RATE MODULATED DELIVERY OF DRUGS FROM A COMPOSITE DELIVERY SYSTEM
First Claim
1. A pharmaceutical dosage form for the delivery of at least one active pharmaceutical ingredient (API) or the pharmaceutically active salts and isomers thereof, to a desired absorption location of the human or animal body in a predetermined rate-modulated manner.
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Accused Products
Abstract
This invention relates to a pharmaceutical dosage form for the delivery of at least one active pharmaceutical ingredient (API) or the pharmaceutically active salts and isomers thereof, to a desired absorption location of the human or animal body, preferably the gastrointestinal tract, in a predetermined rate-modulated manner. The dosage form is orally ingestible and is in the form of a multi-layered tablet preferably three layers and each layer includes an API or capsule containing a multiplicity of multi-layered granules. Each layer contains one or more APIs mixed or blended with at least one and preferably a matrix of polymers and, where appropriate, excipients, which, in use, inhibit release of an API in a region of the gastrointestinal tract other than the desired absorption location and, thus, facilitate release of the API in a rate controlled manner when in the desired absorption location. Methods of manufacturing said dosage form are further disclosed.
27 Citations
33 Claims
- 1. A pharmaceutical dosage form for the delivery of at least one active pharmaceutical ingredient (API) or the pharmaceutically active salts and isomers thereof, to a desired absorption location of the human or animal body in a predetermined rate-modulated manner.
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26. A method of manufacturing a pharmaceutical dosage form comprising
mixing a polymer in various concentrations, a pharmaceutical excipient and at least one API or the pharmaceutically active salts and isomers thereof, to form at least one of layer of a number of layers in the pharmaceutical dosage form, dimensioning and configuring the or each layer so that, in use an API is released therefrom over a desired period of time as a result of variations in the polymeric materials employed, pharmaceutical excipients, chemical interactions such as crosslinking that may be in situ, and/or diffusion path-lengths created.
Specification