately 0.01% and approximately 20% by weight antibacterial component, such as between approximately 0.01% and approximately 5%, approximately 0.01% and approximately 3%, approximately 0.01% and approximately 1%, approximately 0.01% and approximately 0.25%, approximately 0.01% and approximately 0.15%, approximately 0.05% and approximately 0.15%, between 0.1% and 10%, approximately 0.1% and approximately 0.5%, approximately 0.1% and approximately 0.2% approximately 0.2% and approximately 0.8%, approximately 0.2% and approximately 0.6%, approximately 0.2% and approximately 0.4%, approximately 0.3% and approximately 1%, approximately 0.3% and approximately 0.8%, approximately 0.3% and approximately 0.6%, approximately 0.4% and approximately 1%, approximately 0.5% and approximately 1%, approximately 0.5% and approximately 8%, approximately 0.6% and approximately 1%, approximately 0.6% and approximately 0.8%, approximately 0.8% and approximately 1%, approximately 1% and approximately 3%, approximately 1% and approximately 10%, approximately 1% and approximately 8%, approximately 1% and approximately 5%, approximately 1% and approximately 3%, approximately 3% and approximately 10%, approximately 3% and approximately 8%, approximately 3% and approximately 5%, between 5% and 10%, approximately 5% and approximately 8%, approximately 6% and approximately 10%, approximately 6% and approximately 8%, approximately 7% and approximately 10%, approximately 8% and approximately 10%, approximately 10% and approximately 20%, approximately 10% and approximately 15%, approximately 10% and approximately 12%, approximately 12% and approximately 15%, or between approximately 15% and approximately 20% antibacterial component by weight. In some embodiments, the amount of antibacterial component by weight may be approximately 0.01%, approximately 0.05%, approximately 0.1%, approximately 0.5%, approximately 1%, approximately 1.5%, approximately 2%, approximately 2.5%, approximately 3%, approximately 3.5%, approximately 4%, approximately 4.5%, approximately 5%, approximately 5.5%, approximately 6%, approximately 6.5%, approximately 7%, approximately 7.5%, approximately 8%, approximately 8.5%, approximately 9%, approximately 9.5%, approximately 10%, approximately 11%, approximately 12%, approximately 13%, approximately 14%, approximately 15%, approximately 17%, approximately 19%, approximately 20%, or any other percentage between approximately 0.01% and 20% by weight of the topical composition.
In some examples, the topical composition comprises from approximately 0.3% w/w to approximately 3% w/w, approximately 0.5% w/w to approximately 2.5% w/w, approximately 1.0% w/w to approximately 9.0% w/w, approximately 2.0% w/w to approximately 8.0% w/w, from approximately 3.0% w/w to approximately 7.0% w/w, or from approximately 4.0% w/w to approximately 7.0% w/w of an antifungal component identified herein. For example, the topical composition may comprise itraconazole, voriconazole, fluconazole, or combination thereof. In an example, the topical composition comprises from approximately 0.3% w/w to approximately 3% w/w, approximately 0.5% w/w to approximately 2.5% w/w, approximately 1.0% w/w to approximately 9.0% w/w, approximately 2.0% w/w to approximately 8.0% w/w, from approximately 3.0% w/w to approximately 7.0% w/w, or from approximately 4.0% w/w to approximately 7.0% w/w of a first antifungal component identified herein and from approximately 0.3% w/w to approximately 3% w/w, approximately 0.5% w/w to approximately 2.5% w/w, approximately 1.0% w/w to approximately 9.0% w/w, approximately 2.0% w/w to approximately 8.0% w/w, approximately 3.0% w/w to approximately 7.0% w/w, or from approximately 4.0% w/w to approximately 7.0% w/w of a second antifungal component identified herein.
