PHARMACEUTICAL CAPSULE CONTAINING AT LEAST TWO TABLETS

Abstract

The present invention is directed to an oral pharmaceutical dosage form comprising a capsule containing at least two tablets, each tablet containing at least one different pharmaceutically active ingredient

Claims

1. An oral pharmaceutical dosage form comprising a capsule containing at least two tablets, each tablet containing at least one different pharmaceutically active ingredient wherein each of the at least two tablets have different dimensions.

2. An oral pharmaceutical dosage form as claimed in claim 1, wherein after dissolution of the capsule the at least two tablets release the active pharmaceutical ingredients contained therein comparably to each of the at least two tablets being administered individually.

3. An oral pharmaceutical dosage form as claimed in claim 1, wherein the at least two tablets can have the same or a different geometric form, the same or a different weight, and the same or a different volume with the proviso that at least one of the geometric form, weight or volume is different between the tablets.

4. An oral pharmaceutical dosage form as claimed in claim 1, wherein the capsule has a length of up to 35 mm, a width of up to 15 mm and a depth of up to 15 mm.

5. An oral pharmaceutical dosage form as claimed in claim 4, wherein the capsule has have a length of 25-30 mm, a width of 8-10, and a depth of 8-10 mm.

6. An oral pharmaceutical dosage form as claimed in claim 4, wherein the capsule has have a length of 20-24 mm, a width of 8-10, and a depth of 8-10 mm.

7. An oral pharmaceutical dosage form as claimed in claim 1, wherein the at least two different tablets may comprise one or more active pharmaceutical active ingredients selected from analgesics, antihistamines, decongestants, antitussives, expectorants, vitamins, probiotics, anti-inflammatories, anti-infectives, antibiotics, acid reducers, and laxatives.

8. An oral pharmaceutical dosage form as claimed in claim 7, wherein the at least two tablets comprise an analgesic, an expectorant and at least one additional active pharmaceutical ingredient.

9. An oral pharmaceutical dosage form as claimed in claim 8, wherein the analgesic is selected from naproxen, ketoprofen, diclofenac, ibuprofen, paracetamol, aspirin and flurbiprofen.

10. An oral pharmaceutical dosage form as claimed in claim 8, wherein the expectorant can be guaifenesin or N-acetyl cysteine (NAC).

11. An oral pharmaceutical dosage form as claimed in claim 8, wherein the at least one other drug can be selected from an antitussive or cough suppressant such as dextromethorphan, dextromethorphan hydrobromide, codeine, codeine phosphate, codeine sulphate, diphenhydramine citrate, diphenhydramine hydrochloride and diphenhydramine citrate, a decongestant such as phenylephrine hydrochloride, phenylpropanolamine hydrochloride, pseudoephedrine hydrochloride or ephedrine, an antihistamine such as chlorpheniramine maleate, brompheniramine maleate, phenindamine tartrate, pyrilamine maleate, doxylamine succinate, phenyltoloxamine citrate, diphenhydramine hydrochloride, diphenhydramine citrate, promethazine, and clemastine fumerate, or a combination thereof.

12. An oral pharmaceutical dosage form as claimed in claim 11, wherein the at least one other drug is dextromethorphan hydrobromide or pseudoephedrine hydrochloride.

13. An oral pharmaceutical dosage form as claimed in claim 1, wherein the first tablet is an immediate release tablet which comprises naproxen, and the second tablet comprises an immediate release portion comprising guaifenesin and dextromethorphan and a sustained release portion comprising guaifenesin and dextromethorphan.

14. An oral pharmaceutical dosage form as claimed in claim 13, wherein the first tablet comprises: (a) 50-52% Naproxen; (b) 35-40% Microcrystalline cellulose; (c) up to 5% Povidone; (d) 5-8% Croscarmellose sodium; and (e) up to 1% Magnesium stearate.

15. An oral pharmaceutical dosage form as claimed in claim 13, wherein the first tablet comprises: (a) 70-75% Naproxen; (b) 20-25% Microcrystalline cellulose; (c) up to 5% Povidone; and (d) up to 1% Magnesium stearate.

16. An oral pharmaceutical dosage form as claimed in claim 13, wherein the first tablet comprises: (a) 70-75% Naproxen; (b) 9-10% Microcrystalline cellulose; (c) up to 5% Povidone; (d) up to 1% Magnesium stearate; (e) 5-10% Lactose; and (f) 5-10% Croscarmellose sodium.

