Intas Pharmaceuticals Limited

Rikin Patel

Ashish Sehgal

Piyush Kansagra

Balvir Singh

Mayank Saxena

Satyavan Dhavale

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

An extended release pharmaceutical composition of Clozapine The extended release composition of Clozapine provides an extended release pharmaceutical composition having Clozapine, a seal coating, an acidic coating, and an extended release coating. The composition is particularly suitable for dispensing a once-a-day solid oral pharmaceutical formulation which releases a therapeutically effective amount of Clozapine over an extended time period.

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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Sanand, India

Rikin Patel