In one example, the topical composition comprises from approximately 0.3% w/w to approximately 3% w/w, approximately 0.5% w/w to approximately 2.5% w/w, approximately 1.0% w/w to approximately 9.0% w/w, approximately 2.0% w/w to approximately 8.0% w/w, approximately 3.0% w/w to approximately 7.0% w/w, or from approximately 4.0% w/w to approximately 7.0% w/w of an antibacterial component identified herein. In another example, the transfer volume or dosage volume of the topical composition comprises from approximately 0.3% w/w to approximately 3% w/w, approximately 0.5% w/w to approximately 2.5% w/w, approximately 1.0% w/w to approximately 9.0% w/w, approximately 2.0% w/w to approximately 8.0% w/w, approximately 3.0% w/w to approximately 7.0% w/w, or from approximately 4.0% w/w to approximately 7.0% w/w of a first antibacterial component identified herein and from approximately 0.3% w/w to approximately 3% w/w, approximately 0.5% w/w to approximately 2.5% w/w, approximately 1.0% w/w to approximately 9.0% w/w, approximately 2.0% w/w to approximately 8.0% w/w, approximately 3.0% w/w to approximately 7.0% w/w, or from approximately 4.0% w/w to approximately 7.0% w/w of a second antibacterial component identified herein. For example, the topical composition may comprise mupirocin and tobramycin, mupirocin and doxycycline, mupirocin and doxycycline hyclate, mupirocin and azithromycin, or mupirocin, doxycycline, and ketoconazole.
In one example, the topical composition comprises from approximately 0.3% w/w to approximately 3% w/w, approximately 0.5% w/w to approximately 2.5% w/w, approximately 1.0% w/w to approximately 9.0% w/w, approximately 2.0% w/w to approximately 8.0% w/w, approximately 3.0% w/w to approximately 7.0% w/w, or from approximately 4.0% w/w to approximately 7.0% w/w of an antifungal component identified herein and from approximately 0.3% w/w to approximately 3% w/w, approximately 0.5% w/w to approximately 2.5% w/w, approximately 1.0% w/w to approximately 9.0% w/w, approximately 2.0% w/w to approximately 8.0% w/w, approximately 3.0% w/w to approximately 7.0% w/w, or from approximately 4.0% w/w to approximately 7.0% w/w of an antibacterial component identified herein. For example, the antibacterial component may comprise doxycycline, tobramycin, ciprofloxacin, mupirocin, or combination thereof and the antifungal component may comprise ketoconazole, itraconazole, voriconazole, or combination thereof.
In some embodiments, the topical composition may comprise one or more excipients or additives. In an aspect, excipients or additives include, but are not limited to, the following: solvents, surfactants, humectants, preservatives, flavorings, stabilizers (including antioxidants), binders, and colorants.
In various embodiments, the topical composition comprises the antibacterial component alone or in combination with one or more additional active agents selected from an antifungal component, an antiviral agent, an anti-inflammatory agent, an non-steroidal anti-inflammatory (NSAID) agent, an anti-allergic agent, an antimicrobial agent, an anti-depressant agent, a stimulant agent, a disinfectant agent, an anticonvulsant agent, a local anesthetic agent, or combinations thereof, which may include one or more active pharmaceutical drugs of selected components or agents. In one embodiment, the topical composition includes additional active agents selected from one or more anticonvulsants, nerve depressants, muscle relaxants, NMDA (N-Methyl-D-aspartate) receptor antagonists, opiate or opioid agonists, antidepressants, and/or other active agents. In some embodiments, the topical composition may comprise the antibacterial component alone or in combination with an antifungal component, steroid agent, antiviral component, NSAID agent, antidepressant agent, anticonvulsant agent, analgesic agent, opioid agent, keratolytic agent, or combination thereof, which may include one or more active pharmaceutical drugs of selected components or agents. In various embodiments, the topical composition may comprise the antibacterial component alone or in combination with one or more antifungal components.
As introduced above, the topical composition may comprise one or more additional active agents. It will be appreciated that topical compositions herein may include or specifically exclude additional active agents. It will also be appreciated that topical compositions may exclude an antimicrobial agent and rather include one or more of the additional active agents described herein.
