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US 2021/0196636 A1Published application
Process for producing a pharmaceutical composition containing micro particles
AssigneeSunstar Inc.
InventorsMayo ARAKI, Rie TANAKA, Youko TAKEDA
Life of this patent
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Abstract
A pharmaceutical composition having consistently a desirable release rate is prepared by controlling the finally mixing time based on the molecular weight measured in the intermediate product. The pharmaceutical composition includes micro particles containing a polyhydric alcohol, a salt, a water-soluble polymer and a pharmaceutically active ingredient. The micro particles are dispersed in a matrix of a hydrophobic ingredient and an amphipathic ingredient.
Claims17
A process for preparing a pharmaceutical composition, the process comprising:
- i) obtaining a mixture comprising ingredients (A), (B) and (C) having a molecular weight M measured by gel permeation chromatography;
- and
- ii) mixing the mixture with a pharmaceutically active ingredient (D), a hydrophobic ingredient (E) and an amphipathic ingredient (F) at a temperature ranging from about 30° C. to 70° C. for a period of T minutes, thereby producing the pharmaceutical composition comprising micro particles dispersed in a matrix,
- wherein:
- T satisfies:
- 0.00136M−230<T<0.00136M−169;
- the ingredient (A) is a polyhydric alcohol;
- the ingredient (B) is an inorganic salt of magnesium, calcium or barium, or a hydrate thereof;
- and
- the ingredient (C) is a water-soluble polymer.
7 more elements
Dependencies are inferred from the claim text.