17. An oral pharmaceutical dosage form as claimed in claim 13, wherein the first tablet comprises: (a) 70-75% Naproxen; (b) 6-7% Microcrystalline cellulose; (c) up to 5% Povidone; (d) up to 1% Magnesium stearate; (e) 1-2% Croscarmellose sodium; and (f) 15-20% Sodium lauryl sulfate.

18. An oral pharmaceutical dosage form as claimed in claim 13, wherein the first tablet comprises: (a) 70-75% Naproxen; (b) 3-5% Microcrystalline cellulose; (c) up to 5% Povidone; (d) up to 1% Magnesium stearate; (e) up to 5% Lactose; and (f) 15-20% Sodium lauryl sulfate.

19. An oral pharmaceutical dosage form as claimed in claim 13, wherein the first tablet comprises: (a) 70-75% Naproxen; (b) 9-10% Microcrystalline cellulose; (c) up to 5% Povidone; (d) up to 1% Magnesium stearate; (e) up to 5% Croscarmellose sodium; and (f) 5-10% Lactose.

20. An oral pharmaceutical dosage form as claimed in claim 13, wherein the first tablet comprises: (a) 70-75% Naproxen or a pharmaceutically acceptable salt thereof; (b) 5-10% Microcrystalline cellulose; (c) up to 5% Povidone; (d) up to 1% Magnesium stearate; (e) 5-10% Lactose; and (f) up to 5% Croscarmellose sodium.

21. An oral pharmaceutical dosage form as claimed in claim 13, wherein the first tablet comprises: (a) 70-75% Naproxen or a pharmaceutically acceptable salt thereof; (b) 5-10% Microcrystalline cellulose; (c) up to 5% Povidone; (d) up to 1% Magnesium stearate; (e) 5-10% Lactose; and (f) 5-10% Croscarmellose sodium.

22. An oral pharmaceutical dosage form as claimed in claim 13, wherein the first tablet comprises: (a) 70-75% Naproxen or a pharmaceutically acceptable salt thereof; (b) 5-10% Microcrystalline cellulose; (c) up to 5% Povidone; (d) up to 1% Magnesium stearate; (e) up to 5% Lactose; and (f) 15-20% Sodium Lauryl Sulphate.

23. An oral pharmaceutical dosage form as claimed in claim 13, wherein the first tablet comprises: (a) 70-75% Naproxen or a pharmaceutically acceptable salt thereof; (b) 5-10% Microcrystalline cellulose; (c) up to 5% Povidone; (d) up to 1% Magnesium stearate; (e) up to 2% Croscarmellose sodium; and (f) 15-20% Sodium Lauryl Sulphate.

24. An oral pharmaceutical dosage form as claimed in claim 13, wherein the immediate release portion of the second tablet comprises: (a) 30-40% Guaifenesin; (b) up to 5% Dextromethorphan; (c) 50-60% Microcrystalline cellulose; (d) up to 7% Povidone; (e) up to 7% Croscarmellose sodium; and (f) up to 1% Magnesium stearate.

25. An oral pharmaceutical dosage form as claimed in claim 13, wherein the immediate release portion of the second tablet comprises: (a) 40-50% Guaifenesin; (b) up to 5% Dextromethorphan HBr; (c) 40-50% Microcrystalline cellulose; (d) up to 5% Hypromellose; (e) up to 5% Sodium starch glycolate; and (f) up to 1% Magnesium stearate.

26. An oral pharmaceutical dosage form as claimed in claim 13, wherein the immediate release portion of the second tablet comprises: (a) 60-65% Guaifenesin; (b) up to 5% Dextromethorphan HBr; (c) 25-30% Microcrystalline cellulose; (d) up to 5% Povidone; (e) up to 5% Croscarmellose Sodium; and (f) up to 1% Magnesium stearate.

27. An oral pharmaceutical dosage form as claimed in claim 13, wherein the immediate release portion of the second tablet comprises: (a) 50-60% Guaifenesin; (b) up to 5% Dextromethorphan HBr; (c) 35-40% Microcrystalline cellulose; (d) up to 5% Povidone; (e) up to 5% Croscarmellose Sodium; and (f) up to 1% Magnesium stearate.

