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COMPOSITION OF FENTANYL CITRATE ORAL SOLID TRANSMUCOSAL DOSAGE FORM, DEXTROSE MONOHYDRATE AS MAJOR EXCIPIENT AND BINDING MATERIAL THEREFOR AND METHODS OF PRODUCING THEM
COMPOSITION OF FENTANYL CITRATE ORAL SOLID TRANSMUCOSAL DOSAGE FORM, DEXTROSE MONOHYDRATE AS MAJOR EXCIPIENT AND BINDING MATERIAL THEREFOR AND METHODS OF PRODUCING THEM
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机译:芬太尼枸O酸口服固体经皮给药剂型,作为主要赋形剂的一水合右旋糖酐的组成及其结合方法和制备方法
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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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