Comparison of Pharmaceutical-Technological Properties of Commercially Available Ranitidine Tablets
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.