In various embodiments, the topical composition comprises the antimicrobial agent and a nonsteroidal anti-inflammatory drug (NSAID) agent. The NSAID agent may include one or more NSAIDS selected from oxicams, such as meloxicam or piroxicam; salicylic acid derivatives, such as aspirin, diflunisal, salsalate, or trilisate; propionic acids, such as flurbiprofen, ibuprofen, ketoprofen, naproxen, or oxaprozin; acetic acids, such as diclofenac, etodolac, indomethacin, ketorolac, nabumetone, sulindac, or tolmetin; fenamates, such as meclofenamate; and/or COX-2 inhibitors, such as celecoxib, rofecoxib, or valdecoxib. In various embodiments, the topical composition may comprise between approximately 0.01% and approximately 20% by weight NSAID agent.
In some embodiments, the topical composition comprises the antimicrobial agent and a local anesthetic agent. The local anesthetic agent may be selected from lidocaine, prilocaine, benzocaine, or combination thereof. The local anesthetic agent may comprise between approximately 0.01% and approximately 15% by weight of the topical composition.
In an embodiment, the topical composition comprises the antimicrobial agent a steroid agent. In one example, the steroid agent comprises a corticosteroid selected from amcinonide, betamethasone dipropionate, betamethasone valerate, clobetasol propionate, desoximetasone, diflorasone diacetate, flurandrenolide, fluticasone propionate, fluocinonide, halcinonide, halobetasol propionate, mometasone furoate, triamcinolone acetonide, or combination thereof. In various embodiments, the topical composition comprises between approximately 0.001% and approximately 1% by weight steroid agent.
In various embodiments, the topical composition comprises the antimicrobial agent and a muscle relaxant agent comprising one or more muscle relaxants selected from baclofen, carisoprodol, chlorzoxazone, cyclobenzaprine, dantrolene, diazepam, metaxalone, methocarbamol, orphenadrine, quinine sulfate, tizanidine, and/or other muscle relaxants. In various embodiments, the topical composition comprises between approximately 0.001% and approximately 5% by weight muscle relaxant agent.
In some embodiments, the topical composition comprises the antimicrobial agent and an anticonvulsant or nerve depressant agent. The anticonvulsant or nerve depressant agent may comprise one or more nerve depressants and/or anticonvulsants selected from gabapentin, topiramate, lamotrigine, or combinations thereof. In various embodiments, the anticonvulsant or nerve depressant agent may comprise between approximately 0.01% and approximately 20% by weight of the topical composition.
In one embodiment, the topical composition comprises the antimicrobial agent and a NMDA receptor antagonist agent such as ketamine. In some embodiments, the topical composition may comprise an opiate or opioid agonist agent selected from tramadol; one or more C2 opiate agonists selected from oxycodone, morphine, methadone, hydromorphone, and fentanyl; one or more C3 opiate agonists selected from hydrocodone, codeine, propoxyphene, butalbital, and pentazocine; or any combination thereof.
In an embodiment, the topical composition comprises the antimicrobial agents a keratolytic agent selected form urea, salicylic acid, papain, or combinations thereof. For example, the topical composition may comprise the antimicrobial agent and urea. In various embodiments, the topical composition may comprise between approximately 1% and approximately 30% by weight urea.
The topical composition may be provided in a topical format, which may include a carrier for topical administration. In various embodiments, the topical composition may include a colloid or emulsion (o/w, w/o), cream, lotion, ointment, foam, aqueous or non-aqueous gel, aqueous or non-aqueous solution, which may include a dispersion, powder, nail lacquer, bath, or paste.
The topical composition may be administered topically by contacting an external surface of the body, which may include skin, e.g., intact, wounded, broken skin; nails; mucosal tissue lining a vaginal or anal orifice. The topical composition may be administered in a spray, coating, soak, powder, spread, or the like, for example, suitable to the topical format.
