In Vitro Evaluation of the Antimicrobial and Antimycobacterial Activities of Solanum guaraniticum A. St.-Hil. Leaves.

With the emergence of antimicrobial resistance, it becomes necessary to search for new alternatives for the treatment of infectious diseases. Solanum guaraniticum is a shrub known as jurubeba or false jurubeba that has hepatoprotective and antioxidant activities, used in popular medicine for the treatment of various diseases. The aim of this study was to evaluate the in vitro antimicrobial and antimycobacterial activities of crude extract, chloroforn, ethyl acetate and butanol fractions from its leaves. Good activities were observed for the ethyl acetate fraction against Staphylococcus intermedius and Listeria monocytogenes (MIC = 64 μg/mL) and for the crude extract against Micrococcus luteus (MIC = 32 μg/mL). In general, the extracts showed moderate activity against Gram-positive bacteria, and were inactive against Gram-negative bacteria and fungi. It was also verified considerable activity against Mycobacterium smegmatis, mainly by chloroform fraction (MIC = 156 μg/mL). These results are probably due to the good antioxidant activity and to the presence of high contents of polyphenols, tannins and alkaloids, metabolites known to possess antimicrobial activity. Studies aiming the isolation of compounds are necessary in order to know the main component involved in these activities, since the plant has an antimicrobial potential.

Validação de método analítico para avaliação da qualidade de cápsulas de cloridrato de metformina manipuladas / Validation of analytical method for quality control of compounded metformin hydrochloride capsules

As farmácias magistrais têm se mostrado uma alternativa quando o paciente procura medicamentos com doses personalizadas ou custos mais baixos, o que resultou em um crescente aumento pela procura de medicamentos manipulados. Porém, apesar das vantagens, estes medicamentos não passam por um rígido controle de qualidade, o que pode colocar o tratamento do paciente em risco. Este trabalho teve como objetivos validar metodologia analítica e avaliar a qualidade das cápsulas de cloridrato de metformina manipuladas por sete farmácias de Santa Maria – RS. O método validado mostrou-se seletivo, linear, preciso, exato e robusto, podendo ser utilizado para a determinação quantitativa de cloridrato de metformina em cápsulas. As cápsulas produzidas pelas farmácias A, B, D, F e G cumpriram com os requisitos mínimos de controle de qualidade e as cápsulas manipuladas pelas farmácias C e E foram reprovadas nos testes de doseamento e uniformidade de doses unitárias.

Compounding pharmacies have proved a useful alternative when patients look for drugs fitted to their needs in dose number and size, or for less expensive drug forms, leading to an increasing demand for compounded drugs. However, despite the advantages, these drugs do not always go through a strict quality control, which may be detrimental to patient care. The aim of the present study is to validate an analytical method and use it to assess the quality of metformin hydrochloride capsules obtained from seven different compounding pharmacies in Santa Maria, RS (Brazil). The validated method proved to be selective, linear, precise, accurate and robust and can be used for the quantitative determination of metformin hydrochloride in capsules. The capsules compounded by pharmacies A, B, D, F and G met the minimum requirements of quality control, while those from pharmacies C and E failed in the assays of dose and uniformity of dosage units.

Equivalência farmacêutica e estudo comparativo dos perfis de dissolução de medicamentos genéricos contendo paracetamol / Pharmaceutical equivalence and comparative study of dissolution profiles of generic drugs containing acetaminophen

Este trabalho teve como objetivo principal comparar, através do estudo de equivalência farmacêutica e do perfil de dissolução in vitro, oito medicamentos genéricos contendo paracetamol 750 mg, comercializados na região central do Rio Grande do Sul. As análises foram realizadas em conformidade com a monografia do paracetamol comprimidos, descrita na Farmacopeia Brasileira (2010). Os genéricos A, B, D, E, F, G e H são equivalentes farmacêuticos do medicamento referência, pois foram aprovados em todos os testes a que foram submetidos. O Genérico C, no entanto, foi reprovado no doseamento. Quando avaliados em relação ao perfil de dissolução, pelos critérios descritos na RDC 31/2010, somente o genérico E não possui o mesmo perfil de dissolução que o medicamento referência, porém quando comparados pela eficiência de dissolução (ED) podemos verificar que somente os Genéricos G, H, F e A possuem a mesma ED que o medicamento referência.

The aim of this study was to compare, by testing their pharmaceutical equivalence and dissolution profiles in vitro, eight generic medicines containing 750 mg paracetamol, marketed in the central region of Rio Grande do Sul (Brazil). Analyses were carried out in accordance with the monograph on paracetamol tablets in the Brazilian Pharmacopoeia (2010). The generic medicines A, B, D, E, F, G and H are pharmaceutically equivalent to the drug reference, since they passed all the tests they underwent. Of all the samples analyzed, only drug E did not have the same dissolution profile as the reference drug, a fact that may interfere with the interchangeability of these products, which is required of a drug being marketed as a generic. Regarding dissolution efficiency (DE), the ANOVA showed a significant difference between the products, so the Tukey test was applied, showing that only the generics A, F, G and H have the same DE as the reference drug.