Varon, Steven C. (Hillsborough, NJ, US)

09/729230

06/06/2002

12/04/2000

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206/538

206/534, 206/531, 206/526

(IPC1-7): B65D085/00; B65D083/04

Watov & Kipnes, P.C.,Kenneth Watov, Esquire (P.O. Box 247, Princeton Junction, NJ, 08550, US)

What I claim is:

1. A therapy pack for providing a prescribed combined daily oral dose of muscle relaxant drug tablets or capsules and a nonsteroidal anti-inflammatory drug (NSAID) capsules or tablets, comprising: a blister card including at least one pair of blister cells, with each pair including one cell for containing a prescribed single oral dose strength of said muscle relaxant, and one cell for containing a prescribed single oral dose strength of said NSAID for providing a combined dose thereof at a given time.

2. The therapy pack of claim 1, further including a plurality of said blister cards for providing a prescribed multiple day treatment.

3. The therapy pack of claim 2, wherein said muscle relaxant drug is cyclobenzaprine hydrochloride, and said NSAID is etodolac.

4. The therapy pack of claim 2, further including a carton for containing said plurality of said blister cards for individual disbursement for each daily or day's treatment.

5. The therapy pack of claim 1, wherein three of said pairs of blister cells are provided, with each being designated by indicia on the associated blister card for morning, afternoon, and bedtime combined doses, respectively.

6. The therapy pack of claim 5, wherein each of said three pairs of blister cells are arranged in three successive rows.

7. The therapy pack of claim 6, wherein each blister cell of each pair of blister cells is arranged in a column, thereby forming first and second spaced apart columns.

8. The therapy pack of claim 7, wherein said muscle relaxant drug is cyclobenzaprine hydrochloride, and said NSAID is etodolac.

9. The therapy pack of claim 8, wherein said first and second columns are labeled via indicia on said blister card as “Cyclobenzaprine”, and “Etodolac”, respectively.

10. The therapy pack of claim 7, wherein it is further indicated by indicia that each blister cell of said first column contains 10 milligrams of cyclobenzaprine, and of said second column contains 330 milligrams of etodolac.

11. The therapy pack of claim 3, wherein 10 milligrams is the prescribed single dose of cyclobenzaprine hydrochloride, and 330 milligrams is the prescribed single dose of etodolac.

12. A blister card for providing a single days prescribed multiple and time separated combined doses of muscle relaxant drug tablets, and nonsteroidal anti-inflammatory drug (NSAID) capsules or tablets, comprising: a plurality of pairs of blister cells arranged into first and second columns and a plurality of rows; said first column of blister cells each containing a single dose tablet or capsule of muscle relaxant; and said second column of blister cells each containing a single dose tablet or capsule of NSAID.

13. The blister card of claim 12, wherein said muscle relaxant drug is cyclobenzaprine hydrochloride, and said NSAID capsule or tablet is etodolac.

14. The blister card of claim 12, wherein said first column of blister cells is identified by indicia thereon as each containing “Cyclobenzaprine 10 mg,” and said second column is identified by indicia thereon as each containing “Etodolac 330 mg.”

15. The blister card of claim 12, wherein first and second columns of blister cells are spaced apart, and said plurality of pairs of blister cells are arranged into three rows labeled by indicia as “MORNING”, “AFTERNOON”, and “BEDTIME,” respectively.

16. The blister card of claim 14, wherein said first and second columns of blister cells are spaced apart, and said plurality of pairs of blister cells are arranged into three rows labeled by indicia as “MORNING”, “AFTERNOON”, and “BEDTIME,” respectively.

17. A therapy pack for providing a prescribed combined daily oral dose of tablets or capsules of the muscle relaxant drug cyclobenzaprine, and the nonsteroidal anti-inflammatory drug (NSAID) etodolac comprising: a blister card including at least one pair of blister cells, with each pair including one cell for containing a prescribed single oral dose strength of said muscle relaxant and one cell for containing a prescribed single oral dose strength of said NSAID for providing a combined dose thereof at a given time.

18. The therapy pack of claim 17, further including a plurality of said blister cards for providing a prescribed multiple day treatment.

