Pharmaceutical formulations of aliphatic amine polymers and methods for their manufacture
AssigneeTeva Pharmaceutical Industries Ltd.
InventorsJulia Hrakovsky, Ruth Tenengauzer, Alla Ioffe, Eleonora Moin-Kotliar
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Abstract
The present invention provides pharmaceutical compositions comprising aliphatic amine polymers such as for example Sevelamer HCl as the active pharmaceutical ingredient, wherein the aliphatica amine polymers are spray granulated. The present invention further provides methods of preparing stable pharmaceutical compositions of aliphatic amine polymers such as for example Sevelamer HCl, preferably in tablets dosage forms.
Claims38
A pharmaceutical composition comprising;
- a) wet granulated aliphatic amine polymers;
- and
- b) at least one pharmaceutical excipient.
A method of preparing a granular composition comprising wet granulated aliphatic amine polymers comprising the following steps of
- a) providing aliphatic amine polymers;
- b) preparing a granulating solution or liquid;
- c) spraying the granulating liquid or solution onto aliphatic amine polymers and forming a spray granulate;
- and
- d) mixing the spray granulate with one or more excipients forming a final blend.
Dependencies are inferred from the claim text.