COMPARATIVE IN-VITRO EVALUATION OF METFORMIN HCl AND PARACETAMOL TABLETS COMMERCIALLY AVAILABLE IN KANDY DISTRICT, SRI LANKA

Authors

  • T. W. Hettiarachchi Department of Pharmacy, University of Peradeniya
  • D. B. M. Wickramaratne Department of Pharmacy, University of Peradeniya
  • S. H. T. Sudeshika Department of Pharmacy,University of Peradeniya
  • Dakshila Niyangoda Department of Pharmacy, University of Peradeniya
  • M. H. F. Sakeena Department of Pharmacy,University of Peradeniya
  • H. M. D. R. Herath Department of Pharmacy, University of Peradeniya

Keywords:

Generic drugs, Brand named drugs, Metformin HCl, Paracetamol, In-vitro efficacy

Abstract

Objective: Availability of numerous brands of tablets with price variations compared to their generic drugs in the current drug market places health practitioners, pharmacists and patients in a dilemma of generic substitution. In such background, this study was aimed to compare the in-vitro efficacy of some of the low priced generic tablets with their brands commonly available in Sri Lanka.

Methods: A survey of the prices of commonly used tablets and capsules available at pharmacies in Kandy area in Sri Lanka was carried out. Based on the results of the survey, frequently used two tablets; Metformin HCl (one locally manufactured generic (M1) and 3 brands M2-M4) and Paracetamol (one locally manufactured generic (P1) and two brands P2-P3) were selected for the study. All the products were examined visually for their organoleptic properties and tested for uniformity of weight, disintegration time, assay value, dissolution rate, hardness or crushing strength and friability. Pertinent official guidelines were followed throughout all the tests.

Results: The results of aesthetic assessment showed no sign of defects and all the tested tablets complied with the official standards for the above parameters. Despite some minor differences in tablet hardness and disintegration time profiles, other in-vitro characteristics of the tested brands; Paracetamol and Metformin HCl and their locally manufactured generics appears to be similar and not significantly different from each other.

Conclusion: According to in-vitro official quality control tests, all the generics and brands of the respective drugs tested could be regarded as equally effective.

 

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Author Biographies

T. W. Hettiarachchi, Department of Pharmacy, University of Peradeniya

 Demonstrator (Temporary),

Department of Pharmacy

D. B. M. Wickramaratne, Department of Pharmacy, University of Peradeniya

Senior Lecturer,

Department of Pharmacy

S. H. T. Sudeshika, Department of Pharmacy,University of Peradeniya

 Lecturer (Probationary),

Department of Pharmacy

Dakshila Niyangoda, Department of Pharmacy, University of Peradeniya

Lecturer (Probationary),

Department of Pharmacy

M. H. F. Sakeena, Department of Pharmacy,University of Peradeniya

Lecturer (Senior),

Department of Pharmacy

H. M. D. R. Herath, Department of Pharmacy, University of Peradeniya

Lecturer (Senior),

Department of Pharmacy

References

World Health Organization-IMPACT. Counterfeit Medicines: an update on estimates, 15 November 2006; Available from: www.who.int/medicines/services/counterfeit/impact/TheNewEstimatesCounterfeit.pdf. [Last Accessed 6 November 2014].

Stoppler MD. Medicine Net. Retrieved December 5, 2014, from Generic Drugs, Are They as Good as Brand Names? Available from: http://www.medicinenet.com/script/main/art.asp?articlekey=46204

Aaron SK, Alexander SM, Joy LL, Margaret RS, Alan B, Niteesh KC, et al. Clinical equivalence of generic and brand name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA 2008;300;2514-26.

GPhA, Savings: An economic analysis of generic drug usage in the US; 2011.

Ngwuluka NC, Lawal K, Olorunfemi PO, Ochekpe NA. Post-market in vitro bioequivalence study of six brands of ciprofloxacin tablets/caplets in Jos, Nigeria. Sci Res Essay 2009;4;298-305.

Meredith P. Bioequivalence and other unresolved issues in generic drug substitution. Clin Ther 2003;25:2875-90.

British Pharmacopoeia. Her Majesty’s Stationery Office, London; 2012.

United States Pharmacopeia and National Formulary USP 24–NF 19. United States Pharmacopeial Convention, Inc. Rockville, Maryland; 2012.

Shah V. Dissolution: a quality control test vs a bioequivalent test. Dissolution Technol 2001;8;1-2.

Chandrasekaran AR, Jia CY, Theng CS, Muniady T, Muralidharan S, Dhanaraj SA. In-vitro studies and evaluation of metformin marketed tablets-Malaysia. J Appl Pharm Sci 2011;1;214-7.

