Preparation of an enteric release system

摘要

Hydrophobic liquids are microencapsulated by an enteric matrix in an environment substantially free of organic solvents. The process includes forming an emulsion of the enteric material and hydrophobic liquid in water, titrating the emulsion with an acid to form a particulate precipitate and optionally coating the particulate with a combination of enteric material and plasticizer.

主权项

1. A method of microencapsulating an active ingredient with an enteric matrix, the method comprising:
a) agitating a combination of water and enteric materials, the combination substantially free of organic solvents, at a pH so that the enteric materials are soluble in the water to form a solution, the enteric materials including shellac and sodium caseinate; b) mixing a hydrophobic liquid containing the active ingredient into the solution; c) homogenizing the hydrophobic liquid and the solution to create an emulsion; and d) acid titrating the emulsion with an amount of acid to a pH at about an isoelectric point of sodium caseinate effective to precipitate a particulate of a plurality of hydrophobic liquid drops homogenously dispersed throughout an enteric matrix of the shellac and sodium caseinate.