Claims for Patent: 4,395,421

Summary for Patent: 4,395,421

Title:	Disodium cromoglycate formulations
Abstract:	There is described disodium cromoglycate in a form having a bulk density of greater than 0.45 g per ml when measured according to British Standard Test No 1460 (1967). There are also described granular and unit dosage forms of disodium cromoglycate. The disodium cromoglycate is useful, e.g. in the treatment of certain conditions of the gastrointestinal tract.
Inventor(s):	Taylor; James E. (Loughborough, GB2), Stevenson; Neil A. (Loughborough, GB2)
Assignee:	Fisons Limited (Ipswich, GB2)
Application Number:	06/067,104
Patent Claims:	1. Disodium cromoglycate produced by wet granulation in a form having a bulk density of from 0.34 to 0.7 g per ml. and containing less than 5% by weight of any other compound, with the exception of water. 2. Disodium cromoglycate according to claim 1 having a bulk density of from 0.53 to 0.66 g per ml. 3. Disodium cromoglycate according to claim 1 in hard granular form. 4. Disodium cromoglycate according to claim 1 containing none of any other compound, with the exception of water. 5. Disodium cromoglycate according to claim 1 in particulate form, wherein less than 20% by weight of the particles are greater than 200 microns in diameter. 6. Disodium cromoglycate according to claim 1 in particulate form, wherein not more than 60% by weight consists of particles of less than 60 microns diameter. 7. Disodium cromoglycate according to claim 1, wherein less than 20% by weight consists of particles of less than 60 microns diameter. 8. A unit dosage form containing 1 to 250 mg of disodium cromoglycate produced by wet granulation in a granular form having a bulk density of from 0.45 to 0.7 g per ml. and less than 5% by weight of any other compound, with the exception of water. 9. A unit dosage form according to claim 8 and containing no lubricant. 10. A unit dosage form according to any of claims 8 or 9 comprising a capsule which is from 60 to 80% full when loosely filled. 11. A unit dosage form of disodium cromoglycate produced by wet granulation containing more than 10% by weight of granular disodium cromoglycate having a bulk density of from 0.45 to 0.70 g per ml., from 5 to 12% by weight of water, and from 35 to 85% by weight of encapsulating material. 12. A unit dosage form according to claim 11 containing more than 50% by weight of granular disodium cromoglycate. 13. A method for alleviating the symptoms of a disorder of the gastrointestinal tract in which an allergic reaction is involved which comprises oral administration of an effective amount of disodium cromoglycate according to claim 1 to a patient suffering from such a condition. 14. A method for alleviating the symptoms of a disorder of the nose in which an allergic reaction is involved which comprises intranasal administration of an effective amount of disodium cromoglycate according to claim 1 to a patient suffering from such a condition.