Patent Grant
8967374
The present invention relates to delivery devices and related methods, and more particularly, to delivery devices including first chambers for containing medicaments or other desired substances and second chambers for containing beverages or other desired substances that are connectable in fluid communication with respective first chambers when ready for use to mix the medicaments and beverages or other desired substances prior to delivery, and to related methods of making and using same.
Optimized pH and local enzymatic metabolisms (e.g., metabolizing and transporting enzymes) can be critical to the absorption and activity of a specific drug or medicament. It is well known that drug metabolizing and drug transporting enzymes can be enhanced or inhibited within the lining of the gut wall. For example, it has been shown that grapefruit can inhibit the absorption of many drugs up to 8 to 12 hours after intake. Similarly, milk has been shown to reduce absorption and transportation of some antibiotics. Many foods likewise decrease the rate of absorption of acetaminophen and thereby reduce its analgesic affect. However, some beverages have been known to speed up the rate of absorption of acetaminophen and thereby increase its analgesic affect.
Many drugs or medicaments are not well tolerated when administered enterally. For example, aspirin, ibuprofen, and naproxen are known to irritate the stomach. In order address these problems, physicians may recommend that certain drugs be taken with food to improve tolerance. However, each drug has a specific pH of absorption, and the food intake recommended by a physician for improving tolerance can significantly alter the absorption, transport and/or bioavailability of the drug. For example, high fiber foods may bind to a drug and prevent its absorption. If the coating on a tablet or capsule is not subject to the appropriate environment, it may not dissolve as intended, thus causing the drug within the tablet or capsule, or a significant portion thereof, to pass directly to the feces. On the other hand, particularly in children, diarrhea may speed up the dissolution of tablets or capsules, and may thereby prevent the drug from achieving an expected therapeutic effect.
Although it would be desirable to mix drugs and beverages in the same packages or dispensers in order to enhance drug tolerance, and/or to enhance drug absorption, transport and/or bioavailability, many such drug/beverage combinations are not believed to be shelf stable, and/or are not approved for combination by the United States Food and Drug Administration (“FDA”) or other applicable regulatory agencies.
Many reconstitution packages have been made in different fields of use, including pharmaceuticals. A typical reconstitution package allows the manufacturer to fill two different active ingredients in different compartments of a common package such that each compartment is approved for stability of the respective ingredient. This can be a significant advantage where the two active ingredients are not shelf stable when combined. Typically, the user mixes or “reconstitutes” the two active ingredients immediately prior to ingestion. The present inventor is not aware of any reconstitution packages including a drug or medicament in one compartment and a food or beverage in another compartment. One possible reason for this is that drugs, on the one hand, and foods and beverages, on the other hand, are subject to different regulatory requirements, such as those imposed by the FDA. Foods and beverages are frequently enriched solutions or suspensions, and in many cases have low levels of acidity, and thus frequently provide excellent media for bacterial and/or yeast growth. As a result, the FDA and other applicable regulatory agencies impose limited shelf life and period of use restrictions on such food and beverage products unless they are terminally sterilized. Terminal sterilization typically involves the application of radiation, such as gamma or ebeam radiation, or the application of heat, such as by retort. For many drugs, however, terminal sterilization is not possible because it would either destroy or damage the active ingredients. Accordingly, typically there are substantial differences between the aseptic processes and equipment used to manufacture drugs in comparison to those for foods and beverages. Similarly, there can be substantial differences in the FDA and other applicable regulations for the manufacture of drugs in comparison to those for foods and beverages.
Accordingly, it is an object of the present invention to overcome one or more of the above described drawbacks and/or disadvantages of the prior art.
In accordance with one aspect, the present invention is directed to a device comprising a body defining at least one first chamber for receiving therein a first substance, and at least one second chamber for receiving therein a second substance. In accordance with some embodiments of the present invention, the first substance is a drug or medicament, and the second substance is a food and/or beverage. A first sealing portion of the device is located between the first and second chambers and is movable between a closed position preventing fluid communication between the first and second chambers, and an open position permitting fluid communication between the first and second chambers for mixing the first and second substances when ready for use. A first penetrable and thermally resealable portion is in fluid communication with the first chamber, and is penetrable by an injection member to form an injection aperture therethrough and introduce the first substance through the injection member and into the first chamber, and is thermally resealable to seal the injection aperture and the first substance within the first chamber by applying energy thereto. A second penetrable and thermally resealable portion is in fluid communication with the second chamber, and is penetrable by an injection member to form an injection aperture therethrough and introduce the second substance through the injection member and into the second chamber, and is thermally resealable to seal the injection aperture and the second substance within the second chamber by applying energy thereto.
