Injectable Suspensions
AssigneeAsarina Pharma AB
InventorsMagnus Brisander, Karol Horvath, Björn Norrlind
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Abstract
The present invention relates to aseptic suspensions, physically stable and injectable through a 25G needle or thinner, comprising crystalline, non-micronized 3-beta-hydroxy-5-alpha-pregnan-20-one particles, a mixture of acylglycerols and cholesterol, processes for preparing crystalline, non-micronized, 3-beta-hydroxy-5-alpha-pregnan-20-one suitable for such suspensions, as well as methods for manufacturing such suspensions.
Claims16
A sterile, pharmaceutical, physically stable and injectable suspension, injectable through a 25G needle or thinner, comprising the following components:
- non-micronized, sterile, crystalline, 3-beta-hydroxy-5-alpha-pregnan-20-one particles;
- mixture of acylglycerols;
- and
- cholesterol;
- wherein said suspension is prepared by mixing said components under aseptic conditions within 24 hours or less.
The suspension according to claim 6, wherein said medium-chain acylglycerol is a medium chain triglyceride (MCT).
Crystalline 3-beta-hydroxy-5-alpha-pregnan-20-one particles, produced by the method comprising:
- (i) dissolving 3-beta-hydroxy-5-alpha-pregnan-20-one in an organic solvent solution with a water content of at least 0.1% (v/v), at a temperature of at least 45° C.;
- (ii) adding the solution of step (i) into liquid alkane at [[holding]] a temperature of 10° C. or lower, and stirring said solution mixture to obtain precipitation of crystalline 3-beta-hydroxy-5-alpha-pregnan-20-one;
- followed by;
- (iii) filtering and drying the precipitated crystalline 3-beta-hydroxy-5-alpha-pregnan-20-one obtained in step (ii);
- wherein any micronization step of said crystalline 3-beta-hydroxy-5-alpha-pregnan-20-one particles is omitted.
A sterile, pharmaceutical, physically stable and injectable suspension, injectable through a 25G needle or thinner, comprising the following components:
- sterile, crystalline, non-micronized 3-beta-hydroxy-5-alpha-pregnan-20-one particles;
- mixture of acylglycerols;
- and
- cholesterol;
- wherein said suspension is prepared by a process comprising the steps of:
- sterilizing crystalline, non-micronized 3-beta-hydroxy-5-alpha-pregnan-20-one particles with gamma irradiation;
- mixing the mixture of acylglycerols with the cholesterol and stirring until the cholestorl is completely dissolved in the mixture of acylglycerols;
- filtering the mixture of acylglycerols/cholesterol mixture aseptically into a sterile vessel, adding said sterilized 3-bet-hydroxy-5-alpha-pregnan-20-one particles, and mixing for 24 hours or less to form a suspension.
Dependencies are inferred from the claim text.