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Dosage form comprising therapeutic formulation

Dosage form comprising therapeutic formulation description/claims

This application is a continuation of U.S. application Ser. No. 10/373529, filed Feb. 24, 2003, which is a continuation of U.S. application Ser. No. 09/353519, filed Jul. 14, 1999, now U.S. Pat. No. 6,551,613, which claims the benefit of U.S. Provisional Application No. 60/099401, filed Sep. 8,1998, the disclosures of all of which are hereby incorporated by reference.

The present invention pertains to both a useful dosage form and to the process of manufacturing the dosage form. More particularly, the invention relates to a dosage form comprising a wall that surrounds an internal compartment comprising a therapeutic formulation, a piston, a driving member, and a passageway for delivering the therapeutic formulation from the dosage form. The invention concerns also a process for manufacturing the dosage form comprising the steps of uniting the components of the dosage form into the manufactured dosage form. The invention relates also to a method of using the dosage form for dispensing the therapeutic formulation at a controlled rate over a sustained-release period of time.

In the fields of pharmacy and medicine, many drugs are blended with a pharmaceutically acceptable carrier for administering to a patient. For example, many drugs are administered to a patient by dissolving the drug in an aqueous or in a non-aqueous pharmaceutically acceptable carrier, by suspending the drug in a pharmaceutically acceptable solvent, or by incorporating the drug into one of two phases of an acceptable oil and water system.

These pharmaceutical preparations are useful as they can be formulated for different routes of administration, including oral use, administering into body openings such as the vagina and anus, or applied topically. Their dose can be adjusted, and they can be administered to children and adults.

The preparation of these pharmaceutical preparations involves considerations on the part of the pharmacist, including the purpose of the drug, internal or external use, concentration of the drug, the pharmaceutical carrier, and other characteristics that lead to the final pharmaceutical preparation. However, there are serious shortcomings associated with these pharmaceutical preparations; mainly, the absence of a dosage form for administering the pharmaceutical preparations at a controlled rate over a sustained-release period for administering the drug for a therapeutic benefit.

It will be appreciated by those versed in the drug dispensing art in view of the above presentation, that if a dosage form is made available for delivering pharmaceutical formulations that overcomes tribulations of the prior art, such a dosage form would have a practical value in the drug dispensing art. Likewise, it will be scientifically self-evident to those versed in the drug delivery art, that if a dosage form is made available that can administer pharmaceutical formulations comprising the prescribed dose at a sustained-release and controlled rate, such an unexpected dosage form would have an immediate acceptance for positive therapy in both human and veterinary medicine.

Accordingly, in view of the above presentation it is an immediate object of the invention to provide a dosage form that can deliver a pharmaceutical formulation and thereby overcome the tribulations of the prior art.

Yet another object of the invention is to provide a dosage form that can deliver a pharmaceutical formulation at a sustained-release and controlled rate over an extended time.

Yet another object of this invention is to provide a dosage form that can deliver an initially dry pharmaceutical formulations that converts to a liquid pharmaceutical formulation in the dosage form during the use of the dosage form in a liquid environment of use.

Another object of the invention is to provide a dosage form comprising an internal capsule which comprises a liquid formulation containing a drug and a separate layer possessing expansion properties.

Another object of the invention is to provide a dosage form comprising a non-aqueous liquid formulation comprising an orally administrable drug that can deliver a prescribed dose of drug to a patient in need of therapy.

Another object of the invention is to provide a dosage form comprising a liquid formulation containing a liquid soluble drug that can be dispensed in a known dose for a therapeutic benefit.

Another object of the invention is to provide a dosage form comprising a capsule containing a non-aqueous liquid in which a protein or proteinaceous drug is dissolved or dispersed for sustained-release administration at a controlled rate over time.

Another object of the invention is to provide a dosage form comprising a capsule that contains an emulsion-drug composition that can be delivered at a controlled rate over a delivery period up to 30 hours.

Another object of the invention is to provide a dosage form comprising a capsule that comprises an expandable layer, a piston, and a liquid formulation.

Another object of the invention is to provide a dosage form comprising a semipermeable composition coated capsule that comprises a drug-emulsion composition.

Another object of the invention is to provide a process for manufacturing a dosage form, which process comprises the steps of adding to a capsule a composition containing a drug, placing a layer that expands when contacted by an aqueous fluid, closing the capsule, and coating the capsules with a semipermeable coat.

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