Intas Pharmaceuticals Limited

Satyavan Dhavale

Ashish Sehgal

Rikin Patel

Piyush Kansagra

Kavan Pandya

Disclosed are stable extended release formulations and pharmaceutical compositions of Clozapine that exhibit improved stability under a variety of conditions, as well as processes for the preparation of such formulations and compositions.

Stable extended release pharmaceutical composition of clozapine

Disclosed is an extended release pharmaceutical composition of Clozapine, which can be provided as a reservoir type dosage form, and when dosed to a patient once daily achieves at steady state, AUC, Cand Cin patient plasma that are within 80 to 125% bioequivalence criteria compared to immediate release Clozapine dosed at the same total daily dose divided twice per day. Further, the pharmaceutical composition of Clozapine can provide once daily dosing regimen in order to improve patient compliance and reduces side effects in patients in need thereof. The pharmaceutical composition further lacks any significant food effect on oral administration.

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Ahmedabad, India

Satyavan Dhavale