In one embodiment of the present invention, the device further comprises at least one dispensing port in fluid communication with at least one of the first and second chambers, and a sealing member movable between a closed position sealing the dispensing port, and an open position allowing the first and second substances to flow through the dispensing port. In one such embodiment, the dispensing port is frangibly connected to the body.
In one embodiment of the present invention, the body includes at least one substantially flexible portion defining at least one of the first and second chambers. In one such embodiment, the body includes a first substantially flexible portion, a second substantially flexible portion, at least one peripheral sealing portion extending between the first and second flexible portions and forming a fluid-tight seal therebetween, and at least one second sealing portion extending between the first and second flexible portions and substantially preventing fluid communication between the first and second chambers. In one such embodiment, the first sealing portion is formed within the second sealing portion. In one such embodiment, the first sealing portion is formed by a relatively weak sealing region of the second sealing portion. In one embodiment, the first sealing portion is defined by a frangible portion of the second sealing portion that is breakable in response to pressure in the first chamber and/or second chamber exceeding a substantially predetermined threshold pressure. In one such embodiment, the frangible portion is breakable by manually engaging and squeezing a flexible portion of the body. Preferably, the first sealing portion is selected from the group including (i) a frangible portion, (ii) a sealing portion defining a reduced seal thickness in comparison to contiguous sealing portions, (iii) a relatively weak wall portion, and (iv) a stopper received within an aperture connectable in fluid communication between the first and second chambers.
In one embodiment of the present invention, the body further defines at least one third sealing portion preventing fluid communication therethrough and extending between the first and second substantially flexible portions. The third sealing portion defines at least one of (i) a plurality of first chambers located on opposite sides of the third sealing portion relative to each other, and (ii) a plurality of second chambers located on opposite sides of the third sealing portion relative to each other. Preferably, the device defines a plurality of delivery devices, wherein each delivery device includes a respective first chamber, a respective second chamber, and a respective first sealing portion. In one such embodiment, the device further comprises a plurality of separable portions located between adjacent delivery devices for manually engaging and separating one delivery device from the other. Preferably, each separable portion is selected from the group including (i) a frangible portion, (ii) a sealing portion defining a reduced seal thickness in comparison to contiguous sealing portions, and (iii) a relatively weak wall portion. Preferably, each device further includes a dispensing port in fluid communication with the first and/or second chambers, and a fourth sealing member movable between a closed position sealing the respective dispensing port, and an open position allowing the first and second substances to flow through the respective dispensing port.
In some embodiments of the present invention, the first and/or second penetrable and thermally resealable portions are formed by one or more stoppers located on the body. Preferably, the stopper is coupled to the body by one or more of (i) co-molding the stopper and body, (ii) over-molding the stopper and/or body to the other, (iii) thermally sealing the stopper and/or body to the other, and (iv) adhesively attaching the stopper and/or body to the other.
In some embodiments of the present invention, the first chamber includes therein a medicament, and the second chamber includes therein a food and/or beverage. In one such embodiment, the food and/or beverage is non-medicated. In some such embodiments, the first and/or second chambers are substantially airless and/or are hermetically sealed with respect to the ambient atmosphere. Preferably, the form of the medicament is selected from the group including (i) a liquid, (ii) a powder, (iii) a gel, (iv) nano particles, and (v) gelules; and the form of the food and/or beverage is selected from the group including a liquid and a gel.
