title: Formulation development and comparative in vitro study of metoprolol tartrate (IR) tablets.
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.affiliation: Department of Pharmaceutics, Faculty of Pharmacy & Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.
authors.forename: Tazeen
authors.initials: T
authors.lastname: Husain
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy & Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.
authors.forename: Muhammad Harris
authors.initials: MH
authors.lastname: Shoaib
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy & Pharmaceutical Sciences, University of Karachi, Karachi, Pakistan.
authors.forename: Rabia Ismail
authors.initials: RI
authors.lastname: Yousuf
authors.affiliation: Faculty of Pharmacy, Jinnah University for Women, Karachi, Pakistan.
authors.forename: Madiha
authors.initials: M
authors.lastname: Maboos
authors.affiliation: Faculty of Pharmacy, Jinnah Sindh Medical University, Karachi, Pakistan.
authors.forename: Madeeha
authors.initials: M
authors.lastname: Khan
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, Federal Urdu University of Arts, Science and Technology, Karachi, Pakistan.
authors.forename: Lubna
authors.initials: L
authors.lastname: Bashir
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, Federal Urdu University of Arts, Science and Technology, Karachi, Pakistan.
authors.forename: Shazia
authors.initials: S
authors.lastname: Naz
mesh_terms: D000284:Administration, Oral; D058671:Adrenergic beta-1 Receptor Antagonists / Q000008:administration & dosage / Q000737:chemistry*; D002482:Cellulose / Q000737:chemistry; D002626:Chemistry, Pharmaceutical; D005079:Excipients / Q000737:chemistry; D007700:Kinetics; D008790:Metoprolol / Q000008:administration & dosage / Q000737:chemistry*; D008956:Models, Chemical; D011205:Povidone / Q000737:chemistry; D011312:Pressure; D012995:Solubility; D013229:Stearic Acids / Q000737:chemistry; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods
chemical_list: D058671:Adrenergic beta-1 Receptor Antagonists; D005079:Excipients; D013229:Stearic Acids; D013607:Tablets; C031183:stearic acid; D002482:Cellulose; D011205:Povidone; D008790:Metoprolol; C109691:microcrystalline cellulose