Bioactivity of abobotulinum toxin is preserved till 2 weeks upon storage at room temperature: Half body comparative study on rabbit model.
abobotulinum toxin A
bioactivity
botulinum neurotoxin
room temperature
storage
Journal
Journal of cosmetic dermatology
ISSN: 1473-2165
Titre abrégé: J Cosmet Dermatol
Pays: England
ID NLM: 101130964
Informations de publication
Date de publication:
May 2021
May 2021
Historique:
received:
19
10
2020
accepted:
30
10
2020
pubmed:
11
11
2020
medline:
15
5
2021
entrez:
10
11
2020
Statut:
ppublish
Résumé
Breakages of the cold chain of botulinum neurotoxin A (BONT-A) preparations is not a rare event and occurs due to several unexpected and unintentional reasons during daily practice and intervention schedules could not be proposed due to the lack of data. To investigate the heat stability of abobotulinum toxin A (AboBONT-A) in terms of efficacy and duration of action upon storage at room temperature (25°C) for 2, 4, and 8 weeks. Twenty rabbits were divided into four groups and received an injection of ideally stored AboBONT-A (Group 1) and stored AboBONT-A for 2 (Group 2), 4 (Group 3), and 8 weeks (Group 4) at room temperature into the anterior auricular muscle. All rabbits were followed up and photographed by weekly for 16 weeks. Grade of paralysis was evaluated by using a modified visual scoring system. No significant alteration was found in initial potency of stored AboBONT-A at room temperature for up to 4 weeks. Storage at room temperature for 2 weeks did not affect the duration of action (group 2; P = .69), and faster recovery was observed in group 3 and group 4. The bioactivity of AboBONT-A is not altered till 2 weeks upon storage at room temperature.
Sections du résumé
BACKGROUND
BACKGROUND
Breakages of the cold chain of botulinum neurotoxin A (BONT-A) preparations is not a rare event and occurs due to several unexpected and unintentional reasons during daily practice and intervention schedules could not be proposed due to the lack of data.
OBJECTIVE
OBJECTIVE
To investigate the heat stability of abobotulinum toxin A (AboBONT-A) in terms of efficacy and duration of action upon storage at room temperature (25°C) for 2, 4, and 8 weeks.
METHODS AND MATERIALS
METHODS
Twenty rabbits were divided into four groups and received an injection of ideally stored AboBONT-A (Group 1) and stored AboBONT-A for 2 (Group 2), 4 (Group 3), and 8 weeks (Group 4) at room temperature into the anterior auricular muscle. All rabbits were followed up and photographed by weekly for 16 weeks. Grade of paralysis was evaluated by using a modified visual scoring system.
RESULTS
RESULTS
No significant alteration was found in initial potency of stored AboBONT-A at room temperature for up to 4 weeks. Storage at room temperature for 2 weeks did not affect the duration of action (group 2; P = .69), and faster recovery was observed in group 3 and group 4.
CONCLUSION
CONCLUSIONS
The bioactivity of AboBONT-A is not altered till 2 weeks upon storage at room temperature.
Substances chimiques
Botulinum Toxins, Type A
EC 3.4.24.69
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1367-1373Subventions
Organisme : Turkish Society of Dermatology with a Scholarship of Scientific Research Projects
Informations de copyright
© 2020 Wiley Periodicals LLC.
Références
Lowe NJ, Shah A, Lowe PL, Patnaik R. Dosing, efficacy and safety plus the use of computerized photography for botulinum toxins type A for upper facial lines. J Cosmet Laser Ther. 2010;12(2):106-111.
Grando SA, Zachary CB. The non-neuronal and nonmuscular effects of botulinum toxin: an opportunity for a deadly molecule to treat disease in the skin and beyond. Br J Dermatol. 2018;178(5):1011-1019.
Carruthers J, Fagien S, Matarasso SL. Consensus recommendations on the use of botulinum toxin type a in facial aesthetics. Plast Reconstr Surg. 2004;114(6 Suppl):1s-22s.
Trindade De Almeida AR, Secco LC, Carruthers A. Handling botulinum toxins: an updated literature review. Dermatol Surg. 2011;37(11):1553-1565.
Jabor MA, Kaushik R, Shayani P, et al. Efficacy of reconstituted and stored botulinum toxin type A: an electrophysiologic and visual study in the auricular muscle of the rabbit. Plast Reconstr Surg. 2003;111(7):2419-2426; discussion 27-31.
Sibar S, Findikcioglu K, Zinnuroglu M, Cenetoglu S. The effect of albumin and platelet-poor plasma supplemented botulinum A toxin on bioavaliability: an experimental rabbit model. Ann Plast Surg. 2017;78(4):436-442.
Çalıskan E, Gamsızkan M, Açıkgöz G, et al. Intralesional treatments for hypertrophic scars: comparison among corticosteroid, 5-fluorouracil and botulinum toxin in rabbit ear hypertrophic scar model. Eur Rev Med Pharmacol Sci. 2016;20(8):1603-1608.
Scott AB. Botulinum toxin injection into extraocular muscles as an alternative to strabismus surgery. J Pediatr Ophthalmol Strabismus. 1980;17(1):21-25.
Kazim NA, Black EH. Botox: shaken, not stirred. Ophthalmic Plast Reconstr Surg. 2008;24(1):10-12.
Trindade De Almeida AR, Kadunc BV, Di Chiacchio N, Neto DR. Foam during reconstitution does not affect the potency of botulinum toxin type A. Dermatol Surg. 2003;29(5):530-531; discussion 2.
Shome D, Nair AG, Kapoor R, Jain V. Botulinum toxin A: is it really that fragile a molecule? Dermatol Surg. 2010;36(Suppl 4):2106-2110.
Hexsel DM, de Almeida AT, Rutowitsch M, et al. Multicenter, double-blind study of the efficacy of injections with botulinum toxin type A reconstituted up to six consecutive weeks before application. Dermatol Surg. 2003;29(5):523-529; discussion 9.
Soares DJ, Dejoseph LM, Zuliani GF, Liebertz DJ, Patel VS. Impact of postreconstitution room temperature storage on the efficacy of incobotulinumtoxinA treatment of dynamic lateral canthus lines. Dermatol Surg. 2015;41(6):712-717.
Samizadeh S, De Boulle K. Botulinum neurotoxin formulations: overcoming the confusion. Clin Cosmet Investig Dermatol. 2018;11:273-287.