Ochekpe NA, Ngwuluka NC, Owolayo H, Fashedemi T. Dissolution profiles of three brands of lamivudine and zidovudine combinations in the nigerian market. Dissolution Technol 2006;13;12-7.

Troy DB, Beringer P. Remington: The science and practice of pharmacy. In: Chaudary AK, Singh G, Stephenson GA, Ackermann BL, eds. Instrumental Methods of Analysis. 21st ed. USA: Lippincott Williams and Willkins; 2006. p. 672-87.

Barone JA. Comparative potency and dissolution performance of internationally available piroxicam products. Pharmacoeconomics 1992;(1, Suppl 1):49-52.

Agrawal G, Dungi P, Shukla RN. Comparative physico-chemical study of some different brands of drugs containing metformin hydrochloride. Int J Pharm Res Dev 2012;04:48-52.

M Olusola, Adelaja I, Adekoya, Odulaja J. Comparative evaluation of physicochemical properties of some commercially available brands of metformin hcl tablets in lagos, nigeria. olanrewaju. J Appl Pharm Sci 2012;2:41-4.

Zaid A, Rinno T, Jaradath N, Jodeh S, Khammash S. Interchangeability between paracetamol tablets marketed in Palestine: is there a quality reason for a higher price? Eastern Mediterranean Health J 2013;19(6);542-6.

Chandrasekaran AR, Han CY, Chung ACY, Cheang LW, Ping LS. Post-market in vitro equivalency evaluation of paracetamol tablets Kedah, Malaysia. Int J Pharm Sci Nanotechnol 2011;04;1403-7.

Kumar GT, Nandini B, Saurab V, Amith A, Ajazuddin, Hemanth B, et al. Comparative assessment of the quality measurement of some commercially available paracetamol tablets. Int J Pharm Sci Rev Res 2012;14:42.

Okunlola A, Adegoke OA, Odeku OA. Generic versus innovator: analysis of the pharmaceutical qualities of paracetamol and ibuprofen tablets in the Nigerian Market. East Central Afr J Pharm Sci 2009;12;55-64.

Nayak AK. Comparative in vitro dissolution assessment of some commercially available paracetamol tablets. Int J Pharm Sci Rev Res 2010;02;29-30.

Clinical Guidelines Task Force, International Diabetes Federation (2005). "Glucose control: oral therapy". Global Guideline for Type 2 Diabetes. Brussels: International Diabetes Federation; Available from: http://www.idf.org/[Last Accessed 8 November 2014]

Drug Bank 2005. Acetaminophen; Available from: http: //www.drugbank.ca/drugs/DB00316. [Last Accessed 05 March 2014].

Oyetunde OO, Tayo F, Akinleye MO, Aina BA. In-vitro equivalence studies of generic metformin hydrochloride tablets and propranolol hydrochloride tablets under biowaiver conditions in lagos state, Nigeria. Dissolution Technol 2012;19;51-3.

Cosmetics, Devices and drug regulatory Authority, Sri Lanka (2014). Drugs registration procedure; Available from: http://www.cdda.gov.lk/index.php [Last Accessed 19. November 2014]

US. Food and Drug Administration. Facts about Generic Drugs 2012; Available from:http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm167991.htm. [Last Accessed 20 November 2014].

Allen LV, Popvich NG, Ansel HC. Ansel’s pharmaceutical dosage forms and drug delivery systems, 8th ed. Philadelphia: Lippincott Williams & Wilkins; 2004.

Odeniyi OA, Adegoke AO, Adereti RB, Odeku OA, Itiola OA. Comparative analysis of eight brands of sulfodoxine-pyrimethamine tablets. Tropical J Pharm Res 2003;02;161–7.

Voegele D. Drug release in vitro-an aid in clinical trials? Methods Find Exp Clin Pharmacol 1999;21(1);55–62.

Moore JW, Flanner HH. Mathematical comparison of dissolution profiles. Pharm Technol 1996;20;64–74.

Published

01-02-2015

How to Cite

Hettiarachchi, T. W., D. B. M. Wickramaratne, S. H. T. Sudeshika, D. Niyangoda, M. H. F. Sakeena, and H. M. D. R. Herath. “COMPARATIVE IN-VITRO EVALUATION OF METFORMIN HCl AND PARACETAMOL TABLETS COMMERCIALLY AVAILABLE IN KANDY DISTRICT, SRI LANKA”. International Journal of Pharmacy and Pharmaceutical Sciences, vol. 7, no. 2, Feb. 2015, pp. 520-4, https://journals.innovareacademics.in/index.php/ijpps/article/view/3959.

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