In some embodiments of the present invention, the first chamber includes therein a medicament and the second chamber includes therein a food and/or beverage. The food and/or beverage defines one or more of (i) a substantially predetermined pH selected to control at least one of absorption, residence time, transport and bioavailability of the medicament in a mammal, (ii) at least one predetermined medicament metabolizing enzyme, (iii) at least one predetermined medicament transporting enzyme, (iv) at least one predetermined flavor, and (v) a predetermined viscosity of the beverage combined with the medicament. In some such embodiments, the food and/or beverage (i) defines a substantially predetermined pH selected to control absorption of the medicament in a target tissue of a mammal, and/or (ii) is selected to substantially coat intestinal mucosa of a mammal to enhance tolerance and/or reduce irritability of the medicament.
In accordance with another aspect, the present invention is directed to a medicament delivery device comprising a body defining at least one first chamber including therein a medicament, and at least one second chamber including therein a food and/or beverage. A first sealing portion is located between the first and second chambers and is movable between a closed position preventing fluid communication between the first and second chambers, and an open position permitting fluid communication between the first and second chambers for mixing the medicament and the food and/or beverage when ready for use. A dispensing port is in fluid communication with the first and/or second chambers, and a sealing member is movable between a closed position sealing the dispensing port, and an open position allowing the medicament and the food and/or beverage to flow through the dispensing port.
In some embodiments of the present invention, the food and/or beverage defines one or more of (i) a substantially predetermined pH selected to control the absorption, residence time, transport and/or bioavailability of the medicament in a mammal, (ii) at least one predetermined medicament metabolizing enzyme, (iii) at least one predetermined medicament transporting enzyme, (iv) at least one predetermined flavor, and (v) a predetermined viscosity of the food and/or beverage combined with the medicament. In some such embodiments, the food and/or beverage (i) defines a substantially predetermined pH selected to control absorption of the medicament in a target tissue of a mammal, and/or (ii) is selected to substantially coat intestinal mucosa of a mammal to enhance tolerance of the medicament by, and/or reduce irritability of the medicament to, the mammal.
Preferably, the device further comprises a first penetrable and thermally resealable portion in fluid communication with the first chamber that is penetrable by an injection member to form an injection aperture therethrough, and introduce the first substance through the injection member and into the first chamber, and is thermally resealable to seal the injection aperture and the first substance within the first chamber by applying energy thereto. The device preferably further comprises a second penetrable and thermally resealable portion in fluid communication with the second chamber that is penetrable by an injection member to form an injection aperture therethrough, and introduce the second substance through the injection member and into the second chamber, and is thermally resealable to seal the injection aperture and the second substance within the second chamber by applying energy thereto. In some such embodiments, each of the first and second penetrable and thermally resealable portions is needle penetrable and laser resealable, and includes a thermoplastic that is pierceable with a needle to form a needle aperture therethrough, and is laser resealable to hermetically seal the needle aperture by applying laser radiation at a predetermined wavelength and power thereto.
In accordance with another aspect, the present invention is directed to a method comprising the following steps:
In one embodiment of the present invention, the method further comprises the step of delivering a combination of a medicament and a food and/or beverage when ready for use by (i) moving the first sealing portion between a closed position and an open position and, in turn, placing the first chamber in fluid communication with the second chamber and mixing the medicament and the food and/or beverage, and (ii) moving the sealing member from the closed to the open position, and delivering the combination of the medicament and the food and/or beverage through the dispensing port.
In some embodiments of the present invention, the method further comprises forming at least one wall defining at least a portion of the first and/or second chambers of a flexible material, manually pressing the flexible material and causing the medicament and/or the food and/or beverage to exceed a threshold pressure that, in turn, causes the first sealing portion to move from a closed position to an open position.
In some embodiments of the present invention, the method further comprises the step of selecting the food and/or beverage to define one or more of (i) a substantially predetermined pH to control absorption, residence time, transport and/or bioavailability of the medicament in a mammal, (ii) at least one predetermined medicament metabolizing enzyme, (iii) at least one predetermined medicament transporting enzyme, (iv) at least one predetermined flavor, and (v) a predetermined viscosity of the beverage combined with the medicament. In some such embodiments, the method further comprises the step of selecting the food and/or beverage to define (i) a substantially predetermined pH to control absorption of the medicament in a target tissue of a mammal, and/or (ii) to substantially coat intestinal mucosa of a mammal to enhance tolerance of the medicament by, and/or reduce irritability of the medicament to, the mammal. In some such embodiments, the method further comprises the step of selecting the food and/or beverage based on the respective medicament to define a pH selected to achieve a substantially predetermined rate of absorption of the respective medicament in a mammal, a substantially predetermined residence time of the respective medicament in the stomach of the mammal, and a substantial tolerance of the respective medicament by the mammal.
