Process for preparing rapidly disintegrating granulates
First Claim
1. A process for the preparation of a rapidly disintegrating core comprising a pharmaceutically active compound, said process comprising adding an emulsifier/tenside having a HLB-value corresponding to the solubility characteristics of the pharmaceutically active compound in a solution or a suspension of the pharmaceutically active compound in a water:
- alcohol mixture having a weight ratio of 40-80;
60-20 to form a pumpable composition, subjecting the pumpable composition to an intense treatment in an apparatus selected from the group of homogenizer, colloid mill, pearl mill, and pebble mill wherein the composition is distributed over a bed of at least one solid material having a large effective surface area and having nonbinding properties to the said pharmaceutically active compound so as to form an agglomerate, and drying the agglomerate to form a granulate having irregular or spherical form.
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Abstract
The present invention relates to a process for preparing a rapidly disintegrating core granulate containing a pharmaceutically active compound, which granulate is optionally intended to be coated with a release determining coating, as well as such cores, whereby one adds a pharmaceutically active compound, optionally together with an emulsifier, to a solvent, and optionally treats the composition obtained intensively, optionally while reducing its particle size, distributes the treated composition obtained over a bed of a solid, preferably water soluble material, and dries the agglomerates thus obtained to the so as to form a rapidly disintegrating core granulate.
153 Citations
20 Claims
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1. A process for the preparation of a rapidly disintegrating core comprising a pharmaceutically active compound, said process comprising adding an emulsifier/tenside having a HLB-value corresponding to the solubility characteristics of the pharmaceutically active compound in a solution or a suspension of the pharmaceutically active compound in a water:
- alcohol mixture having a weight ratio of 40-80;
60-20 to form a pumpable composition, subjecting the pumpable composition to an intense treatment in an apparatus selected from the group of homogenizer, colloid mill, pearl mill, and pebble mill wherein the composition is distributed over a bed of at least one solid material having a large effective surface area and having nonbinding properties to the said pharmaceutically active compound so as to form an agglomerate, and drying the agglomerate to form a granulate having irregular or spherical form. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
- alcohol mixture having a weight ratio of 40-80;
Specification