title: Evaluation of Physical Properties of Generic and Branded Travoprost Formulations.
abstract: OBJECTIVE
  Comparative evaluation of pharmaceutical characteristics of three marketed generic vs branded travoprost formulations.
  
  
  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.
  
  
  CONCLUSIONS
  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. How to cite this article: 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.
authors.affiliation: Senior Research Officer, Glaucoma Research Facility and Clinical Services Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Meenakshi
authors.initials: M
authors.lastname: Wadhwani
authors.affiliation: Associate Professor, Department of Opthalmology, Army Research and Referral Hospital, New Delhi, India.
authors.forename: Sanjay K
authors.initials: SK
authors.lastname: Mishra
authors.affiliation: Senior Research Associate, Glaucoma Research Facility and Clinical Services Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Dewang
authors.initials: D
authors.lastname: Angmo
authors.affiliation: Professor, Department of Ocular Pharmacology, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences New Delhi, India.
authors.forename: Thirumurthy
authors.initials: T
authors.lastname: Velpandian
authors.affiliation: Professor, Glaucoma Research Facility and Clinical Services Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Ramanjit
authors.initials: R
authors.lastname: Sihota
authors.affiliation: PhD Student, Department of Ocular Pharmacology, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences New Delhi, India.
authors.forename: Ankita
authors.initials: A
authors.lastname: Kotnala
authors.affiliation: Senior Consultant, Department of Opthalmology, Fortis Memorial Research Institute, Gurgaon, Haryana, India.
authors.forename: Shibal
authors.initials: S
authors.lastname: Bhartiya
authors.affiliation: Professor, Glaucoma Research Facility and Clinical Services Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India.
authors.forename: Tanuj
authors.initials: T
authors.lastname: Dada
keywords: Branded drugs; Ophthalmic generics; Prostaglandin analogs; Travoprost.