In some embodiments of the present invention, the method further comprises forming the body of the device by providing first and second flexible sheets, and sealing at least one of the first and second flexible sheets to the other to define the first and second chambers therebetween. Preferably, the method further comprises filling the first and second chambers through the penetrable and thermally resealable portions, opposing pressing portions of the first and/or second sheets toward the other and, in turn, forming a plurality of first chambers located on opposite sides of the pressed portion relative to each other, and a plurality of second chambers located on opposite sides of the pressed portion relative to each other, and then sealing the pressed opposing portions to, in turn, prevent fluid communication between adjacent chambers. In one such embodiment, the method further comprises orienting the sheets substantially vertically during the stop of pressing. Preferably, the method further comprises substantially evenly distributing the filled medicament in adjacent first chambers, and the filled food and/or beverage in adjacent second chambers.
In some embodiments of the present invention, the method further comprises removing the penetrable and thermally resealable portions from the device after filling the first and second chambers therethrough.
One advantage of the currently preferred embodiments of the present invention is that the food and/or beverage can be selected to enhance or optimize the desired absorption and/or activity of the respective medicament. For example, the food and/or beverage can be selected to coat the gastric mucosa and provide the requisite pH to improve tolerance, efficacy and/or compliance in comparison to the prior art.
Yet another advantage of the currently preferred embodiments of the present invention is that the medicament and the food and/or beverage are maintained in separate chambers until ready for use. Accordingly, the problems encountered in mixing medicaments with foods and/or beverages at the time of manufacture or filling are substantially avoided. In addition, the medicament and the food and/or beverage can be mixed, if desired, immediately prior to use, and the combined medicament and food and/or beverage can significantly increase the absorption, transport, bioavailability and/or tolerance in comparison to taking the medicament itself.
Other objects and advantages of the present invention will become more readily apparent in view of the following detailed description of the currently preferred embodiments and the accompanying drawings.
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During the manufacture of the device 10, and as described further below, a first penetrable and thermally resealable portion 22 is in fluid communication with the first chambers 16 and is penetrable by an injection member to form an injection aperture therethrough, and introduce the first substance through the injection member and into the first chambers 16, and is thermally resealable to seal the injection aperture and the first substance within the first chambers 16 by applying energy thereto. Also during the manufacture of the device 10, and as described further below, a second penetrable and thermally resealable portion 24 is in fluid communication with the second chambers 18 and is penetrable by an injection member to form an injection aperture therethrough, and introduce the second substance through the injection member and into the second chambers 18, and is thermally resealable to seal the injection aperture and the second substance within the second chambers 18 by applying energy thereto.
Each body 14 is defined by opposing walls 25. In the illustrated embodiment, and as described further below, each wall 25 is formed from a sheet of flexible plastic material that can be die cut and heat sealed, and is compatible with the substances to be contained therein. For example, in some embodiments of the present invention, the material forming the walls 25 does not leach an undesirable amount of leachables into the substances contained within the device, does not absorb an undesirable amount of active ingredients and/or other components from the substances contained within the device, and/or provides a requisite moisture and vapor transmission (“MVT”) barrier. In one embodiment of the present invention, the material forming the walls 25 is a laminate of clear or substantially clear or translucent barrier plastic, such as an EVOH material. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the material forming the walls 25 of the device 10 may be any of numerous different materials or combinations of materials that are currently known or that later become known, and/or the walls may be formed of any of numerous different layers of materials that are currently known, or that later become known. In addition, the device 10 may be formed in accordance with any of numerous different manufacturing processes that are currently known or that later become known.
