Journal of Current Glaucoma Practice

Register      Login

VOLUME 10 , ISSUE 2 ( May-August, 2016 ) > List of Articles

Original Article

Evaluation of Physical Properties of Generic and Branded Travoprost Formulations

Meenakshi Wadhwani, Sanjay K Mishra, Dewang Angmo, Thirumurthy Velpandian, Ramanjit Sihota, Ankita Kotnala, Shibal Bhartiya, Tanuj Dada

Keywords : Branded drugs, Ophthalmic generics, Prostaglandin analogs, Travoprost

Citation Information : Wadhwani M, Mishra SK, Angmo D, Velpandian T, Sihota R, Kotnala A, Bhartiya S, Dada T. Evaluation of Physical Properties of Generic and Branded Travoprost Formulations. J Curr Glaucoma Pract 2016; 10 (2):49-55.

DOI: 10.5005/jp-journals-10008-1201

License: CC BY-NC 4.0

Published Online: 01-08-2016

Copyright Statement:  Copyright © 2016; Jaypee Brothers Medical Publishers (P) Ltd.


Abstract

Purpose: Comparative evaluation of pharmaceutical characteristics of three marketed generic vs branded travoprost formulations. Materials and methods: Three generic travoprost formulations and one branded (Travatan without benzalkonium chloride) formulation (10 vials each), obtained from authorized agents from the respective companies and having the same batch number, were used. These formulations were coded and labels were removed. At a standardized room temperature of 25°C, the drop size, pH, relative viscosity, and total drops per vial were determined for Travatan (Alcon, Fort Worth, TX, USA) and all the generic formulations. Travoprost concentration in all four brands was estimated by using liquid chromatography-coupled tandem mass spectrometry LCMS. Results: Out of the four formulations, two drugs (TP 1 and TP 4) were found to follow the United States Pharmacopoeia (USP) limits for ophthalmic formulation regarding drug concentration, while the remaining two drugs failed due to the limits being either above 110% (TP 2) or below 90% (TP 3). Two of them (TP 1 and TP 2) had osmolality of 313 and 262 mOsm respectively, which did not comply with the osmolality limits within 300 mOsm (+ 10%). The pH of all the formulations ranged between 4.7 and 5.9, and the mean drop size was 30.23 ± 6.03 uL. The total amount of drug volume in the bottles varied from 2.58 ± 0.15 to 3.38 ± 0.06 mL/bottle. Conclusion: There are wide variations in the physical properties of generic formulations available in India. Although some generic drugs are compliant with the pharmacopeia standards, this study underscores the need for a better quality control in the production of generic travoprost formulations.


PDF Share
  1. Pascolini D, Mariotti SP. Global estimates of visual impairment:
  2. Br J Ophthalmol 2012 May;96(5):614-618.
  3. Alexander CL, Miller SJ, Abel SR. Prostaglandin analog treatment of glaucoma and ocular hypertension. Ann Pharmacother 2002 Mar;36(3):504-511.
  4. Parrish RK, Palmberg P, Sheu WP. A comparison of latanoprost, bimatoprost, and travoprost in patients with elevated intraocular pressure: a 12-week, randomized, maskedevaluator multicenter study. Am J Ophthalmol 2003 May; 135(5):688-703.
  5. Weinreb RN, Lindsey JD, Marchenko G, Marchenko N, Angert M, Strongin A. Prostaglandin FP agonists alter metalloproteinase gene expression in sclera. Invest Ophthalmol Vis Sci 2004 Dec;45(12):4368-4377.
  6. Meredith PA. Generic drugs. Therapeutic equivalence. Drug Saf 1996 Oct;15(4):233-242.
  7. Available from: http://www.who.int/medicines/services/counterfeit/overview/en/ (28 February 2009).
  8. Borgheini G. The bioequivalence and therapeutic efficacy of generic versus brand-name psychoactive drugs. Clin Ther 2003 Jun;25(6):1578-1592.
  9. Alm A, Grierson I, Shields B. Adverse events associated with prostaglandin analogue therapy. Surv Ophthalmol 2008 Nov;53 (Suppl 6):S93-S105.
  10. Alm A, Schoenfelder J, Mc Dermott J. A 5-year, multicenter, open-label, safety study of adjunctive latanoprost therapy for glaucoma. Arch Ophthalmol 2004 Jul;122(7):957-965.
  11. Chambers WA. Ophthalmic generics – Are they really the same? Ophthalmology 2012 Jun;119(6):1095-1096.
  12. Mammo ZN, Flanagan JG, James DF, Trope GE. Generic versus brand-name North American topical glaucoma drops. Can J Ophthalmol 2012 Feb;47(1):55-61.
  13. Johnson TV, Gupta PK, Vudathala DK, Blair IA, Tanna AP. Thermal stability of bimatoprost, latanoprost and travoprost under simulated daily use. J Ocul Pharmacol Ther 2011 Feb;27(1):51-59.
  14. Paolera MD, Kasahara N, Umbelino CC, Walt JG. Comparative study of the stability of bimatoprost 0.03% and latanoprost 0.005%: a patient-use study. BMC Ophthalmol 2008 Jun11;8:11.
  15. Narayanaswamy A, Neog A, Baskaran M, George R, Lingam V, Desai C, Rajadhyaksha V. A randomized, crossover, open label pilot study to evaluate the efficacy and safety of Xalatan® in comparison with generic latanoprost (Latoprost) in subjects with primary open angle glaucoma or ocular hypertension. Indian J Ophthalmol 2007 Mar-Apr;55(2):127-131.
  16. Roberts CW. A comparison of branded to generic prednisolone acetate for control of postoperative inflammation. Invest Ophthalmol Vis Sci 2000;41:S150.
  17. Weir RE, Zaidi FH, Charteris DG, Bunce C, Soltani M, Lovering AM. Variability in the content of Indian generic ciprofloxacin eye drops. Br J Ophthalmol 2005 Sep;89(9): 1094-1096.
  18. Kahook MY, Fechtner RD, Katz LJ, Noecker RJ, Ammar DA. A comparison of active ingredients and preservatives between brand name and generic topical glaucoma medications using liquid chromatography tandem mass spectrometry. Curr Eye Res 2012 Feb;37(2):101-108.
  19. Velpandian T, Kotnala A, Halder N, Ravi AK, Archunan V, Sihota R. Stability of latanoprost in generic formulations using controlled degradation and patient usage simulation studies. Curr Eye Res 2015 May;40(6):561-571.
PDF Share
PDF Share

© Jaypee Brothers Medical Publishers (P) LTD.