Comparative Quantitative Evaluation of Marketed Available Dexibuprofen Product: Assessment of Quality, Effectiveness and Interchangeability
Abstract
NSAIDs are the most consumable class of drugs used in daily life for a number of ailments like analgesia, anti-inflammatory, antipyretic effect. One of the racemic NSAIDs of the parent drug ibuprofen is Dexibuprofen. As reported in numerous studies, Dexibuprofen is more potent in effect. Dexibuprofen can be interchanged in the clinical practice. This research focuses on the comparative analysis of different commercial brands of Dexibuprofen from different perspectives, including physicochemical properties, pharmacokinetic properties, and pharmacopeial properties. A comparison of Dexibuprofen will provide significant aspects of this product and show its cost effectiveness and interchangeability. Different tests were performed on six marketed common brands of Dexibuprofen. The results were compared and analyzed using different statistical tools and presented in tables are graphs. All the brands followed USP/BP guidelines and their properties lie within acceptable ranges, it has been observed in research through statistical tools that all these six brands in terms of hardness, thickness, weight variation, and dissolution profile (at different pH media) showed significance, which indicates that all the brands have similarities in their properties and significant variations in drug performance of all marketed brands in different pH as dissolution medium at different time intervals. Although in certain points of percentages the results indicate the superiority of brands 01 (DS) in many properties but due to the high price of this brand it might not be preferred in common population, while study concludes that all brands are similar in comparative analysis in different properties and followed by guidelines, they exhibit acceptable properties and are safe to use.
Keywords: Dexibuprofen, non-steroidal anti-inflammatory drugs, marketed brands, comparative analysis.
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BINDU S, MAZUMDER S, and BANDYOPADHYAY U. Non-steroidal anti-inflammatory drugs (NSAIDs) and organ damage: A current perspective. Biochemical Pharmacology, 2020, 180: 114147. https://doi.org/10.1016/j.bcp.2020.114147
DAVIS A, & ROBSON J. The dangers of NSAIDs: look both ways. British Journal of General Practice, 2016, 66(645): 172-173.
ALI FR, SHOAIB MH, YOUSUF RI, et al. Design, development, and optimization of Dexibuprofen microemulsion based transdermal reservoir patches for controlled drug delivery. BioMed Research International. 2017. https://doi.org/10.1155/2017/4654958
GLISZCZYŃSKA A, and SÁNCHEZ-LÓPEZ E. Dexibuprofen Therapeutic Advances: Prodrugs and Nanotechnological Formulations. Pharmaceutics, 2021, 13(3): 414. https://doi.org/10.3390/pharmaceutics13030414
MAGUIRE J A, JIANG W, and YU L X. Modern Pharmaceutical Regulations: Quality Assessment for Drug Products. In Developing Solid Oral Dosage Forms, pp. 1095-1126. Academic Press, 2017. https://doi.org/10.1016/B978-0-12-802447-8.00040-6
ABDUL-HASAN M T, Al-SHAIBANI A J N, WANNAS A N, & HASAN AL-GBURI K M. Quality control testing of conventional clopidogrel bisulfate tablets marketed in Iraq. International Journal of Applied Pharmaceutics, 2022: 221-225. https://doi.org/10.22159/ijap.2022v14i1.43331
HAMEED A, SHARIF N, ASHRAF M, et al. Pharmaceutical Equivalent Analysis Work for Fexofenadine Preparations Accessible in Pakistan. SAJ Pharmacy and Pharmacology, 2018, 5: 203. http://article.scholarena.com/Pharmaceutical-Equivalent-Analysis-Work-for-Fexofenadine-Preparations-Accessible-in-Pakistan.pdf
LOMBARDO L, PALONE M, LONGO M, et al. MicroCT X-ray comparison of aligner gap and thickness of six brands of aligners: an in-vitro study. Progress in Orthodontics, 2020, 21(1): 1-12. https://progressinorthodontics.springeropen.com/articles/10.1186/s40510-020-00312-w
HAMBISA S, BELEW S, and SULEMAN S. In vitro comparative quality assessment of different brands of norfloxacin tablets available in Jimma, Southwest Ethiopia. Drug Design, Development and Therapy, 2019, 13: 1241. https://doi.org/10.2147/DDDT.S189524
ALSAIFI A, and ALYAHAWI A. Quality assessment of different brands of paracetamol tablets in Yemeni market. Universal Journal of Pharmaceutical Research, 2018, 3(4): 39-43. https://doi.org/10.22270/UJPR.V3I4.182
ALSAIFI A. Comparative evaluation quality of different brands of ibuprofen 400 mg tablets available in Yemeni’s Market. Chronicles of Pharmaceutical Science, 2018, 3: 730-742.
WEBER A, STEINER W J, and LANG S. A comparison of semiparametric and heterogeneous store sales models for optimal category pricing. OR Spectrum, 2017, 39(2): 403-445.
