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Studies on Indomethacin Intraocular Implants Using Different in vitro Release Methods
J Balasubramaniam1, A Srinatha, J K Pandit
1ISP (Hong Kong) Limited, H. No 6-3-1090/A, Bhupal Towers, Rajbhavan Road, Somajiguda, Hyderabad-500 082, India.
Intra ocular implants of sodium alginate alone and in combination with hydroxypropylmethylcellulose with or without calcium chloride were formulated with indomethacin as a model drug. The drug release from the implants was evaluated using static method, continuous flow through apparatus (developed in house), USP dissolution and agar diffusion. Except in the static method, indomethacin particle size did not impart any effect on the drug release. In agar diffusion method, an increase in agar concentration from 1 to 2% resulted in a significant decrease (P< 0.005) in the amount of drug released. Inclusion of hydroxypropylmethylcellulose (33.3, 41.6 and 50% w/w), resulted in decrease of indomethacin release irrespective of the method of dissolution study. The agar diffusion method and the continuous flow through methods seem to simulate to a certain extent the in vivo conditions as far as the placement of the device and the hydrodynamic diffusion layer around the intra ocular implant is concerned. The static method and USP method affected the hydrodynamic diffusion layer either too slowly or too fast.
Intra ocular implants of sodium alginate alone and in combination with hydroxypropylmethylcellulose with or without calcium chloride were formulated with indomethacin as a model drug. The drug release from the implants was evaluated using static method, continuous flow through apparatus (developed in house), USP dissolution and agar diffusion. Except in the static method, indomethacin particle size did not impart any effect on the drug release. In agar diffusion method, an increase in agar concentration from 1 to 2% resulted in a significant decrease (P< 0.005) in the amount of drug released. Inclusion of hydroxypropylmethylcellulose (33.3, 41.6 and 50% w/w), resulted in decrease of indomethacin release irrespective of the method of dissolution study. The agar diffusion method and the continuous flow through methods seem to simulate to a certain extent the in vivo conditions as far as the placement of the device and the hydrodynamic diffusion layer around the intra ocular implant is concerned. The static method and USP method affected the hydrodynamic diffusion layer either too slowly or too fast.
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