Controlled release pharmaceutical formulations of nitazoxanide
AssigneeRomark Laboratories L.C.
InventorsJean-Francois Rossignol, Marc Ayers
Life of this patent
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Abstract
Solid dosage formulations of nitazoxanide or a nitazoxanide analogue are provided that comprise a controlled release portion and an immediate release portion. The pharmaceutical composition is typically in the form of a bilayer solid oral dosage form comprising (a) a first layer comprising a first quantity of nitazoxanide or analogue thereof in a controlled release formulation; and (b) a second layer comprising a second quantity of nitazoxanide or analogue thereof in an immediate release formulation. Method of using the formulations in the treatment of hepatitis C are also provided.
Claims15
A pharmaceutical composition in the form of a solid oral dosage form comprising:
- (a) a first portion comprising a first quantity of nitazoxanide or an analogue thereof in a controlled release formulation;
- and
- (b) a second portion comprising a second quantity of nitazoxanide or an analogue thereof in an immediate release formulation,
- wherein the ratio of the first quantity of nitazoxanide or an analogue thereof to the second quantity of nitazoxanide or an analogue thereof is about 2.5:1 to about 4:1.
A bilayer tablet for oral administration, the tablet comprising:
- (a) a first layer comprising about 500 mg of nitazoxanide in a controlled release formulation;
- and
- (b) a second layer comprising about 175 mg of nitazoxanide in an immediate release formulation, the second layer deposited on top of and compressed with the first layer to form a core tablet;
- and
- (c) an outer coating applied to the core tablet;
- wherein the first layer further comprises a low-viscosity hydroxypropylmethylcellulose.
Dependencies are inferred from the claim text.