Abstract
BackgroundSecondary 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. ObjectivesTo 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. MethodsThe 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). ResultsIn 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. ConclusionsA 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.
Highlights
Drugs are divided into two categories according to the innovation criteria: 1 – original; 2 – generic [1]
The aim of the study is to determine the peculiarities of the use of generic non-steroidal anti-inflammatory drugs (NSAIDs) in dental practice by pilot survey of dentists, to clarify satisfaction with outcomes of their patient after prescribing generic nonsteroidal anti-inflammatory drugs (NSAIDs), and to conduct a pilot comparative analysis of generic and original NSAIDs containing nimesulide granules using optical microscopy
Validation results confirm that dry residues of all samples contained nimesulide active pharmaceutical ingredient (API)
Summary
Drugs are divided into two categories according to the innovation criteria: 1 – original; 2 – generic (reproduced) [1]. 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). 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
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