Stabilization of botulinum toxin type A during lyophilization.
Botulinum toxin for medical use is diluted to very low concentrations (nanograms per milliliter); when it is preserved by lyophilization, considerable loss of activity can occur. In the present study, conditions that gave > 90% recovery of the toxicity after lyophilization of solutions containing 20 to 1,000 mouse 50% lethal doses per ml were found. Toxicity was recovered upon drying 0.1 ml of toxin solution when the pH was maintained below 7 and bovine or human serum albumins were used as stabilizers. Various other substances tested with albumin, including glucose, sucrose, trehalose, mannitol, glycine, and cellibiose, did not increase recovery on drying.
Goodnough
M C
MC
Department of Food Microbiology and Toxicology, University of Wisconsin, Madison 53706.
Johnson
E A
EA
D000818:Animals; D001905:Botulinum Toxins / Q000737:chemistry / Q000633:toxicity*; D004355:Drug Stability; D005612:Freeze Drying; D006863:Hydrogen-Ion Concentration; D051379:Mice; D012710:Serum Albumin, Bovine; D012965:Sodium Chloride
D012710:Serum Albumin, Bovine; D012965:Sodium Chloride; D001905:Botulinum Toxins