Stabilization of Clostridium botulinum neurotoxin complex
AssigneeB.B. Scientific L.L.C.
InventorsBal Ram Singh, Andrew M. Ress
Life of this patent
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Abstract
A stable composition including botulinum neurotoxin and a cyclodextrin and a method of preserving botulinum neurotoxin and for producing a botulinum neurotoxin composition with improved stability properties in an efficient and economically advantageous manner. The invention seeks to alleviate the problems associated with rapid degradation or denaturation of botulinum neurotoxin by providing a novel composition that exhibits improved stability properties. The botulinum neurotoxin is preferably stabilized by forming a cyclodextrin inclusion complex.
Claims13
A stabilized neurotoxin composition comprising:
- a botulinum neurotoxin;
- and
- a cyclodextrin having cyclic multicyclopyranose units connected by alpha-(1-4) linkages, wherein the cyclodextrin and the botulinum neurotoxin form an inclusion complex, wherein the composition has a shelf life of at least four weeks.
A stabilized neurotoxin composition comprising:
- a botulinum neurotoxin;
- and
- a cyclodextrin,
- wherein the cyclodextrin and the botulinum neurotoxin are present in a molar ratio of at least 25:1 to 50:1 to form a complex that exhibits improved stability compared to the neurotoxin alone as evidenced by a shelf life of at least four weeks with about 55% to about 80% of the botulinum neurotoxin remaining as the complex for a period of at least 2 weeks and by exhibiting less than 65% degradation over a period of time of about 23 weeks at storage temperatures that are between 4° and 25° C.
Dependencies are inferred from the claim text.