Process for preparing solid pharmaceutical dosage forms of hydrophobic substances

Abstract

A process for the preparation of an oral rapidly disintegrating dosage form of a hydrophobic pharmaceutically active substance which process comprises forming a suspension of the hydrophobic pharmaceutically active substance in a solvent containing a pharmaceutically acceptable surfactant together with a water-soluble or water-dispersible carrier material, forming discrete units of the suspension and removing solvent from the discrete units under conditions whereby a network of the carrier material carrying a dosage of the hydrophobic pharmaceutically active substance is formed.

Description

technical field [0001] The invention relates to a method for preparing a solid drug dosage form of a drug active substance, in particular to a method for preparing an oral solid rapidly disintegrating dosage form of a drug active substance. Background technique [0002] Many pharmaceutically active substances are administered orally in the form of tablets, pills or capsules. Tablets, pills or capsules are generally swallowed with water to allow the pharmaceutically active substance to be absorbed through the gastrointestinal tract. Swallowing tablets, pills, or capsules is difficult or impossible for some patients, especially children and elderly patients. Similar difficulties are often encountered when attempting to administer tablets to non-human animals, who may not cooperate when taking tablets, pills or capsules. [0003] GB-A-1548022 and GB-A-2111423 propose oral solid pharmaceutical dosage forms that disintegrate rapidly in the mouth and their preparation methods. ...

AI Technical Summary

Problems solved by technology

For many drugs, due to their hydrophobic nature, a stable foam is formed during mixing, making it impossible to prepare a homogeneous suspension, resulting in uneven drug content in the final product

For very fine particles, more air remains during agitation, exacerbating the problem