19. The therapy pack of claim 18, further including a carton for containing said plurality of said blister cards for individual disbursement for each daily or day's treatment.

20. The therapy pack of claim 17, wherein said three pairs of blister cells are designated by indicia printed on the associated blister card for identifying morning, afternoon, and bedtime combined doses, respectively.

21. The therapy pack of claim 20, wherein each of said three pairs of blister cells are arranged in three successive rows.

22. The therapy pack of claim 21, wherein each blister cell of each pair of blister cells is arranged in a column, thereby forming first and second spaced apart columns.

23. The therapy pack of claim 22, wherein said first and second columns are labeled via indicia on said blister card as cyclobenzaprine and etodolac, respectively.

24. The therapy pack of claim 23, wherein it is further indicated by said indicia that each blister cell of said first column contains a 10 milligram dose of cyclobenzaprine, and each blister cell of said second column contains a 330 milligram dose of etodolac.

25. The therapy pack of claim 17, wherein 10 milligrams is the prescribed single dose of cyclobenzaprine hydrochloride, and 330 milligrams is the prescribed single dose of etodolac.

26. A blister card for providing a single days prescribed three time separated combined doses of cyclobenzaprine hydrochloride capsules or tablets, and etodolac capsules or tablets, comprising: three pairs of blister cells arranged into first and second columns and three rows; said first column of blister cells each containing a single dose tablet or capsule of cyclobenzaprine hydrochloride; and said second column of blister cells each containing a single dose tablet or capsule of etodolac.

27. The blister card of claim 26, wherein a single dose tablet of cyclobenzaprine hydrochloride contains 10 milligrams thereof, and a single dose capsule or tablet of etodolac contains 330 milligrams thereof.

28. The blister card of claim 26, wherein said first column of blister cells is identified by indicia thereon as each containing “Cyclobenzaprine 10 mg,” and a second column is identified by indicia thereon as each containing “Etodolac 330 mg.”

29. The blister card of claim 26, wherein said columns of blister cells are spaced apart, and each of said three rows are labeled by indicia as “MORNING”, “AFTERNOON”, and “BEDTIME,” respectively.

30. The blister card of claim 28, wherein said columns of blister cells are spaced apart, and each of said three rows are labeled by indicia as “MORNING”, “AFTERNOON”, and “BEDTIME,” respectively.

FIELD OF THE INVENTION

[0001] The field of the present invention relates generally to the packaging of tablet form medications, and more particularly to packaging for dispensing tablets and/or capsules in a controlled manner for the combined oral dose of a muscle relaxant drug, and a nonsteroidal anti-inflammatory drug (NSAID).

BACKGROUND OF THE INVENTION

[0002] Cyclobenzaprine HCl, a muscle relaxant drug manufactured and sold by Merck & Co., Inc., West Point, Pa., under the brand name Flexeril®, is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful, musculoskeletal conditions. More specifically, this drug relieves skeletal muscle spasm of local origin without interfering with muscle function. Specifically, it is typically used for periods of two or three weeks in view of the typical duration of muscle spasm associated with acute, painful, musculoskeletal conditions.

[0003] Etodolac, manufactured and sold by Ayerst Laboratories, Inc., Philadelphia, Pa., under the brand name Lodine®, is indicated for acute and long-term use in the management of signs and symptoms of osteoarthritis, and also for the management of pain. This drug is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic, and antipyretic activity.

[0004] The present inventor compiled data of prescription use for the twelve month period ending November 1999, illustrating the use of Lodine® 154,000 times as concomitant therapy with Flexeril®. This data shows that physicians in private practice frequently prescribe use of the aforesaid products together in a combined therapy, requiring the physician to write two separate prescriptions, for each product, respectively. The present inventor recognized that both physicians and a substantial number of patients who received separate prescriptions for these products, namely cyclobenzaprine and etodolac, would benefit from a packaging product that would permit only one prescription to be required, and would enhance the likelihood of patient compliance to thereby improve the physician's management of symptoms being treated. However, this invention is not limited to the aforesaid specific drugs, and is meant to cover any combined therapy consisting of a muscle relaxant drug, and an NSAID.

