Investigation of in vitro permeation and release assays of semi-solid topical formulations to standardization of quality requirements on a pharmaceutical industry
DOI:
https://doi.org/10.33448/rsd-v9i11.10210Keywords:
Semisolid drugs; In vitro assays; Quality.Abstract
Semisolid drug development is a strategy applied for drug release, both local and systemically administration. However, as the skin has several layers, the formulation must be designed in order to overcome these barriers. As in 2019, Brazilian Health Surveillance National Agency (Anvisa) has published No. 20/2019 Guide, that disposes about Quality Requirements to Topical and Transdermal Products Register, which contains quality analysis and in vitro performance evaluation assays. No. 20/2019 Guide, although it is current, it is available for contributions throughout one year from its publication. Thus, it was led a bibliographical research about the available assays to quality evaluation of semisolid products produced on a generic drugs industry based on information mentioned on No. 20/2019 Guide. That was considered cream, oilment, and gel formulations and applied on indicated tests, such as release and permeation tests, forasmuch as the formulation characteristics, route of administration, and place of action. It was evaluated the apparatus mix applied and the peculiarities for the respective analysis as well. According to the results found, it is possible to affirm that both the assays are specific for the study of the three semisolid forms, regarding the “sameness” between the apparatus as the respectively values are similar.
References
Addor, F. A. S. A., & Aoki, V. (2009). Barreira cutânea na dermatite atópica. Anais Brasileiros de Dermatologia, 85(2), 184-194.
Al-Ghabeish, M., Xu, X., Krishnaiah, Y. S. R., Rahman, Z., Yang, Y., & Khan, M. A. (2015). Influence of drug loading and type of ointment base on the in vitro performance of acyclovir ophthalmic ointment. International Journal of Pharmaceutics, 495(2), 783-791.
Beber, T. C., Andrade, D. F., Kann, B., Fontana, M. C., Coradini, K., Windbergs, M., & Beck, R. C. R. (2014). Submicron polymeric particles prepared by vibrational spray-drying: semisolid formulation and skin penetration/permeation studies. European Journal of Pharmaceutics and Biopharmaceutics, 88(3), 602-613.
Bemvindo, C. S. (2006). Estudo comparativo da liberação e penetração cutânea de nitrato de miconazol de emulsões tópicas comerciais. Dissertação de Mestrado - Universidade Federal do Rio de Janeiro.
Bolla, P. K., Clark, B. A., Cheruvu, H. S., & Renukuntla, K. (2020). Evaluation of formulation parameters on permeation of ibuprofen from topical formulations using Strat-m® membrane. Pharmaceutics, 12(2), 151.
Brasil. (2019). Guia nº20, de 13 de dezembro de 2018. Agência Nacional de Vigilância Sanitária, 1, 1-22.
Ciurlizza, C., Fernández, F., Calpena, A. C., Lázaro, R., Parra, A., & Clares, B. (2014). Semisolid formulations containing cetirizine: human skin permeation and topical antihistaminic evaluation in a rabbit model. Archives for Dermatological Research, 306(8), 711-717.
Lourenço, A. R. (2013). Administração tópica de fármacos – Das restrições aos desafios. Dissertação de Mestrado - Universidade Lusófona de Humanidades e Tecnologias.
Olejnik, A., Goscianska, J., & Nowak, I. (2012). Active compounds release from semisolid dosage forms. Journal of Pharmaceutical Sciences, 101(11), 4032-4045.
Otto, V., França, F., & Hoefler, R. (2018). Formas farmacêuticas semissólidas para tratamento tópico. Revista CFF, 22(1), 3-9.
Pham, J., Nayel, A., Hoang, C., & Elbayoumi, T. (2014). Enhanced effectiveness of tocotrienol-based nano-emulsified system for topical delivery against skin carcinomas. Drug Delivery, 23(5), 1514-1524.
Reichling, J., Landvatter, U., Wagner, H., Kotstka, K. H., & Schaefer, U. F. (2006). In vitro studies on release and human skin permeation of Australian tea tree oil (TTO) from topical formulations. European Journal of Pharmaceutics and Biopharmaceutics, 64(2), 222-228.
Rottke, M., Lunter, D. J., & Daniels, R. (2014). In vitro studies on release and skin permeation of nonivamide from novel oil-in-oil emulsions. European Journal of Pharmaceutics and Biopharmaceutics, 86(2), 260-266.
Ruela, A. L. M., Perissinato, A. G., Lino, M. E. S., Mudrik, P. S., & Pereira, G. R. (2016). Evaluation of skin absorption of drugs from topical and transdermal formulations. Brazilian Journal of Pharmaceutical Sciences, 52(3), 527-544.
Sampaio, R. F., & Mancini, M. C. (2007). Estudos de revisão sistemática: um guia para síntese criteriosa da evidência científica. Revista Brasileira de Fisioterapia, 11(1), 83-89.
Schmook, F. P., Meingassner, J. G., & Billich, A. (2001). Comparison of human skin or epidermis models with human and animal skin in in-vitro percutaneous absorption. International Journal of Pharmaceutics, 215(1-2), 51-56.
Silva, J. A., Apolinário, A. C, Souza, M. S. R., Damasceno, B. P. G. L., & Medeiros, A. C. D. (2010). Administração cutânea de fármacos: desafios e estratégias para o desenvolvimento de formulações transdérmicas. Revista de Ciências Farmacêuticas Básica e Aplicada, 31(3), 125-131.
Tiffner, K. I., Kanfer, I., Augustin, T., Raml, R., Raney, S. G., & Sinner, F. (2018). A comprehensive approach to qualify and validate the essential parameters of an in vitro release test (IVRT) method for acyclovir cream, 5%. International Journal of Pharmaceutics, 535(1-2), 217-227.
Ueda, C. T., Shah, V. P., Derdzinski, K., Ewing, G., Flynn, G., & Maibach, H. (2009). Topical and transdermal drug products. Pharmacopeial Forum, 35(3), 750-64.
Viljoen, J. M., Botes, D., & Steenekamp, J. H. (2018). Formulation and evaluation of selected transmucosal dosage forms containing a double fixed-dose of acyclovir and ketoconazole. European Journal of Pharmaceutical Sciences, 111, 509-519.
WHO. (2015). The International Pharmacopoeia. Geneva: World Health Organization, Dept. of Essential Medicines and Pharmaceutical Policies.
Yang, Y., Manda, P., Pavurala, N., Khan, M. A., & Krishnaiah, Y. S. R. (2015). Development and validation of in vitro-in vivo correlation (IVIVC) for estradiol transdermal drug delivery systems. Journal of Controlled Release, 210, 58-66.
Zillich, O. V., Schweiggert-Weisz, U., Hasenkopf, K., Elsner, P., & Kerscher, M. (2013). Release and in vitro skin permeation of polyphenols from cosmetic emulsions. International Journal of Cosmetic Science, 35(3), 491-501.
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