RISK ANALYSIS OF THE PHOTOPROTECTION PROCESS OF CIPROFLOXACIN
DOI:
https://doi.org/10.37951/2596-1578.cipeex.2023.10488Palavras-chave:
Ciprofloxacin, Risk Analysis, PhotostabilityResumo
To ensure the integrity of the experiments in obtaining photoprotection of the API (Active Pharmaceutical
Ingredient) ciprofloxacin, a Risk Analysis was conducted to identify the possible risks associated with
the mixture of ciprofloxacin with the excipient curcumin in the respective proportions of 1/1, 1/0.5, and
2/1. Within this evaluation, it was possible to define the critical and non-critical attributes of the API that
could interfere with the experiments. The methodology adopted to obtain the results followed the
guidelines of the ICHQ9 Guide from January 2023, and the risk assessment of each attribute within the
experiment was based on the information provided by the IFA manufacturer, Sigma-Aldrich, and data
evidenced in the literature. According to the risk analysis, the only attribute considered critical for the
experiment was the active ingredient content, which has a potency different from 100%, and its mass
was adjusted so that the proportion between the mixtures of raw materials could be corrected.
Referências
TORNIAINEN, K.; TAMMILEHTO, S; ULVI, V. The effect of pH, buffer type and drug concentration on the photodegradation of ciprofloxacin. International Journal of Pharmaceutics, v.132, p.53-61, 1996.
ICH, ICH. Q9 Quality Risk Management. In: Proceedings of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 2023
Cipro. [Bula]. Leverkusen – Alemanha. Bayer AG . DisponÃvel em: <https://consultas.anvisa.gov.br/#/bulario/q/?nomeProduto=CIPRO>. Acesso em: 13/09/2023.
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