Research Journal of Pharmacy and Technology

Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Comparative In-vitro Evaluation of Metformin HCl Extended Release Tablets Marketed in Syria


Affiliations
1 Pharmaceutics and Pharmaceutical Technology Department, Tishreen University, Lattakia, Syrian Arab Republic
2 Pharmaceutics and Pharmaceutical Technology Department, Tishreen University, Syrian Arab Republic
3 Pharmaceutical Chemistry and Quality Control Department, Tishreen University and Andalus University, Syrian Arab Republic
     

   Subscribe/Renew Journal


Metformin hydrochloride extended release tablets are available in many brands in the Syrian market, which make it difficult to select the safe, effective and economic one. The aim of this study was to evaluate the quality control standards of generic different brands of metformin extended release tablets, and compare them with the innovator Glucophage XR®. Two brands AandB (two batches from each brand) were selected. The physiochemical equivalence of all tablets were assessed through the evaluation of weight variation test, assay, swelling behavior study and dissolution test which was carried out for 12 hours using USP apparatus Ι in phosphate buffer pH= 6.8 as a dissolution media. The release mechanism were explored and explained with zero order, first order, Higuchi and Korsmeyer-Peppas equations. In order to compare dissolution profiles, dissolution data was taken and compared through model independent- methods: difference factor f1, similarity factor f2 and dissolution efficiency DE. The tablets had been passed weight variation test and the percent of assay for all brands were within the acceptable ranges. Fitting dissolution data to Korsmeyer-Peppas equation indicated that diffusion along with polymer relaxation could be the mechanism of drug release from brand B and the reference, whereas Fickian diffusion was the predominant mechanism of metformin release from brand A. The study showed that, brand B had similar dissolution profiles with the reference (F2>50), whereas brand A was different in its release behavior (F2>15).

Keywords

Metformin HCl, Extended Release, Dissolution Profiles, Swelling Index, In-Vitro Release.
Subscription Login to verify subscription
User
Notifications
Font Size


  • Rojas LB, Gomes MB. Metformin: an old but still the best treatment for type 2 diabetes. Diabetology and Metabolic Syndrome Journal. 5(6); 2013.

  • Global report on diabetes. World Health Organization, Geneveo; 2016.

  • Sho R, Li X, Billing H. Promising clinical practices of metformin in women with PCOS and early stage endometrial cancer. BBA clinical. 2; 2014: 7-9.

  • Elnashar AM. The role of metformin in ovulation induction: current status. Middle East Society Journal. 16; 2011: 175-181.

  • Alan D. The use of medicines in the United States IMS institutes for health care informatics. 28; 2011.

  • Mc Creight L, Bailey C, Pearson E. Metformin and the gastrointestinal tract. Diabetologia. 59; 2016: 426-435.

  • Gong L, Goswamin S, Giacomini K, Altman R, Klein T. Metformin pathways: pharmacokinetics and pharmacodynamic. Pharmacogenet Genomics. 22(11); 2012: 820-827.

  • Chandira M, Venkateswarlu B, Shankarrao J, Bhowmik D, Jayakar B, Narayana T. Formulation and evaluation of extended release tablets containing metformin HCl. International Journal of Chem Tech Research. 2(2); 2010: 1320-1329.

  • Sougi A, Ofori-Kwakye K, Kuntworbe N, Kipsol L, El Boakye-Gyasi M. Evaluation of the physiochemical and invitro dissolution properties of metformin hydrochloride tablet brands marketed in five cities in Gana. British Journal of Pharmaceutical Research. 9(1); 2016: 1-14.

  • Afifi SA, Ahmadeen S. A comparative study for evaluation of different brands of metformin hydrochloride 500 mg tablets marketed in Saudi Arabia. Life Science Journal. 9(4); 2012.

  • Dunne S, Shannon B, Dunne C, Cullen W. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacology and Toxicology. 14(1); 2013.

  • Olusola AM, Adekoya AI, Olanrewaju OJ. Comparative evaluation of physiochemical properties of some commercially available brands of metformin HCl tablets in Lagos, Nigeria. Journal of Applied Pharmaceutical Science. 2(2); 2012: 41-44.

  • Najwade B, Mhases S, Manvi F. Formulation of extended- release metformin hydrochloride matrix tablets. Tropical Journal of Pharmaceutical Research. 10(4); 2011: 375-383.

