Preservative-free triamcinolone acetonide suspension developed for intravitreal injection

Bitter, C. and Suter, K. and Figueiredo, V. and Pruente, C. and Hatz, K. and Surber, C.. (2008) Preservative-free triamcinolone acetonide suspension developed for intravitreal injection. Journal of ocular pharmacology and therapeutics, Vol. 24, H. 1. pp. 62-69.

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Official URL: http://edoc.unibas.ch/dok/A6007194

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OBJECTIVES: All commercially available triamcinolone acetonide (TACA) suspensions, used for intravitreal treatment, contain retinal toxic vehicles (e.g., benzyl alcohol, solubilizer). Our aim was to find a convenient and reproducible method to compound a completely preservative-free TACA suspension, adapted to the intraocular physiology, with consistent quality (i.e., proven sterility and stability, constant content and dose uniformity, defined particle size, and 1 year shelf life). METHODS: We evaluated two published (Membrane-filter, Centrifugation) and a newly developed method (Direct Suspending) to compound TACA suspensions for intravitreal injection. Parameters as TACA content (HPLC), particle size (microscopy and laser spectrometry), sterility, and bacterial endotoxins were assessed. Stability testing (at room temperature and 40 degrees C) was performed: color and homogeneity (visually), particle size (microscopically), TACA content and dose uniformity (HPLC) were analyzed according to International Conference on Harmonisation guidelines. RESULTS: Contrary to the known methods, the direct suspending method is convenient, provides a TACA suspension, which fulfills all compendial requirements, and has a 2-year shelf life. CONCLUSIONS: We developed a simple, reproducible method to compound stable, completely preservative-free TACA suspensions with a reasonable shelf-life, which enables to study the effect of intravitreal TACA--not biased by varying doses and toxic compounds or their residues.
Faculties and Departments:03 Faculty of Medicine > Bereich Spezialfächer (Klinik) > Ophthalmologie USB
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Spezialfächer (Klinik) > Ophthalmologie USB
UniBasel Contributors:Prünte, Christian
Item Type:Article, refereed
Article Subtype:Research Article
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:23 May 2014 08:33
Deposited On:23 May 2014 08:33

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