Table of Contents
ISRN Toxicology
Volume 2012, Article ID 813836, 14 pages
http://dx.doi.org/10.5402/2012/813836
Research Article

In Vitro-In Vivo Correlation Evaluation of Generic Alfuzosin Modified Release Tablets

Environmental and Analytical Chemistry Division, School of Advanced Sciences, VIT University, Vellore 632014, India

Received 1 September 2012; Accepted 3 October 2012

Academic Editors: A. I. Haza, Y. C. Hseu, and J. V. Rogers

Copyright © 2012 Utpal Kumar Sanki and Badal Kumar Mandal. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Supplementary Material

Details of formulation, process specification, testing procedure of API and impurities as well as characterization of Alfuzosin are reported in the supplementary document. In process specification and testing procedure fixed for pilot and pivotal formulation development and scale up are presented in Table S1. Table S2 presents relative retention time (in h) of the impurities of the alfuzosin by HPLC. Table S3 shows ratio of rate controlling membrane used for formulation development to evaluate the performance of the rate controlling agent in the drug release rate in pilot formulation whereas Table S4 presents result of in process parameters testing for pivotal and commercial production batch of alfuzosin 10 mg extended release formulation. Table S5 provides percentage of controlled drug release (% CDR) at each time points of 12 reference tablets UROXATRAL 10 mg extended release tablets at 0.1 N HCl (pH 1.2). Table S6 provides % CDR of at each time points of 12 test tablets of final alfuzosin 10 mg extended release tablets formulation at 0.1N HCl (pH 1.2). Similarly, Table S7 details % CDR of at each time points of 12 reference tablets Uroxatral (alfuzosin 10 mg) extended release tablets formulation at pH 4.7 and Table S8 narrates % CDR of at each time points of 12 test tablets of final alfuzosin 10 mg extended release tablets formulation batch at pH 4.7, while Table reports S9 % CDR of at each time points of 12 reference tablets Uroxatral (alfuzosin 10 mg) extended release tablets formulation at pH 6.8 and Table S10 mentions % CDR of at each time points of 12 reference tablets (alfuzosin 10 mg) extended release tablets formulation at pH 6.8. Table S11 has given results on Freeze and Thaw Stability of QC samples of Alfuzosin in Human Plasma (1 to 4 and 6 Cycles). IR peak assignment for both test and reference alfuzosin are reported in Table S12. Table S13 shows Proton NMR peak assignment and Table S14 for 13C NMR Chemical shift Assignment of alfuzosin test and standard drug. Mass spectrometric analysis reports are summarized in Table S15. Figure S1 has mentioned all steps for large scale manufacturing process of Alfuzosin and its formulation.

  1. Supplementary Material