Patent Application
20080017658
a and 2b are schematic depictions of intranasal drug delivery units delivered by one embodiment of the present invention.
a and 3b are schematic top and side views of the base of one embodiment of the present invention.
a and 4b are schematic top and side views of the housing of one embodiment of the present invention.
a-5d are schematic top and side views of the magazine of two embodiments of the present invention.
a and 6b are schematic top and side views of the link of one embodiment of the present invention.
The invention relates broadly to a device for the controlled dispensing of drug delivery units. As used herein, the term “drug delivery unit” is intended to refer to a unit dose of a pharmaceutical composition or an applicator for providing a unit dose of a pharmaceutical composition. Thus, while the term “drug delivery unit” may refer to a pill, tablet, capsule, caplet, etc., (i.e., a unit dose of a pharmaceutical composition) which is ingested by a patient, the term is also intended to refer to a device for delivering a unit dose of a pharmaceutical composition to a patient. Examples herein include, but are not limited to, intranasal applicators, such as applicators designed to deliver a single unit or bidose or multiunit dose of a pharmaceutical composition to a patient. Thus, as will become apparent, the present device may be used to dispense compositions which are ingestible as well as devices for delivering compositions which are administered by means other than ingestion. In one preferred embodiment, the invention is configured to dispense intranasal applicators (such as those manufactured by Ing. Erich Pfeiffer GmbH, Radofzell, Germany; Pfeiffer of America, Princeton, N.J.), each loaded with a unit dose of intranasal ketamine, intranasal morphine, or mixtures thereof, either with or without other constituents. Likewise, the invention may be configured to dispense more than one drug delivery unit at any given time, or it may be configured to dispense a drug delivery unit in the form of, for example, a capsule at one or more time intervals and a drug delivery unit in the for of, for example, an intranasal applicator at one or more different time intervals.
While the device is intended to be used to dispense any of a wide variety of drug delivery units, it is particularly adapted for dispensing controlled, scheduled drugs in a manner that prevents or provides indicia of overdosing. As noted above, the device is well-suited for the delivery of intranasal applicators, each loaded with a unit dose of intranasal ketamine, intranasal morphine, or mixtures thereof, either with or without other constituents; however, other drug delivery units are contemplated as well. These include, but are not limited to, the following drugs listed on DEA Schedules II, III, IV and V:
Apart from the above-noted intranasal applicators, each loaded with a unit dose of intranasal ketamine, intranasal morphine, or mixtures thereof, other preferred drug delivery units include unit doses of prescription drugs such as digoxin, β-blockers, α2-antagonists, thyroid replacement drugs, drugs to treat specific diseases (Alzheimer's, AIDS, diabetes, etc.), anticoagulants, vitamins having potentially toxic overdosages, and any other ingestible, inhalable, injectable or topical drug that is provided according to a scheduled regimen. Other representative drugs include, but are not limited to: betamethasone, budesonide, cortisone, dexamethasone, hydrocortisone, methyl-predinisolone, prednisolone, triamcinolone, capecitabine, chlorambucil, cyclophosphamide, etoposide, hydroxyurea, imatinib, mercaptopurine, methotrexate, buprenorphine, butorphanol, codeine, hydrocodone, hydromorphone, levorphanol, meperidine, methadone, morphine, opium, oxycodone, pentazocine, oxymorphone, anisindione, dicumarol, warfarin, isocarboxazid, phenelzine, tranylcypromine, amitriptyline, amoxaphine, clomipramine, desipramine, doxapin, imipramine, nortriptyline, protriptyline, trimipramine, olanzapine, risperidone, quetiapine, ziprasidone, aripiprazole, clozapine, chlorpromazine, fluphenazine, trifluoperazine, perphenazine, thioridazine, haloperidol, thiothixene, molindone, loxapine, apomorphine, benztropine mesylate, entacapone, levodopa/carbidopa/entacapone, carbidopa/levodopa, pergolide, ropinirole Hcl, amantadine Hcl, and selegiline Hcl.
