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Elaboration of travoprost eye drops formulation.

Anna Szydłowska 1Grzegorz Huszcza 2Magdalena M. Dąbrowska 2Michał Chodyński 2

1. Pharmaceutical Research Institute, Rydygiera 8, Warsaw 01-793, Poland
2. Instytut Farmaceutyczny (PRI), Rydygiera 8, Warszawa 01-793, Poland

Abstract

Prostaglandin analogs are an important therapeutic agents used in treating glaucoma. This increasingly common disease manifests itself inter alia by increased intraocular pressure. Consequently, it causes irreversible degenerative changes in the visual organ, hence importance of efficacious pharmacological treatment. Research towards development of a formulation process for generic prostaglandin eye drops will be presented on the example of travoprost. Typical hurdles of the process development involving prostaglandin are: low dose of the active substance, difficulties connected with dissolving it in the target formulation and obtaining a homogenous solution. The result of  experiments demonstrating significance of various factors used in the process elaboration to select the most effective way of transferring the active pharmaceutical ingredient to the final form of preparation, while avoiding the content loss and creation of impurities, will be presented. As a result of conducted research, product specification fulfilling the requirements imposed by pharmacopoeia, and documenting suitable stability, was established.

Project is co-financed by European Union, POIG no. UDA-POIG.01.03.01-14-068.

 

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Submitted: 2014-03-26 14:43
Revised:   2014-04-29 11:57