In some embodiments, the topical composition comprises a nail lacquer for direct application to nail tissue. A nail lacquer format may include one or more antimicrobial actives formulated for topical application to nail tissue. In some embodiments, a nail lacquer format may include additives such as thickening agents, plasticizers, polymers, volatile organic compounds, or other additives to promote effective localization of the medication following application. In some embodiments, a nail lacquer format may comprise a solution, which may be a suspension or mixture. In some embodiments, a nail lacquer format may lack traditional lacquer additives. In various embodiments, a nail lacquer format may comprise an aqueous solution formulated for application to a nail surface whereon the carrier evaporates or is absorbed. In some embodiments, a nail lacquer solution may have a fluid or semi-fluid consistency. In some embodiments, a carrier for a nail lacquer format may be thickened with a viscosity agent to increase viscosity for administration. In some embodiments, a nail lacquer format may comprise a solution comprising a cream, lotion, gel, or ointment.
Further to the above, in some embodiments, the topical composition comprises a treatment solution for a footbath, irrigation, or spray administration.
In various embodiments, the topical composition comprises an antimicrobial agent comprising an antifungal component comprising at least two antifungal pharmaceutical drugs, an antibacterial component comprising at least two antibacterial pharmaceutical drugs, or an antifungal component comprising one or more antifungal pharmaceutical drugs and an antibacterial component comprising one or more antibacterial pharmaceutical drugs.
In one example, the topical composition comprises mupirocin and/or azithromycin and an antifungal component selected from abafungin, albaconazole, amorolfin, amphotericin b, anidulafungin, bifonazole, butenafine, butoconazole, candicidin, caspofungin, ciclopirox, clotrimazole, econazole, fenticonazole, filipin, fluconazole, flucytosine, griseofulvin, haloprogin, hamycin, isavuconazole, isoconazole, itraconazole, ketoconazole, micafungin, miconazole, naftifine, natamycin, nystatin, omoconazole, oxiconazole, polygodial, posaconazole, ravuconazole, rimocidin, sertaconazole, sulconazole, terbinafine, terconazole, tioconazole, tolnaftate, undecylenic acid, voriconazole, or a combination thereof. The antifungal component may comprise itraconazole and/or fluconazole, for example. In one embodiment, the topical composition comprises mupirocin and itraconazole, mupirocin and nystatin, or azithromycin and fluconazole. In another example, the topical composition comprises mupirocin and/or azithromycin and an additional antibacterial pharmaceutical drug identified herein.
In another example, the topical composition comprises an antifungal component including itraconazole and a second, different, antimicrobial pharmaceutical drug. For example, the topical composition may comprise an antibacterial component comprising the second antimicrobial pharmaceutical drug that includes one or more antibacterial pharmaceutical drugs selected from afenide, amikacin, amoxicillin, ampicillin, arsphenamine, azithromycin, azlocillin, aztreonam, bacampicillin, bacitracin, carbacephem (loracarbef), carbenicillin, cefaclor, cefadroxil, cefalotin, cefamandole, cefazolin, cefdinir, cefditoren, cefepime, cefixime, cefoperazone, cefotaxime, cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, ceftizoxime, ceftobiprole, ceftriaxone, cefuroxime, cephalexin, chloramphenicol, chlorhexidine, ciprofloxacin, clarithromycin, clavulanic acid, clindamycin, cloxacillin, colimycin, colistimethate teicoplanin, colistin, demeclocycline, dicloxacillin, dirithromycin, doripenem, doxycycline, efprozil, enoxacin, ertapenem, erythromycin, ethambutol, flucloxacillin, fosfomycin, furazolidone, gatifloxacin, geldanamycin, gentamicin, grepafloxacin, herbimycin, imipenem, isoniazid, kanamycin, levofloxacin, lincomycin, linezolid, lomefloxacin, meropenem, meticillin, metronidazole, mezlocillin, minocycline, mitomycin, moxifloxacin, mupirocin, nafcillin, neomycin, netilmicin, nitrofurantoin, norfloxacin, ofloxacin, oxacillin, oxytetracycline, paromomycin, penicillin G, penicillin V, piperacillin, pivmecillinam, platensimycin, polymyxin