HOT-MELT EXTRUDED PHARMACEUTICAL DOSAGE FORM
First Claim
1. A hot-melt extruded pharmaceutical dosage form with controlled release of a pharmacologically active ingredient (A) embedded in a matrix comprising a polymer (C), the dosage form having an oblong shape comprising a longitudinal direction of extension, a transversal direction of extension orthogonal to the longitudinal direction of extension, a front side, an opposite back side and a circumferential rim between said front and back side;
- whereinthe core of the pharmaceutical dosage form has a morphological orientation caused by hot-melt extrusion that is substantially orthogonal to the longitudinal direction of extension of the dosage form; and
/orthe release per area of the pharmacologically active ingredient (A) through the front side and the opposite back side is faster than the release through the circumferential rim.
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Accused Products
Abstract
The invention relates to a hot-melt extruded pharmaceutical dosage form with controlled release of a pharmacologically active ingredient (A) embedded in a matrix comprising a polymer (C), the dosage form exhibiting a breaking strength of at least 300 N and having an oblong shape comprising a longitudinal direction of extension, a transversal direction of extension orthogonal to the longitudinal direction of extension, a front side, an opposite back side and a circumferential rim between said front and back side;
wherein
- the core of the pharmaceutical dosage form has a morphological orientation caused by hot-melt extrusion that is substantially orthogonal to the longitudinal direction of extension of the dosage form; and/or
- the release per area of the pharmacologically active ingredient (A) through the front side and the opposite back side is faster than the release through the circumferential rim.
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Citations
14 Claims
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1. A hot-melt extruded pharmaceutical dosage form with controlled release of a pharmacologically active ingredient (A) embedded in a matrix comprising a polymer (C), the dosage form having an oblong shape comprising a longitudinal direction of extension, a transversal direction of extension orthogonal to the longitudinal direction of extension, a front side, an opposite back side and a circumferential rim between said front and back side;
wherein the core of the pharmaceutical dosage form has a morphological orientation caused by hot-melt extrusion that is substantially orthogonal to the longitudinal direction of extension of the dosage form; and
/orthe release per area of the pharmacologically active ingredient (A) through the front side and the opposite back side is faster than the release through the circumferential rim. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 11)
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10. A process for the manufacture of a hot-melt extruded pharmaceutical dosage form with controlled release of a pharmacologically active ingredient (A) embedded in a matrix comprising a polymer (C), the dosage form exhibiting a breaking strength of at least 300 N and having an oblong shape comprising a longitudinal direction of extension, a transversal direction of extension orthogonal to the longitudinal direction of extension, a front side, an opposite back side and a circumferential rim between said front and back side, comprising the steps of
(a) hot-melt extruding a mass comprising the pharmacologically active ingredient (A) and the polymer (C), through an oblong die thereby obtaining an extrudate with an oblong cross-section; -
(b) cutting said extrudate into slices having two opposing cut surfaces of oblong shape; (c) placing said slices into a tabletting tool comprising upper punch and lower punch in a manner so that the opposing surfaces of oblong shape face said upper and lower punch, respectively; (d) press-forming dosage forms from the slices; and (e) optionally, applying a film coating. - View Dependent Claims (12, 13, 14)
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Specification