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US 11,690,805 B2Granted
Multi-particulate pharmaceutical composition of quetiapine
AssigneeSun Pharmaceutical Industries Limited
InventorsAmit Kumar, Ravindra Agarwal, Pulak Kumar Metia, Kalaiselvan Ramaraju, Sumit Madan, Romi Barat Singh
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Abstract
The present invention discloses an extended release multi-particulate sprinkle composition comprising a plurality of discrete units, each discrete unit comprising quetiapine or a pharmaceutically acceptable salt thereof and one or more pharmaceutically acceptable excipients.
Claims20
An extended release multi-particulate sprinkle dosage form comprising a plurality of discrete units, wherein each unit comprises:
- a) a drug core comprising an active pharmaceutical ingredient and pharmaceutically acceptable excipients, wherein the active pharmaceutical ingredient consists of quetiapine or a pharmaceutically acceptable salt thereof;
- b) at least two coatings on the drug core and a pore former wherein a first of the at least two coatings is an extended release coating comprising a pH neutral polymer and a second of the at least two coatings comprises a pH sensitive polymer;
- wherein the pore former is in the extended release coating and the ratio of PH neutral polymer and pore former in the extended release coating is 80:20 to 95:5, and
- wherein the release of the drug is controlled by a combination of said at least two coatings,
- wherein said dosage form with high fat meals results in not more than a 35% change in Cmax or AUC when compared to a similar dosing under fasting condition.
2 more elements
An extended release multi-particulate sprinkle dosage form prepared by a process comprising:
- mixing quetiapine or its pharmaceutically acceptable salt with suitable excipients and at least two coatings on a drug core wherein one of the at least two coatings comprises a pH sensitive polymer;
- and
- wherein the release of the drug is controlled by a combination of the at least two coatings.
Dependencies are inferred from the claim text.