Journal of Global Pharma Technology
Volume 12 Issue 11 (2020) Nov. 2020

Efficacy, Safety, Quality Assurance of Isomers of Non-Steroidal Anti-Inflammatory Drugs: Dexketoprofen and Dexibuprofen

Elena Litvinova (Department of Management, Economy and Quality Assurance in Pharmacy, National University of Pharmacy of the Ministry of Health of Ukraine, Kharkiv, Ukraine)
Mariya Zarichkova (Department of Management and Economics of Pharmacy, Institute of Pharmacy Professionals Qualification Improvement, National University of Pharmacy of the Ministry of Health of Ukraine, Kharkiv, Ukraine)
Svitlana Kovalenko (Department of Management, Economy and Quality Assurance in Pharmacy, National University of Pharmacy of the Ministry of Health of Ukraine, Kharkiv, Ukraine)
Olga Posylkina (Department of Management, Economy and Quality Assurance in Pharmacy, National University of Pharmacy of the Ministry of Health of Ukraine, Kharkiv, Ukraine)
Olena Tkachenko (Department of Management, Economy and Quality Assurance in Pharmacy, National University of Pharmacy of the Ministry of Health of Ukraine, Kharkiv, Ukraine)
Anastasiia Lisna (Department of Management, Economy and Quality Assurance in Pharmacy, National University of Pharmacy of the Ministry of Health of Ukraine, Kharkiv, Ukraine)



Article Info

Publish Date
06 Feb 2021

Abstract

The aim of this work is to analyze and systematize data on efficacy, safety, and quality assurance for NSAID isomers – dexketoprofen and dexibuprofen. Studies were conducted using databases on the Internet: PubMed; Food and Drug Administration, European Medicines Agency. It has used retrospective, logical, systematic and analytical methods. The results of a multifaceted analysis of sources of data of clinical use proved the high analgesic efficacy of dexketoprofen and dexibuprofen in acute and chronic pain of various etiologies, such as toothache, dysmenorrhea, pain after surgery, muscle pain, headache, back pain, pain from bone metastases, etc. To achieve the effect obtained with the use of 1 dose of racemic NSAIDs, half the dose of their active isomers is sufficient. The high clinical effectiveness of dexketoprofen, dexibuprofen combines with their relative tolerance, in particular from the gastrointestinal tract. In large part, the safety of dexketoprofen is due to the presence of only the active S (+) - enantiomer of ketoprofen, dexibuprofen is due to the presence of only active S (+) - ibuprofen, which eliminates the side effects associated with the influence of the R (-) - enantiomers. The results of the analysis of quality assurance of generic dexketoprofen (class 1 of biopharmaceutical classification system) and dexibuprofen (class 2 of biopharmaceutical classification system) during the biowaiver procedure are systematized. It has been shown that not only high permeability and high solubility, but also the composition of the drug excipients are important for pharmaceutical equivalence in vitro. Based on the results research findings presented, it is possible to optimize the technological process and analytical methods, which allows taking into account critical factors and ensuring the quality of the medicine and its bioequivalence to the reference drug.

Copyrights © 2020






Journal Info

Abbrev

jgpt

Publisher

Subject

Medicine & Pharmacology

Description

ournal of Global Pharma Technology is a monthly, open access, Peer review journal of Pharmacy published by JGPT Journal publishes peer-reviewed original research papers, case reports and systematic reviews. The journal allows free access to its contents, which is likely to attract more readers and ...