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Orlistat Capsule/Pharmaceutical Formulation with High Stability and Dissolution and Manufacturing Process
Korea Health Industry Development Institute (KHIDI) South Korea flag South Korea
Abstract ID:
Disclosed herein are a pharmaceutical formulation with high stability and dissolution, and a method for preparing the pharmaceutical formulation,...
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Orlistat is a reversible inhibitor of lipases. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine residue site of gas

Crystallinity required in maintaining good chemical stability of orlistat and its related materials is disadvantageous in terms of bioavailability.  However, transformation of a crystal form into an amorphous form to increase bioavailability results in damage to chemical stability.  An important point of the Technology is to provide solutions to satisfy the contradictory requiremnets.  Therefore, the Technology suggests the following solutions: reduction of excessive crystallinity, use of a solubilized composition, improvement of antioxidative ability, use of porous and cellulose type adsorbents to solve instability problems and determination of a pH value suitable to achieve maximum chemical stability.The formulation according to the Technology shows enhanced solubility rate and stability when compared to other orlistat products. The pharmaceutical formulation comprises a pharmacologically active substance, a solvent, a solubilizer, a surfactanct, an antioxidant, and an adsorbent. According to the pharmaceutical formulation and the method, the pharmacologically active substance to obtain an amorphous liquid or semi-solid state, the antioxidant is melted together with the mixture to solve poor chemical stability of the pharmacologically a8ctive substance in an amorphous or liquid state, and the adsorbent is strongly adsorbed to the molten mixture so as to be transformed into a powder form so that the resulting molecules are reconstituted into very tiny crystal forms within the adsorbent to ensure chemical stability.


Type of Business Relationship Sought
Patent Pending
Last Updated Jun 2016
Technology Type MECHANISM
Phase of Development CLINICAL TRIALS