SUMMARY OF THE INVENTION

[0005] An object of the invention is to provide a packaging system providing combined daily oral doses of a muscle relaxant drug, and an NSAID.

[0006] Another object of the invention is to provide a packaging system that permits cyclobenzaprine hydrochloride tablets, and etodolac capsules or tablets to be dispensed together in a prescribed dosage regimen.

[0007] With this and other objects in mind, in one embodiment of the invention, a co-packaging system includes a dispensing carton containing ten blister cards. Each blister card includes one or more sets of blister cells, with each set containing two cells, with one cell thereof containing a prescribed dose of a muscle relaxant drug such as but not limited to a cyclobenzaprine hydrochloride tablet, and the associated neighboring cell containing a prescribed dose of an NSAID such as but not limited to etodolac, in capsule or tablet form, for example. Each blister card includes the required number of sets of blister cells for containing the number of doses of these drugs required over a 24 hour period. Indicia is imprinted on each blister card for instructing a patient when to take a given combined dose of these drugs. The ten blister cards provide a typical ten day prescribed dosage. In other embodiments of the invention, the number of blister cards can be increased or decreased to accommodate other prescribed dosing periods, such as a two or three week period, for example.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Various embodiments of the present invention are described in detail below with reference to the drawings, in which like items are indicated by the same reference designation, wherein:

[0009] FIG. 1 shows one embodiment of the invention for providing a carton containing a plurality of blister packs; and

[0010] FIG. 2 shows an embodiment of the invention for a blister pack providing a single day dosage, with each dosage comprising the combined cyclobenzaprine hydrochloride tablet with an etodolac capsule or tablet.

DETAILED DESCRIPTION OF THE INVENTION

[0011] Various embodiments of the present invention will be described in detail with reference to FIGS. 1 and 2 . The embodiment illustrated herein includes a carton 1 containing a predetermined number of individual blister packs 3 , for providing a prescribed total dosage therapy. Each blister pack 3 includes three paired doses 5 , 7 , and 9 , for example a paired morning, afternoon, and bedtime dose, respectively, as shown. For each combined dosage, a prescribed strength of cyclobenzaprine hydrochloride tablet 11 , is combined with a prescribed dose or strength of etodolac capsule or tablet 13 . In a typical recommended therapy, each blister card 3 for daily use contains three tablets 11 of cyclobenzaprine hydrochloride tablets having a strength of 10 milligrams (mg), and three each of etodolac capsules or tablets of 330 mg strength, respectively. Such a combination of tablet dosage strengths corresponds to current prescribing practices, but is not meant to be limiting, and can be changed according to different prescribing practices. Note that for each blister card 3 , in this example, each tablet or capsule 11 , 13 is contained in a blister cell or cavity 12 as is known in the art.

[0012] Presently, the maximum recommended daily dosage for etodolac is 1000 mg (milligrams). Therefor, the use of 330 mg strength etodolac capsules or tablets 13 will substantially provide for the recommended daily dosage thereof. In summary, for each blister card 3 , the individual combined dose of 330 mg of etodolac satisfies the therapeutic requirement of physicians treating acute musculoskeletal injuries, combined with a 10 mg dose of cyclobenzaprine, as a rational therapeutic combination for the adjunctive treatment of acute painful musculoskeletal injuries. Each blister card 3 is self instructing for a patient's use, and as indicated above, the number of blister packs can be varied to accommodate the number of days of desired treatment. In this example, the instructions are in the form of printed indicia, namely “MORNING”, “AFTERNOON”, and “BEDTIME”, positioned as shown in this example, between associated pairs of blister cells in rows 5 , 7 , and 9 , respectively. Also, in this example, the column of blister cells 12 containing cyclobenzaprine tablets 11 is labeled “Cyclobenzaprine 10 mg”, and the column of blister cells 12 containing etodolac tablets or capsules is labeled “Etodolac 330 mg”, as shown.

[0013] Although various embodiments of the invention have been shown and described, they are not meant to be limiting. Those of ordinary skill in the art may recognize various modifications to these embodiments, which modifications are meant to be covered by the spirit and scope of the appended claims.