28. An oral pharmaceutical dosage form as claimed in claim 13, wherein the immediate release portion of the second tablet comprises: (a) 40-50% Guaifenesin; (b) up to 5% Dextromethorphan or a pharmaceutically acceptable salt thereof; (c) 40-50% Microcrystalline cellulose; (d) up to 5% Hypromellose; (e) up to 5% Sodium starch glycolate; and (f) up to 1% Magnesium stearate.

29. An oral pharmaceutical dosage form as claimed in claim 13, wherein the immediate release portion of the second tablet comprises: (a) 50-65% Guaifenesin; (b) up to 5% Dextromethorphan or a pharmaceutically acceptable salt thereof; (c) 25-40% Microcrystalline cellulose; (d) up to 5% Povidone; (e) up to 5% Croscarmellose sodium; and (f) up to 1% Magnesium stearate.

30. An oral pharmaceutical dosage form as claimed in claim 13, wherein the modified release portion of the second tablet comprises: (a) 80-90% Guaifenesin; (b) up to 5% Dextromethorphan HBr; (c) up to 10% Hypromellose; (d) up to 5% Carbomer; and (e) up to 1.55% Magnesium stearate.

31. An oral pharmaceutical dosage form as claimed in claim 13, wherein the modified release portion of the second tablet comprises: (a) 80-90% Guaifenesin; (b) 3-6% Dextromethorphan HBr; (c) up to 5% Hypromellose; (d) up to 2% Hydroxy ethylcellulose; (e) up to 5% Microcrystalline cellulose; and (f) up to 1% Magnesium stearate.

32. An oral pharmaceutical dosage form as claimed in claim 13, wherein the modified release portion of the second tablet comprises: (a) 80-90% Guaifenesin; (b) 3-6% Dextromethorphan HBr; (c) up to 5% Hypromellose; (d) up to 5% Hydroxyethylcellulose; (e) up to 5% Microcrystalline cellulose; and (f) up to 1% Magnesium stearate.

33. An oral pharmaceutical dosage form as claimed in claim 13, wherein the modified release portion of the second tablet comprises: (a) 80-90% Guaifenesin; (b) 3-6% Dextromethorphan HBr; (c) 5-10% Hypromellose; (d) up to 5% Hydroxyethylcellulose; (e) up to 5% Microcrystalline cellulose; and (f) up to 1% Magnesium stearate.

34. An oral pharmaceutical dosage form as claimed in claim 13, wherein the modified release portion of the second tablet comprises: (a) 85-90% Guaifenesin; (b) 4-5% Dextromethorphan or a pharmaceutically acceptable salt thereof; (c) 3-6% Hypromellose; (d) 1-3% Carbomer; and (e) 0.5-1% Magnesium stearate.

35. An oral pharmaceutical dosage form as claimed in claim 13, wherein the modified release portion of the second tablet comprises: (a) 90-93% Guaifenesin; (b) 4-6% Dextromethorphan or a pharmaceutically acceptable salt thereof; (c) 1-3% Carbomer; and (d) 0.5-1% Magnesium stearate.

36. The use of an oral pharmaceutical dosage form as claimed in claim 1 for the treatment of a patient wherein a single dose of said oral pharmaceutical dosage form provides the required therapeutic effect for a period of up to 12 hours.

Description

[0348] Embodiments of the invention will now be described by way of example only, with reference to the accompanying Figures in which:

[0349] FIGS. 1-4 illustrate example embodiments of a pharmaceutical dosage form in accordance with the present invention;

EXAMPLES

[0350] Referring firstly to FIG. 1, a pharmaceutical dosage form in accordance with the present invention is generally depicted at 1. The dosage form 1 comprises a first tablet 2 and a second tablet 3. The tablets 2 and 3 are encased in a gelatin or HPMC capsule 4. The gelatin or HPMC capsule comprises two separate shells 5 and 6. The capsule shells 5 and 6 have different dimensions such that one of the shells is larger than the other. Each of the shells 5 and 6 are provided with means in the form of grooves that allow the shells to reversibly engage with each other.

[0351] The pharmaceutical dosage form 1 is made by inserting the tablets into the longer shell 5. Shell 6 is then connected to shell 5 to form the final dosage form 1.

