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[Triamcinolone acetonide without solvents]
M Martínez Rubio1, M Moya Moya, J Selva Otaola-Urruchi
1Servicio de Oftalmología, Hospital General Universitario Alicante, Alicante, España. martinez_magrub@gva.es
Archivos De La Sociedad Espanola De Oftalmologia
|October 2, 2012
Summary
This study introduces a new sterile method for preparing pure triamcinolone acetonide without preservatives, crucial for avoiding benzyl alcohol toxicity in ophthalmic preparations.
Area of Science:
- Ophthalmology
- Pharmaceutical Sciences
- Sterile Manufacturing
Context:
- Commercially available triamcinolone acetonide often contains benzyl alcohol, a solvent with potential toxic side-effects.
- Purification of triamcinolone acetonide is essential for safe intravitreal administration.
- Developing preservative-free formulations is a key goal in pharmaceutical development.
Purpose:
- To present a novel, sterile technique for preparing pure triamcinolone acetonide.
- To eliminate the need for organic solvents like benzyl alcohol in the preparation process.
- To establish a reliable method for producing preservative-free triamcinolone acetonide suspensions.
Summary:
- A sterile suspension of triamcinolone acetonide was prepared using only sterile distilled water.
- The suspension was processed under aseptic conditions and terminally sterilized via autoclaving.
- High-pressure liquid chromatography confirmed the final concentration for intravitreal injection was 3.77mg/0.1ml.
Impact:
- This method yields pure triamcinolone acetonide without harmful preservatives.
- The resulting formulation is chemically, physically, and microbiologically stable for six months when refrigerated.
- Offers a safer alternative for ophthalmic treatments requiring triamcinolone acetonide.
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