Title:
【発明の名称】製薬懸濁剤の新規な滅菌方法
Document Type and Number:
Japanese Patent JP2001526089
Kind Code:
A
Abstract:
The invention is directed to a method for sterilizing a pharmaceutical formulation comprising a suspension of a water-insoluble pharmaceutical, comprising the steps of heat-sterilizing an aqueous solution of a viscosity enhancer, to result in a first sterile pre-mix. Next is sterile-filtering an aqueous solution of a mixture of a pharmaceutically-active compound, which results in a second sterile pre-mix. Next is heat-sterilizing a mixture of water, a water-insoluble pharmaceutical, and at least a partial amount of an electrolyte to provide a sub-saturated solution of the electrolyte, and adding under aseptic conditions an aqueous surfactant, to give a third sterile pre-mix. Finally, combining all three pre-mixes in sterile fashion to achieve a sterile suspended pharmaceutical formulation. Thus, for the third pre-mix, use of either Sodium chloride (in varying proportion) or Sodium acetate (in one proportion, but not limited to) is given as an example. The invention is also directed to methods for making sterile suspensions of pharmaceutically active compositions including Ciprofloxacin and hydrocortisone, and pharmaceutical compositions made according to this process.
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Inventors:
Purwal, Shivaji
Application Number:
JP2000525146A
Publication Date:
December 18, 2001
Filing Date:
December 07, 1998
Export Citation:
Assignee:
Bayer Actien Gezershyaft
International Classes:
A61K9/10; A61K9/107; A61L2/00; A61L2/04; (IPC1-7): A61L2/04; A61K9/107
Attorney, Agent or Firm:
Heiyoshi Odashima