[0352] The tablets of the example embodiments of the present invention can be used using standard tableting procedures well-known to the man skilled in the art.

[0353] FIGS. 2-4 illustrate alternative embodiments of the present invention in which the tablets are different.

[0354] Example embodiments of the individual pharmaceutical compositions that can be used in the dosage form of the present invention will now be described by way of example only.

Example 1

[0355]

TABLE-US-00001 Tablet 1: Naproxen Ingredient mg/tablet % Weight Naproxen Sodium 110.0 mg 73.33% Microcrystalline Cellulose 34.45 mg 22.96% Povidone  4.50 mg 3.0% Mg Stearate  1.05 mg 0.7% Total Tablet 150.0 mg 100.0%

TABLE-US-00002 Tablet 2: Immediate/Sustained Release Dextromethorphan and Guaifenesin Ingredient mg/tablet % Weight Guaifenesin 600.0 mg  76.41% Hypromellose 50.00 mg   6.37% MCC 87.52 mg  11.15% Dextromethorphan HBr 30.0 mg  3.82% Carbomer 7.50 mg  0.96% Sodium Starch Glycolate 3.98 mg  0.51% Colourant 0.20 mg 0.025% Mg Stearate  6.0 mg  0.76% Total Tablet 785.2 mg  100.0%

Example 2

[0356]

TABLE-US-00003 Tablet 1: Naproxen Ingredient mg/tablet % Weight Naproxen Sodium 110.0 mg 51.16% Microcrystalline Cellulose 81.00 mg 37.67% Crospovidone  7.50 mg  3.49% Croscarmellose sodium 15.00 mg  6.98% Mg Stearate  1.50 mg  0.7% Total Tablet 215.0 mg 100.0%

TABLE-US-00004 Tablet 2: Immediate/Sustained Release Dextromethorphan and Guaifenesin Ingredient mg/tablet % Weight Guaifenesin 600.0 mg  74.77% Hypromellose 19.00 mg  2.37% MCC 129.40 mg  16.12% Dextromethorphan HBr 30.0 mg 3.74% Povidone 7.00 mg 0.87% Croscarmellose Sodium 6.00 mg 0.74% Hydroxy ethyl cellulose 9.00 mg 1.12% Colourant 0.20 mg 0.025% Mg Stearate  1.9 mg 0.24% Total Layer 802.5 mg  100.0%

Example 3

[0357]

TABLE-US-00005 Tablet 1: Naproxen Ingredient mg/tablet % Weight Naproxen Sodium 110.0 mg 73.33%  Microcrystalline Cellulose 14.55 mg 9.7% Lactose 12.65 mg 8.4% Povidone  4.65 mg 3.1% Croscarmellose sodium  7.15 mg 4.8% Mg Stearate    1 mg 0.7% Total Tablet 150.0 mg 100.0% 

TABLE-US-00006 Tablet 2: Immediate/Modified Release Dextromethorphan and Guaifenesin Ingredient mg/tablet % Weight Immediate Release Layer Guaifenesin 200 mg  63.77% Dextromethorphan HBr 10 mg 3.19% Microcrystalline Cellulose 85 mg 27.10% Povidone 10 mg 3.19% Croscarmellose Sodium 8.5 mg  2.71% Mg Stearate 0.15 mg.sup.  0.05% Total Layer 313.65 mg    100.00% Modified Release Layer Guaifenesin 400 mg  84.54% Dextromethorphan HBr 20 mg 4.23% Hypromellose (K100M) 24.5 mg.sup.  5.18% Hydroxyethylcellulose 12.25 mg   2.59% Microcrystalline Cellulose 14.75 mg   3.12% Colourant 0.1 mg  0.02% Mg Stearate 1.55 mg.sup.  0.33% Total Layer 473.15 mg    100.00% Total Tablet 786.8 mg   100.0%

Example 4

[0358]

TABLE-US-00007 Tablet 1: Naproxen Ingredient mg/tablet % Weight Naproxen Sodium 110 mg  73.33% Microcrystalline Cellulose 6 mg 4.00% Lactose 5 mg 3.33% Povidone 3 mg 2.00% Sodium lauryl sulfate 25 mg  16.67% Mg Stearate 1 mg 0.67% Total Tablet 150.0 mg    100.0%

