In order to achieve a zero-order release of protein drugs, we have developed a new drug delivery system using silicone, which is named the covered-rod-type formulation. Preparation of the covered-rod-type formulation was conducted under mild conditions without heat treatment or the use of organic solvents. The covered-rod-type formulation released human serum albumin (HSA) or interferon (IFN) at a constant rate for 30-100 days in vitro without significant initial burst. When the IFN covered-rod-type formulation was implanted in nude mice, the serum IFN concentration was maintained at a constant level during the period of observation, i.e., 28 days. The covered-rod-type formulation enabled precise control of the release of the protein drugs and would be expected to increase the duration of the drug effect and to reduce the frequency of administration and side effects.
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Study on accelerated evaluation system for release profiles of covered-rod type silicone formulation using indomethacin as a model drug.
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Formulation Research Laboratories, Sumitomo Pharmaceuticals Co Ltd, 3-45 Kurakakiuchi 1-Chome, Ibaraki-shi, Osaka 567-0878, Japan.
The purpose of this study was to establish a method allowing rapid evaluation in vitro of the profiles of drug release from covered-rod type silicone formulation (CR silicone formulation), which releases drug for a prolonged period of time. Three CR silicone formulations containing indomethacin (IDM) with different release profiles were used in this study. The release of IDM was accelerated in a mixture of methanol and water (MeOH/water) compared with in phosphate-buffered saline (PBS) added by Tween 20 (PBS-based solvent).
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Formulation Research Laboratories, Sumitomo Pharmaceuticals Co. Ltd., 3-45 Kurakakiuchi 1-Chome, Ibaraki-shi, 567-0878, Osaka, Japan.
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Research Center, Sumitomo Pharmaceuticals Co. Ltd., 3-45 Kurakakiuchi 1-chome, Ibaraki-shi, 567-0878, Osaka, Japan.
In order to achieve a zero-order release of protein drugs, we have developed a new drug delivery system using silicone, which is named the covered-rod-type formulation. Preparation of the covered-rod-type formulation was conducted under mild conditions without heat treatment or the use of organic solvents. The covered-rod-type formulation released human serum albumin (HSA) or interferon (IFN) at a constant rate for 30-100 days in vitro without significant initial burst.
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