Pharmaceutical formulation with high stability and...

A - Human Necessities – 61 – K

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A61K 47/44 (2006.01)

Patent

CA 2617140

Disclosed herein are a pharmaceutical formulation with high stability and dissolution, and a method for preparing the pharmaceutical formulation. The pharmaceutical formulation comprises a pharmacologically active substance, a solvent, a solubilizer, a surfactant, an antioxidant, and an adsorbent. According to the pharmaceutical formulation and the method, the pharmacologically active substance is mixed with the solvent, the solubilizer agent and the surfactant for improving the solubility of 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 active 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.

La présente invention se rapporte à une formulation pharmaceutique à stabilité et dissolution élevées, et à un procédé de préparation de cette formulation pharmaceutique. Cette formulation pharmaceutique comprend une substance pharmacologiquement active, un solvant, un solubilisant, un surfactant, un antioxydant et un absorbant. Selon la formulation pharmaceutique et la méthode, la substance pharmacologiquement active est mélangée avec le solvant, l~agent solubilisant et le surfactant pour améliorer la solubilité de la substance pharmacologiquement active afin d~obtenir un liquide amorphe ou un état semi-solide, l~antioxydant est fondu avec le mélange pour résoudre la mauvaise stabilité chimique de la substance pharmacologiquement active dans un état amorphe ou liquide, et l~absorbant est fortement absorbé dans le mélange fondu de façon à être transformé en poudre de sorte que les molécules résultantes soient reconstituées en minuscules cristaux dans l~absorbant afin de garantir la stabilité chimique.

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