Sulfoalkyl ether cyclodextrin based controlled release solid pharmaceutical formulations

A controlled release solid pharmaceutical formulation comprising:

• a core comprising a first composition comprising a physical mixture of a therapeutic agent and at least one sulfoalkyl ether cyclodextrin, wherein a major portion of the therapeutic agent is not complexed with the sulfoalkyl ether cyclodextrin;
• and
• a coating surrounding said core and consisting of a film forming agent;
• wherein, said therapeutic agent of the first composition is released from the core at a controlled rate in the absence of a pore forming agent in the coating.

A multi-layered controlled release solid pharmaceutical formulation comprising:

• at least one first layer comprising a physical mixture of a therapeutic agent and a sulfoalkyl ether cyclodextrin;
• and
• at least one second layer comprising a release rate modifier;
• wherein,
• said first and second layers are juxtaposed;
• said therapeutic agent is released from said core at a controlled rate;
• and
• a major portion of said therapeutic agent is not complexed with said sulfoalkyl ether cyclodextrin.

A multi-layered combined rapid and controlled release solid pharmaceutical formulation comprising:

• at least one controlled release first layer comprising a physical mixture of a first therapeutic agent, a release rate modifier and a sulfoalkyl ether cyclodextrin for releasing said first therapeutic agent at a controlled rate into a first environment of use;
• and
• at least one rapid release second layer comprising a preformed complex of a second therapeutic agent and a sulfoalkyl ether cyclodextrin for releasing said second therapeutic agent rapidly into a second environment of use;
• wherein,
• said first and second layers are juxtaposed;
• a major portion of said first therapeutic agent is not complexed with said sulfoalkyl ether cyclodextrin.

A multi-layered combined rapid and controlled release solid pharmaceutical formulation comprising:

• at least one controlled release first layer comprising a physical mixture of a first therapeutic agent, a release rate modifier and a sulfoalkyl ether cyclodextrin for releasing said first therapeutic agent at a controlled rate into a first environment of use;
• and
• at least one rapid release second layer comprising a physical mixture of a second therapeutic agent and a sulfoalkyl ether cyclodextrin for releasing said second therapeutic agent rapidly into a second environment of use;
• wherein,
• said first and second layers are juxtaposed;
• and
• major portions of each of said first and second therapeutic agents are not complexed with said sulfoalkyl ether cyclodextrin.

An osmotic solid pharmaceutical formulation for the controlled diffusional and osmotic delivery of a therapeutic agent to an environment of use comprising:

• a core comprising a physical mixture of a sulfoalkyl ether cyclodextrin, a therapeutic agent and a pharmaceutically acceptable carrier;
• and
• a membrane surrounding said core and comprising a film forming agent and a pore forming agent, said membrane having a passageway therethrough for communicating said core to an environment of use;
• wherein,
• a first portion of said therapeuic agent diffuses through said membrane and a second portion of said therapeutic agent passes through said passageway;
• and
• a major portion of said therapeutic agent is not complexed with said sulfoalkyl ether cyclodextrin.