Multiplex drug delivery system suitable for oral administration

Details Multiplex drug delivery system suitable for oral administration Multiplex drug delivery system suitable for oral administration

1998-09-29

2003-08-05

Azpuru, Carlos A. (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

C424S464000, C424S467000, C424S468000, C424S471000, C424S472000, C424S475000, C424S476000

Reexamination Certificate

active

06602521

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to a single drug delivery unit suitable for oral administration containing at least two distinct drug dosage packages. This multiplex system contains at least two immediate-release compartments substantially enveloped by a scored extended-release compartment. The scored nature of the extended-release *compartment facilitates the separation by the patient of the multiplex drug delivery system into individual drug dosage packages for oral administration of the prescribed dosage. Upon separation, each individual drug dosage package can exhibit an equivalent, and preferably identical, release profile for the active agent as compared to one another and to that of the entire multiplex system. Accordingly, in a preferred embodiment, the separability of the multiplex drug delivery system enables its use throughout the entire course of a varying dosage regimen, and thus, facilitates cost effective patient compliance.
BACKGROUND OF THE INVENTION
Drug efficacy depends upon the maintenance of the proper therapeutic levels of the drug over the required treatment period. With respect to orally administered drugs, the effectiveness of treatment depends, in part or sometimes in whole, on patient compliance with the prescribed dosage regimen. Particularly where the prescribed dosage increases or decreases during the treatment period, patient compliance can suffer because of the unavailability of, or inconvenience in obtaining, the appropriate dosage of the prescribed medication at different times.
It would therefore be beneficial for patients to have one drug delivery unit that allows patients themselves to regulate the amount of drug to administer. Such a capability would enable patients to use the same drug delivery unit throughout their entire treatment period even where their prescribed dosage changes during that time. Patients in such circumstances would have the convenience and cost effectiveness of obtaining in one unit and at the same time the different dosages of their prescribed drug that would be needed during their treatment period.
A valuable contribution to the art therefore would be the development of a multiplex drug delivery system suitable for oral administration containing at least two immediate-release compartments substantially enveloped by a scored extended-release compartment that facilitates the separation of the multiplex drug delivery system into individual drug dosage packages for oral administration of the prescribed dosage, each of which can exhibit an equivalent, and preferably identical, release profile for the active agent as compared to one another and to that of the entire multiplex system.
SUMMARY OF THE INVENTION
Accordingly, an objective of the present invention is a single drug delivery unit suitable for oral administration that patients could separate into individual drug dosage packages. These individual drug dosage packages can exhibit an equivalent, and preferably identical, release profile for the active agent when compared to one another or when compared to the entire, intact multiplex drug delivery system.
The present invention accomplishes this objective through a multiplex drug delivery system suitable for oral administration containing at least two immediate-release compartments. The scored extended-release compartment of the invention allows the separation of the multiplex drug delivery system into individual drug dosage packages for oral administration of the prescribed dosage, each of which can exhibit an equivalent, and preferably identical, release profile for the active agent as compared to one another and to that of the entire multiplex system.
One preferred embodiment of the claimed invention is a multiplex drug delivery system suitable for oral administration comprising at least two immediate-release compartments substantially enveloped by a scored extended-release compartment. The extended-release compartment can comprise a combination of a hydrophobic and a hydrophobic material. In such an embodiment, the hydrophilic polymer(s) dissolves away to weaken the extended-release compartment, while the hydrophobic material retards the water, thus helping to preserve the integrity of the drug delivery system. Where the immediate-release compartments are inert (i.e., do not comprise an active agent), they can facilitate a bursting effect, which can disrupt any remaining integrity of the extended-release compartment.
In another preferred embodiment of the claimed invention, each immediate-release compartment further comprises an effective amount of an active agent, or a pharmaceutically acceptable salt thereof and the scored extended-release compartment further comprises an effective amount of an active agent, or a pharmaceutically acceptable salt thereof, in a compressed blend with the combination of a hydrophilic polymer and a hydrophobic material.
In a further preferred embodiment, each immediate-release compartment further comprises an effective amount of an active agent, or a pharmaceutically acceptable salt thereof, in a compressed blend with a polymer. In one other preferred embodiment, the scored extended-release compartment further comprises an effective amount of an active agent, or a pharmaceutically acceptable salt thereof, in a compressed blend with the combination of a hydrophilic polymer and a hydrophobic material. By varying the composition of the polymer(s) in the immediate-release compartments and/or the relative composition of the hydrophilic polymer and hydrophobic material in the extended-release compartment, the respective time periods for the dissolution of the active agent or the bursting effect can be adjusted.
In a preferred embodiment of the claimed invention, the active agent contained in the multiplex drug delivery system can be a drug. In other embodiments, that drug can be a therapeutic or a prophylactic drug.
In one preferred embodiment of the claimed invention, the drug of the multiplex drug delivery system can be diltiazem, trapidil, urapidil, benziodarone, dipyridamole, isosorbide mononitrate, or lidoflazine. In another embodiment, the drug can be a non-steroidal antiinflammatory drug (NSAID) or steroidal antiinflammatory drug. In an embodiment, the steroidal antiinflammatory drug can be diclofenac sodium, ibuprofen, ketoprofen, diflunisal, piroxicam, motrin, or naproxen. In yet another embodiment, the drug can be acetaminophen, aldosterone, alprenolol, amitryptyline, aspirin, beclomethasone, diproprionate, bromocriptine, butorphanol tartrate, chlormethiazole, chlorpheniramine, chlorpromazine HCl, cimetidine, codeine, cortisone, cyclobenzamine HCl, desmethylimipramine, dextropropoxyphene, dihydroergotamine, diltiazem HCl, dobutamine HCl, domperidone, dopamine HCl, doxepin HCl, epinephrine, ergoloid mesylates, ergotamine tartrate estradiol, ethinylestradiol, flunisolide, fluorouracil, flurazepam HCl, 5-fluoro-21-deoxyuridine, furosemide, glipizide, glyburide, glyceryl trinitrate, guanethidine sulfate, hydralazine HCl, imipramine HCl, indoramin, isoethorine HCl, isoethrine mesylate, isoprenaline, isoproterenol sulfate, isosorbide dinitrate, levallorphan tartrate, levodopa, lidocaine HCl, lignocaine, lorcainide, meperidine HCl, 6-mercaptopurine, metaproterenol sulfate, methoxamine HCl, methylphenidate, methylpreonisolone, methyltestosterone mesylate, metoclopramide, metoprolol tartrate, morphine sulfate, nalbuphine HCl, naloxone HCl, neostigmine, nifedipine, nitrendipine, nitroglycerin, norepinephrine bitartrate, norethindrone, nortriptylene HCl, oxprenolol, oxyphenbutazone, penicillamine, pentazocine HCl, pentazocine lactate, pentobarbital, petnidine, phenacetin, phentolamine HCl, phentolamine mesylate, phenylephrine HCl, phenylephrine bitartrate, phenytoin, pindolal, prazosin, prednisone, progesterone, propoxyphene HCl, propoxyphene napsylate, propranolol HCl, quinidine, reserpine, ritodrine HCl, salicylamide, salbutamol, secobarbital, testosterone, terbutaline, timolol maleate, tolbutamide, or verapamil HCl.
In one other preferred embodiment of the claimed i

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