Each body 14 includes a second sealing portion or peripheral seal 26 extending about the periphery of the body and forming a fluid-tight seal between the interior and the exterior of the body. Each body 14 further includes a third sealing portion or interior seal 28 extending laterally through the body between the respective first chamber 16 and second chamber 18 and forming a fluid-tight seal therebetween. As can be seen, each third sealing portion 28 defines an axially-extending portion 30 having formed within it a channel 32 in fluid communication with the respective first chamber 16 and receiving therein a first substance from the first chamber. As also shown, each first sealing portion 20 is formed at the distal end of the respective axially-extending portion 30 and channel 32. In the illustrated embodiment, each first sealing portion 20 is defined by a frangible portion of the seal that is capable of being broken or is breakable. In the illustrated embodiment, the first sealing portion 20 defines a relatively reduced thickness in comparison to the adjacent portions of the third sealing portion 28, 30. As a result, and as described further below, when the opposing walls 25 of a respective body 14 are manually engaged and squeezed toward each other, the pressure within the first chamber 16 and/or the second chamber 18 will exceed a substantially predetermined threshold pressure that will cause the first sealing portion 20 to break or rupture, and thereby place the respective first chamber 16 in fluid communication with the respective second chamber 18 and allow intermixing of the first and second substances.
Each body 14 defines at its end opposite the respective second chamber 18 a dispensing port 34 defining a dispensing aperture 36 therein that is in fluid communication with the respective first chamber 16. Each body 14 further includes a respective fourth sealing portion or sealing member 38 formed at the end of the respective dispensing port 34 and forming a fluid-tight seal between the respective dispensing channel 36 and the ambient atmosphere. Each dispensing port 34 defines a frangible portion 40 formed approximately at the junction of the dispensing channel 36 and sealing member 38. As described further below, the respective sealing member 38 can be manually engaged and flexed or otherwise pulled away from the remainder of the body to, in turn, break the frangible portion 40 and open the dispensing port to release a mixture of the first and second substances therethrough. Each frangible portion 40 is capable of being broken, or is breakable, by manipulating the respective sealing member 38 such as by manual engagement. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the sealing member 38 may be connected to the body in any of numerous different ways, and/or the frangible portion 40 may be formed in any of numerous different ways, that are currently known, or that later become known. Each sealing member 38 defines an aperture 42 therethrough. As described further below, the aperture(s) 42 can be used to hold the device and/or manipulate the device during manufacture or thereafter.
The device 10 further comprises a plurality of frangible portions 44 extending axially between adjacent delivery units 12 that are breakable or capable of being broken in order to remove a respective delivery unit 12 from the device when ready for use. In the illustrated embodiment, each frangible portion 44 defines an axially-extending perforation that allows the respective delivery unit 12 to be separated from the device along a line defined by the perforation. As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the frangible portions 44, or the mechanism for separating the delivery units 12 from the device 10, may take the form of any such mechanisms that are currently known, or that later become known.
In the illustrated embodiment of the present invention, the first substance located within the first chambers 16 is a medicament, and the second substance located within the second chambers 18 is a food and/or beverage. If desired, the food and/or beverage also may be medicated, or may be non-medicated. Also if desired, the first and/or second chambers may be substantially airless. Preferably, the form of the medicament is selected from the group including (i) a liquid, (ii) a powder, (iii) a gel, (iv) nano particles, and (v) gelules; and the form of the food and/or beverage is selected from the group including a liquid and a gel.
The food and/or beverage preferably defines one or more of (i) a substantially predetermined pH selected to control at least one of absorption, residence time, transport and bioavailability of the respective medicament in a mammal, (ii) at least one predetermined enzyme for metabolizing the respective medicament, (iii) at least one predetermined enzyme for transporting the respective medicament, (iv) at least one predetermined flavor, and (v) a predetermined viscosity of the food and/or beverage combined with the respective medicament. Preferably, the food and/or beverage (i) defines a substantially predetermined pH selected to control absorption of the respective medicament in a target tissue of a mammal, and/or (ii) is selected to substantially coat intestinal mucosa of a mammal to enhance tolerance and/or reduce irritability of the respective medicament.
