This study creates evidence that the physical-chemical parameters required by ANVISA are not sufficient to assess the reproducibility of raw materials. It is noteworthy that the margin between minimum and maximum values of physical-chemical parameters required by ANVISA is very large and this may compromise the therapeutic efficacy of pharmaceutical compounding by introducing the possibility of changes in concentration of the active ingredient in these formulations.
Control and standardization of quality control is necessary for the stages of production, as it ranges from the acquisition of raw materials to therapeutic monitoring. According to ANVISA, through the General Office of Inspection and Control of Medicinal Products, there is an absence of a technical literature to systematize testing, processes, and materials that are used by the Quality Control Laboratories and production, thus failing to provide uniformity in the methodologies used in the analysis of drug control. Thus, it is essential for suppliers to ensure that the final product attains the parameters of quality specified in the product report from the manufacturer in order to ensure the batch-to-batch reproducibility of the product.
The materials sampled play an important role in the maintenance and repair of articular cartilage. Having been compared, there was no significant difference in solubility tests and organoleptic characteristics between batches analyzed in relation to pharmacy-supplied samples. However, the pH of glucosamine for Supplier 1 was of low reproducibility, while for Supplier 2 the values were in excellent agreement with manufacturer-published values; whereas for chondroitin sulfate, the ICC values were of low reproducibility for both Suppliers...
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...o adopt other strategies to ensure the quality of raw materials, such as the analysis of samples by vibrational spectroscopy.
Conclusion
Compounding pharmacies are an important market segment in the trade of drugs, offering prices more accessible than industrialized drugs. It is necessary to implement more efficient legislation to ensure the quality of the final product being that the only evaluation criteria recommended by ANVISA, the evaluation of physical-chemical parameters, is insufficient to ensure product quality. Sample testing showed great variability in physical-chemical tests that nonetheless remained in the range required for each substance analyzed. However vibrational spectroscopy demonstrated that the raw materials had different concentrations along the scale of production, which may compromise patient safety and the therapeutic efficacy of drugs.