Comparison of Pharmaceutical-Technological Properties of Commercially Available Ranitidine Tablets
Journal Title: IOSR Journal of Pharmacy (IOSRPHR) - Year 2018, Vol 8, Issue 3
Abstract
In this work, we compared the pharmaceutical-technological characteristics of ranitidine hydrochloride film coated tablets (tablets R1, tablets R2) of different manufacturers as well as the influence of excipients of the core tablet and/or film-coating. The results of assay (R1=97.55% ± 1.81%; R2=95.03% ± 0.82%), uniformity of dosage units (R1=267.55 mg ± 4.96 mg; R2=308.75 mg ± 2.67 mg), friability testing (R1=0.037%; R2=0.009%) and disintegration time (R1=239 sec; R2=317 sec) of tablets for both generic drugs meet pharmacopoeial requirements. Significant variations were observed in hardness testing for tablets R1 (RSD=26.69%) compared to hardness testing for tablets R2 (RSD=5.64%). Tested pharmaceutical equivalents may be considered bioequivalent because of the results of in vitro dissolution testing of ranitidine tablets (R1=97.17% ± 1.39%; R2=96.99% ± 3.76%). Tested tablets, containing various excipients, and having different pharmaceutical-technological characteristics, have met all requirements of the European and American pharmacopoeias. Tablets R2 were harder and had lower disintegration time, which resulted in the dissolution of more than 80% of ranitidine within 45 minutes. Patients with lactose intolerance have to be cautious when taking tablets R2, since these tablets contain lactose.
Authors and Affiliations
Jasmina Hadžiabdić, Aida Bureković, Amra Demirović, Ognjenka Rahić, Alisa Elezović1
Keywords
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