RESUMO
BACKGROUND: Secondary to increased development of generic nonsteroidal anti-inflammatory drugs (NSAIDs), there is a lack of simple and inexpensive ways of pilot detection of differences between the batches of generic drugs and the original ones. OBJECTIVES: To determine the peculiarities of the use of generic NSAIDs in routine practice through a pilot survey of dentists and to conduct a pilot comparative analysis of generic and original NSAIDs containing nimesulide granules using optical microscopy. METHODS: The first part of the study included a pilot survey Convenience sampling of 192 dentists to study the use of generic NSAIDs in their routine practice. The second part included the use of a pilot optical microscopy of nimesulide particles isolated from four drugs: original drug (NA) and generic ones (NB, NC, ND). RESULTS: In the questionnaires, dentists pointed to a 68.7% lower clinical efficacy and a 62.6% higher percentage of side effects of generic NSAIDs compared to the original ones. Based on the results of pilot optical microscopy, a statically significant difference in the size distribution of the drug substance particles in all generic nimesulide granules was determined as follows: NB (χ2: 15.15; p < 0.01); NC (χ2: 11.09; p < 0.05); ND (χ2: 1625.34; p < 0.001) compared with the original drug NA. CONCLUSIONS: A pilot survey of dentists showed that doctors noted the practical difference in the effects of the original and generic NSAIDs. A significant difference in the size of nimesulide particles and their distribution in generic drugs NB, NC, ND compared to the original NA suggests a possible difference in bioavailability and bioequivalence.
RESUMO
Fast and simple spectrophotometric method for quantitative determination of mometasone furoate in a single dose (single actuation) of its nasal spray was developed and validated. This method is based on the spectrophotometric analysis of turbid solution of a single spray in 20 mL isopropanol at 220-310 nm. We further show applicability of this method for analysis of large number of single sprays for the dosing homogeneity. It is based on a new approach to the development of spectrophotometric quantitative determination methods for drug products and possibly other objects, allowing measurements to be carried out on sufficiently turbid test solutions. The proposed approach is not a variant of the derivative spectrophotometry and can replace the methods of derivative spectrophotometry in cases where: derivative of analyte spectrum is not intense enough; derivative of the spectrum of the matrix (turbidity and remaining components of the product) is significant when compared with the derivative of the analyte.