Monolithic dosage form, useful in a therapy for treating e.g. pain, psychiatric disorders, cardiovascular diseases, migraine and vertigo of any genesis, comprises first and active ingredients, an emulsifier, and a retarding agent

摘要

Monolithic dosage form comprises: at least one first active ingredient and second active ingredient, where the first active ingredient at a pH value of 7 and a temperature of 22[deg] C has a solubility of less than 0.01 mg/ml, and the second active ingredient at a pH value of 7 and a temperature of 22[deg] C has a solubility that exceeds the solubility of the first active ingredient at pH 7 and 22[deg] C by at least one order of magnitude; at least one emulsifier having a polyalkylene oxide structural motif (I); and at least one retarding agent. Monolithic dosage form comprises: at least one first active ingredient and second active ingredient, where the first active ingredient at a pH value of 7 and a temperature of 22[deg] C has a solubility of less than 0.01 mg/ml, and the second active ingredient at a pH value of 7 and a temperature of 22[deg] C has a solubility that exceeds the solubility of the first active ingredient at a pH value 7 and 22[deg] C by at least one order of magnitude; at least one emulsifier having a polyalkylene oxide structural motif of formula (R1-O-[CH 2-CH 2-O-] n-R2) (I); and at least one retarding agent, where the sum of the amount of retarding agent and the emulsifier is at least 40 wt.% and the mass ratio of the second active ingredient to the retarding agent is less than 1:1. R1, R2 : H, alkyl, glyceride or polyalkylene oxide; and n : 4. An independent claim is included for producing the dosage form, comprising (a) mixing components of the dosage form, (b) granulating the components, and (c) making the monolithic dosage form from the granules. ACTIVITY : Analgesic; Neuroleptic; Cardiovascular-Gen.; Antimigraine; CNS-Gen.; Respiratory-Gen.; Gastrointestinal-Gen.; Fungicide; Vasotropic; Antiallergic; Auditory. MECHANISM OF ACTION : None given.