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US 2010/0074865 A1Published application
Formulations of peg-interferon alpha conjugates
AssigneeCadila Healthcare Limited
InventorSanjay BANDYOPADHYAY
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Abstract
Lyophilized and stabilized formulations of PEG-Interferon alpha conjugates and the process for their preparation that reduces lyophilization cycle time and are more cost competitive.
Claims24
A formulation comprising PEG-interferon alpha conjugates, a buffer, a stabilizer, a cryoprotectant and a solvent, wherein said buffer is selected from the group consisting of sodium phosphate, sodium succinate, potassium succinate, histidine chloride, sodium glycinate either alone or in combination, and said cryoprotectant is lactose.
A process of formulating a lyophilized powder, comprising:
- providing a formulation comprising PEG-interferon alpha conjugates, a buffer, a stabilizer, lactose and a solvent, wherein said buffer is selected from the group consisting of sodium phosphate, sodium succinate, potassium succinate, histidine chloride, sodium glycinate either alone or in combination;
- and
- lyophilizing the formulation thereby producing the lyophilized powder.
Dependencies are inferred from the claim text.