Avaliação da Neutralização do Sistema Conservante e Controle de Qualidade Microbiológico de Formulação Oral de Cannabis sativa L.

Abstract

The growing therapeutic interest in Cannabis sativa L. derivatives, particularly cannabidiol, for the treatment of neurodegenerative diseases, epilepsy, and chronic pain requires rigorous quality control, given the sanitary risks associated with non-regulated products. This study aimed to evaluate the microbiological quality of a finished Cannabis sativa L.–based product (3% extract in extra-virgin olive oil) produced by an association, using analytical methods in accordance with the Brazilian Pharmacopoeia. Microbiological quality control included the determination of the Total Aerobic Mesophilic Count (TAMC), Total Yeasts and Molds Count (TYMC), and the detection of Escherichia coli. Due to the intrinsic antimicrobial activity of the formulation, neutralization of the inhibitory effect using polysorbate 20 was employed to ensure adequate microbial recovery during testing. The results demonstrated full sanitary compliance, with TAMC < 10² CFU/mL, TYMC < 10¹ CFU/mL, and absence of E. coli in 1 mL of the product. The finished product exhibited excellent microbiological quality, highlighting the effectiveness of Good Manufacturing Practices adopted by the producing association, combined with the inhibitory potential of cannabidiol and olive oil. This study contributes to the standardization of microbiological control of lipophilic Cannabis sativa L.-based preparations, supporting sanitary risk mitigation within the regulatory framework.