Is it Possible to Accurately Determine Content of Botulinum Neurotoxin Type A in Drug Products?

Sesardic, Dorothea

doi:10.1007/bf03259779

Cited by 4 publications

(7 citation statements)

References 6 publications

(6 reference statements)

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“…Potency is related to the quantity (nanogram) of toxin protein content (i.e., 150 kD neurotoxin including NAPs) required to achieve an LD 50 unit . Despite attempts to establish comparative potency among the BoNT products, the issue remains an unresolved and controversial topic . Each BoNT formulation contains different amounts of 150 kD toxin (and NAPs)/LD 50 unit (Table ) .…”

Section: Toxin Potencymentioning

confidence: 99%

Abo‐, Inco‐, Ona‐, and Rima‐Botulinum Toxins in Clinical Therapy: A Primer

Chen

Dashtipour

2013

Pharmacotherapy

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Botulinum neurotoxin (BoNT) is an acetylcholine release inhibitor and a neuromuscular-blocking agent used for the treatment of a variety of medical and cosmetic indications. Currently, in the United States, there are four BoNT formulations licensed for use: abobotulinumtoxinA, incobotulinumtoxinA, onabotulinumtoxinA, and rimabotulinumtoxinB. These revised name designations were established to reinforce the understanding that each BoNT product has an individual potency and is not interchangeable with any other BoNT product. The therapeutic use of BoNTs is expanding and new formulations are on the horizon. This article is a primer that describes distinctions among currently available, licensed BoNT formulations. Toxin pharmacology, product characteristics, storage, handling, preparation, and dosages will be reviewed. In addition, issues related to dose equivalency ratios, immunogenicity, potency, and toxin spread will be discussed. Therapeutic indications and safety are discussed briefly. Knowledge of the available and licensed BoNT formulations and the ability to make distinctions in toxin pharmacology, product characteristics, and indications are vital for product selection, preparation, drug information, avoidance of drug errors, quality assurance, and patient safety.

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Section: Toxin Potencymentioning

confidence: 99%

Abo‐, Inco‐, Ona‐, and Rima‐Botulinum Toxins in Clinical Therapy: A Primer

Chen

Dashtipour

2013

Pharmacotherapy

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“…The recent article from Dr Frevert of Merz,[1] together with the accompanying commentary from Dr Sesardic of NIBSC,[2] makes a new contribution to the data available for clinical botulinum toxin type A (BoNT-A) products. However, in addition to the comments about the various technical aspects of the data provided by Dr Frevert, as described by Dr Sesardic,[2] one important and key factor about the BoNT-A products has not been mentioned.…”

mentioning

confidence: 99%

“…However, in addition to the comments about the various technical aspects of the data provided by Dr Frevert, as described by Dr Sesardic,[2] one important and key factor about the BoNT-A products has not been mentioned. The units of each product are different, not interchangeable, and no fixed or established conversion ratio exists between them,[3–5] regardless of what clinical data are presented.…”

mentioning

confidence: 99%

Consistent Biochemical Data are Essential for Comparability of Botulinum Toxin Type A Products

Pickett¹

2011

Drugs R D

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“…The recent article from Dr Frevert of Merz, [1] together with the accompanying commentary from Dr Sesardic of NIBSC, [2] makes a new contribution to the data available for clinical botulinum toxin type A (BoNT-A) products. However, in addition to the comments about the various technical aspects of the data provided by Dr Frevert, as described by Dr Sesardic, [2] one important and key factor about the BoNT-A products has not been mentioned.…”

mentioning

confidence: 99%

“…However, in addition to the comments about the various technical aspects of the data provided by Dr Frevert, as described by Dr Sesardic, [2] one important and key factor about the BoNT-A products has not been mentioned. The units of each product are different, not interchangeable, and no fixed or established conversion ratio exists between them, [3][4][5] regardless of what clinical data are presented.…”

mentioning

confidence: 99%

Consistent Biochemical Data are Essential for Comparability of Botulinum Toxin Type A Products

Pickett¹

2011

Drugs R D

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Is it Possible to Accurately Determine Content of Botulinum Neurotoxin Type A in Drug Products?

Cited by 4 publications

References 6 publications

Abo‐, Inco‐, Ona‐, and Rima‐Botulinum Toxins in Clinical Therapy: A Primer

Abo‐, Inco‐, Ona‐, and Rima‐Botulinum Toxins in Clinical Therapy: A Primer

Consistent Biochemical Data are Essential for Comparability of Botulinum Toxin Type A Products

Consistent Biochemical Data are Essential for Comparability of Botulinum Toxin Type A Products

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