Sprinkle formulations——A review of commercially available products

• 作者: Cheong-Weon Cho Dae-Duk Kim Han Sol Lee Jae-Young Lee Jeong-Jun Lee Ki-Taek Kim Myeong-Gyu Kim
• 来源期刊: 亚洲药物制剂科学(英文)
• 学科: 经济
• 关键词: Sprinkle formulation Soft food GERIATRIC PEDIATRIC DYSPHAGIA Guidance for industry
• 年，卷（期）: 2020,（3）
• 页码范围: 292-310
• 页数: 19页
• 分类号: F42

摘要

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 dysphagia.Due 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 documented.In 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.