Pharmaceutical formulation in the form of a capsule or a compressed tablet comprising efavirenz and process for its preparation

摘要

Pharmaceutical formulation in the form of a capsule or a compressed tablet comprising a therapeutically effective amount of efavirenz and more than 10 % by weight of a disintegrant relative to the total dry weight of the pharmaceutical formulation. Preferred disintegrant is sodium starch glycolate. Method for producing pharmaceutical formulation in the form of a capsule or a compressed tablet comprising a therapeutically effective amount of efavirenz and more than 10 % by weight of sodium starch glycolate relative to the total dry weight of the pharmaceutical formulation which comprises (a) wet granulating efavirenz and sodium starch glycolate in a high-shear granulator using an aqueous solution of sodium lauryl sulfate; (b) drying the product of step (a); (c) milling the product of step (b); (d) dry blending the product of step (c) with sodium starch glycolate and additional pharmaceutically acceptable excipients; and (e) encapsulating or compressing into tablets the product of step (d).