B, prontosil, pvampicillin, pyrazinamide, quinupristin/dalfopristin, rifampicin, rifampin, roxithromycin, sparfloxacin, spectinomycin, spiramycin, sulbactam, sulfacetamide, sulfamethizole, sulfamethoxazole, sulfanilimide, sulfisoxazole, sulphonamides, sultamicillin, telithromycin, tetracycline, thiamphenicol, ticarcillin, tobramycin, trimethoprim, trimethoprim-sulfamethoxazole, troleandomycin, trovafloxacin, or a combination thereof. In another example, the topical composition comprises an antifungal component including itraconazole and a second, different, antimicrobial pharmaceutical drug, comprising an additional antifungal pharmaceutical drug selected from an azole. In one example, the azole includes clotrimazole, econazole, fluconazole, isoconazole, ketoconazole, voriconazole, or combination thereof. In another example, the additional antifungal pharmaceutical drug is selected from antimetabolites, allylamines, morpholine, glucan synthesis inhibitors (echinocandins), polyenes, benoxaaborale; other antifungal/onychomycosis agents, and new classes of antifungal/onychomycosis agents. In another example, the additional antifungal pharmaceutical drug is selected from abafungin, albaconazole, amorolfin, anidulafungin, bifonazole, butenafine, butoconazole, candicidin, caspofungin, ciclopirox, fenticonazole, filipin, flucytosine, griseofulvin, haloprogin, hamycin, isavuconazole, micafungin, miconazole, naftifine, natamycin, omoconazole, oxiconazole, polygodial, posaconazole, ravuconazole, rimocidin, sertaconazole, sulconazole, terbinafine, terconazole, tioconazole, undecylenic acid, or a combination thereof. In another example, the additional antifungal pharmaceutical drug is selected from amphotericin b, nystatin, tolnaftate, or combination thereof.
In some embodiments, medication transfer system may be utilized to treat infections associated with MRSA, a Candida, such as Candida albicans, Candida auris, Candida glabrata, Candida krusei, or Candida tropicalis may include topically applying the topical composition to target skin or mucosal surface. In some examples, the antimicrobial agent may comprise an antifungal component comprising an azole. In one example, the antifungal component comprises itraconazole. In a further example, the topical composition comprises itraconazole oral solution. In a further example, the topical composition comprises itraconazole oral solution and a carrier, such as a diluent or base for compounding. The topical composition may also include one or more additional antifungal active drugs, an antibacterial component, and/or one or more additional active agents.
In some embodiments, the medication comprises a commercially available
In one embodiment, the medication comprises a commercially available Itraconazole Oral Solution or Levofloxacin Oral Solution. For example, Itraconazole Oral Solution may contain 10 mg of itraconazole per mL, solubilized by hydroxypropyl-β-cyclodextrin (400 mg/mL) as a molecular inclusion complex and may have a target pH of 2. Accordingly, the solution may have a low pH of approximately 2. Other ingredients may include hydrochloric acid, propylene glycol, purified water, sodium hydroxide, sodium saccharin, sorbitol, cherry flavor, and caramel flavor. It will be appreciated that oral solutions comprising other flavorings may also be used if they become available. Similarly, other pH adjusting agents may also be used if they become available. Levofloxacin oral solution, which is available in the United States in 25 mg/mL strength formulations. Such oral solutions also include inactives such as vehicles, solvents, stabilizers, coloring agents, or flavoring agents. In one example, levofloxacin oral solution contains, in addition to levofloxacin, artificial and natural flavors, ascorbic acid, benzyl alcohol, caramel color, glycerin, hydrochloric acid, propylene glycol, purified water, sucralose and sucrose. As another example, levofloxacin oral solution contains the following inactive ingredients: artificial bubble gum flavor, artificial grape flavor, ascorbic acid, benzyl alcohol, glycerin, hydrochloric acid, PFC Bitter Mask F9885, propylene glycol, purified water, saccharin sodium, and sucrose. Sodium hydroxide may be used to adjust pH (between approximately 5.0 to approximately 6.0). Levofloxacin is also currently administered parenterally via intravenous injection. Levofloxacin