Process for preparing sterile aripiprazole formulation
AssigneeMylan Laboratories Limited
InventorsBhaveshkumar Vallabhbhai Patel, Manoj Pananchukunnath, Arvindrao Atul Bodkhe
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Abstract
The invention provides a process for preparing a sterile suspension comprising aripiprazole. More particularly, the invention provides the process for preparing the sterile suspension comprising aripiprazole, wherein said process involves in-process moist-heat sterilization of said suspension comprising aripiprazole. The in-process moist-heat sterilization is particularly efficient and economical process for the sterilization of aripiprazole formulations for parenteral administration, wherein the formulation obtained by said process have comparable physicochemical characteristics with the commercially available Ability Maintena® Injection.
Claims10
A process for preparing a sterile suspension comprising aripiprazole, wherein said process involves the steps of:
- a. preparing a suspension by mixing aripiprazole, at least one viscosity enhancing agent and one or more other pharmaceutically acceptable excipient(s) in purified water,
- b. sterilizing the suspension of step (a),
- c. homogenizing the sterilized suspension of step (b), and
- d. milling the homogenized suspension of step (c),
- wherein the sterilization of step (b) is done by moist-heat sterilization at 121° C. for at least 20 minutes.
A process for preparing a sterile composition comprising aripiprazole for parenteral administration involving the steps of:
- a. preparing a suspension by mixing aripiprazole, at least one viscosity enhancing agent and one or more other pharmaceutically acceptable excipient(s) in purified water,
- b. sterilizing the suspension of step (a),
- c. homogenizing the sterilized suspension of step (b),
- d. milling the homogenized suspension of step (c), and
- e. lyophilizing the milled suspension of step (d),
- wherein the sterilization of step (b) is done by moist-heat sterilization at 121° C. for at least 20 minutes.
A composition comprising a sterile suspension of aripiprazole for parenteral administration, wherein said composition is prepared by:
- a. preparing a suspension by mixing aripiprazole, at least one viscosity enhancing agent and one or more other pharmaceutically acceptable excipient(s) in purified water,
- b. sterilizing the suspension of step (a),
- c. homogenizing the sterilized suspension of step (b),
- d. milling the homogenized suspension of step (c), and
- e. lyophilizing the milled suspension of step (d),
- wherein the sterilization of step (b) is done by moist-heat sterilization at 121° C. for at least 20 minutes.
Dependencies are inferred from the claim text.