Controlled release pharmaceutical composition
OwnerJose Gutierrez-Rocca, Josephine Dunne +1inventors
InventorsJose Gutierrez-Rocca, Josephine Dunne, Saul A. Rios
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Abstract
A sustained/prolonged release pharmaceutical dosage form is disclosed. The form comprises a hard shell capsule and a formulation comprising (a) a water insoluble medicament, (b) a high melting fatty ester, (c) a low viscosity oil, (d) a cellulosic polymer, and (e) a non-ionic surfactant.
Claims42
A sustained/or prolonged release pharmaceutical unit dosage form comprising a hard shell capsule and a formulation comprising:
- (a) a water insoluble medicament;
- (b) a high melting fatty acid ester selected from the group consisting of glyceryl behenate, glyceryl palmitostearate and glyceryl stearate;
- (c) a low viscocity oil selected from the group consisting of corn oil, cottonseed oil, menhaden oil, safflower oil, sesame oil, shark-liver oil, soybean oil, olive oil and saturated polyglycolized glycerides;
- (d) a cellulosic polymer selected from the group consisting of methocel A series, methocel E series, methocel K series, and ethocel P series;
- low-substituted hydroxypropyl ether cellulose polymers selected from the group consisting of LH11, LH22, and LH30;
- and
- (e) a non-ionic surfactant.
A pharmaceutical formulation comprising a water insoluble medicament selected from the group consisting of hydroxyzine pamoate, nifedipine, nimodipine, nisoldipine, nicardipine, amlodipine, atorvastatin, simvastatin, lovastatin, genfibrozil, fenofibrate and clofibrate associated with,
- (a) a high melting fatty acid ester selected from the group consisting of glyceryl behenate, glyceryl palmitostearate and glyceryl stearate;
- (b) an oil selected from the group consisting of corn oil, cottonseed oil, menhaden oil, safflower oil, sesame oil, shark-liver oil, soybean oil, olive oil, wheat grain oil and a low viscocity polyglycolized glyceride;
- (c) a cellulosic polymer selected from the group consisting of methocel E series, methocel A series, ethocel P series, methocel K series, low substituted hydroxypropyl ether cellulosic polymers, selected from the group consisting of LH11, LH22 and LH30;
- and
- (d) a non-ionic surfactant.
A process for the preparation of a sustained/prolonged release pharmaceutical unit dosage form comprising the steps of:
- (a) fluidizing a high melting fatty acid ester,
- (b) granulating the fluidized fatty acid ester, an oil, a cellulosic polymer, a surfactant and a water insoluble medicament;
- (c) transferring the fluidized granulate to a hard shell capsule.
A modulated release pharmaceutical construct which comprises a matrix of a material selected from the group consisting of (a) a high melting fatty acid ester, (b) an oil, (c) a cellulosic polymer and (d) a mixture of any of the foregoing, and a water insoluble medicament associated with said matrix.
A sustained release pharmaceutical composition comprising:
- a construct comprising a component selected from the group consisting of (a) a high melting fatty acid ester, (b) an oil, (c) a cellulosic polymer and (d) a mixture of any of the foregoing, and a water insoluble medicament associated with said construct;
A sustained release/prolonged release pharmaceutical unit dosage form comprising:
- (a) a hard shell capsule;
- (b) a carrier construct having a matrix of a material selected from the group consisting of (a) a high melting fatty acid ester, (b) an oil, (c) a cellulosic polymer and (d) a mixture of any of the foregoing, and a water insoluble medicament associated with said matrix.
A process for preparing a sustained/prolonged release pharmaceutical unit dosage form, which comprises:
- (a) fluidizing a carrier comprising a component selected from (a′) a high melting fatty acid ester, (b′) an oil, (c′) a cellulosic polymer and (d′) a mixture of any of the foregoing components, to form a carrier solution;
- (b) adding a water insoluble medicament to said carrier solution to form a medicament solution;
- (c) transferring said medicament solution to a hard shell capsule to solidify said medicament solution to form the dose having a component matrix with said medicament associated therewith.
Dependencies are inferred from the claim text.