Iniparib formulations and uses thereof
AssigneeTriact Therapeutics, Inc.
InventorsThomas F. White, Stephen M. Nava
Life of this patent
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Abstract
Disclosed herein are pharmaceutical compositions, formulations, and dosage forms and their use in the treatment of a cancer. Also disclosed herein are methods of treating a cancer in a subject in need thereof.
Claims20
An oral dosage formulation, comprising:
- (i) iniparib or a pharmaceutically acceptable salt, solvate, metabolite, or prodrug thereof;
- (ii) at least one pharmaceutically acceptable excipient;
- and
- (iii) optionally one or more agents selected from the group consisting of surfactants, preservatives, flavoring agents, sweetening agents, and antifoaming agents;
- wherein a median particle size of iniparib or the pharmaceutically acceptable salt, solvate, metabolite, or prodrug thereof is from about 20 μm to about 400 μm;
- and
- wherein the formulation is stable at about 5±5° C. to about 25±5° C. for at least 12 months.
A controlled-release iniparib formulation comprising a controlled-release matrix and from about 30 mg to about 400 mg of iniparib or a pharmaceutically acceptable salt, solvate, or prodrug thereof, wherein a median particle size of iniparib or the pharmaceutically acceptable salt, solvate, metabolite, or prodrug thereof is from about 20 μm to about 400 μm;
- and
- wherein said formulation provides a maximum mean blood concentration of iniparib of between about 200 ng/ml and about 6000 ng/ml upon oral administration to a subject in need thereof.
A controlled-release formulation, comprising:
- (i) iniparib or a pharmaceutically acceptable salt, solvate, metabolite, or prodrug thereof, wherein a median particle size of iniparib or the pharmaceutically acceptable salt, solvate, metabolite, or prodrug thereof is from about 20 μm to about 400 μm;
- (ii) at least one pharmaceutically acceptable excipient;
- and
- (iii) optionally one or more agents selected from the group consisting of surfactants, preservatives, flavoring agents, sweetening agents, and antifoaming agents;
- wherein the controlled release formulation comprises an additional controlled-release layer comprising an anticancer agent, wherein the anticancer agent is temozolomide.
Dependencies are inferred from the claim text.