Article
The quantity of sterile triamcinolone acetonide crystals derived from Volon A with use of different preparation methods
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Published: | September 22, 2004 |
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Outline
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Objective
To evaluate different purification methods of commercially available triamcinolone acetonide (TA) in regard to handling, yield, concentration, crystal diameter and reproducibility
Methods
1ml of Volon A containing 40mg of TA (Bristol-Myers) was purified using several methods: (1) Sedimentation: for 15 min in a tuberculine syringe. Supernatant removal and resuspension with BSS was repeated three times; (2) Filtration with use of different filters (pore size from 0.1 up to 5μm and filter diameter from 2 up to 26mm); (3) Centrifugation: for 10min with 2000rpm. After the purification by different methods was completed, each time 0,2ml of the solution was left in the syringe. All assays were performed six times. Crystal diameter was evaluated with the use of particle counter. Concentration measurement was performed after solubilisation with 100% methanol using calibrated spectrophotometry. All samples were read in triplicate.
Results
The following average quantities of triamcinolone acetonide were obtained: (1) 11.29mg ±1.86 SD in 0.2ml; (3) 39.24 ± 0.78 SD in 0.2ml; (2) Depending on pore size and volume different filters show a yield of 13.24mg in 0.2ml up to 28.24mg in 0.2ml. Crystal diameter was up to 50μm.
Conclusions
Reproducibility and predictability of TA concentration are a prerequisite for successful clinical use of intravitreal TA injection. The widely used sedimentation method yields significantly lower quantity than estimated. New methods such as the use of filters allow for better yield. Centrifugation method leads to the recovery of the largest quantity of TA crystals and better control of the quality of the injected drug.