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Sprinkle formulations——A review of commercially available products

Asian Journal of Pharmaceutical Sciences 2020年第3期15卷 292-310页

作者： Han Sol Lee Jeong-Jun Lee Myeong-Gyu Kim Ki-Taek Kim Cheong-Weon Cho Dae-Duk Kim Jae-Young Lee College of Pharmacy Chungnam National UniversityDaejeon 34134Republic of Korea Graduate School of Clinical Pharmacy CHA UniversityPocheon 11160Republic of Korea College of Pharmacy and Natural Medicine Research Institute Mokpo National UniversityJeonnam 58554Republic of Korea College of Pharmacy and Research Institute of Pharmaceutical Sciences Seoul National UniversitySeoul 08826Republic of Korea

Currently, sixty-five original sprinkle drug products are available in various dosage forms including tablets, powders, granules, immediate-release capsules, extended-release capsules, delayed-release capsules, and multiparticulate drug delivery systems. By sprinkling on soft food vehicles, these products provide dosing flexibility and convenience of administration, which potentially improve the compliance of patients with *** to these advantages, the growth of sprinkle products picked up since the 1990s, and several regulatory issues regarding this dosage form have been raised and *** this article, the types of sprinkle formulations were discussed by dividing them into seven categories, and the commercial products were summarized in terms of the drug substance, pharmaceutical excipients, storage conditions and administration methods. In addition, several US food and Drug Administration guidelines related to the regulatory issues of sprinkle formulations were reviewed, which led to the conclusion that the future development of this promising dosage form demands integrated guidance for industry rather than scattered information in various documents.

关键词： Sprinkle formulation soft food Geriatric Pediatric Dysphagia Guidance for industry

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