MURRAY L, ARIAS A, LI J, et al. Innovative in vitro methodologies for establishing therapeutic equivalence. Revista Panamericana de Salud Publica, 2016, 40: 23-28. https://www.scielosp.org/article/rpsp/2016.v40n1/23-28/
CRISTOFOLETTI R, ROWLAND M, LESKO LJ, et al. Past, present, and future of bioequivalence: improving assessment and extrapolation of therapeutic equivalence for oral drug products. Journal of Pharmaceutical Sciences, 2018, 107(10): 2519-2530.
SANTORO A, GENOV G, SPOONER A, et al. Promoting and protecting public health: how the European Union pharmacovigilance system works. Drug Safety, 2017, 40(10): 855-69.
HANIF AM, SIAL AA, ALI H, et al. Dexibuprofen: Statistical assessment of drug release kinetics and investigative quality perspective. Pakistan Journal of Pharmaceutical Sciences, 2018, 31(5): 2157-2162
MUSHTAQ M, FAZAL N, and NIAZ A. Formulation and evaluation of fast-disintegrating tablets of flurbiprofen and metoclopramide. Journal of Pharmaceutical Innovation, 2021, 16(3): 419-438.
LAI J, LIN W, SCHOLES P, and LI M. Investigating the effects of loading factors on the in vitro pharmaceutical performance of mesoporous materials as drug carriers for ibuprofen. Materials, 2017, 10(2): 150.
SHAHID MA. Development of analytical method of Dexibuprofen in different pharmaceutical dosage forms available in the market by HPLC method 2017. https://scholar.google.com.pk/scholar?hl=en&as_sdt=0%2C5&as_ylo=2017&as_yhi=2022&as_vis=1&q=Shahid+MA.+Development+of+analytical+method+of+dexibuprofen+in+different+pharmaceutical+dosage+forms+available+in+the+market+by+HPLC+method+2017.&btnG=
MOHAMED H R S A K, CHUNGATH T T, SRIDHAR K, et al. Development and Validation of a Discriminative Dissolution Medium for a Poorly Soluble Nutraceutical Tetrahydrocurcumin. Turkish Journal of Pharmaceutical Sciences, 2021, 18(5): 565. https://doi.org/10.4274/tjps.galenos.2021.91145
PESTIEAU A, and EVRARD B. In vitro biphasic dissolution tests and their suitability for establishing in vitro-in vivo correlations: A historical review. European Journal of Pharmaceutical Sciences, 2017, 102: 203-219. https://doi.org/10.1016/j.ejps.2017.03.019
HAMED R, ALNADI S H, and AWADALLAH A. The effect of enzymes and sodium lauryl sulfate on the surface tension of dissolution media: toward understanding the solubility and dissolution of carvedilol. AAPS PharmSciTech, 2020, 21(5): 1-11.
SIMIONATO L D, PETRONE L, BALDUT M, et al. Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina. Saudi Pharmaceutical Journal, 2018, 26(4): 578-584.
CASCONE S. Modeling and comparison of release profiles: Effect of the dissolution method. European Journal of Pharmaceutical Sciences, 2017, 106: 352-361.
BUSHRA R, SHOAIB MH, ALI H, et al. In vitro drug analysis and stability studies of optimized formulations of Aceclofenac (100 mg) Tablets. Latin American Journal of Pharmacy, 2016, 35(4): 695-704.
WORLD HEALTH ORGANIZATION. Systematic reviews for the update of the WHO guideline on country pharmaceutical pricing policies. World Health Organization, 2020. https://apps.who.int/iris/bitstream/handle/10665/335704/9789240011892-eng.pdf
WOUTERS O J, KANAVOS P G, and MCKEE M. Comparing generic drug markets in Europe and the United States: prices, volumes, and spending. The Milbank Quarterly, 2017, 95(3): 554-601. https://onlinelibrary.wiley.com/doi/pdfdirect/10.1111/1468-0009.12279
VICENT M. Assessment of quality of Metropolitan tablet brands sold in Ishaka town pharmacies. Research Report. Kampala International School of Health Sciences Press, 2018.
AREFIN P, AHMED R, HABIB M S, et al. Evaluation of Critical Quality Attributes of Immediate Release Ciprofloxacin Tablets of Different Pharmaceutical Companies in Bangladesh. Biosciences Biotechnology Research Asia, 2021, 17(4): 781.
RAHMAN S. Comparative in vitro quality evaluation of different brands of Ebastine 10 mg tablets commercially available in Bangladesh. PhD Thesis, Bracu University, 2019. http://dspace.bracu.ac.bd/xmlui/bitstream/handle/10361/13923/15146048_PHR.pdf?sequence=2&isAllowed=y
JAIN A, CHAUDHARY J, SAINI A, and MEHAN N. Quality assessment and comparative study of different marketed brands of metformin. Research Journal of Pharmacy and Technology, 2019, 12(3): 1357-1360. https://rjptonline.org/HTML_Papers/Research%20Journal%20of%20Pharmacy%20and%20Technology__PID__2019-12-3-67.html
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