COMPARATIVE IN VITRO EVALUATION OF DIFFERENT BRANDS OF NIFEDIPINE 20mg RETARD TABLET PRODUCTS MARKETED IN ADDIS ABABA, ETHIOPIA

  • Girma Agune Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia
  • Muluken Nigatu Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia
  • Tesfaye Gabriel Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia
  • Abrham Temesgen Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia
  • Yonas Brhane Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia
  • Marew Tesfa Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Abstract

Nifedipine has been formulated and marketed as extended-release-film coated tablet. A certain degree of success has been achieved in reducing the incidence of adverse effects by the use of slow-release formulations such as nifedipine retard. The aim of the present study was to evaluate the physicochemical quality attributes and in vitro equivalence of six brands of nifedipine retard tablets available in different retail outlets in Addis Ababa, Ethiopia. After constructing the calibration curve, the in vitro drug release studies were carried out using USP type I dissolution apparatus at 100 rpm. The dissolution was done in a medium of 0.1N HCl containing 0.5% sodium lauryl sulfate for 12 hrs. All the tablets met the requirement for tablet weight uniformity. The mean crushing strengths of sample tablets ranged from 49.2 to 111.2 N. All the brands  studied released more than 80% within 12 hours which is within the tolerance limit.  However the release profile revealed that five of the brands showed over 15% drug release at 1st hour except product F which released only 14.32%. In conclusion, all the brands of tablets had uniform thickness and good hardness. Despite all the brands could sustained the release for over 12 hours recommended for such formulations, five of them showed higher release in the first hour which may affect their in vivo performance.â€

Keywords: nifedipine, retard tablets, physicochemical properties, crushing strengths, in vitro drug release

Downloads

Download data is not yet available.

Author Biographies

Girma Agune, Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Muluken Nigatu, Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Tesfaye Gabriel, Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Abrham Temesgen, Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Yonas Brhane, Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Marew Tesfa, Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

Department of Pharmaceutics and Social Pharmacy, School of Pharmacy, College of Health Sciences, Addis Ababa, University, Addis Ababa, Ethiopia

References

1. Asare CO, Kipo SL, Kwakye KO, Gyasi MEB. Comparative in vitro dissolution of commercially available sustained release nifedipine tablet brands in the Kumasi Metropolis, Ghana. Journal of Applied Pharmaceutical Science; 2015; 5:54-60
2. Bloch MJ. Worldwide prevalence of hypertension exceeds 1.3 billion. Journal of the American Society of Hypertension; 2016; 10:753–754
3. Nshisso LD, Reese A, Gelaye B, Lemma S, Berhane Y, Williams MA. Prevalence of Hypertension and Diabetes among Ethiopian Adults. Diabetes Metab Syndr.; 2012; 6:36–41
4. Meredith PA, Elliott HL. A review of the gastrointestinal therapeutic system (GITS) formulation and its effectiveness in the delivery of antihypertensive drug treatment (focus on nifedipine GITS). Integrated Blood Pressure Control; 2013; 6:79–87
5. Shimamoto K, Kimoto M, Matsuda Y, Asano K, Kajikawa M. Long-term safety and efficacy of high-dose controlled-release nifedipine (80mg per day) in Japanese patients with essential hypertension. Hypertension Research: 2015; 1–6
6. Snider ME, Nuzum DS, Veverka A. Long-acting nifedipine in the management of the hypertensive patient. Vascular Health and Risk Management; 2008; 4:1249–1257
7. Gajendran J, Kramer J, Shah VP, Langguth P, Polli J, Mehta M, Groot DW, Cristofoletti R, Abrahamsson B, Dressman JB. Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Nifedipine. Journal of Pharmaceutical Sciences; 2015; 104:3289 - 98
8. Akhter DT, Uddin R, Huda NH, Sutradhar KB. Design and Formulation of Twice Daily Nifedipine Sustained Release Tablet Using Methocel K15M CR and Methocel K100LV CR. Int J Pharm Pharm Sci; 2012; 4:121-124
9. Garbacz G, Golke B, Wedemeyer RS, Axell M, Soderlind E, Abrahamsson B, Weitschies W. Comparison of dissolution profiles obtained from nifedipine extended release once a day products using different dissolution test apparatuses. European Journal of Pharmaceutical Sciences; 2009; 38:147–155
10. Ghosh S, Ghosh NS, Debnath S, kumar GG, Chakraborty R, Sen S. Formulation and evaluation of sustained release dosage form of nifedipine hydrochloride using multi-unit chitosan treated alginate. IJPBR; 2010; 1:124-131
11. Minami J, Numabe A, Andoh N, Kobayashi N, Horinaka S, Ishimitsu T, Matsuoka H. Comparison of once-daily nifedipine controlled-release with twice-daily nifedipine retard in the treatment of essential hypertension. Br J Clin Pharmacol; 2004; 57:632-639
12. Okoye EI, Iwuagwu MA. Physicochemical equivalence of some brands of Nifedipine retard tablets available in Nigeria. Afr. J. Biotechnol.; 2010; 9:1274-1279
13. Muaz J, Gazali LK, Sadiq GU,Tom GM. Comparative in vitro evaluation of the pharmaceutical and chemical equivalence of multi-source generic ciprofloxacin hydrochloride tablets around Maiduguri metropolitan area. Nig. Journ. Pharm. Sci.; 2009; 8:102 - 106
14. Akarawut W, Suvakontha T, Poompanich A. Pharmaceutical Quality of Nifedipine Soft Capsules Commercially Available in Thailand. Journal of Health Science; 2002; 11:1-8
15. Awofisayo SO, Awofisayo OA, Eyen N, Udoh IE. Comparative Assessment of the Quality Control Measurements of Multisource Ofloxacin Tablets Marketed in Nigeria. Dissolution Technologies; 2010; 17:20-25
16. CDSCO. Guidelines for Bioavailability & Bioequivalence Studies, Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, New Delhi. 2005
17. Ilic M, Kovacevic I, Parojcic J. Deciphering nifedipine in vivo delivery from modified release dosage forms: Identification of food effect. Acta Pharm.; 2015; 65:427–441
18. Poonguzhali S, Anusha K, Mounica T, Niharika PML, Kumar MS, Nadendla R. Comparative in vitro Evaluation of Commercial Atenolol Tablets. RJPBCS 2014; 5(6):30-35
Statistics
671 Views | 730 Downloads
How to Cite
1.
Agune G, Nigatu M, Gabriel T, Temesgen A, Brhane Y, Tesfa M. COMPARATIVE IN VITRO EVALUATION OF DIFFERENT BRANDS OF NIFEDIPINE 20mg RETARD TABLET PRODUCTS MARKETED IN ADDIS ABABA, ETHIOPIA. JDDT [Internet]. 14May2018 [cited 9Aug.2022];8(3):1-. Available from: http://jddtonline.info/index.php/jddt/article/view/1685

Most read articles by the same author(s)