Pharmacopeial specifications and analytical data from post-marketing quality sampling and testing programs: A perspective beyond out-of-specification results.

Ensuring that marketed medicines meet acceptable standards (safety, quality, and efficacy) involves aspects of product development, compliance with good manufacturing practices, and monitoring and testing of these products already on the market. Pharmacopeias are one of the main tools used by regulatory authorities in the analytical testing for quality assessment; there are almost 60 pharmacopeias in the world. Thus, this research evaluated the potential impacts of the differences between the pharmacopeial specifications in the quality assessment of these products. It also assessed the use of analytical data to strengthen these surveillance systems. The pharmacopeial specifications for assay determination and dissolution test from United States Pharmacopeia (USP), British (BP), Brazilian (FB), Portuguese (FP), Argentine (FA), and International (Ph. Int.) Pharmacopeias were compared. The quality control reports and results of the Brazilian conformity assessment program were used to support the research. The possibility of selection of medicines or manufacturers for monitoring, sampling, and testing, as well as good manufacturing practice inspections based on analytical data were observed, even considering compliant cases or those within the tolerance limits. An important impact of acceptance criteria given in the individual monographs of different pharmacopeias regarding quality testing was also observed. Strengthening of the pharmacopeial harmonization projects and universalization of the requirements provided by the individual monographs can help in supporting the internationalization of the pharmaceutical market and improving access to medicines.

Triterpenes from Pouteria ramiflora (Mart.) Radlk. Leaves (Sapotaceae).

Pouteria ramiflora (Mart.) Radlk. (Sapotaceae) is a species used by inhabitants from the Cerrado for its edible fruits and medicinal value. Hexane crude extracts from leaves and fractions were evaluated for in vitro α-amylase inhibitory activity and antioxidant potential. The fraction with the highest α-amylase inhibitory activity was submitted to a phytochemical study. Three triterpenes were isolated, friedelin, epi-friedelanol, and taraxerol. This is the first report of these compounds isolated from P. ramiflora. Moreover, this is the first report of friedelin isolated from Pouteria sp. Epi-friedelanol was present in significant amounts, suggesting that this compound could be a candidate marker for this species.

Pouteria torta epicarp as a useful source of α-amylase inhibitor in the control of type 2 diabetes.

Type 2 diabetes plays a major role in public health, affecting about 400 million adults. One of the used strategies to control type 2 diabetes is the inhibition of α-amylase activity to reduce post-prandial blood glucose levels. Therefore, in past decades, the search of new α-amylase inhibitors has led to the evaluation of natural products as a source of these compounds. Pouteria torta (Sapotaceae) is widespread in Brazil and bears edible fruits. Epicarp and pulp crude extracts of fresh fruits were studied for in vitro α-amylase inhibition activity. The pulp did not present activity while epicarp, usually considered as waste, showed a high α-amylase inhibitory capacity when compared with acarbose and Triticum aestivum. Therefore, an assay-guided fractionation study of epicarp crude extract was performed. Fraction VI shows very high inhibitory activity with IC50 of 9 µg/mL. However, subsequent fractionation led to lower inhibition potential (IC50 of 22.1 µg/mL). The qualitative characterization of fraction VI were performed by chromatographic and spectrometric analysis and showed the presence of epicatechin, catechin, sucrose, glucose, and fructose. Total phenolic and flavonoid contents and antioxidant capacity were also assessed and there seemed to be no correlation between phenolic or flavonoids-rich fractions and antioxidant capacity or α-amylase inhibitory activity.