Process for the production of an abuse-proofed dosage form
First Claim
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1. A process for the production of a solid dosage form, said process comprising:
- a) producing a formulation mixture by homogeneously mixing (i) at least one active ingredient with potential for abuse selected from the group consisting of oxycodone, oxymorphone, hydrocodone, hydromorphone, morphine, tramadol, (1R,2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol, and physiologically acceptable salts thereof, and (ii) at least 40 wt. %, based on the weight of the solid dosage form, of at least one polyalkylene oxide (C) having a molecular weight of at least 1,000,000 g/mol and exhibiting a breaking strength of at least 500 N;
b) producing a uniformly moistened formulation mixture by combining the formulation mixture produced in a) with (iii) a solvent for the polyalkylene oxide (C), wherein said solvent is in the form of a foam, the form is stabilized by foam stabilizers, and the solvent is in a quantity sufficient to provide uniform moistening of the formulation mixture;
c) optionally dividing the uniformly moistened formulation mixture into sub-portions;
d) drying the uniformly moistened formulation mixture or the sub-portions to granules; and
e) shaping the granules to produce a solid dosage form that exhibits a breaking strength of at least 500 N and cannot be comminuted using a hammer or with the assistance of a mortar and pestle.
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Accused Products
Abstract
The present invention relates to a process for the production of an abuse-proofed dosage form containing, apart from one or more active ingredients with potential for abuse and optionally physiologically acceptable auxiliary substances, at least one synthetic or natural polymer (C) with a breaking strength of at least 500 N, wherein the formulation mixture is combined with a solvent for the polymer (C) at least in quantities such that the formulation mixture is at least uniformly moistened, the at least moistened composition is optionally divided into sub-portions, dried and shaped to yield the dosage form.
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Citations
22 Claims
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1. A process for the production of a solid dosage form, said process comprising:
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a) producing a formulation mixture by homogeneously mixing (i) at least one active ingredient with potential for abuse selected from the group consisting of oxycodone, oxymorphone, hydrocodone, hydromorphone, morphine, tramadol, (1R,2R)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)phenol, and physiologically acceptable salts thereof, and (ii) at least 40 wt. %, based on the weight of the solid dosage form, of at least one polyalkylene oxide (C) having a molecular weight of at least 1,000,000 g/mol and exhibiting a breaking strength of at least 500 N; b) producing a uniformly moistened formulation mixture by combining the formulation mixture produced in a) with (iii) a solvent for the polyalkylene oxide (C), wherein said solvent is in the form of a foam, the form is stabilized by foam stabilizers, and the solvent is in a quantity sufficient to provide uniform moistening of the formulation mixture; c) optionally dividing the uniformly moistened formulation mixture into sub-portions; d) drying the uniformly moistened formulation mixture or the sub-portions to granules; and e) shaping the granules to produce a solid dosage form that exhibits a breaking strength of at least 500 N and cannot be comminuted using a hammer or with the assistance of a mortar and pestle. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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Specification