Enteric coating composition and method of making and using the same
AssigneeSensient Colors LLC
InventorsSteven Luedecke, Houston Smith
Life of this patent
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Abstract
A dosage form coating composition is disclosed. The composition includes an alginate, a pectin, a plasticizer, and optionally an emulsifying agent. The alginate is present in an amount by weight of at least 40.0% and at most 80.0% and the pectin is present in an amount by weight of at least 16.0% and at most 40.0%—and/or—the alginate and the pectin are present in a weight ratio of at least 1:1 and at most 5:1. The dosage form coating composition, when applied to a dosage form to a 3% to 5% weight gain, provides a coated dosage form having an enteric coating. The coated dosage form has at least two sequentially observed properties exhibiting enteric coating behavior.
Claims20
A dosage form coating composition comprising:
- an alginate in an amount by weight of at least 40.0% and at most 80.0%;
- a pectin in an amount by weight of at least 16.0% and at most 40.0%;
- and
- a plasticizer in an amount by weight of at least 0.5% and at most 30.0%;
- wherein the dosage form coating composition, when applied to a dosage form to a 3% to 5% weight gain, provides a coated dosage form having an enteric coating and at least the following two sequentially observed properties:
- (i) the enteric coating does not exhibit visible signs of dissolution after being immersed in a 0.1 M solution of hydrochloric acid or simulated gastric fluid at a predetermined temperature and for a first predetermined length of time, wherein the predetermined temperature is between 30° C. and 45° C., wherein the first predetermined length of time is between 15 minutes and 3 hours;
- and
- (ii) after the being immersed in the 0.1 M solution of hydrochloric acid or simulated gastric fluid, the enteric coating is at least partially dissolved after being immersed in a phosphate buffer having a pH between 6.5 and 7.0 or simulated intestinal fluid at the predetermined temperature for a second predetermined length of time, wherein the second predetermined length of time is between 60 minutes and 6 hours.
A dosage form coating composition comprising:
- an alginate in an amount by weight of at least 40.0% and at most 80.0%;
- a pectin;
- and
- a plasticizer;
- wherein the alginate and the pectin are present in a weight ratio of at least 1:1 and at most 5:1, wherein the dosage form coating composition, when applied to a dosage form to a 3% to 5% weight gain, provides a coated dosage form having an enteric coating and at least the following two sequentially observed properties:
- (i) the enteric coating does not exhibit visible signs of dissolution after being immersed in a 0.1 M solution of hydrochloric acid or simulated gastric fluid at a predetermined temperature and for a first predetermined length of time, wherein the predetermined temperature is between 30° C. and 45° C., wherein the first predetermined length of time is between 15 minutes and 3 hours;
- and
- (ii) after the being immersed in the 0.1 M solution of hydrochloric acid or simulated gastric fluid, the enteric coating is at least partially dissolved after being immersed in a phosphate buffer having a pH between 6.5 and 7.0 or simulated intestinal fluid at the predetermined temperature for a second predetermined length of time, wherein the second predetermined length of time is between 60 minutes and 6 hours.
Dependencies are inferred from the claim text.