Non-protein clostridial toxin compositions
AssigneeAllergan, Inc.
InventorsMaurice Abiad, Bhas Dani, Evgenyi Shalaev
Life of this patent
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Abstract
Pharmaceutical compositions that stabilize a Clostridial toxin active ingredient are described. The compositions can be liquid or solid compositions, and comprise a surfactant and an antioxidant. In some embodiments, the compositions comprise a surfactant selected from a poloxamer and a polysorbate; an antioxidant selected from methionine, N-acetyl cysteine, ethylenediaminetetraacetic acid and combinations thereof, and, optionally, a tonicity agent and/or a lyoprotector selected from, for example, trehalose, sucrose.
Claims17
1-19. (canceled)
A method of making a stable solid pharmaceutical composition which is free of animal protein excipients, the method comprising:
- compounding a Clostridial botulinum toxin active ingredient with two or more non-protein excipients to form a compounded mixture;
- wherein the two or more non-protein excipients comprise:
- (i) a poloxamer surfactant;
- and
- (ii) about 0.01 to 5 wt % methionine;
- and
- lyophilizing or vacuum drying the compounded mixture to produce the solid pharmaceutical composition;
- wherein the composition is suitable for subcutaneous or intramuscular injection after reconstitution with an aqueous carrier.
A stable solid pharmaceutical composition which is free of animal protein excipients, the composition comprising:
- (i) a Clostridial botulinum toxin active ingredient;
- (ii) a poloxamer surfactant;
- and
- (iii) about 0.01 to 5 wt % methionine;
- wherein the composition is suitable for subcutaneous or intramuscular injection after reconstitution with an aqueous carrier.
A method of making a stable liquid pharmaceutical composition, the method comprising:
- compounding a Clostridial botulinum toxin active ingredient in an amount of about 1.0 U/ml to about 1,000 U/ml with four or more non-protein excipients;
- wherein the four or more non-protein excipients comprise:
- (i) a tonicity agent selected from trehalose, sucrose, sodium chloride, mannitol, sorbitol, glucose, and combinations thereof;
- (ii) a poloxamer surfactant;
- (iii) methionine in an amount between about 0.01 to 5 wt %;
- and
- (iv) a buffering agent,
- wherein the composition has a pH of between about 5 and 8;
- wherein the composition is suitable for subcutaneous or intramuscular injection.
A stable liquid pharmaceutical composition, the composition comprising:
- (i) a Clostridial botulinum toxin active ingredient in an amount of about 1.0 U/ml to about 1,000 U/ml;
- (ii) a tonicity agent selected from trehalose, sucrose, sodium chloride, mannitol, sorbitol, glucose, and combinations thereof;
- (iii) a poloxamer surfactant;
- (iv) methionine in an amount between about 0.01 to 5 wt %;
- and
- (v) a buffering agent,
- wherein the composition has a pH of between about 5 and 8;
- wherein the composition is suitable for subcutaneous or intramuscular injection.
Dependencies are inferred from the claim text.