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Fentanyl citrate oral solid transmucosal dosage form, excipient and composition of binding materials thereof, and production method
Fentanyl citrate oral solid transmucosal dosage form, excipient and composition of binding materials thereof, and production method
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机译:柠檬酸芬太尼口服固体透粘膜剂型,赋形剂及其结合材料的组成及其制备方法
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摘要
A process of preparing a highly uniform oral transmucosal lozenge of fentanyl citrate (a "fentanyl lollipop") provides uniform distribution of the drug. The content uniformity between the lozenges and uniform distribution of the drug within a lozenge is achieved by dry mixing a micronized drug of a particle size of about one to ten microns with at least one major excipient, such as a dextrose, having cavities and pores on its surface after pressing into the lozenge shape. The major component of the lozenge can be a binding material prepared with a mixture of dextrose hydrate, food grade starch and water. This binding material has better strength to bind the stick to the lozenge due to stronger cross-linked matrix formation between the lozenge and the binding material.
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