Anticipate generic drug launch
Drug patents …
… from Kazakhstan to Kalamazoo
Manage your formulary budget
Find generic entry opportunities
Deep knowledge on
small-molecule drugs and
the 110,000 global patents
Proactively manage your pharmacy inventory
Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
|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.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.