Film-coating of solid medicaments e.g. tablets - using a solvent-poor emulsion of film-forming agent contg. a lipophilic solvent, a hydrophilic solvent, and water

摘要

New process for film-coating a particulate, solid medicament comprises (A) coating the medicament in a conventional manner with a solvent-poor emulsion contg. at least two phases finely dispersed in each other, of which one contains the dissolved film-forming agent and the major part of a predominantly lipophilic solvent and the other contains the major part of a predominantly hydrophilic solvent and water, and (B) evaporating the solvent in a conventional manner. New emulsions for carrying out the above process contain a lipophilic solvent; a hydrophilic solvent; water; a water-insoluble polymeric film-forming agent; usual additives; and, optionally, surface-active amphiphilic substances for film-coating. Film-coating of solid pharmaceutical dosage forms such as granulates pellets, tablets, or capsules, e.g. to impart resistance to gastric or intestinal juices. Using emulsions as specified above permits a major part of the organic solvent usually used in film-coating to be replaced by water without adversely affecting the film-forming properties by coagulation or swelling.