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AssigneeBristol-Myers Squibb Company
InventorsWilliam T. Makooi-Morehead, John D. Buehler, Brian R. Landmann
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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.
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 capsule or compressed tablet according to any preceding claim which is prepared using a wet granulation step containing efavirenz and one or more modified starches, wherein the modified starch is present in the wet granulation step in an amount of from about 10% to about 75% by weight relative to the total dry weight of the components of the wet granulation step.
A capsule or compressed tablet according to any preceding claim, wherein the modified starch is present in the wet granulation step of the manufacturing process in an amount of from about 20% to about 55% by weight relative to total dry weight of the components of the wet granulation step.
A capsule according to any preceding claim, wherein the efavirenz is present in the pharmaceutical dosage form in an amount of from about 5 to about 1000 mg.
A capsule according to any preceding claim, wherein the efavirenz is present in the pharmaceutical dosage form in an amount of from about 5 to about 500 mg.
A capsule according to any preceding claim, wherein the efavirenz is present in the pharmaceutical dosage form in an amount of from 500 to about 1000 mg.
A capsule according to any preceding claim, wherein the efavirenz is present in the pharmaceutical dosage form in an amount of from about 25 to about 350 mg.
A capsule according to any preceding claim, wherein the efavirenz is present in the pharmaceutical dosage form in an amount of from about 50 to about 200 mg.
A pharmaceutical dosage form comprising:
A method for producing a capsule or a compressed tablet pharmaceutical dosage form comprising a therapeutically effective amount of efavirenz and greater than about 10% by weight of sodium starch glycolate relative to the total dry weight of the pharmaceutical dosage form comprising:
Dependencies are inferred from the claim text.