Evaluation of Physical Properties of Generic and Branded Travoprost Formulations

JOURNAL TITLE: Journal of Current Glaucoma Practice

Author
1. Ramanjit Sihota
2. Meenakshi Wadhwani
3. Thirumurthy Velpandian
4. Dewang Angmo
5. Ankita Kotnala
6. Sanjay K Mishra
ISSN
0974-0333
DOI
10.5005/jp-journals-10008-1201
Volume
10
Issue
2
Publishing Year
2016
Pages
7
Author Affiliations
    1. 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
    1. Department of Ophthalmology, Army Research and Referral Hospital, New Delhi, India
    1. 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
    1. Professor, Department of Ocular Pharmacology, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences New Delhi, India
    1. Dr RP Centre for Ophthalmic Sciences, AIIMS, New Delhi
    2. Dr. R.P. Centre for Ophthalmic Sciences, AIIMS, Ansari Nagar, New Delhi
    3. Dr RP Centre for Ophthalmic Sciences, AIIMS, Ansari Nagar, New Delhi, India
    4. All India Institute of Medical Sciences, New Delhi, India
    5. Dr Rajendra Prasad Center for Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi, India
    1. PhD Student, Department of Ocular Pharmacology, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences New Delhi, India
  • Article keywords
    Branded drugs, Ophthalmic generics, Prostaglandin analogs, Travoprost

    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.

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