PHARMACODYNAMICS EFFECT OF METHYLPREDNISOLONE TABLETS ON THE SERUM CONCENTRATION OF ANNEXIN A1: IN VIVO COMPARATIVE STUDY BETWEEN GENERIC AND INNOVATOR DRUG
Objective: The aims of this study were to investigate the comparative pharmacodynamics effect of methylprednisolone (MP) innovator, MP branded generic, and MP generic products to the serum concentration of annexin A1 (AnxA1).
Methods: It was conducted by two-way crossover design in male rabbits. AnxA1 was measured at 0, 0.5, 1, 2, 3, 5, 7, and 9 h after the administration of the drugs. The peak concentration (Cmax), the time at which the peak concentration was achieved (Tmax), and the area under the plasma concentration-time curve (AUC) were also determined.
Results: The highest concentration and widest AUC of AnxA1 were obtained in MP innovator drug. MP innovator and branded generic reaches the peak time (Tmax) at the third 3rd h, while the MP generic reaches the peak time at the 5th h. The results showed that there was no significant difference in the serum concentration of AnxA1 between MP tablets after analyzed with a one-way analysis of variance.
Conclusion: It could be concluded that the innovator drug of MP tablet gave the same effect on the serum concentration of AnxA1 than its generic counterparts, but an onset of action MP innovator and branded generic is faster than the generic product.
2. Wouters OJ, Kanavos PG, McKEE M. Comparing generic drug markets in Europe and the United States: Prices, volumes, and spending. Milbank Q 2017;95:554-601.
3. Colombo GL, Montecucco CM. Generic vs. brand originator alendronate: Analysis of persistence and compliance in five local healthcare units in the Lombardy region of Italy. Clin Cases Miner Bone Metab 2013;10:195-8.
4. Takizawa O, Urushihara H, Tanaka S, Kawakami K. Price difference as a predictor of the selection between brand name and generic statins in Japan. Health Policy 2015;119:612-9.
5. Sukapti S, Dwiyanti D. Generic drug prescribing and its influencing factors at outpatients departments in some government hospitals in West Sumatra, Indonesia. Andalas J Public Heal 2010;5:21-7.
6. Brown JP, Davison KS, Olszynski WP, Beattie KA, Adachi JD. A critical review of brand and generic alendronate for the treatment of osteoporosis. Springerplus 2013;2:550.
7. Del Tacca M, Pasqualetti G, Di Paolo A, Virdis A, Massimetti G, Gori G, et al. Lack of pharmacokinetic bioequivalence between generic and branded amoxicillin formulations. A post-marketing clinical study on healthy volunteers. Br J Clin Pharmacol 2009;68:34-42.
8. Garg G, Gogia A, Kakar A. Comparison of the acute side effect profile of zoledronic acid innovator versus generic preparation. Curr Med Res Pract 2016;6:181-3.
9. Diaz JA, Silva E, Arias MJ, GarzÃ³n M. Comparative in vitro study of the antimicrobial activities of different commercial antibiotic products of vancomycin. BMC Clin Pharmacol 2011;11:9.
10. Cooper-DeHoff RM, Elliott WJ. Generic drugs for hypertension: Are they really equivalent? Curr Hypertens Rep 2013;15:340-5.
11. Zaid AN, Al Ramahi R, Bustami R, Mousa A, Khasawneh S. Comparative fasting bioavailability of two clopidogrel formulations in healthy mediterranean volunteers: An in vitro-in vivo correlation. Drug Des Devel Ther 2015;9:2359-65.
12. Tjandrawinata RR, Setiawati E, Yunaidi DA, Simanjuntak R, Santoso ID, Susanto LW, et al. Bioequivalence study of two formulations of candesartan cilexetil tablet in healthy subjects under fasting conditions. Drug Des Devel Ther 2013;7:841-7.
13. Ramamoorthy S, Cidlowski JA. Corticosteroids: Mechanisms of action in health and disease. Rheum Dis Clin North Am 2016;42:15-31, vii.
14. Toverud EL, Hartmann K, HÃ¥konsen H. A systematic review of physiciansâ€™ and pharmacistsâ€™ perspectives on generic drug use: What are the global challenges? Appl Health Econ Health Policy 2015;13 Suppl 1:S35-45.
15. Babar ZU, Stewart J, Reddy S, Alzaher W, Vareed P, Yacoub N, et al. An evaluation of consumersâ€™ knowledge, perceptions and attitudes regarding generic medicines in Auckland. Pharm World Sci 2010;32:440-8.