TABLE-US-00008 Tablet 2: Immediate/ Modified Release Dextromethorphan and Guaifenesin Ingredient mg/tablet % Weight Immediate Release Layer Guaifenesin  200 mg 63.77% Dextromethorphan HBr   10 mg  3.19% Microcrystalline Cellulose   85 mg 27.10% Povidone   10 mg  3.19% Croscarmellose Sodium  8.5 mg  2.71% Mg Stearate 0.15 mg  0.05% Total Layer 313.65 mg  100.00%  Modified Release Layer Guaifenesin   400 mg 84.54% Dextromethorphan HBr   20 mg  4.23% Hypromellose (K100M)  24.5 mg  5.18% Hydroxyethylcellulose 12.25 mg  2.59% Microcrystalline Cellulose 14.75 mg  3.12% Colourant  0.1 mg  0.02% Mg Stearate  1.55 mg  0.33% Total Layer 473.15 mg  100.00%  Total Tablet 786.8 mg 100.0%

Example 5

[0359]

TABLE-US-00009 Tablet 1: Naproxen Ingredient mg/tablet % Weight Naproxen Sodium 110.0 mg 73.33% Microcrystalline Cellulose 14.55 mg  9.7% Lactose 12.65 mg  8.4% Povidone  4.65 mg  3.1% Croscarmellose sodium  7.15 mg  4.8% Mg Stearate    1 mg  0.7% Total Tablet 150.0 mg 100.0%

TABLE-US-00010 Tablet 2: Immediate/Modified Release Dextromethorphan and Guaifenesin Ingredient mg/tablet % Weight Immediate Release Layer Guaifenesin  130 mg 54.83% Dextromethorphan HBr 7.00 mg 2.95% Microcrystalline Cellulose 85.00 mg  35.85% Povidone 8.00 mg 3.37% Croscarmellose Sodium 7.00 mg 2.95% Mg Stearate 0.10 mg 0.04% Total Layer 237.10 mg  100.00% Modified Release Layer Guaifenesin  470 mg 86.35% Dextromethorphan HBr .sup. 23 mg 4.23% Hypromellose (K100M) .sup. 17 mg 3.12% Hydroxyethylcellulose .sup. 17 mg 3.12% Microcrystalline Cellulose 15.5 mg 2.85% Colourant  0.1 mg 0.02% Mg Stearate  1.7 mg 0.31% Total Layer 544.3 mg  100.00% Total Tablet 781.40 mg  100.0%

Example 6

[0360]

TABLE-US-00011 Tablet 1: Naproxen Ingredient mg/tablet % Weight Naproxen Sodium 110 mg  73.33% Microcrystalline Cellulose 6 mg 4.00% Lactose 5 mg 3.33% Povidone 3 mg 2.00% Sodium lauryl sulfate 25 mg  16.67% Mg Stearate 1 mg 0.67% Total Tablet 150.0 mg    100.0%

TABLE-US-00012 Tablet 2: Immediate/Modified Release Dextromethorphan and Guaifenesin Ingredient mg/tablet % Weight Immediate Release Layer Guaifenesin   130 mg 54.83% Dextromethorphan HBr  7.00 mg  2.95% Microcrystalline Cellulose 85.00 mg 35.85% Povidone  8.00 mg  3.37% Croscarmellose Sodium  7.00 mg  2.95% Mg Stearate  0.10 mg  0.04% Total Layer 237.10 mg  100.00%  Modified Release Layer Guaifenesin   470 mg 86.35% Dextromethorphan HBr    23 mg  4.23% Hypromellose (K100M)    17 mg  3.12% Hydroxyethylcellulose    17 mg  3.12% Microcrystalline Cellulose  15.5 mg  2.85% Colourant   0.1 mg  0.02% Mg Stearate   1.7 mg  0.31% Total Layer 544.3 mg 100.00%  Total Tablet 781.40 mg  100.0%

Example 7

[0361]

TABLE-US-00013 Tablet 1: Naproxen Ingredient mg/tablet % Weight Naproxen Sodium   110 mg 73.33% Microcrystalline Cellulose 34.45 mg 22.97% Povidone  4.5 mg  3.00% Mg Stearate  1.05 mg  0.7% Total Tablet 150.0 mg 100.0%

