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Claims for Patent: 4,515,805

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Claims for Patent: 4,515,805

Title: Soluble sodium cromoglycate compositions
Abstract:There is described a mixture of sodium cromoglycate of mass median diameter from 2 to 30 microns with a pharmaceutically acceptable water soluble carrier of sieve size from 200 to 1000 microns, the carrier having a solubility of greater than 1 to 5 by weight in water at 20.degree. C. The mixture is useful in the treament of conditions of the gastrointestinal tract.
Inventor(s): Newman; Peter M. (Keyworth, GB2), Jenkins; Anthony W. (Loughborough, GB2)
Assignee: Fisons plc (Ipswich, GB2)
Application Number:06/515,608
Patent Claims: 1. A water-soluble composition for treatment of a condition of a gastro-intestinal tract comprising:

a particulate water-soluble pharmaceutically acceptable carrier consisting essentially of sucrose and having a particle size of 200-1000 microns; and

particulate sodium cromoglycate having a mass median diameter of 2-30 microns forming a coating on said carrier particles.

the proportion of carrier to sodium cromoglycate in the coated particles being 2-20 parts by weight of carrier to 1 part of sodium cromoglycate.

2. A composition according to claim 1, wherein the sodium cromoglycate has a mass median diameter of from 2 to 10 microns, and the water soluble carrier has a particle size of from 200 to 500 microns.

3. A composition according to claim 1 containing from 5 to 12 parts by weight of sucrose for each part by weight of sodium cromoglycate.

4. A composition according to claim 1 in unit dosage form containing from 50 to 300 mg of sodium cromoglycate.

5. A composition according to claim 4 contained in a sachet made of material which will prevent the ingress of water.

6. A composition according to claim 1 containing less than 2% by weight of water.

7. A composition according to claim 1 containing no other excipient than the water soluble carrier.

8. A method for preparing a sodium cromoglycate composition having an increased rate of dissolution in cold water which comprises depositing particulate sodium cromoglycate having a mass median diameter of 2-30 microns as a surface layer on a particulate water-soluble pharmaceutically acceptable carrier having a particle size of 200-1000 microns and consisting essentially of sucrose, the proportion of carrier to sodium cromoglycate in the coated particles being 2-20 parts of weight of carrier to 1 part of sodium cromoclycate.

9. The method of claim 8 wherein the sodium cromoglycate has a mass median diameter of 2-10 microns, and the water soluble carrier has a particle size of 200-500 microns.

10. The method of claim 8 wherein the proportion of carrier to sodium cromoglycate in the coated particles is 5-12 parts by weight of carrier to 1 part of sodium cromoglycate.
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