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Claims for Patent: 6,500,456

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Claims for Patent: 6,500,456

Title: Compressed nitroglycerin tablet and its method of manufacture
Abstract:The present invention is directed to a stable nitroglycerin containing pharmaceutical composition, preferably a tablet which is prepared by direct compression technology. The formulation closely replicates the properties of nitroglycerin molded sublingual tablets (e.g. adequate disintegration and sublingual absorption), while reducing the problems experienced with compressed tablets (e.g. friability and weight variations). The stable tablets are characterized by a decreased migration of nitroglycerin, decreased potency loss, excellent content uniformity when stored. The preferred combination of components are: nitroglycerin/lactose dilution, hydrous lactose, glyceril monostearate, fumed silica, pregelantinized starch and calcium stearate. The preferred process employs direct compression technology to yield composition showing adequate disintegration, bioavailability and improved stability.
Inventor(s): Capella; Roberto L. (Landing, NJ)
Assignee: Warner-Lambert Company (Morris Plains, NJ)
Application Number:09/508,705
Patent Claims: 1. A stable composition comprising effective amounts of nitroglycerin, lactose, silica, starch, a stabilizer comprising glyceryl monostearate in an amount of about 0.5 to 10 weight %, and a lubricant, wherein nitroglycerin is the sole pharmacologically active agent.

2. The composition of claim 1 wherein the composition is available as a sublingual tablet.

3. The composition of claim 1 wherein the starch is pregelatinized starch used a disintegrant.

4. The composition of claim 1 wherein the silica is a fumed silica.

5. The composition of claim 1 wherein the lubricant is an alkali metal salt.

6. The composition of claim 1 wherein the lactose is hydrous lactose.

7. The composition of claim 1 comprising the following amounts: 0.5 to about 5 weight % of nitroglycerin; greater than about 90 diluent weight % of lactose; 0.1 to about 1 weight % of silica; 0.1 to about 1 weight % of calcium stearate; 5 to about 15 weight % of starch and about 0.5 to about 10 weight % of glyceryl monostearate.

8. The composition of claim 1 wherein the composition disintegrates on the order from about 20 to about 30 seconds.

9. The composition of claim 1 wherein the variation in weight of the composition is about 1 to about 2% relative standard deviation (RSD).

10. The composition of claim 1 wherein the composition has the following properties: disintegration on the order of about 20 to about 30 seconds; weight variations on the order of about 1 to about 2% relative standard deviation (RSD); content variations on the order of less than about 4% relative standard deviation (RSD); friability on the order of less than about 1%; thickness on the order of about 0.07-0.10", and hardness on the order of about 1-4 kp.

11. The composition of claim 1 wherein the composition is a compressed tablet.

12. A stable compressed tablet consisting essentially of effective amounts of nitroglycerin, lactose, silica, pregelatinized starch, glyceryl monostearate, and lubricant, wherein nitroglycerin is the sole pharmacologically active agent.

13. The composition of claim 12 wherein the silica is fumed silica.

14. The composition of claim 13 wherein the lubricant is calcium stearate.

15. The composition of claim 14 wherein the lactose is hydrous lactose.

16. A dry, compressed product containing nitroglycerin produced by the steps comprising: (a) commingling nitroglycerin with lactose to produce a nitroglycerin dilution in which the content of the active agent is about 2 percent or less; (b) adding and mixing the nitroglycerin dilution with silica, lubricant, glyceryl monostearate, starch, and optionally additional lactose to produce a blend; (c) compressing the blend; and (d) thereafter, recovering the blend as a compressed product.

17. The product of claim 16 wherein the starch is pregelatinized starch.

18. A process for preparing a dry, compressed product containing nitroglycerin produced by the steps comprising: (a) commingling nitroglycerin with lactose to produce a nitroglycerin dilution in which the content of the active agent is about 2 percent or less; (b) adding and mixing the nitroglycerin dilution with silica, lubricant, glyceryl monostearate, starch, and optionally additional lactose to produce a blend; (c) compressing the blend; and (d) thereafter, recovering the blend as a compressed product.

19. A stable composition comprising effective amounts of nitroglycerin, lactose, silica, starch, a stabilizer consisting essentially of glyceryl monostearate in an amount of about 0.5 to 10 weight %, and a lubricant, wherein nitroglycerin is the sole pharmacologically active agent.
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