PHARMACEUTICAL EQUIVALENT STUDY OF DICLOFENAC SODIUM TABLET FORMULATIONS AVAILABLE IN GUJRAT, PAKISTAN
Main Article Content
Keywords
Pharmaceutical Equivalent, Diclofenac Sodium, Quality Control parameters, Bioequivalence, Pharmacopeial standards.
Abstract
This study aims to check pharmaceutical equivalents of different brands of Diclofenac sodium tablets available in Gujrat, Pakistan. Two different brands of diclofenac sodium tablets (500mg) were investigated in the study. Five quality control parameters; weight variation test, hardness test, friability test, disintegration test and dissolution test were carried out as specified by BP/USP (British Pharmacopeia, United State Pharmacopeia). The result of the study revealed that all the parameters such as the weight variation test, hardness test, friability test, disintegration test and dissolution test were following USP/BP.
References
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25. Sullivan, J. O., Blake, K., Berntgen, M., Salmonson, T., Welink, J., & Party, P. W. (2018). Overview of the European Medicines Agency's Development of Product‐Specific Bioequivalence Guidelines. Clinical Pharmacology & Therapeutics, 104(3), 539-545.
26. Yacobi, A., Shah, V. P., Bashaw, E. D., Benfeldt, E., Davit, B., Ganes, D., Ghosh, T., Kanfer, I., Kasting, G. B., & Katz, L. (2014). Current challenges in bioequivalence, quality, and novel assessment technologies for topical products. Pharmaceutical research, 31, 837-846.
27. Yuen, G. J., Lou, Y., Bumgarner, N. F., Bishop, J. P., Smith, G. A., Otto, V. R., & Hoelscher, D. D. (2004). Equivalent steady-state pharmacokinetics of lamivudine in plasma and lamivudine triphosphate within cells following administration of lamivudine at 300 milligrams once daily and 150 milligrams twice daily. Antimicrobial agents and chemotherapy, 48(1), 176-182.
2. Chow, S. C. (2014). Bioavailability and bioequivalence in drug development. Wiley Interdisciplinary Reviews: Computational Statistics, 6(4), 304-312.
3. Cristofoletti, R., Rowland, M., Lesko, L. J., Blume, H., Rostami-Hodjegan, A., & Dressman, J. B. (2018). Past, present, and future of bioequivalence: improving assessment and extrapolation of therapeutic equivalence for oral drug products. Journal of Pharmaceutical Sciences, 107(10), 2519-2530.
4. Davit, B., Braddy, A. C., Conner, D. P., & Yu, L. X. (2013). International guidelines for bioequivalence of systemically available orally administered generic drug products: a survey of similarities and differences. The AAPS journal, 15, 974-990.
5. De Mora, F. (2015). Biosimilar: what it is not. British Journal of Clinical Pharmacology, 80(5), 949-956.
6. Graefe-Mody, U., Giessmann, T., Ring, A., Iovino, M., & Woerle, H.-J. (2011). A randomized, open-label, crossover study evaluating the effect of food on the relative bioavailability of linagliptin in healthy subjects. Clinical therapeutics, 33(8), 1096-1103.
7. Gupta, M. M., Khoorban, A., Ali, A., Ramlogan, O., & Talukdar, D. (2020). Comparative quality control study of different brands of diclofenac sodium tablet available in local and government pharmacies by in-vitro testing. Cureus, 12(11).
8. Hammami, M. M., Hussein, R. F., AlSwayeh, R., & Alvi, S. N. (2020). Eight enteric-coated 50 mg diclofenac sodium tablet formulations marketed in Saudi Arabia: in vitro quality evaluation. BMC research notes, 13, 1-6.
9. Huang, J., Fu, C.-x., Yang, X.-y., Cui, C., Yang, S., Kuang, Y., Guo, C.-x., Hu, P., Pei, Q., & Yang, G.-p. (2018). Pharmacokinetics of single-and multiple-dose roflumilast: an open-label, three-way crossover study in healthy Chinese volunteers. Drug Design, Development and Therapy, 4047-4057.
10. Jalali, R. K., & Rasaily, D. (2018). Generic Drug and Bioequivalence Studies. In Pharmaceutical Medicine and Translational Clinical Research (pp. 327-339). Elsevier.
11. Kang, J.-S., & Lee, M.-H. (2009). Overview of therapeutic drug monitoring. The Korean journal of internal medicine, 24(1), 1.
12. Kefalas, C. H., Ciociola, A. A., & Gastroenterology, F.-R. M. C. o. t. A. C. o. (2011). The FDA's generic-drug approval process: Similarities to and differences from brand-name drugs. Official journal of the American College of Gastroenterology| ACG, 106(6), 1018-1021.
13. Lui, K.-J. (2016). Crossover designs: testing, estimation, and sample size. John Wiley & Sons.
14. Mannhold, R., Kubinyi, H., & Folkers, G. (2012). Pharmacokinetics and metabolism in drug design (Vol. 51). John Wiley & Sons.
15. Martin, W. E., & Bridgmon, K. D. (2012). Quantitative and statistical research methods: From hypothesis to results. John Wiley & Sons.
