Stability of equine IgG antivenoms obtained by caprylic acid precipitation: towards a liquid formulation stable at tropical room temperature.
Abstract: Liquid formulations of antivenom require a cold chain for their distribution and storage, especially in tropical countries characterized by high temperature and humidity (climatic zone IV). Since cold chain is often deficient in many regions, there is a need to develop novel formulations of liquid antivenoms of higher stability at room temperatures. The effect of addition of the polyols mannitol and sorbitol on the thermal stability of caprylic acid-fractionated equine whole IgG antivenoms was assessed in preparations having different concentrations of protein and phenol. Results evidenced that: (1) turbidity increases proportionally to phenol and protein concentration. (2) After one year of storage at 25 degrees C, caprylic acid-purified antivenoms, formulated with or without polyols, did not show evidences of instability. (3) Formulation of antivenoms with 2.0 M sorbitol prevents the appearance of turbidity after one year storage at 37 degrees C; however, there was a partial loss in neutralizing potency in these conditions. Results suggest that formulation based on sorbitol is an option to obtain liquid whole IgG antivenoms of higher stability at tropical room temperatures.
Publication Date: 2009-08-13 PubMed ID: 19673074DOI: 10.1016/j.toxicon.2009.01.012Google Scholar: Lookup
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- Journal Article
- Research Support
- Non-U.S. Gov't
Summary
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The research aims to improve stability of equine IgG antivenoms at room temperature, specifically in tropical regions. The study examines how the addition of polyols (sorbitol and mannitol) affects the thermal stability of the antivenoms.
Key Research Aims and Methods
- The key objective of this study is to enhance the stability of equine IgG antivenoms at tropical room temperature by modifying their formulation. This would bypass the need for cold storage and distribution, which can be challenging in certain regions.
- This research involved assessing the effect of adding polyols mannitol and sorbitol to caprylic acid-fractionated equine whole IgG antivenoms, particularly focusing on preparations with varying protein and phenol concentrations.
Findings of the Study
- The researchers found that the turbidity of the antivenom increases in direct proportion to the concentration of phenol and protein. Turbidity is often used as a measure of the stability of liquid formulations.
- When stored at 25 degrees Celsius for a year, caprylic acid-purified antivenoms, both with and without added polyols, did not show signs of instability. This suggests that this treatment can maintain stability at regular room temperature.”
- Formulations of antivenoms with 2.0 M sorbitol prevented the formation of turbidity after being stored at 37 degrees Celsius for one year. However, the researchers observed a partial loss of neutralizing potency under these conditions.
Conclusions and Suggestions
- Based on the results, the researchers suggest the use of sorbitol-based formulation as an option for creating more stable liquid whole IgG antivenoms for tropical room temperature.
- However, they also alert to the fact that the addition of sorbitol may cause a reduction in neutralizing potency of the antivenom, indicating the need for further research to optimize the formulation for maintaining both stability and efficacy.
Cite This Article
APA
Segura A, Herrera M, González E, Vargas M, Solano G, Gutiérrez JM, León G.
(2009).
Stability of equine IgG antivenoms obtained by caprylic acid precipitation: towards a liquid formulation stable at tropical room temperature.
Toxicon, 53(6), 609-615.
https://doi.org/10.1016/j.toxicon.2009.01.012 Publication
Researcher Affiliations
- Instituto Clodomiro Picado, Facultad de Microbiología, Universidad de Costa Rica, San José, Costa Rica.
MeSH Terms
- Animals
- Antivenins / analysis
- Antivenins / chemistry
- Antivenins / toxicity
- Caprylates / chemistry
- Chemical Precipitation
- Drug Stability
- Immunoglobulin Fab Fragments / chemistry
- Immunoglobulin G / chemistry
- Mice
- Proteins / analysis
- Rabbits
- Sorbitol / chemistry
- Temperature
Citations
This article has been cited 10 times.- Aglanu LM, Amuasi JH, Prokesh E, Beyuo A, Dari CD, Ravensbergen SJ, Agbogbatey MK, Adobasom-Anane AG, Abass KM, Lalloo DG, Blessmann J, Kreuels B, Stienstra Y. Community members and healthcare workers' priorities for the control and prevention of snakebite envenoming in Ghana. PLoS Negl Trop Dis 2023 Jul;17(7):e0011504.
- León G, Herrera M, Vargas M, Arguedas M, Sánchez A, Segura Á, Gómez A, Solano G, Corrales-Aguilar E, Risner K, Narayanan A, Bailey C, Villalta M, Hernández A, Sánchez A, Cordero D, Solano D, Durán G, Segura E, Cerdas M, Umaña D, Moscoso E, Estrada R, Gutiérrez J, Méndez M, Castillo AC, Sánchez L, Sánchez R, Gutiérrez JM, Díaz C, Alape A. Development and characterization of two equine formulations towards SARS-CoV-2 proteins for the potential treatment of COVID-19. Sci Rep 2021 May 10;11(1):9825.
- Mateljak Lukačević S, Kurtović T, Lang Balija M, Brgles M, Steinberger S, Marchetti-Deschmann M, Halassy B. Quality-Related Properties of Equine Immunoglobulins Purified by Different Approaches. Toxins (Basel) 2020 Dec 14;12(12).
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- Mendonça-da-Silva I, Magela Tavares A, Sachett J, Sardinha JF, Zaparolli L, Gomes Santos MF, Lacerda M, Monteiro WM. Safety and efficacy of a freeze-dried trivalent antivenom for snakebites in the Brazilian Amazon: An open randomized controlled phase IIb clinical trial. PLoS Negl Trop Dis 2017 Nov;11(11):e0006068.
- Kaale E, Manyanga V, Chambuso M, Liana J, Rutta E, Embrey M, Layloff T, Johnson K. The Quality of Selected Essential Medicines Sold in Accredited Drug Dispensing Outlets and Pharmacies in Tanzania. PLoS One 2016;11(11):e0165785.
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