IP Library › Patent Application 13131370
Patent Application
App. No. 13/131,370

PHEHYLEPHRINE FORMULATIONS WITH IMPROVEDS STABILITY

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Patent No.
US None
App. No.
13/131,370
Abstract

A pharmaceutical composition includes a pharmaceutical polysaccharide and phenylephrine hydrochloride. The ratio of said polysaccharide to phenylephrine hydrochloride is sufficient to dilute the composition such that phenylephrine hydrochloride is stable at high temperature and humidity.

Claims (29)

1 . A composition comprising

a pharmaceutical polysaccharide and phenylephrine hydrochloride;

wherein the ratio of said polysaccharide to phenylephrine hydrochloride is sufficient to dilute the composition such that phenylephrine hydrochloride is stable at high temperature and humidity.

2 . The composition of claim 1 wherein the weight ratio of phenylephrine hydrochloride to polysaccharide is at least 1:20.

3 . The composition of claim 1 wherein the weight ratio of phenylephrine hydrochloride to polysaccharide is at least 1:30.

4 . The composition of claim 1 wherein the weight ratio of phenylephrine hydrochloride to polysaccharide is at least 1:40.

5 . The composition of claim 1 wherein the polysaccharide is maltodextrin.

6 . The composition of claim 5 wherein the weight ratio of phenylephrine hydrochloride to maltodextrin is at least 1:20.

7 . The composition of claim 5 wherein the weight ratio of phenylephrine hydrochloride to maltodextrin is at least 1:30.

8 . The composition of claim 5 wherein the weight ratio of phenylephrine hydrochloride to maltodextrin is at least 1:40.

9 . The composition of claim 1 comprising 650 mg acetaminophen, 25 mg diphenhydramine hydrochloride, 10 mg phenylephrine hydrochloride, and 312 mg maltodextrin per dose.

10 . The composition of claim 1 comprising 650 mg acetaminophen, 20 mg dextromethorphan hydrobromide, 10 mg phenylephrine hydrochloride and 456 mg maltodextrin per dose.

11 . The composition of claim 1 comprising 650 mg acetaminophen, 20 mg pheniramine maleate, 10 mg phenylephrine hydrochloride, 400-600 mg maltodextrin, and 50 mg ascorbic acid

12 . The composition of any of claims 1 to 11 wherein when the composition is exposed to a temperature of 30° C. and 70% relative air humidity for 24 months, at least 95% of the original amount of phenylephrine hydrochloride is still present in the composition.

13 . The composition of any of claims 1 to 12 wherein the composition is processed by a roller compactor-mill-sieve equipment train.

14 . A method of making a composition according to any of claims 1 to 13 comprising

combining a pharmaceutical polysaccharide and phenylephrine hydrochloride; and

mixing to form a pharmaceutical composition;

wherein the amount of the polysaccharide is sufficient to dilute the phenylephrine hydrochloride such that phenylephrine hydrochloride is stable at high temperature and humidity.

15 . The method of claim 14 wherein the polysaccharide is maltodextrin.

16 . The method of claim 15 wherein the weight ratio of phenylephrine hydrochloride to maltodextrin is at least 1:20.

17 . The method of claim 15 wherein the weight ratio of phenylephrine hydrochloride to maltodextrin is at least 1:30.

18 . The method of claim 15 wherein the weight ratio of phenylephrine hydrochloride to maltodextrin is at least 1:40.

19 . The method of claim 14 wherein the weight ratio of phenylephrine hydrochloride to polysaccharide is at least 1:20.

20 . The method of claim 14 wherein the weight ratio of phenylephrine hydrochloride to polysaccharide is at least 1:30.

21 . The method of claim 14 wherein the weight ratio of phenylephrine hydrochloride to polysaccharide is at least 1:40.

22 . The method of claim 14 wherein the tableting composition comprises 650 mg acetaminophen, 25 mg diphenhydramine hydrochloride, 10 mg phenylephrine hydrochloride and 312 mg maltodextrin per dose.

23 . The method of claim 14 wherein the tableting composition comprises 650 mg acetaminophen, 20 mg dextromethorphan hydrobromide, 10 mg phenylephrine hydrochloride and 456 mg maltodextrin per dose.

24 . The method of claim 14 wherein the tableting composition comprises 650 mg acetaminophen, 20 mg pheniramine maleate, 10 mg phenylephrine hydrochloride, 400-600 mg maltodextrin, and 50 mg ascorbic acid.