As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the medicament used in connection with the present invention may take the form of any substance or agent that is administered to promote recovery from an injury or ailment, or that treats or prevents or alleviates the symptoms of a disease, injury or ailment, such as any of numerous different medicines, medications or drugs, including without limitation any of numerous different vaccines, pharmaceuticals, ophthalmic, cosmeceutical, cosmetic and veterinary products that are currently known, or that later become known. Similarly, the foods and beverages used in connection with the present invention may take the form of any of numerous different foods and beverages that are currently known, or that later become known, including without limitation dairy products, such as milk, milk-based products, soy, soy-based products, fruit juices, fruit-juice based drinks, coffee, tea, soft drinks, and nutritional supplements.
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The needle penetrable and laser resealable stoppers 22 and 24 may be made, and the sterile, empty devices 10 may be needle filled and thermally resealed in accordance with the teachings of any of the following patent applications and patents that are hereby incorporated by reference in their entireties as part of the present disclosure: U.S. patent application Ser. No. 10/766,172 filed Jan. 28, 2004, entitled “Medicament Vial Having A Heat-Sealable Cap, And Apparatus and Method For Filling The Vial”, which is a continuation-in-part of similarly titled U.S. patent application Ser. No. 10/694,364, filed Oct. 27, 2003, which is a continuation of similarly titled co-pending U.S. patent application Ser. No. 10/393,966, filed Mar. 21, 2003, which is a divisional of similarly titled U.S. patent application Ser. No. 09/781,846, filed Feb. 12, 2001, now U.S. Pat. No. 6,604,561, issued Aug. 12, 2003, which, in turn, claims the benefit of similarly titled U.S. Provisional Application Ser. No. 60/182,139, filed Feb. 11, 2000; similarly titled U.S. Provisional Patent Application No. 60/443,526, filed Jan. 28, 2003; similarly titled U.S. Provisional Patent Application No. 60/484,204, filed Jun. 30, 2003; U.S. patent application Ser. No. 10/655,455, filed Sep. 3, 2003, entitled “Sealed Containers And Methods Of Making And Filling Same”; U.S. patent application Ser. No. 10/983,178 filed Nov. 5, 2004, entitled “Adjustable Needle Filling and Laser Sealing Apparatus and Method; U.S. patent application Ser. No. 11/070,440 filed Mar. 2, 2005, entitled “Apparatus and Method for Needle Filling and Laser Resealing”; U.S. patent application Ser. No. 11/074,513 filed Mar. 7, 2005, entitled “Apparatus for Molding and Assembling Containers with Stoppers and Filling Same; U.S. patent application Ser. No. 11/074,454 filed Mar. 7, 2005, entitled “Method for Molding and Assembling Containers with Stoppers and Filling Same”; and U.S. patent application Ser. No. 11/339,966, filed Jan. 25, 2006, entitled “Container Closure With Overlying Needle Penetrable And Thermally Resealable Portion And Underlying Portion Compatible With Fat Containing Liquid Product, And Related Method”; and U.S. patent application Ser. No. 11/786,206, filed Apr. 10, 2007, entitled “Ready To Drink Container With Nipple And Needle Penetrable And Laser Resealable Portion, And Related Method”.
In the event either the medicament, or the food or beverage is in a powder form, the powder is injected through the respective filling needle by using pressurized sterile air (such as filtered air) or other gas to push the powder through the needle and into the respective chamber. If necessary, the needle may include a vacuum port, or a separate vacuum needle may be employed, to evacuate any such sterile air that enters the respective chamber of the device. Alternatively, the needle may include one or more vent grooves, or otherwise may define one or more vent apertures between the needle and stopper to allow any such sterile air or gas that enters the respective chamber to vent therethrough.
If desired, the stopper or stoppers may be molded in the same mold as the body, or may be molded in adjacent molding machines, and at least one of the stopper(s) and the body may be assembled within or adjacent to the mold in accordance with the teachings of U.S. patent application Ser. Nos. 11/074,454 and 11/074,513 incorporated by reference above, and/or U.S. Provisional Patent Application Ser. No. 60/727,899 filed Oct. 17, 2005, entitled “Sterile De-Molding Apparatus And Method”, and/or U.S. patent application Ser. No. 11/374,522 filed Mar. 13, 2006, entitled “Sterile De-Molding Apparatus and Method, each of which is hereby expressly incorporated by reference as part of the present disclosure. One advantage of this approach is that the device is closed to define sealed, empty sterile internal chambers at essentially the time of formation, and the device is never opened (through filling, resealing, and during shelf life) until the product is dispensed. Accordingly, a significantly high level of sterility assurance can be achieved.
