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.

[1]  L. Martini,et al.  Excipients: Pharmaceutical Dosage Forms , 2017 .

[2]  Lirong Liu,et al.  Chapter 34 – Development, Optimization, and Scale-Up of Process Parameters: Pan Coating , 2017 .

[3]  P. Patel,et al.  Formulation and characterization of sustained release dosage form of moisture sensitive drug , 2015, International journal of pharmaceutical investigation.

[4]  Leon Shargel,et al.  Introduction to Generic Drug Product Development , 2014 .

[5]  G. Amidon,et al.  G.L. Amidon, H. Lennernas, V.P. Shah, and J.R. Crison. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of In Vitro Drug Product Dissolution and In Vivo Bioavailability, Pharm Res 12, 413–420, 1995—Backstory of BCS , 2014, The AAPS Journal.

[6]  Nadine Judith Bezzegh,et al.  Test of dissolution and comparison of in vitro dissolution profiles of coated ranitidine tablets marketed in Bahia, Brazil , 2014 .

[7]  R. Thapa,et al.  A COMPARISON OF THE TECHNICAL QUALITY OF NEPALESE AND INDIAN RANITIDINE HYDROCHLORIDE TABLETS AVAILABLE IN POKHARA , 2014 .

[8]  A. Dash,et al.  Pharmaceutics : basic principles and application to pharmacy practice , 2014 .

[9]  W. Cullen,et al.  A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study , 2013, BMC Pharmacology and Toxicology.

[10]  Arthur H. Kibbe,et al.  Generic Drugs and Generic Equivalency , 2012 .

[11]  Shaik Mastan,et al.  The basic regulatory considerations and prospects for conducting bioavailability/bioequivalence (BA/BE) studies – an overview , 2011 .

[12]  Amitava Ghosh,et al.  Effects of plasticizers and surfactants on the film forming properties of hydroxypropyl methylcellulose for the coating of diclofenac sodium tablets. , 2009, Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society.

[13]  A. Sakr,et al.  Tablet Dosage Forms , 2009 .

[14]  A. Gasbarrini,et al.  Low‐dose lactose in drugs neither increases breath hydrogen excretion nor causes gastrointestinal symptoms , 2008, Alimentary pharmacology & therapeutics.

[15]  Dave A. Miller,et al.  Aqueous Polymeric Film Coating , 2008 .

[16]  D M Barends,et al.  Biowaiver monographs for immediate release solid oral dosage forms: ranitidine hydrochloride. , 2005, Journal of pharmaceutical sciences.

[17]  Beom-Jin Lee,et al.  Effect of solvents on physical properties and release characteristics of monolithic hydroxypropylmethylcellulose matrix granules and tablets , 2005, Archives of pharmacal research.

[18]  Leon Shargel,et al.  Generic drug product development : solid oral dosage forms , 2004 .

[19]  J. Crison,et al.  A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of in Vitro Drug Product Dissolution and in Vivo Bioavailability , 1995, Pharmaceutical Research.

[20]  D. Notterman,et al.  "Inactive" ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics Committee on Drugs. , 1997, Pediatrics.

[21]  R. Korpela,et al.  Tolerance to small amounts of lactose in lactose maldigesters. , 1996, The American journal of clinical nutrition.

[22]  G. Cole.  Introduction and overview of pharmaceutical coating , 1995 .

[23]  J. Hogan.  Film-coating materials and their properties Summary , 1995 .

[24]  Jm Newton,et al.  The mechanical strength of tablets , 1981 .

[25]  R. E. King.  Oral Solid Dosage Forms , 2022 .