TABLE-US-00014 Tablet 2: Immediate/Modified Release Dextromethorphan and Guaifenesin Ingredient mg/tablet % Weight Immediate Release Layer Guaifenesin 85.5 mg 47.50% Dextromethorphan HBr 6.75 mg 3.75% Microcrystalline Cellulose 78.77 mg  43.76% Hypromellose 4.50 mg 2.50% Sodium Starch Glycolate 3.58 mg 1.99% Mg Stearate 0.90 mg 0.50% Total Layer 180.00 mg  100.00% Modified Release Layer Guaifenesin 514.50 mg  88.83% Dextromethorphan HBr 23.25 mg  4.03% Hypromellose 27.50 mg  4.75% Carbomer 8.25 mg 1.42% Colourant 0.22 mg 0.04% Mg Stearate 5.50 mg 0.95% Total Layer 579.22 mg  100.00% Total Tablet 759.22 mg  100.0%

Example 8

[0362]

TABLE-US-00015 Tablet 1: Naproxen Ingredient mg/tablet % Weight Naproxen Sodium .sup. 110 mg 73.33% Microcrystalline Cellulose 34.45 mg 22.97% Povidone  4.5 mg 3.00% Mg Stearate  1.05 mg 0.7% Total Tablet 150.0 mg 100.0%

TABLE-US-00016 Tablet 2: Immediate/Modified Release Dextromethorphan and Guaifenesin Ingredient mg/tablet % Weight Immediate Release Layer Guaifenesin 76.00 mg 47.50% Dextromethorphan HBr  6.00 mg  3.75% Microcrystalline Cellulose 70.02 mg 43.76% Hypromellose  4.00 mg  2.50% Sodium Starch Glycolate  3.18 mg  1.99% Mg Stearate  0.80 mg  0.50% Total Layer 160.00 mg  100.00%  Modified Release Layer Guaifenesin 424.00 mg  91.74% Dextromethorphan HBr 24.00 mg  5.19% Carbomer  9.90 mg  2.14% Colourant  0.26 mg  0.06% Mg Stearate  4.00 mg  0.87% Total Layer 462.16 mg  100.00%  Total Tablet 622.16 mg  100.0%

Example 9

[0363]

TABLE-US-00017 Tablet 1: Naproxen Ingredient mg/tablet % Weight Naproxen Sodium  110 mg 73.33% Microcrystalline Cellulose 14.5 mg  9.67% Povidone 4.75 mg  3.17% Mg Stearate 0.75 mg   0.7% Lactose 10.00 mg   6.67% Croscarmellose Sodium 10.00 mg   6.67% Total Tablet 150.0 mg  100.0%

TABLE-US-00018 Tablet 2: Immediate/Modified Release Dextromethorphan and Guaifenesin Ingredient mg/tablet % Weight Immediate Release Layer Guaifenesin 85.5 mg 47.50% Dextromethorphan HBr 6.75 mg 3.75% Microcrystalline Cellulose 78.77 mg  43.76% Hypromellose 4.50 mg 2.50% Sodium Starch Glycolate 3.58 mg 1.99% Mg Stearate 0.90 mg 0.50% Total Layer 180.00 mg  100.00% Modified Release Layer Guaifenesin 514.50 mg  88.83% Dextromethorphan HBr 23.25 mg  4.03% Hypromellose 27.50 mg  4.75% Carbomer 8.25 mg 1.42% Colourant 0.22 mg 0.04% Mg Stearate 5.50 mg 0.95% Total Layer 579.22 mg  100.00% Total Tablet 759.22 mg  100.0%

Example 10

[0364]

TABLE-US-00019 Tablet 1: Naproxen Ingredient mg/tablet % Weight Naproxen Sodium   110 mg 73.33%  Microcrystalline Cellulose  14.5 mg 9.67% Povidone  4.75 mg 3.17% Mg Stearate  0.75 mg  0.7% Lactose 10.00 mg 6.67% Croscarmellose Sodium 10.00 mg 6.67% Total Tablet 150.0 mg 100.0% 

