COMPARATIVE IN VITRO EVALUATION OF DIFFERENT BRANDS OF NIFEDIPINE 20mg RETARD TABLET PRODUCTS MARKETED IN ADDIS ABABA, ETHIOPIA
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 brandsÂ studied released more than 80% within 12 hours which is within the tolerance limit. Â 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
2. Bloch MJ. Worldwide prevalence of hypertension exceeds 1.3 billion. Journal of the American Society of Hypertension; 2016; 10:753â€“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; 6:36â€“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; 6:79â€“87
5. Shimamoto K, Kimoto M, Matsuda Y, Asano K, Kajikawa M. Long-term safety and efï¬cacy of high-dose controlled-release nifedipine (80mg per day) in Japanese patients with essential hypertension. Hypertension Research: 2015; 1â€“6
6. Snider ME, Nuzum DS, Veverka A. Long-acting nifedipine in the management of the hypertensive patient. Vascular Health and Risk Management; 2008; 4:1249â€“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 proï¬les obtained from nifedipine extended release once a day products using different dissolution test apparatuses. European Journal of Pharmaceutical Sciences; 2009; 38:147â€“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; 65:427â€“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
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 International (CC BY-NC 4.0). 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).