Sulfoalkyl ether cyclodextrin based solid pharmaceutical formulations and their use
AssigneeCydex, Inc.
InventorsValentino Stella, Roger A. Rajewski, James W. McGinity
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Abstract
Sulfoalkyl ether-cyclodextrin (SAE-CD) based pharmaceutical formulations are provided by the present invention. These formulations comprise SAE-CD derivatives and a therapeutic agent, a major portion of which is not complexed to the SAE-CD. The present formulations are advantageously easier to prepare than other SAE-CD based formulations in the art yet provide similar or improved effectiveness. The SAE-CD derivative can be used to modify the bioavailability and/or rate of bioabsorption of therapeutic agents.
Claims20
A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a physical mixture of a sulfoalkyl ether-cyclodextrin derivative and a therapeutically effective amount of therapeutic agent wherein a major portion of the therapeutic agent is not complexed to the sulfoalkyl ether-cyclodextrin derivative.
A process for the preparation of a sulfoalkyl ether-cyclodextrin containing pharmaceutical dosage form comprising the steps of:
- forming a solid core comprising a physical mixture of a sulfoalkyl ether-cyclodextrin derivative, a pharmaceutical carrier and an effective amount of a therapeutic agent, a major portion of which is not complexed to the sulfoalkyl ether-cyclodextrin derivative;
- and
- coating said solid core with a film coating comprising a film forming agent and a pore forming agent to provide a pharmaceutically acceptable solid dosage form.
A solid pharmaceutical formulation comprising a film coating and a solid core, wherein the film coating comprises a film forming agent and a pore forming agent, and the solid core comprises a pharmaceutically acceptable carrier and a physical mixture of a therapeutically effective amount of a therapeutic agent and a sulfoalkyl ether-cyclodextrin (SAE-CD), wherein a major portion of the therapeutic agent is not complexed to the SAE-CD.
Dependencies are inferred from the claim text.