TABLE-US-00020 Tablet 2: Immediate/Modified Release Dextromethorphan and Guaifenesin Ingredient mg/tablet % Weight Immediate Release Layer Guaifenesin 76.00 mg 47.50% Dextromethorphan HBr  6.00 mg  3.75% Microcrystalline Cellulose 70.02 mg 43.76% Hypromellose  4.00 mg  2.50% Sodium Starch Glycolate  3.18 mg  1.99% Mg Stearate  0.80 mg  0.50% Total Layer 160.00 mg  100.00%  Modified Release Layer Guaifenesin 424.00 mg  91.74% Dextromethorphan HBr 24.00 mg  5.19% Carbomer  9.90 mg  2.14% Colourant  0.26 mg  0.06% Mg Stearate  4.00 mg  0.87% Total Layer 462.16 mg  100.00%  Total Tablet 622.16 mg  100.0%

Example 11

[0365]

TABLE-US-00021 Tablet 1: Naproxen Ingredient mg/tablet % Weight Naproxen Sodium  110 mg 72.37%  Microcrystalline Cellulose 9.25 mg 6.09% Povidone 4.75 mg 3.13% Mg Stearate 1.00 mg 0.66% Sodium Lauryl Sulphate 25.00 mg  16.45%  Croscarmellose Sodium 2.00 mg 1.32% Total Tablet 150.0 mg  100.0% 

TABLE-US-00022 Tablet 2: Immediate/Modified Release Dextromethorphan and Guaifenesin Ingredient mg/tablet % Weight Immediate Release Layer Guaifenesin 85.5 mg 47.50% Dextromethorphan HBr 6.75 mg  3.75% Microcrystalline Cellulose 78.77 mg  43.76% Hypromellose 4.50 mg  2.50% Sodium Starch Glycolate 3.58 mg  1.99% Mg Stearate 0.90 mg  0.50% Total Layer 180.00 mg   100.00%  Modified Release Layer Guaifenesin 514.50 mg  88.83% Dextromethorphan HBr 23.25 mg  4.03% Hypromellose 27.50 mg  4.75% Carbomer  8.25 mg  1.42% Colourant  0.22 mg  0.04% Mg Stearate  5.50 mg  0.95% Total Layer 579.22 mg  100.00%  Total Tablet 759.22 mg  100.0%

Example 12

[0366]

TABLE-US-00023 Tablet 1: Naproxen Ingredient mg/tablet % Weight Naproxen Sodium   110 mg 72.37% Microcrystalline Cellulose  9.25 mg  6.09% Povidone  4.75 mg  3.13% Mg Stearate  1.00 mg  0.66% Sodium Lauryl Sulphate 25.00 mg 16.45% Croscarmellose Sodium  2.00 mg  1.32% Total Tablet 150.0 mg 100.0%

TABLE-US-00024 Tablet 2: Immediate/Modified Release Dextromethorphan and Guaifenesin Ingredient mg/tablet % Weight Immediate Release Layer Guaifenesin 76.00 mg 47.50% Dextromethorphan HBr  6.00 mg  3.75% Microcrystalline Cellulose 70.02 mg 43.76% Hypromellose  4.00 mg  2.50% Sodium Starch Glycolate  3.18 mg  1.99% Mg Stearate  0.80 mg  0.50% Total Layer 160.00 mg  100.00%  Modified Release Layer Guaifenesin 424.00 mg  91.74% Dextromethorphan HBr 24.00 mg  5.19% Carbomer  9.90 mg  2.14% Colourant  0.26 mg  0.06% Mg Stearate  4.00 mg  0.87% Total Layer 462.16 mg  100.00%  Total Tablet 622.16 mg  100.0%

[0367] An advantage of the present invention is that there is provided a pharmaceutical dosage form which brings together two or more medicaments and which is simple to manufacture.

[0368] In addition, the pharmaceutical dosage form of the present invention allows for individual tablets having different dimensions to be combined into a single administrable dosage form.

[0369] The present application is primarily directed to the combination of two tablets. However, the person skilled in the art will easily be able to adapt the pharmaceutical dosage form to the presence of more than two tablets, especially three or four tablets.

[0370] In addition, it is possible by to incorporate separating sheets or walls into the capsule where necessary. For example, it will be possible for the person skilled in the art to envisage pharmaceutical dosage forms comprising multi-compartment gelatin or HPMC capsules.

[0371] Such a gelatin or HPMC capsule therefore comprises at least two compartments each containing a tablet according to the invention, which are separated from one another by a separating wall.

[0372] Further modifications and developments can be made without departing from the scope of the invention described herein.