기본 정보
연구 분야
프로젝트
발행물
구성원
review|
인용수 28
·2019
Sprinkle formulations—A review of commercially available products
Han Sol Lee, Jeongjun Lee, Jeongjun Lee, Myeong Gyu Kim, Ki-Taek Kim, Cheong‐Weon Cho, Dae‐Duk Kim, Jae-Young Lee, Jae-Young Lee
IF 11.9Asian Journal of Pharmaceutical Sciences
초록

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.

키워드
Food and drug administrationDosage formFlexibility (engineering)DrugDrug administrationBiotechnologyGenerally recognized as safeDosingActive ingredientPharmacology
타입
review
IF / 인용수
11.9 / 28
게재 연도
2019