Pharmaceutical manufacturing process
AssigneeNorton Healthcare Limited
InventorsJohn Miller, Donald MacDonald, Martin Oliver, Matthew Pollard, Paul Ronald, Adrian Ashley, Paul Lamb
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Abstract
The present invention provides a method for preparing a sterile suspension of a glucocorticosteroid. The glucocorticosteroids used in the invention are preferably antiinflammatory glucocorticosteroids. By making the last stage of product preparation be the sterilization process, the potential for contamination during manufacture and heat degradation of products is greatly reduced.
Claims22
1-21. (canceled)
A composition comprising a sterile suspension of a glucocorticosteroid made by a process comprising the following steps:
- (i) heating a glucocorticosteroid suspension comprising a glucocorticosteroid, water and a surfactant in a mixing vessel to sterilize the glucocorticosteroid suspension, (ii) re-circulating the glucocorticosteroid suspension via a homogenizer before, during and/or after step (i), and subsequently (iii) mixing the glucocorticosteroid suspension with sterile water or a sterile excipient liquid comprising water and one or more pharmaceutically acceptable excipients.
A composition as claimed in 28, wherein at least 60% of the glucocorticosteroid in the glucocorticosteroid suspension is in the form of a suspension during heating.
Dependencies are inferred from the claim text.