IN VITRO COMPARATIVE STUDY OF DIFFERENT BRANDS OF PANTOPRAZOLE SODIUM ENTERIC COATED TABLETS MARKETED IN ADDIS ABABA, ETHIOPIA
DOI:
https://doi.org/10.22270/ajprd.v7i1.467Keywords:
brands, disintegration time, in vitro release, pantoprazole sodiumAbstract
Pantoprazole is a substituted benzimidazole proton pump inhibitor used in treatment of patients with serious or refractory acid-related diseases. The objective of the present study was to undertake comparative in vitro evaluation of different brands of pantoprazole sodium tablets available in different retail outlets in Addis Ababa, Ethiopia. All brands were evaluated using established procedures to assess the pharmaceutical quality characteristics. The measured thickness of studied brand tablets was found to be in the range of 2.79 to 3.49 mm.Brand E (175.4 ± 3.73 N) exhibited maximum hardness while brand C (110.2 ± 6.43 N) had the lowest hardness. When the mean weights of the sample brands are compared,brandC had maximum weight (151.22mg) and brandD weighed the least (79.18 mg).The disintegration time test indicated that any of the pantoprazole sodium tablet brands did not disintegrate in 0.1N HClacidic medium for 2 hrs but all disintegrated in the time range of 12.43 min to 24.42 min in phosphate buffer.The in vitrodrug release study depicted that all brands of pantoprazole sodium tablets released not more than 10% of the labeled amount within 2 hrs under 0.1N HClmedium but showed similar drug release in the buffer medium ranging between 89 and 92% within 45 minutes.Therefore, the results of the present study revealed that all of the tested brands of the pantoprazole sodium enteric coated tablet fulfilled the criteria set in the official monograph for in vitro quality control tests.
Downloads
References
2. Robinson M. New-generation proton pump inhibitors: overcoming the limitations of early-generation agents. Eur J GastroenterolHepatol. 2001;1:S43-7.
3. Robinson M and Horn J. Clinical pharmacology of proton pump inhibitors: what the practising physician needs to know. Drugs. 2003;63:2739-54.
4. Welage LS and Berardi RR. Evaluation of omeprazole, lansoprazole, pantoprazole, and rabeprazole in the treatment of acid-related diseases. J Am Pharm Assoc. 2000; 40:52- 62.
5. Rani TN, Kumari CTL, Reddy BM, Reddy DRB. Comparativein vitro evaluation of different commercially available brands of pantoprazole tablets. IJPSR. 2012;3:1108-11.
6. Avner DL. Clinical Experience with Pantoprazole in Gastroesophageal Reflux Disease. Clin.Ther.2000; 22:1169-85.
7. Paul S, Bose A, Konar I, Kara PK, Roy T, Mukherjee P. Comparative in vitro characterization of different commercially available brands of pantoprazole sodium tablets. World JPharmPharm Sci.2017; 6: 778-83.
8. Poole P. Pantoprazole. Am J Health Syst Pharm.2001; 58:999-1008.
9. Zyl J, Rensburg C, Vieweg W, Fischer R. Efficacy and Safety of Pantoprazole versus Ranitidine in the Treatment of Patients with Symptomatic Gastroesophageal Reflux Disease. Digestion.2004; 70:61-9.
10. Ceunca Eand Zaragoza F. Generic drugs in psychopharmacology: pros and cons. ActasEspPsiquiatr. 1999;27:351-7.
11. Hottinger M and Liang BA. Deficiencies of the FDA in Evaluating Generic Formulations: Addressing Narrow Therapeutic Index Drugs. Am J Law Med.2012; 38: 667-89.
12. Genazzani AA and Pattarino F. Difficulties in the Production of Identical Drug Products from a Pharmaceutical Technology Viewpoint. Drugs R D. 2008;9:65-72.
13. Naqori BP,Mathur V, Garq S. Generic drug approval: a US perspective. Curr Med Res Opin.2011;27:541-5.
14. Oner ZG and Polli JE. Authorized Generic Drugs: an Overview. AAPS PharmSciTech. 2018; 19:2450-8.
15. Singh SB, Singh S, Tiwari A, Pandey SS. Comparative in vitro evaluation of different marketed formulations of cetirizine HCL tablets (10mg) available in local market. Int J Curr Res.2014; 6:10228-31.
16. Birhanu G, Hymete A, Debella A, Ashenef A. Quality evaluation of the commonly prescribed antipsychotic drugs (chlorpromazine &thioridazine tablets) marketed in Ethiopia. IJPSR. 2014; 5:3031-41.
17. Dulla O, Sultana S, Hosen MS.In vitro comparative quality evaluation of different brands of esomeprazole tablets available in selected community pharmacies in Dhaka, Bangladesh. BMC Res Notes. 2018; 11:1-5.
18. Farooq MA, Khan DH, Dar UI, Khan I, Waqas R, Tanvir S, Farooq A, Sohail M.Comparative study of commercially available brands of acetaminophen in Lahore, Pakistan.World JPharmPharm Sci.2016; 8:155-62.
19. Jakaria M, Mousa AY, Parvez M, Zaman R, Arifujjaman, Sayeed MA, Ali MH.In vitro Comparative Study of Different Brands of Dexamethasone Tablet Available in Bangladesh. IJPQA. 2016; 7:24-8.
20. Kishore KA and Amareshwar P. Quality evaluation and comparative study on tablet formulations of different pharmaceutical companies. J. Curr. Chem. Pharm. Sc.2012; 2:24-31.
21. Sultana S, Dulla O, Hosen MS. Comparative Quality Evaluation of Different Brands of Esomeprazole Tablets Available In pharmaceutical market of Bangladesh. PhOL;2017; 2:1-9.
22. Okoye EI and Iwuagwu MA. Physicochemical equivalence of some brands of Nifedipine retard tablets available in Nigeria. Afr. J. Biotechnol.2010;9:1274-9.
23. Anand O, Yu LX, Conner DP, Davit BM. Dissolution Testing for Generic Drugs: An FDA Perspective. The AAPS Journal. 2011; 13: 328-35.
24. Kraemer J, Gajendran J, Guillot A, Schichtel J, Tuereli A. Dissolution testing of orally disintegrating tablets.J Pharm Pharmacol. 2012; 64:911-8.
25. Limberg J and Potthast H.Regulatory status on the role of in vitro dissolution testing in quality control and biopharmaceutics in Europe.Biopharm. Drug Dispos.2013; 34:247-53.
Published
How to Cite
Issue
Section
AUTHORS WHO PUBLISH WITH THIS JOURNAL AGREE TO THE FOLLOWING TERMS:
Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 Unported License. that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
.