Stabilized picoplatin oral dosage form
AssigneePoniard Pharmaceuticals, Inc.
InventorsAlistair J. Leigh, Christopher A. Procyshyn, Ernest S.Y. Wong, Christen M. Giandomenico
Life of this patent
Estimating the term…
Abstract
The invention provides an oral dosage form for the anti-cancer drug picoplatin comprising a core and a coating, the dosage form being free of redox-active metal salts. The core of the tablet is a substantially dry powder comprising about 10 to 60 wt % picoplatin wherein the picoplatin is a particulate of less than about 10 microns average particle diameter, about 40-80 wt % of a filler comprising a substantially water-soluble, water-dispersible, or water-absorbing carbohydrate, and an effective amount of up to about 5 wt % of a lubricant. The dosage form can further include a dispersant.
Claims65
An oral dosage form for picoplatin wherein the dosage form comprises a solid core comprising about 10 to 60 wt % particulate picoplatin wherein the picoplatin is a particulate of less than about 10 microns average particle diameter, about 40-80 wt % of a filler comprising a substantially water-soluble, water-dispersible, or water-absorbing carbohydrate, and an effective amount of up to about 5 wt % of a lubricant;
- and a continuous coating on the outer surface of the core;
- wherein the core and the coating are substantially free of a redox-active metal salt.
A process for preparing an oral dosage form for picoplatin, the process comprising:
- forming a solid core comprising about 10 to 60 wt % picoplatin wherein the picoplatin is a particulate of less than about 10 microns average particle diameter, about 40-80 wt % of a filler comprising a substantially water-soluble, water-dispersible, or water-absorbing carbohydrate, an effective amount of up to about 5 wt % of a lubricant, and, optionally, about 5-10 wt % of a dispersant;
- and applying a continuous coating on the outer surface of the core, wherein the core and the coating are free of a redox-active metal salt.
An oral dosage form for picoplatin prepared by a process comprising:
- (a) compressing a powder formed from a granulate comprising about 10-60 wt % picoplatin, wherein the picoplatin is a particulate of less than about 10 microns average particle diameter, about 40-80 wt % of a filler comprising a substantially water-soluble, water-dispersible or water absorbing carbohydrate, an effective amount of up to about 5 wt % lubricant, and optionally a dispersing agent to yield a tablet core, and (b) coating the tablet core to yield a coated tablet having a water-soluble or water dispersible coating on the outer surface thereof, wherein the core and the coating are substantially free of a redox-active metal salt.
An oral dosage form for picoplatin prepared by a process comprising:
- (a) molding a powder formed from a granulate comprising about 10-60 wt % picoplatin, wherein the picoplatin is a particulate of less than about 10 microns average particle diameter, about 40-80 wt % of a filler comprising a substantially water-soluble, water-dispersible or water absorbing carbohydrate, an effective amount of up to about 5 wt % lubricant, and optionally a dispersing agent to yield a pill core, and (b) coating the pill core to yield a coated pill having a water-soluble or water dispersible coating on the outer surface thereof, wherein the core and the coating are substantially free of a redox-active metal salt.
An oral dosage form for picoplatin prepared by a process comprising:
- (a) compressing a powder formed from a granulate comprising about 10-60 wt % picoplatin, wherein the picoplatin is a particulate of less than about 10 microns average particle diameter, about 40-80 wt % of a filler comprising a substantially water-soluble, water-dispersible or water absorbing carbohydrate, an effective amount of up to about 5 wt % lubricant, and optionally a dispersing agent to yield a tablet core, and (b) coating the tablet core with gelatin to yield a geltab, wherein the core and the gelatin are substantially free of a redox-active metal salt.
An oral dosage form for picoplatin wherein the dosage form comprises a solid core comprising about 10 to 60 wt % particulate picoplatin wherein the picoplatin is a particulate of less than about 10 microns average particle diameter, about 40-80 wt % of a filler comprising a substantially water-soluble, water-dispersible, or water-absorbing carbohydrate, and an effective amount of up to about 5 wt % of a lubricant;
- and a continuous coating on the outer surface of the core;
- wherein the coating is substantially free of titanium dioxide.
An oral dosage form for picoplatin wherein the dosage form comprises a solid core comprising about 10 to 60 wt % particulate picoplatin wherein the picoplatin is a particulate of less than about 10 microns average particle diameter, about 40-80 wt % of a filler comprising a substantially water-soluble, water-dispersible, or water-absorbing carbohydrate, and an effective amount of up to about 5 wt % of a lubricant;
- and a continuous coating on the outer surface of the core;
- wherein the coating is substantially free of Fe2O3.
An oral dosage form for picoplatin wherein the dosage form comprises a solid core comprising about 10 to 60 wt % particulate picoplatin wherein the picoplatin is a particulate of less than about 10 microns average particle diameter, about 40-80 wt % of a filler comprising a substantially water-soluble, water-dispersible, or water-absorbing carbohydrate, and an effective amount of up to about 5 wt % of a lubricant;
- and a continuous coating on the outer surface of the core;
- wherein the coating is substantially free of Fe+2.
65-68. (canceled)
Dependencies are inferred from the claim text.