16. Davit BM, Nwakama PE, Buehler GJ, Conner DP, Haidar SH, Patel DT, et al. Comparing generic and innovator drugs: A review of 12 years of bioequivalence data from the united states food and drug administration. Ann Pharmacother 2009;43:1583-97.
17. Arafat MA, Ahmed Z, Arafat O. Comparison between generic drugs and brand name drugs from bioequivalence and thermoequivalence prospective. Int J Pharm Pharm Sci 2017;9:1-4.
18. Yazid S, Ayoub SS, Solito E, McArthur S, Vo P, Dufton N, et al. Anti-allergic drugs and the annexin-A1 system. Pharmacol Rep 2010;62:511 7.
19. Yazid S, Norling LV, Flower RJ. Anti-inflammatory drugs, eicosanoids, and the annexin A1/FPR2 anti-inflammatory system. Prostaglandins Other Lipid Mediat 2012;98:94-100.
20. Yu LX, Amidon GL, Polli JE, Zhao H, Mehta MU, Conner DP, et al. Biopharmaceutics classification system: The scientific basis for biowaiver extensions. Pharm Res 2002;19:921-5.
21. Dressman JB, Reppas C. In vitro-in vivo correlations for lipophilic, poorly water-soluble drugs. Eur J Pharm Sci 2000;11 Suppl 2:S73-80.
22. Flower RJ, Blackwell GJ. Anti-inflammatory steroids induce biosynthesis of a phospholipase A2 inhibitor which prevents prostaglandin generation. Nature 1979;278:456-9.
23. Minghetti L, Nicolini A, Polazzi E, Greco A, Perretti M, Parente L, et al. Down-regulation of microglial cyclo-oxygenase-2 and inducible nitric oxide synthase expression by lipocortin 1. Br J Pharmacol 1999;126:1307-14.
24. Perretti M, Dâ€™Acquisto F. Annexin A1 and glucocorticoids as effectors of the resolution of inflammation. Nat Rev Immunol 2009;9:62-70.
25. Sheikh MH, Solito E. Annexin A1: Uncovering the many talents of an old protein. Int J Mol Sci 2018;19: E1045.
26. Rhen T, Cidlowski JA. Antiinflammatory action of glucocorticoids â€“ new mechanisms for old drugs. N Engl J Med 2005;353:1711-23.
27. Khan AN, Khar RK, Udayabanu M. Quality and affordability of amoxicillin generic products: A patient concern. Int J Pharm Pharm Sci 2016;8:386-90.
28. Zarmpi P, Flanagan T, Meehan E, Mann J, Fotaki N. Biopharmaceutical aspects and implications of excipient variability in drug product performance. Eur J Pharm Biopharm 2017;111:1-5.
29. Thakkar PH. Influence of excipients on drug absorption via the modulation of intestinal transporters activity. Asian J Pharm 2015;9:69 82.
30. US Food and Drug Administration. Abbreviated New Drug Application. 2018. Available from: https://www.fda.gov/Drugs/ DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/ default.htm. [Last accessed 2018 May 20].
31. Alfonso-Cristancho R, Andia T, Barbosa T, Watanabe JH. Definition and classification of generic drugs across the world. Appl Health Econ Health Policy 2015;13 Suppl 1:S5-11.
32. Chong CP, Hassali MA, Bahari MB, Shafie AA. Evaluating community pharmacistsâ€™ perceptions of future generic substitution policy implementation: A national survey from Malaysia. Health Policy 2010;94:68-75.
33. Chua GN, Hassali MA, Shafie AA, Awaisu A. A survey exploring knowledge and perceptions of general practitioners towards the use of generic medicines in the northern state of Malaysia. Health Policy 2010;95:229-35.
34. Molinier A, Palmaro A, Rousseau V, Sommet A, Bourrel R, Montastruc JL, et al. Does substitution of brand-name medications by generics differ between pharmacotherapeutic classes? A population-based cohort study in France. Eur J Clin Pharmacol 2017;73:471-7.
35. Sun D, Hu M, Browning M, Friedman RL, Jiang W, Zhao L, et al. Dissolution failure of solid oral drug products in field alert reports. J Pharm Sci 2017;106:1302-9.
36. Hsu CW, Lee SY, Wang LJ. Comparison of the effectiveness of brand-name and generic antipsychotic drugs for treating patients with schizophrenia in Taiwan. Schizophr Res 2018;193:107-13.
37. Faqeer NA, Mashni O, Dawoud R, Rumman A, Hanoun E, Nazer L, et al. Comparing the incidence of febrile neutropenia resulting in hospital admission between the branded docetaxel and the generic formulations. J Clin Pharmacol 2017;57:275-9.
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