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US 8,541,399 B2Granted
Solvent-based sterilisation of pharmaceuticals
AssigneeResolution Chemicals Limited
InventorsParveen Bhatarah, Kenneth Alan Greenwood
Life of this patent
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Abstract
A sterile composition of a pharmaceutical compound is prepared by combining solvent with a non-sterile pharmaceutical compound to form a solution and filtering to yield a sterile pharmaceutical compound, optionally removing all or part of the solvent, and under sterile conditions combining the compound with a pharmaceutically acceptable carrier.
Claims26
A method for preparing a sterile pharmaceutical composition of a steroid comprising:
- (i) dissolving a non-sterile steroid in a non-aqueous solvent to yield a solution of the steroid,
- (ii) filtering the solution of (i) to yield a sterile solution,
- (iii) combining the sterile solution of (ii) with sterile water to form a sterile aqueous suspension,
- (iv) treating the sterile aqueous suspension of (iii) to obtain a sterile aqueous suspension with a particle size distribution having a mass median diameter less than 10 μm,
- (v) under sterile conditions combining the sterile aqueous suspension of (iv) with a pharmaceutically acceptable carrier to yield a sterile pharmaceutical composition comprising a sterile aqueous suspension of the steroid having a mass median diameter less than 10 μm, and
- (vi) storing the sterile pharmaceutical composition of (v) in sterile containers.
3 more elements
A method for preparing a sterile suspension of budesonide, comprising:
- (i) dissolving non-sterile budesonide in a non-aqueous solvent to yield a budesonide solution,
- (ii) filtering the solution of (i) to yield a sterile solution,
- (iii) combining the sterile solution of (ii) with sterile water to form a sterile aqueous suspension of budesonide,
- (iv) treating the sterile aqueous suspension of (iii) to obtain a sterile aqueous suspension with a particle size distribution having a mass median diameter less than 10 μm,
- (v) under sterile conditions combining the sterile aqueous suspension of (iv) with a pharmaceutically acceptable carrier to yield a sterile pharmaceutical composition comprising the sterile aqueous suspension of budesonide having a mass median diameter less than 10 μm, and
- (vi) storing the sterile pharmaceutical composition of (v) in sterile containers.
3 more elements
A method for preparing a sterile pharmaceutical composition of a steroid comprising:
- (i) dissolving a non-sterile steroid in a non-aqueous solvent to yield a solution of the steroid,
- (ii) filtering the solution of (i) to yield a sterile solution,
- (iii) combining the sterile solution of (ii) with sterile water to form a sterile aqueous suspension,
- (iv) removing all or part of the non-aqueous solvent from the sterile aqueous suspension of (iii) to yield a sterile aqueous suspension having reduced non-aqueous solvent content,
- (v) treating the sterile aqueous suspension having reduced non-aqueous solvent content of (iv) to obtain a sterile aqueous suspension with a particle size distribution having a mass median diameter less than 10 μm,
- (vi) under sterile conditions combining the sterile aqueous suspension of (v) with a pharmaceutically acceptable carrier to yield a sterile pharmaceutical composition comprising a sterile aqueous suspension of the steroid having a mass median diameter less than 10 μm, and
- (vii) storing the sterile pharmaceutical composition of (vi) in sterile containers.
4 more elements
A method for preparing a sterile pharmaceutical composition of budesonide comprising:
- (i) dissolving a non-sterile budesonide in a non-aqueous solvent to yield a budesonide solution,
- (ii) filtering the solution of (i) to yield a sterile solution,
- (iii) combining the sterile solution of (ii) with sterile water to form a sterile aqueous suspension of budesonide,
- (iv) removing all or part of the non-aqueous solvent from the sterile aqueous suspension of (iii) to yield a sterile aqueous suspension having reduced non-aqueous solvent content,
- (v) treating the sterile aqueous suspension having reduced non-aqueous solvent content of (iv) to obtain a sterile aqueous suspension with a particle size distribution having a mass median diameter less than 10 μm,
- (vi) under sterile conditions combining the sterile aqueous suspension of (v) with a pharmaceutically acceptable carrier to yield a sterile pharmaceutical composition comprising a sterile aqueous suspension of budesonide having a mass median diameter less than 10 μm, and
- (vii) storing the sterile pharmaceutical composition of (vi) in sterile containers.
4 more elements
Dependencies are inferred from the claim text.