  • United States Pharmacopeia, USP 34- NF 25.

  • Dash S, Murthy PN, Nath L, Chowdhury P. Kinetics modeling on drug release from controlled drug delivery systems. Acta Poloniae Pharmaceutica- Drug Research. 67(3); 2010: 217-223.

  • Yuskel N, Kanik A, Baykara T. Comparison of in vitro dissolution profiles by ANOVA- based, model- dependent and –independent methods. International Journal of Pharmaceutics. 209; 2000: 57-67.

  • Costa P, Sousa Lobo JM. Modeling and comparison of dissolution profiles. European Journal of Pharmaceutical Silences. 13; 2001: 123-133.

  • Ofori- Kwakye K, Mfoafo KA, Kipo SL, Kuntworbe N, El Boakye- Gyasi M. Development and evaluation of natural gum- based extended release matrix tablets of two model drugs of different water solubilities by direct compression. Saudi Pharmaceutical Journal. 24; 2016: 82-91.

  • Chowdary A, Raparla R, Madhuri M. Formulation and evaluation of multilayered tablets of pioglitazone hydrochloride and metformin hydrochloride. Journal of Pharmaceutics; 2014.

  • Ali M, Singh S, Kumar A, Singh S, Ansari MT, Pattnaik G. Preparation and in- vitro evaluation of sustained release matrix tablets of phenytoin sodium using natural polymers. International Journal of Pharmacy and Pharmaceutical Science. 2(3); 2010: 174-179.

  • Al Ameri M, Nayuni N, Kumar K, Perrett D, Tucker A, Johnston A. The differences between the branded and generic medicines using soild dosage forms: in- vitro dissolution testing. Results in Pharma Sciences. 2; 2012: 1-8.

  • Akbar M, Mawla M, Khan M, Hye T, Asaduzzaman M, Muhit MA, Raihan SZ. In vitro dissolution of different brands of sustained release metformin hydrochloride matrix soild dosage forms available in the pharmaceutical market of Bangladesh. Journal of Pharmacy Research. 4(10); 2011: 3436-3438.

  • Obaidat AA. Characterization and evaluation of the release kinetics of a model poorly water –soluble and low dose drug from matrix tablets composed of blends of swellable and erodible polymers: implications for controlled and complete release. Journal of Applied Pharmaceutical Science. 2(4); 2012: 147-153.


Abstract Views: 325

PDF Views: 0




  • Comparative In-vitro Evaluation of Metformin HCl Extended Release Tablets Marketed in Syria

Abstract Views: 325  |  PDF Views: 0

Authors

Nour Mammari
Pharmaceutics and Pharmaceutical Technology Department, Tishreen University, Lattakia, Syrian Arab Republic
Wehad Ibrahim
Pharmaceutics and Pharmaceutical Technology Department, Tishreen University, Syrian Arab Republic
Mohammad Haroun
Pharmaceutical Chemistry and Quality Control Department, Tishreen University and Andalus University, Syrian Arab Republic

Abstract


Metformin hydrochloride extended release tablets are available in many brands in the Syrian market, which make it difficult to select the safe, effective and economic one. The aim of this study was to evaluate the quality control standards of generic different brands of metformin extended release tablets, and compare them with the innovator Glucophage XR®. Two brands AandB (two batches from each brand) were selected. The physiochemical equivalence of all tablets were assessed through the evaluation of weight variation test, assay, swelling behavior study and dissolution test which was carried out for 12 hours using USP apparatus Ι in phosphate buffer pH= 6.8 as a dissolution media. The release mechanism were explored and explained with zero order, first order, Higuchi and Korsmeyer-Peppas equations. In order to compare dissolution profiles, dissolution data was taken and compared through model independent- methods: difference factor f1, similarity factor f2 and dissolution efficiency DE. The tablets had been passed weight variation test and the percent of assay for all brands were within the acceptable ranges. Fitting dissolution data to Korsmeyer-Peppas equation indicated that diffusion along with polymer relaxation could be the mechanism of drug release from brand B and the reference, whereas Fickian diffusion was the predominant mechanism of metformin release from brand A. The study showed that, brand B had similar dissolution profiles with the reference (F2>50), whereas brand A was different in its release behavior (F2>15).

Keywords


Metformin HCl, Extended Release, Dissolution Profiles, Swelling Index, In-Vitro Release.

References