Hot-melt extruded pharmaceutical dosage form
First Claim
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1. A hot-melt extruded tablet having a front side and an opposite back side, the tablet comprising:
- (i) a pharmacologically active ingredient (A) embedded in a matrix comprising a polymer (C);
(ii) an oblong shape imparted by post-hot-melt-extrusion pressing of a hot-melt extrudate on a tablet-press; and
(iii) a circumferential rim between the front and back sides;
wherein the tablet exhibits a breaking strength of at least 300 N;
wherein the tablet exhibits controlled release of the pharmacologically active ingredient (A);
wherein the tablet comprises a direction of extrusion that runs parallel to a direction of extrusion of the hot-melt extrudate through an extrusion die;
wherein the tablet comprises a longitudinal direction of extension, which longitudinal direction of extension is the longest dimension of the tablet and runs orthogonal to the direction of extrusion;
wherein the tablet comprises a transversal direction of extension orthogonal to the longitudinal direction of extension and orthogonal to the direction of extrusion;
wherein the oblong shape is imparted by post-extrusion pressing of the extrudate on the tablet-press in a pressing direction parallel to said direction of extrusion and orthogonal to both said longitudinal direction of extension and said transversal direction of extension; and
wherein the tablet has a core having a morphological orientation caused by the hot-melt extrusion that is substantially orthogonal to the longitudinal direction of extension of the tablet.
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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
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- 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.
445 Citations
14 Claims
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1. A hot-melt extruded tablet having a front side and an opposite back side, the tablet comprising:
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(i) a pharmacologically active ingredient (A) embedded in a matrix comprising a polymer (C); (ii) an oblong shape imparted by post-hot-melt-extrusion pressing of a hot-melt extrudate on a tablet-press; and (iii) a circumferential rim between the front and back sides; wherein the tablet exhibits a breaking strength of at least 300 N; wherein the tablet exhibits controlled release of the pharmacologically active ingredient (A); wherein the tablet comprises a direction of extrusion that runs parallel to a direction of extrusion of the hot-melt extrudate through an extrusion die; wherein the tablet comprises a longitudinal direction of extension, which longitudinal direction of extension is the longest dimension of the tablet and runs orthogonal to the direction of extrusion; wherein the tablet comprises a transversal direction of extension orthogonal to the longitudinal direction of extension and orthogonal to the direction of extrusion; wherein the oblong shape is imparted by post-extrusion pressing of the extrudate on the tablet-press in a pressing direction parallel to said direction of extrusion and orthogonal to both said longitudinal direction of extension and said transversal direction of extension; and wherein the tablet has a core having a morphological orientation caused by the hot-melt extrusion that is substantially orthogonal to the longitudinal direction of extension of the tablet. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A hot-melt extruded tablet having a front side and an opposite back side, the tablet comprising:
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(i) a pharmacologically active ingredient (A) in a matrix comprising a polymer (C); (ii) an oblong shape imparted by post-hot-melt-extrusion pressing of a hot-melt extrudate on a tablet-press; and (iii) a circumferential rim between the front and back sides; wherein the tablet exhibits a breaking strength of at least 300 N; wherein the tablet exhibits controlled release of the pharmacologically active ingredient (A); wherein the tablet has a direction of extrusion that runs parallel to a direction of extrusion of said hot-melt extrudate through an extrusion die; wherein the tablet has a longitudinal direction of extension, which is the longest dimension in the tablet and runs orthogonal to the direction of extrusion; wherein the tablet has a transversal direction of extension that runs orthogonal to both the direction of extrusion and the longitudinal direction of extension; and wherein the oblong shape is imparted by compressing the hot-melt extrudate parallel to the direction of extrusion and orthogonal to the longitudinal direction of extension.
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Specification