Cargando…
Evaluation of Physical Properties of Generic and Branded Travoprost Formulations
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...
Autores principales: | , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Jaypee Brothers Medical Publishers
2016
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4981658/ https://www.ncbi.nlm.nih.gov/pubmed/27536047 http://dx.doi.org/10.5005/jp-journals-10008-1201 |
_version_ | 1782447642345734144 |
---|---|
author | Wadhwani, Meenakshi Mishra, Sanjay K Angmo, Dewang Velpandian, Thirumurthy Sihota, Ramanjit Kotnala, Ankita Bhartiya, Shibal Dada, Tanuj |
author_facet | Wadhwani, Meenakshi Mishra, Sanjay K Angmo, Dewang Velpandian, Thirumurthy Sihota, Ramanjit Kotnala, Ankita Bhartiya, Shibal Dada, Tanuj |
author_sort | Wadhwani, Meenakshi |
collection | PubMed |
description | 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. 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. |
format | Online Article Text |
id | pubmed-4981658 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | Jaypee Brothers Medical Publishers |
record_format | MEDLINE/PubMed |
spelling | pubmed-49816582016-08-17 Evaluation of Physical Properties of Generic and Branded Travoprost Formulations Wadhwani, Meenakshi Mishra, Sanjay K Angmo, Dewang Velpandian, Thirumurthy Sihota, Ramanjit Kotnala, Ankita Bhartiya, Shibal Dada, Tanuj J Curr Glaucoma Pract Original Article 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. 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. Jaypee Brothers Medical Publishers 2016 2016-08-05 /pmc/articles/PMC4981658/ /pubmed/27536047 http://dx.doi.org/10.5005/jp-journals-10008-1201 Text en Copyright © 2016; Jaypee Brothers Medical Publishers (P) Ltd. This work is licensed under a Creative Commons Attribution 3.0 Unported License. To view a copy of this license, visit http://creativecommons.org/licenses/by/3.0/ |
spellingShingle | Original Article Wadhwani, Meenakshi Mishra, Sanjay K Angmo, Dewang Velpandian, Thirumurthy Sihota, Ramanjit Kotnala, Ankita Bhartiya, Shibal Dada, Tanuj Evaluation of Physical Properties of Generic and Branded Travoprost Formulations |
title | Evaluation of Physical Properties of Generic and Branded Travoprost Formulations |
title_full | Evaluation of Physical Properties of Generic and Branded Travoprost Formulations |
title_fullStr | Evaluation of Physical Properties of Generic and Branded Travoprost Formulations |
title_full_unstemmed | Evaluation of Physical Properties of Generic and Branded Travoprost Formulations |
title_short | Evaluation of Physical Properties of Generic and Branded Travoprost Formulations |
title_sort | evaluation of physical properties of generic and branded travoprost formulations |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4981658/ https://www.ncbi.nlm.nih.gov/pubmed/27536047 http://dx.doi.org/10.5005/jp-journals-10008-1201 |
work_keys_str_mv | AT wadhwanimeenakshi evaluationofphysicalpropertiesofgenericandbrandedtravoprostformulations AT mishrasanjayk evaluationofphysicalpropertiesofgenericandbrandedtravoprostformulations AT angmodewang evaluationofphysicalpropertiesofgenericandbrandedtravoprostformulations AT velpandianthirumurthy evaluationofphysicalpropertiesofgenericandbrandedtravoprostformulations AT sihotaramanjit evaluationofphysicalpropertiesofgenericandbrandedtravoprostformulations AT kotnalaankita evaluationofphysicalpropertiesofgenericandbrandedtravoprostformulations AT bhartiyashibal evaluationofphysicalpropertiesofgenericandbrandedtravoprostformulations AT dadatanuj evaluationofphysicalpropertiesofgenericandbrandedtravoprostformulations |