for injection is commercially available in various strengths and volumes. For example, levofloxacin for injection is currently available in 500 mg/20 mL strength, 20 mL volume single use container, and in 250 mg/50 mL strength, 50 mL, 100 mL, and 150 mL single-use containers. Additional active agents may include one or more antifungal actives, antibacterial actives, or both. Such additional antifungal component may be present in a combined amount between approximately 0.01% and approximately 20% by weight, such as between approximately 0.01% and approximately 5%, approximately 0.01% and approximately 2% by weight, approximately 0.05% and approximately 2%, approximately 0.1% and approximately 2%, approximately 0.5% and approximately 2%, approximately 1% and approximately 2%, approximately 2% and approximately 7%, or approximately 0.05%, approximately 0.1%, approximately 0.5%, approximately 1%, approximately 2%, approximately 3%, approximately 4%, approximately 5%, less than approximately 5%, or greater than approximately 10% itraconazole by weight. The medication may include itraconazole, e.g., itraconazole oral solution, and an antibacterial component comprising the second antimicrobial pharmaceutical drug selected from afenide, amikacin, amoxicillin, ampicillin, arsphenamine, azithromycin, azlocillin, aztreonam, bacampicillin, bacitracin, carbacephem (loracarbef), carbenicillin, cefaclor, cefadroxil, cefalotin, cefamandole, cefazolin, cefdinir, cefditoren, cefepime, cefixime, cefoperazone, cefotaxime, cefoxitin, cefpodoxime, cefprozil, ceftazidime, ceftibuten, ceftizoxime, ceftobiprole, ceftriaxone, cefuroxime, cephalexin, chloramphenicol, chlorhexidine, ciprofloxacin, clarithromycin, clavulanic acid, clindamycin, cloxacillin, colimycin, colistimethate teicoplanin, colistin, demeclocycline, dicloxacillin, dirithromycin, doripenem, doxycycline, efprozil, enoxacin, ertapenem, erythromycin, ethambutol, flucloxacillin, fosfomycin, furazolidone, gatifloxacin, geldanamycin, gentamicin, grepafloxacin, herbimycin, imipenem, isoniazid, kanamycin, levofloxacin, lincomycin, linezolid, lomefloxacin, meropenem, meticillin, metronidazole, mezlocillin, minocycline, mitomycin, moxifloxacin, mupirocin, nafcillin, neomycin, netilmicin, nitrofurantoin, norfloxacin, ofloxacin, oxacillin, oxytetracycline, paromomycin, penicillin G, penicillin V, piperacillin, pivmecillinam, platensimycin, polymyxin B, prontosil, pvampicillin, pyrazinamide, quinupristin/dalfopristin, rifampicin, rifampin, roxithromycin, sparfloxacin, spectinomycin, spiramycin, sulbactam, sulfacetamide, sulfamethizole, sulfamethoxazole, sulfanilimide, sulfisoxazole, sulphonamides, sultamicillin, telithromycin, tetracycline, thiamphenicol, ticarcillin, tobramycin, trimethoprim, trimethoprim-sulfamethoxazole, troleandomycin, trovafloxacin, or a combination thereof.
Additionally or alternatively, additional actives may include other active agents such as one or more active agents selected from an antiviral agent, an anti-inflammatory agent, a steroid, an anti-allergic agent, an antidepressant agent, a stimulant agent, a disinfectant agent, an anticonvulsant agent, a local anesthetic agent, an anticonvulsant agent, a nerve depressant agent, a muscle relaxant agent, a NMDA (N-Methyl-D-aspartate) receptor antagonist agent, an opiate or opioid agonist agent, an NSAID agent, an analgesic agent, a keratolytic agent, or combination thereof. Such additional active agents may be present in a combined amount between approximately 0.01% and approximately 25% by weight, such as between approximately 1% and approximately 10%. The topical composition including the medication comprising itraconazole may be utilized as part of a treatment of a microbial infection. In one example, the topical composition may be topically administered to infected skin forming the outer body covering of a subject or to mucosal tissue of the vagina or anus to treat a microbial infection. For example, the topical composition may comprise a solution or suspension for topical administration in a hand or footbath or by irrigation. In another example, the topical composition comprises a nail lacquer for administration to nails. In some embodiments, the topical composition may be utilized as a wound treatment and administered to broken or unbroken skin or mucosal tissue as indicated above and elsewhere herein.