Broadly, in one embodiment, the device is intended to be loaded with multiple doses of one or more drug delivery units and programmed to allow the drug delivery units to be dispensed at predetermined time intervals. In another embodiment, the device is intended to be loaded with multiple doses of one or more drug delivery units and programmed to allow the drug delivery units to be dispensed to a patient when desired, provided that a minimum time interval has passed between dispensing cycles. In another embodiment, patients requiring a regimen of several different drugs over an extended time period may use the device to dispense the particular prescribed multi-drug regimen at specified time periods.
One necessary element of the present invention is a controllable timing mechanism which is in operable communication with a delivery system within the device. While the timing mechanism will be discussed in greater detail below, it is noted that it may be either an electrical or mechanical timing mechanism. Although both offer desired utility, mechanical timing mechanisms offer the advantage of employing the device in the absence of an electrical source.
For dispensing of drug delivery units over a scheduled time period, it is contemplated herein that the timing mechanism may be controlled either by the device manufacturer or at the time it is loaded with the desired drug delivery units. Thus, in one non-limiting example, in which the devise is intended to dispense drug delivery units hourly over a 12 hour time period, the timing mechanism may be preprogrammed by the manufacturer. In a further embodiment, the timing mechanism may include a user interface through which a particular dosing and time period may be input. One such non-limiting example would allow a healthcare practitioner to load the device with, for example, 12 doses of intranasal ketamine, and then program the timing mechanism to allow the devise to provide one dose every 2 hours.
Likewise, it is also contemplated that the device may include an interface through which a patient may self-administer drugs on an interval-limited basis. In this embodiment, the device may include a patient dosing interface through which the patient requests a drug delivery unit to be dispensed. The timing mechanism may be programmed by either the manufacturer or a healthcare practitioner to allow drug delivery units to be dispensed freely, provided a minimum interval has passed between each dispensing.
In one embodiment, the device may be used to simplify a complicated dosing regimen required by a patient. For example, many patients, particularly elderly patients, require doses of several different drugs one or more times per day. Selecting the particular drugs required at particular times can often be complicated or confusing. In one embodiment, the present invention provides a means by which proper dosing may be simplified. In particular, the device may be loaded in a manner which allows several drug delivery units to be dispensed at one time. As one example, consider the case of a patient requiring drugs A, B, and C every morning, and drugs B and D every evening. The chambers in the magazine of the device may be loaded with alternating combinations of drugs A, B and C and drugs B and D, and the device may be set to dispense the alternating combinations to the patient at twelve hour intervals.
In a preferred embodiment, it is contemplated that the entire device, loaded with the required drug delivery units, may be provided to a patient. This configuration is best applied in situations where the device will be used for short periods, such as for acute post-surgical pain relief. Upon termination of pain medication, the device may be cleaned, loaded with drug delivery units for a different patient, sealed and re-used. Alternatively, in applications in which the device will be used for longer periods, a patient may be provided with a version of the device in which the magazine used to contain drug delivery units is absent. In this case, a healthcare practitioner, pharmacist, or other authorized person may provide a magazine loaded with the appropriate drug delivery units to the patient. Depleted magazines may be either refilled, or replaced with fully loaded units.
The device may be best understood from the description below with reference to the accompanying Figures.
In one embodiment, shown in
The base 12 of the device is depicted schematically as a top view in
The housing 14 of the device is depicted schematically as a top view in
Positioned within the device in the chamber formed between the base 12 and the housing 14 is a magazine 50, shown in
The magazine 50 is rotated within the device using a link 60 shown in
The timing mechanism 70 is depicted schematically in
The timing mechanism 70 is selected such that it provides the magazine with one complete rotation over a predetermined dosing period. Thus, a “one-day” timing mechanism is one that provides the magazine with one complete rotation over a 24 hour period, a “two-day” timing mechanism is one that provides the magazine with one complete rotation over a 48 hour period, a “half-day” timing mechanism is one that provides the magazine with one complete rotation over a 12 hour period, etc. The timing device includes a rotating rod that mates with the link via the timing mechanism interface 64. As such, as the rod on the timing mechanism is rotated, it rotates the link, which, in turn, rotates the magazine.
