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|Title:||Pharmaceutical compositions for freeze drying|
|Abstract:||A pharmaceutical composition comprising a nucleotide analogue, mannitol and a modifying additive which is sodium chloride or a polyol which is suitable for freeze drying.|
|Inventor(s):||Bland; Chris (Leics, GB), Steele; Gerald (Leics, GB)|
|Assignee:||Astra Zeneca UK Limited (London, GB)|
1. A pharmaceutical composition comprising a nucleotide analog, mannitol and a modifying additive which is sodium chloride or a polyol, wherein the nucleotide is a compound
of formula wherein R.sup.1 and R.sup.2 independently represent hydrogen or halogen, R.sup.3 and R.sup.4 independently represent phenyl, or C.sub.1-6 -alkyl optionally substituted by one or more substituents selected from OR.sup.5, C.sub.1-6 -alkylthio,
NR.sup.6 R.sup.7, phenyl, COOR.sup.8 and halogen,
R.sup.5, R.sup.6, R.sup.7 and R.sup.8 independently represent hydrogen or C.sub.1-6 -alkyl, and X represents an acidic moiety, or a pharmaceutically acceptable salt thereof.
2. A pharmaceutical composition according to claim 1 in which R.sup.1 and R.sup.2 are halogen, R.sup.3 is C.sub.1-6 -alkyl optionally substituted by C.sub.1-6 -alkylthio, R.sup.4 is C.sub.1-6 -alkyl optionally substituted by halogen, and X is --P(O)(OH).sub.2, --SO.sub.3 H or --CO.sub.2 H.
3. A pharmaceutical composition according to claim 1 wherein the nucleotide is N-[2-(methylthio)ethyl]-2-[(3,3,3-trifluoropropyl)thio]-5'-adenylic acid, monoanhydride with dichloromethylenebisphosphonic acid.
4. A pharmaceutical composition according to claim 1 in which the modifying additive is a polyol.
5. A pharmaceutical composition according to claim 1 in which the modifying additive is sorbitol.
6. A pharmaceutical composition according to claim 1 which further comprises 1% or more by weight of manntiol.
7. A pharmaceutical composition according to claim 1 which is in freeze-dried, spray dried or vacuum dried form.
8. A pharmaceutical composition according to claim 7 which is in reconstituted form.
9. A pharmaceutical composition according to claim 1 which is at a pH of
about 6 to about 10.
10. A pharmaceutical composition according to claim 1 in which the water content is less than 5% by weight.
11. A process for the preparation of a pharmaceutical composition according to claim 7 which process comprises mixing the ingredients of the composition, and either freezing them and drying the frozen mixture, or spraying them.
12. A method of treating a platelet aggregation disorder which method comprises treating a subject suffering from a said disorder with a therapeutically effective amount of a pharmaceutical composition as defined in claim 2.
13. A process for preparing a pharmaceutical composition as defined in claim 1 which comprises mixing a nucleotide analogue, mannitol and a sodium chloride or polyol modifying additive and subjecting the mixture to a lyophilisation, vacuum drying or spray drying procedure.
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