In an example, the antimicrobial agent includes an antifungal component comprising fluconazole and the method of formulating the topical composition comprises combining a carrier and a commercially available fluconazole, such as Fluconazole in Dextrose Injection Solution; Fluconazole in Sodium Chloride Injection Solution, Ketoconazole Suspension, Clotrimazole Liquid, Voriconazole Oral Suspension, ciprofloxacin, such Ciprofloxacin Hydrochloride Solution/Drops; Ciprofloxacin Hydrochloride Suspension; Azithromycin for Oral Suspension, USP, which may be supplied for suspension in 100 mg/5 mL or 200 mg/5 mL; Clindamycin Phosphate Suspension; Clindamycin Phosphate Injection Solution; Cefepime Hydrochloride Injection Solution; Sulfamethoxazole and Trimethoprim Suspension; Ciprofloxacin Cream, Ciprofloxacin Ointment, Clindamycin Cream, Clindamycin Ointment, Clindamycin Gel, Gentamycin drops, Gentamycin Spray, Gentamycin Cream, Gentamycin Ointment, Levofloxacin Injection Solution, Levofloxacin Drops, Mupirocin Ointment, Mupirocin Cream, Tobramycin Ophthalmic Ointment, Tobramycin Ophthalmic Drops, and/or Tobramycin Otic Drops, linezolid oral suspension; 2% erythromycin solution.
In an aspect, transfer or dosage volume may include between approximately 1 mg and approximately 2000 mg, such as between approximately 100 mg and approximately 1000 mg, approximately 250 mg and approximately 750 mg, approximately 250 mg and approximately 500 mg, or approximately 750 mg levofloxacin in a dosage volume. According to various embodiments, a dosage volume may be approximately 20 mL to approximately 4 L, such as approximately 30 mL to approximately 2 L, approximately 40 mL to approximately 1.5 L, or approximately 40 mL to approximately 1 L. Dosage volumes greater than 4 L may also be used, e.g. greater than 5 L, greater than 10 L, greater than 15 L, or greater than 20 L. In an aspect, transfer or dosage volume may include between approximately 0.01 mg/mL and approximately 24 mg/mL levofloxacin, such as approximately 0.5 mg/mL and approximately 2 mg/mL, approximately 1 mg/mL and approximately 10 mg/mL, approximately 5 mg/mL and approximately 13 mg/mL, or approximately 10 mg/mL and approximately 20 mg/mL. In an aspect, the treatment solution may include greater than a 25 mg/mL levofloxacin concentration. In an aspect, tobramycin may be substituted for levofloxacin.
In an aspect, a transfer or dosage volume may include between approximately 10 mg and approximately 300 mg, such as between approximately 40 mg and approximately 250 mg, approximately 50 mg and approximately 200 mg, approximately 50 mg and approximately 125 mg, approximately 150 mg and approximately 200 mg itraconazole in a dosage volume. In an aspect, a transfer or dosage volume for a small treatment area may contain between approximately 1 mg and approximately 30 mg, such as between approximately 5 mg and approximately 25 mg, approximately 10 mg and approximately 25 mg, approximately 10 mg and approximately 25 mg, approximately 15 mg and approximately 20 mg itraconazole in a dosage volume.