16. Medellín-Garibay, S. E., Correa-López, T., Romero-Méndez, C., Milán-Segovia, R. C., & Romano-Moreno, S. (2014). Limited sampling strategies to predict the area under the concentration–time curve for rifampicin. Therapeutic drug monitoring, 36(6), 746-751.
17. Meredith, P. (2003). Bioequivalence and other unresolved issues in generic drug substitution. Clinical therapeutics, 25(11), 2875-2890.
18. Meretskyi, V., & Meretska, I. (2023). Principles of effective use of non-steroidal anti-inflammatory drugs. Inter Collegas, 10(1), 20-26.
19. Nam, Y., Lim, C.-H., Lee, H. S., Chung, S. J., Chung, Y. H., Shin, Y. K., Kim, M.-G., Sohn, U. D., Kim, H.-C., & Jeong, J. H. (2015). Single-dose, randomized, open-label, 2-way crossover study of the pharmacokinetics of amitriptyline hydrochloride 10-and 25-mg tablet in healthy male Korean volunteers. Clinical therapeutics, 37(2), 302-310.
20. Nation, R. L., & Sansom, L. N. (1994). Bioequivalence requirements for generic products. Pharmacology & therapeutics, 62(1-2), 41-55.
21. Nix, D. E., & Gallicano, K. (2011). Design and data analysis in drug interaction studies. In Drug Interactions in Infectious Diseases (pp. 655-682). Springer.
22. Raney, S. G., Franz, T. J., Lehman, P. A., Lionberger, R., & Chen, M.-L. (2015). Pharmacokinetics-based approaches for bioequivalence evaluation of topical dermatological drug products. Clinical pharmacokinetics, 54, 1095-1106.
23. Scher, J. U., & Pillinger, M. H. (2009). The anti-inflammatory effects of prostaglandins. Journal of Investigative Medicine, 57(6), 703-708.
24. Sheng, Y., He, Y., Huang, X., Yang, J., Wang, K., & Zheng, Q. (2010). Systematic evaluation of dose proportionality studies in clinical pharmacokinetics. Current drug metabolism, 11(6), 526-537.
25. Sullivan, J. O., Blake, K., Berntgen, M., Salmonson, T., Welink, J., & Party, P. W. (2018). Overview of the European Medicines Agency's Development of Product‐Specific Bioequivalence Guidelines. Clinical Pharmacology & Therapeutics, 104(3), 539-545.
26. Yacobi, A., Shah, V. P., Bashaw, E. D., Benfeldt, E., Davit, B., Ganes, D., Ghosh, T., Kanfer, I., Kasting, G. B., & Katz, L. (2014). Current challenges in bioequivalence, quality, and novel assessment technologies for topical products. Pharmaceutical research, 31, 837-846.
27. Yuen, G. J., Lou, Y., Bumgarner, N. F., Bishop, J. P., Smith, G. A., Otto, V. R., & Hoelscher, D. D. (2004). Equivalent steady-state pharmacokinetics of lamivudine in plasma and lamivudine triphosphate within cells following administration of lamivudine at 300 milligrams once daily and 150 milligrams twice daily. Antimicrobial agents and chemotherapy, 48(1), 176-182.
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Published
Aug 30, 2024
Article Details
How to Cite
Maimoona Zulfiqar, Amna Parvez, Momna Murtaza, Wajiha Noor, Ukasha Ehsan, & Muhammad Rehan Malik. (2024). PHARMACEUTICAL EQUIVALENT STUDY OF DICLOFENAC SODIUM TABLET FORMULATIONS AVAILABLE IN GUJRAT, PAKISTAN. Journal of Population Therapeutics and Clinical Pharmacology, 31(8), 3640-3648. https://doi.org/10.53555/jpah4t44
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Author Biographies
Maimoona Zulfiqar
University of Lahore, Gujrat Campus, Pakistan.
University of Chenab, Gujrat, Pakistan.
Amna Parvez
University of Lahore, Gujrat Campus, Pakistan.
University of Chenab, Gujrat, Pakistan.
Momna Murtaza
University of Lahore, Gujrat Campus, Pakistan.
University of Chenab, Gujrat, Pakistan.
Wajiha Noor
University of Lahore, Gujrat Campus, Pakistan.
University of Chenab, Gujrat, Pakistan.
Ukasha Ehsan
University of Lahore, Gujrat Campus, Pakistan.
University of Chenab, Gujrat, Pakistan.
Muhammad Rehan Malik
University of Chenab, Gujrat, Pakistan.
How to Cite
Maimoona Zulfiqar, Amna Parvez, Momna Murtaza, Wajiha Noor, Ukasha Ehsan, & Muhammad Rehan Malik. (2024). PHARMACEUTICAL EQUIVALENT STUDY OF DICLOFENAC SODIUM TABLET FORMULATIONS AVAILABLE IN GUJRAT, PAKISTAN. Journal of Population Therapeutics and Clinical Pharmacology, 31(8), 3640-3648. https://doi.org/10.53555/jpah4t44