Formulation of fast-dissolving efavirenz capsules or tablets using super-disintegrants
AssigneeBristol-Myers Squibb Company
InventorsWilliam T. Makooi-Morehead, John D. Buehler, Brian R. Landmann
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Abstract
The present invention provides improved oral dosage form formulations of efavirenz that are useful in the inhibition of human immunodeficiency virus (HIV), the prevention or treatment of infection by HIV, and in the treatment of the resulting acquired immune deficiency syndrome (AIDS). In particular, the present invention relates to compressed tablets or capsules comprising efavirenz that contain one or more disintegrants that enhance the dissolution rate of the efavirenz in the gastrointestinal tract thereby improving the rate and extent of absorption of efavirenz in the body. The present invention also relates to the process of making such tablets or capsules.
Claims15
A method for treating infection by HIV comprising administering to a patient, in need of such treatment, a capsule or a compressed tablet pharmaceutical dosage form comprising a therapeutically effective amount of efavirenz and greater than about 10% by weight of a disintegrant relative to the total dry weight of the pharmaceutical dosage form.
A method for treating infection by HIV comprising administering to a patient, in need of such treatment, a pharmaceutical dosage form comprising:
- (a) a therapeutically effective amount of efavirenz;
- (b) a surfactant;
- (c) a disintegrant;
- (d) a binder;
- (e) a diluent;
- (f) a glidant;
- and
- (g) optionally additional pharmaceutically acceptable excipients;
- wherein at least one disintegrant is selected from the group consisting of modified starches, croscarmellose sodium, carboxymethylcellulose calcium and crospovidone and such disintegrant is present in an amount greater than about 10% by weight of the total dry weight of the capsule contents or the compressed tablet.
Dependencies are inferred from the claim text.