As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, the first sealing portion may take the form of any of numerous different sealing portions that are currently known or that later become known. For example, the first sealing portion may take the form of any of numerous different frangible constructions that are currently known or that later become known, may otherwise define a reduced seal thickness in comparison to contiguous sealing portions, or may otherwise define a relatively weak wall portion. Alternatively, the first seal portion may take the form of a stopper or other sealing member received within an aperture connectable in fluid communication between the first and second chambers. When the stopper or other sealing member is received within the aperture, it seals the first and second chambers from each other. However, the stopper may be movable out of the aperture and into the first and/or second chamber to, in turn, place the first and second chambers in fluid communication with each other and allow intermixing of the first and second substances. In one such embodiment, the stopper or other sealing member facilitates mixing of the first and second substances after being released from the aperture and due to its movement within the first and/or second chamber.
One advantage of the currently preferred embodiments of the present invention is that they can provide sealed first and second chambers (or additional chambers if desired) that are sterile, such as by being molded as a sealed, empty sterile device, and/or by the application thereto of radiation, fluid sterilant, etc., that can be aseptically or sterile filled at virtually any desired temperature (e.g., at room temperature or at warmer or colder temperatures), such that medicaments or drugs and foods or beverages can be filled into the same device. The device, and related needle or other injection member and laser or other thermal resealing, allow medicaments or drugs and foods or beverages to be filled in the same sterile environment without the need to use, for example, sterile isolators, as encountered in the prior art. The methods and apparatus of the invention allow first and second substances to be filled without contact with the external environment, and without contact with each other, thus allowing sterile or aseptic filling, and preventing any cross-contamination of, or between the first and second substances.
Yet another advantage of the currently preferred embodiments of the present invention is that they can enable optimized pH and local enzymatic metabolisms that can be critical for absorption and activity of specific drugs. Yet another advantage of the currently preferred embodiments of the present invention is that they can enable faster drug absorption, and shorter residence time in the stomach and/or intestine. Yet another advantage of the currently preferred embodiments of the present invention is that they can enable coating of the gastric mucosa with, for example, a pH specific vehicle to improve drug tolerance, efficacy and compliance, especially, for example, in children and elderly patients.
A further advantage of the currently preferred embodiments of the present invention is that the devices can be closed (or the chambers sealed) and formed sterile, or sterilized at the time of formation or thereafter, but prior to filling. For example, the components of the device can be molded in the same mold or in adjacent molds within a sterile or aseptic environment so that the device is sealed sterile at the time of formation. The devices can then be pierced with a non-coring needle or other injection member without particle formation or release into the chambers, and re-sealed with a laser or other thermal or radiation source. The plural chambers can be filled in the same needle filling and laser resealing machine, or can be filled in separate machines. For example, the drug or medicament chambers can be filled in a first machine, and the food and/or beverage chambers can be filled in a second machine. Alternatively, the medicament/drug and food/beverage can be filled in the same machine by different needles or other injection members. The chambers of the device are sterile and protected by the sealed device from contamination throughout the manufacturing processes such that the devices themselves function as “isolators”. As a result, there is no need to use sophisticated or complex isolators and sterile transfer ports during the filling process as encountered in the prior art.
As may be recognized by those of ordinary skill in the pertinent art based on the teachings herein, any of numerous different substances that are currently known, or that later become known, in any of numerous different forms (e.g., liquids, powders, gases, gels) can be used with the devices of the present invention. In one embodiment, the first substance is an analgesic, and the second substance is a food or beverage that increases the rate of absorption of the analgesic in an person over that of the analgesic itself. In another embodiment, the first substance is an anti-inflammatory, and the second substance is a food or beverage that provides a protective formulation for the gastric mucosa. In another embodiment, the first substance is a medicament that was previously provided in the format of a relatively large pill that was difficult to swallow, or that was bitter in taste, and the second substance is a food or beverage that improves the taste profile of the medicament and thereby enhances administration and patient compliance. In another embodiment, the first substance is an oncology drug, and the second substance is a food or beverage that increases the rate of absorption over administration of the drug itself and provides a coating for gastric mucosa to enhance patient tolerance, reduce patient discomfort otherwise associated with intravenous administration, and improves efficacy.
