Ibuprofen composition
View Patent ↗Fumaric acid is added in amounts sufficient to reduce the burn sensation commonly associated with propionic acid derivatives.
1. A method for reducing the burn sensation of propionic acid derivative compositions comprising:
providing a therapeutically effective amount of a racemic mixture of a propionic acid derivative that is provided with a hydrocolloid coating, which is optionally provided as a granule containing active and excipients,
providing from about 50 to about 150 weight percent of fumaric acid based upon the weight of propionic acid derivatives in an excipient formulation;
admixing said racemic mixture of a propionic acid derivative and excipient formulation containing said fumaric acid to form a mixture;
provided said coating is substantially free of fumaric acid.
2. The method of claim 1 wherein the racemic mixture of a propionic acid derivative is ibuprofen.
3. The method of claim 1 wherein the fumaric acid and racemic mixture of a propionic acid derivative are admixed in a granulation process.
4. The method of claim 1 wherein the granulation process is conducted with a non-hydrocolloid binder.
5. The method of claim 2 wherein the ibuprofen is granulated with excipients.
6. The method of claim 1 wherein the hydrocolloid coating consists essentially of one or more cellulose derivatives.
7. The method of claim 1 wherein the hydrocolloid is selected from the group consisting of hydroxyethylcellulose, hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxymethylcellulose and mixtures thereof.
8. The method of claim 5 wherein the excipients are selected from the group consisting of polyvinylpyrrolidone, sodium starch glycolate and sodium lauryl sulfate, and cellulose derivatives.