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US 2016/0106682 A1Published application
Enteric Soft Capsules
AssigneeBanner Life Sciences LLC
InventorsEmadEldin M. HASSAN, Aqeel A. FATMI, Nachiappan CHIDAMBARAM
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Abstract
A gel mass is provided that is useful in manufacturing enteric soft or hard capsules, or enteric tablets without coating.
Claims32
An enteric oral dosage form comprising an enteric soft capsule comprising a capsule shell encapsulating a fill, the capsule shell formed from a gel mass composition comprising:
- (a) a gelatin,
- (b) an acid-insoluble polymer;
- (c) an alkaline aqueous solvent;
- and
- (d) one or more plasticizers;
- wherein
- a weight ratio range of the acid-insoluble polymer to the gelatin in the gel mass composition is from about 30% to about 40%;
- a weight ratio of a combined weight of the plasticizers to a combined weight of the gelatin and the acid-insoluble polymer in the gel mass composition is about 1:2;
- and
- a final pH of the gel mass composition is less than or equal to about 9 pH units.
7 more elements
A process of manufacturing enteric soft capsules, the process comprising:
- (a) preparing a gel mass composition comprising
- (a) a gelatin,
- (b) an acid-insoluble polymer;
- (c) an alkaline aqueous solvent;
- and
- (d) one or more plasticizers;
- wherein
- a weight ratio range of the acid-insoluble polymer to the gelatin in the gel mass composition is from about 30% to about 40%;
- a weight ratio of a combined weight of the plasticizers to a combined weight of the gelatin and the acid-insoluble polymer in the gel mass composition is about 1:2;
- and
- a final pH of the gel mass composition is less than or equal to about 9 pH units;
- (b) casting the gel mass composition into films using heat-controlled drums or surfaces;
- and
- (c) forming a soft capsule using rotary die technology.
11 more elements
Dependencies are inferred from the claim text.