Another advantage of the currently preferred embodiments of the present invention is that the first and second chambers are initially sealed with respect to each other, and include stoppers or like portions that are penetrable by a needle or like injection member and the resulting needle holes or thermally resealable such as by the application of laser energy thereto. As a result, the device, system and method of such embodiments of the present invention can meet current, and even more rigorous than current, regulatory requirements with respect to asepsis. One reason for this is that the first and second chambers are from the outset (prior to filling) sealed with respect to the ambient atmosphere and sterile, and at no time during processing is it necessary to expose the interior of any chamber to the ambient atmosphere. Another advantage is that there is no need to assemble a container closure within a sterile filling machine in contrast to applicable prior art. Yet another advantage is that first and second substances, such as medicaments on the one hand, and foods and/or beverages on the other hand, can be transferred sterile through the filling needles or like injection members into the chambers without any exposure thereof to ambient atmosphere. A still further advantage is that if desired foods and beverages can be sterile filled into the same devices as medicaments, at the same time or at about the same time if desired, in the same filling machine, in a manner that satisfies the regulatory requirements for both medicaments on the one hand, and foods and beverages on the other hand.
As may be recognized by those skilled in the pertinent art based on the teachings herein, numerous changes and modifications may be made to the above-described and other embodiments of the present invention without departing from its scope as defined in the appended claims. For example, the stoppers, walls and other components of the device may be made of any of numerous different materials that are currently known, or that later become known for performing their functions and/or depending on the device application(s), including the products to be stored within the device. In one example, the penetrable and thermally resealable material may be blended with any of numerous different materials to obtain any of numerous different performance objectives. For example, any of the thermoplastic elastomers described in the patent applications incorporated by reference above may be blended with, for example, small beads of glass or other inert beads or particles to enhance absorption of the laser radiation and/or to reduce or eliminate the formation of particles when needle penetrated. In addition, beads or particles of the thermally resealable material may be blended with a cross-linked elastic material to thereby form a material blend that is both needle penetrable and thermally resealable, and that does not leach more than a predetermined amount of leachables into the product stored within the respective chamber. In addition, the device may take any of numerous different shapes and/or configurations, and may be adapted to receive and store within the chambers any of numerous different substances or products that are currently known or that later become known, including without limitation, any of numerous different foods and beverages, including low acid or fat containing liquid products, and any of numerous different medicaments. In addition, the products filled within the device may take any of numerous different forms, including liquid, gaseous, powdered, and semi-solid products. The device also may include any desired number of chambers, and any desired number of needle penetrable and thermally resealable stoppers or other portions for filling such chambers. For example, a single needle penetrable and thermally resealable portion may be in fluid communication with more than one chamber and used to fill such plural chambers. Alternatively, each delivery unit may include its own respective needle penetrable and thermally resealable portion for needle filling each delivery unit separately. In addition, the devices need not be limited to use with products that are enterally ingested. For example, the delivery units may include parenteral products, such as injectable vaccines or pharmaceuticals. In one such example, each delivery unit is in the form of a vial that includes a portion that is needle penetrable to remove the respective injectable product therefrom. In another embodiment, each delivery unit includes a Leur™ Lock or like fixture for connecting the respective delivery unit to a syringe for removing the substance or substances therefrom into a syringe for delivery by syringe injection. In these embodiments, each delivery unit may include only one chamber holding the respective injectable product rather than plural chambers. Accordingly, this detailed description of preferred embodiments is to be taken in an illustrative, as opposed to a limiting sense.
This patent application claims priority on prior provisional patent application Ser. No. 60/801,978, filed May 18, 2006, entitled “Delivery Device With Separate Medicament And Beverage Chambers Connectable In Fluid Communication When Ready For Use, And Related Method”, which is hereby expressly incorporated by reference as part of the present disclosure.
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