In various embodiments, transfer or dosage volume may include itraconazole oral solution, 10 mg/mL, alone or with a diluent, wherein the itraconazole oral solution is in an amount between approximately 1 mL and approximately 25 mL in a dosage volume. For example, the amount of itraconazole oral solution in a dosage volume may be between approximately 1 mL and approximately 3 mL, approximately 3 mL and approximately 25 mL, approximately 5 mL and approximately 20 mL, approximately 5 mL and approximately 10 mL, approximately 10 mL and approximately 20 mL, approximately 15 mL and approximately 25 mL, or greater than approximately 1 mL, approximately 2 mL, approximately 5 mL, approximately 10 mL, approximately 15 mL, approximately 20 mL, or less than approximately 25 mL.
According to various embodiments, a dosage volume may be between approximately 20 mL and approximately 4 L, such as approximately 30 mL and approximately 2 L, approximately 40 mL and approximately 1.5 L, or approximately 40 mL and approximately 1 L. Dosage volumes greater than 4 L may also be used, e.g. greater than 5 L, greater than 10 L, greater than 15 L, or greater than 20 L. In some embodiments, a dosage volume for a small treatment area may comprise between approximately 1 mL and approximately 5 mL, such as approximately 1 mL and approximately 4 mL, approximately 1 mL and approximately 3 mL, approximately 2 mL and approximately 5 mL, approximately 2 mL and approximately 3 mL, or between approximately 3 mL and approximately 5 mL. A transfer volume may be added to a diluent to obtain a full dosage volume including diluent.
In an aspect, a transfer or dosage volume may include between approximately 0.01 mg/mL and approximately 9.5 mg/mL itraconazole, such as between approximately 0.5 mg/mL and approximately 9 mg/mL, approximately 1 mg/mL and approximately 8 mg/mL, approximately 2 mg/mL and approximately 7 mg/mL, or approximately 10 mg/mL and approximately 20 mg/mL. In an embodiment, the treatment solution may include greater than a 10 mg/mL itraconazole concentration. In one embodiment, itraconazole is replaced with tobramycin.
This specification has been written with reference to various non-limiting and non-exhaustive embodiments. However, it will be recognized by persons having ordinary skill in the art that various substitutions, modifications, or combinations of any of the disclosed embodiments (or portions thereof) may be made within the scope of this specification. Thus, it is contemplated and understood that this specification supports additional embodiments not expressly set forth in this specification. Such embodiments may be obtained, for example, by combining, modifying, or reorganizing any of the disclosed steps, components, elements, features, aspects, characteristics, limitations, and the like, of the various non-limiting and non-exhaustive embodiments described in this specification.
Various elements described herein have been described as alternatives or alternative combinations, e.g., in a lists of selectable actives, ingredients, or compositions. It is to be appreciated that embodiments may include one, more, or all of any such elements. Thus, this description includes embodiments of all such elements independently and embodiments including such elements in all combinations.
The grammatical articles “one”, “a”, “an”, and “the”, as used in this specification, are intended to include “at least one” or “one or more”, unless otherwise indicated. Thus, the articles are used in this specification to refer to one or more than one (i.e., to “at least one”) of the grammatical objects of the article. By way of example, “a component” means one or more components, and thus, possibly, more than one component is contemplated and may be employed or used in an application of the described embodiments. Further, the use of a singular noun includes the plural, and the use of a plural noun includes the singular, unless the context of the usage requires otherwise. Additionally, the grammatical conjunctions “and” and “or” are used herein according to accepted usage. By way of example, “x and y” refers to “x” and “y”. On the other hand, “x or y” refers to “x”, “y”, or both “x” and “y”, whereas “either x or y” refers to exclusivity.
Any numerical range recited herein includes all values and ranges from the lower value to the upper value. For example, if a concentration range is stated as 1% to 50%, it is intended that values such as 2% to 40%, 10% to 30%, 1% to 3%, or 2%, 25%, 39% and the like, are expressly enumerated in this specification. These are only examples of what is specifically intended, and all possible combinations of numerical values and ranges between and including the lowest value and the highest value enumerated are to be considered to be expressly stated in this application. Numbers modified by the term “approximately” are intended to include +/−10% of the number modified.
