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Prepration of Botulinum Toxin

By: Pharma Tips | Views: 2573 | Date: 19-Jun-2011

The preparations of BoNT-A marketed in the United States , the United Kingdom and Europe (Dysport, by Speywood-Vaccine and Research Laboratory-Porton Down; Salisbury, UK), and Japan (CS-BOT) differ in potency.

PREPRATIONS

The preparations of BoNT-A marketed in the United States , the United Kingdom and Europe (Dysport, by Speywood-Vaccine and Research Laboratory-Porton Down; Salisbury, UK), and Japan (CS-BOT) differ in potency.

BoNT-A is prepared by laboratory fermentation of C botulinum cultures. Crude botulinum toxin is a protein with a molecular weight of about 190,000 Daltons. After purification, the toxin is diluted with human serum albumin, bottled in vials, lyophilized (freeze-dried), and sealed.

Each freeze-dried vial containing 100 units (U) of BoNT-A is reconstituted with preservative-free normal saline (1-5 mL) just before use. The manufacturer recommends that the toxin be used within 4 hours of reconstitution.

The potency of BoNT-A is measured in mouse units (MU). One MU of BoNT-A is equivalent to the amount of toxin that kills 50% of a group of 20 g Swiss-Webster mice within 3 days of intraperitoneal injection (LD50).

According to one report, 1 nanogram of toxin contains approximately 20 U of BOTOX® (ie, 1 U of BOTOX® is equal to approximately 0.05 nanogram of the toxin).

According to another report comparing the 3 different preparations of BoNT-A, 1 nanogram of Dysport contains approximately 40 MU, whereas 1 nanogram of the BOTOX® contains approximately 4 MU, and 1 nanogram of CS-BOT contains approximately 15.2 MU.

LD50 of BoNT-A for a 70-kg adult male has been calculated to be 2500-3000 U (35-40 U/kg).

Minimum lethal dose of BoNT-B in monkeys is 2400 U/kg.

Clinically, 1 U of BoNT-A is approximately equivalent to 3 U of Dysport.

Standardization efforts are underway using measurements of the toxin's pharmacologically relevant actions (eg, median paralysis unit).

BoNT-B is marketed in the United States as MyoBloc. This preparation is a ready-to-use solution that does not require reconstitution; it is available in 3 vial sizes (ie, 2500 U, 5000 U, and 10,000 U) and is stable for up to 21 months in refrigerator storage.

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