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US 9,433,585 B2Granted
Enteric soft capsules
AssigneeBanner Life Sciences LLC
InventorsEmadEldin M. Hassan, Aqeel A. Fatmi, Nachiapan Chidambaram
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Abstract
Described herein are compositions for manufacturing enteric soft capsules comprising gelatin, methyacrylic copolymers, one or more plasticizers, an alkaline aqueous solvent and, optionally, other ingredients such as colors, and flavors. Capsules made from such compositions are useful for delivery of acid-sensitive dosage forms to the lower gastrointestinal tract or to provide delayed release of active pharmaceutical ingredients.
Claims20
An enteric soft capsule shell comprising:
- (a) gelatin;
- (b) methacrylic acid copolymer;
- (c) plasticizers comprising glycerol and a citric acid ester;
- (c) an alkaline aqueous solvent;
- and
- (d) water;
- wherein
- the weight ratio range of methacrylic acid copolymer to gelatin in the composition is from about 30% to about 40%;
- the weight ratio of the combined weight of plasticizers to the combined weight of gelatin and methacrylic acid copolymer in the composition is about 1:2;
- and
- the final pH of the gel mass is about pH 8.5.
8 more elements
An enteric soft capsule comprising a shell encapsulating a fill, the shell comprising:
- (a) gelatin;
- (b) methacrylic acid copolymer;
- (d) glycerol;
- (e) triethyl citrate;
- (f) ammonia;
- and
- (g) water;
- wherein
- the weight ratio range of methacrylic acid copolymer to gelatin is from about 30% to about 40%;
- the weight ratio of the combined weight of glycerol and triethyl citrate to the combined weight of gelatin and methacrylic acid copolymer is about 50%
- the final pH of the composition about pH 8.5;
- and
- the water content is from about 2% to about 10%.
10 more elements
Dependencies are inferred from the claim text.