The timing mechanism 70 may optionally include an audible and/or visual indicator that provides an indication when a drug deliver unit is available for withdrawal from the device. The audible indicia may be, for example, a bell that rings when a dose is available, and the visual indicia may be, for example, a colored segment that becomes visible through the aperture 42 when a dose is available. Thus, in the case of a 12 dose regimen over the course of one day, an audible indicia would sound every two hours.
As noted in
The device is not intended to be tamper-proof. Rather, the device is intended to provide an indication to a healthcare practitioner that unauthorized access, or attempts at unauthorized access, to the device interior have occurred. It should be understood as well, that any of a wide variety of devices may be used to secure the housing to the base via the flanges. These include dial locks, keyed locks, scored labels and tapes, etc.
In one embodiment of the assembled device, a mechanical timing mechanism is mounted to the underside of the base in a manner such that rotating rod extends through the center of the base and mates with the timing mechanism interface on the link. The magazine, selected for the particular dosing regimen and loaded with drug delivery units is positioned on the base in a manner such that it mates with the magazine interface on the link. The housing is positioned over this assembly and the tamper indicia is employed to hold the housing to the base. In one preferred embodiment, the drug delivery units comprise intranasal dispensers of analgesic medications intended to be dispensed every two hours over the course of a full day. As such, a one-day timer and a magazine having 12 partitions is employed.
The device above could be stored until needed, and then employed simply by providing it to a patient and activating the mechanical timing mechanism, such as by winding. The timing mechanism will begin to rotate the magazine within the device in a manner such that a patient can withdraw one drug delivery unit from the aperture in the housing every two hours. Once a drug delivery unit is removed from the device, another one will not be available until the magazine has rotated sufficiently to make another drug delivery unit available. If the patient attempts to accelerate the dosing by gaining access to the interior of the device, this attempt will be evident via the tamper indicia. If the dosing is intended to be continued over the course of a second day, a healthcare practitioner can open the device, and either reload the magazine or replace it with a preloaded magazine.
In other embodiments of the present invention, individuals may use the device at home to dispense medications according to their particular needs. Thus, a patient taking multiple medications over the course of one or more days may load the magazine, or obtain personalized preloaded magazines, to provide the appropriate medications at the appropriate times.
The individual elements of the device may be made of any of a wide variety of materials. In one preferred embodiment, the base, housing, link and magazine are fabricated from a cast or thermoformed polymer. It is anticipated that the device may be employed in a manner where the elements are reusable, and thus, durable plastics are preferred. In one embodiment, however, the base, housing, timing mechanism and link are intended to be made available as a packaged unit, and the magazine, loaded with the appropriate drug delivery units is obtained separately. In this case, the magazine may be returned during the process of refilling, or it may be discarded. In the latter case, it is preferred that the magazine be formed of a biodegradable or recyclable material.
The device of the present invention offers a simple, durable alternative to conventional patient controlled analgesia (PCA) devices. Unlike common PCA systems, a preferred embodiment the present invention can operate in the absence of electrical power, while providing periodic doses of analgesics in a manner that is tamper evident and self-accounting.
The device lends itself to use in hospitals, semi-supervised care environments, and independent supervised care environments. In post operative patients, the device reduces the cost of care as there is no need for a healthcare practitioner to periodically administer the dispensed medications. For end-of-life care, the device can be used to deliver analgesic medications at a greatly reduced cost and improved safety. For settings where the patient needs assistance with determining when to take the medications, i.e., nursing homes, the device reduces the needs for a healthcare practitioner at each dosing event. Finally, in natural disaster or military situations, the device provides a durable means of dispensing medications in environments where electrical power may be unavailable.
The present invention is not intended to be limited in scope by the specific embodiments described herein, each of which is presented by way of example only. Various modifications of the invention in addition to those described herein will become apparent to those skilled in the art from the foregoing description and the accompanying figures. Such modifications are intended to fall within the scope of the claims.
