Tags

Type your tag names separated by a space and hit enter

Formulation development and comparative in vitro study of metoprolol tartrate (IR) tablets.
Pak J Pharm Sci. 2016 May; 29(3):853-60.PJ

Abstract

The objective of the present work was to develop Immediate Release (IR) tablets of Metoprolol Tartrate (MT) and to compare trial formulations to a reference product. Six formulations (F1-F6) were designed using central composite method and compared to a reference brand (A). Two marketed products (brands B and C) were also evaluated. F1-F6 were prepared with Avicel PH101 (filler), Crospovidone (disintegrant) and Magnesium Stearate (lubricant) by direct compression. Pharmacopoeial and non-pharmacopoeial methods were used to assess their quality. Furthermore, drug profiles were characterized using model dependent and independent (f(2)) approaches. Brands B and C and F5 and F6 did not qualify the tests for content uniformity. Moreover, brand B did not meet weight variation criteria and brand C did not satisfy requirements for single point dissolution test. Of the trial formulations, F2 failed the test for uniformity in thickness while F4 did not disintegrate within time limit. Only F1 and F3 met all quality parameters and were subjected to accelerated stability testing without significant alterations in their physicochemical characteristics. Based on AIC and r(2)(adjusted) values obtained by applying various kinetic models, drug release was determined to most closely follow Hixson-Crowell cube root law. F1 was determined to be the optimized formulation.

Authors+Show Affiliations

Husain T
Department of Pharmaceutics, Faculty of Pharmacy & Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.
Shoaib MH
Department of Pharmaceutics, Faculty of Pharmacy & Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.
Yousuf RI
Department of Pharmaceutics, Faculty of Pharmacy & Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.
Maboos M
Faculty of Pharmacy, Jinnah University for Women, Karachi, Pakistan.
Khan M
Faculty of Pharmacy, Jinnah Sindh Medical University, Karachi, Pakistan.
Bashir L
Department of Pharmaceutics, Faculty of Pharmacy, Federal Urdu University of Arts, Science and Technology, Karachi, Pakistan.
Naz S
Department of Pharmaceutics, Faculty of Pharmacy, Federal Urdu University of Arts, Science and Technology, Karachi, Pakistan.

MeSH

Administration, OralAdrenergic beta-1 Receptor AntagonistsCelluloseChemistry, PharmaceuticalExcipientsKineticsMetoprololModels, ChemicalPovidonePressureSolubilityStearic AcidsTabletsTechnology, Pharmaceutical

Pub Type(s)

Comparative Study
Journal Article

Language

eng

PubMed ID

27166530

Citation

Husain, Tazeen, et al. "Formulation Development and Comparative in Vitro Study of Metoprolol Tartrate (IR) Tablets." Pakistan Journal of Pharmaceutical Sciences, vol. 29, no. 3, 2016, pp. 853-60.
Husain T, Shoaib MH, Yousuf RI, et al. Formulation development and comparative in vitro study of metoprolol tartrate (IR) tablets. Pak J Pharm Sci. 2016;29(3):853-60.
Husain, T., Shoaib, M. H., Yousuf, R. I., Maboos, M., Khan, M., Bashir, L., & Naz, S. (2016). Formulation development and comparative in vitro study of metoprolol tartrate (IR) tablets. Pakistan Journal of Pharmaceutical Sciences, 29(3), 853-60.
Husain T, et al. Formulation Development and Comparative in Vitro Study of Metoprolol Tartrate (IR) Tablets. Pak J Pharm Sci. 2016;29(3):853-60. PubMed PMID: 27166530.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Formulation development and comparative in vitro study of metoprolol tartrate (IR) tablets. AU - Husain,Tazeen, AU - Shoaib,Muhammad Harris, AU - Yousuf,Rabia Ismail, AU - Maboos,Madiha, AU - Khan,Madeeha, AU - Bashir,Lubna, AU - Naz,Shazia, PY - 2016/5/12/entrez PY - 2016/5/12/pubmed PY - 2016/8/11/medline SP - 853 EP - 60 JF - Pakistan journal of pharmaceutical sciences JO - Pak J Pharm Sci VL - 29 IS - 3 N2 - The objective of the present work was to develop Immediate Release (IR) tablets of Metoprolol Tartrate (MT) and to compare trial formulations to a reference product. Six formulations (F1-F6) were designed using central composite method and compared to a reference brand (A). Two marketed products (brands B and C) were also evaluated. F1-F6 were prepared with Avicel PH101 (filler), Crospovidone (disintegrant) and Magnesium Stearate (lubricant) by direct compression. Pharmacopoeial and non-pharmacopoeial methods were used to assess their quality. Furthermore, drug profiles were characterized using model dependent and independent (f(2)) approaches. Brands B and C and F5 and F6 did not qualify the tests for content uniformity. Moreover, brand B did not meet weight variation criteria and brand C did not satisfy requirements for single point dissolution test. Of the trial formulations, F2 failed the test for uniformity in thickness while F4 did not disintegrate within time limit. Only F1 and F3 met all quality parameters and were subjected to accelerated stability testing without significant alterations in their physicochemical characteristics. Based on AIC and r(2)(adjusted) values obtained by applying various kinetic models, drug release was determined to most closely follow Hixson-Crowell cube root law. F1 was determined to be the optimized formulation. SN - 1011-601X UR - https://www.unboundmedicine.com/medline/citation/27166530/Formulation_development_and_comparative_in_vitro_study_of_metoprolol_tartrate__IR__tablets_ DB - PRIME DP - Unbound Medicine ER -