Sprinkle formulations—A review of commercially available products

Han Sol Lee, Jeong Jun Lee, Myeong Gyu Kim, Ki Taek Kim, Cheong Weon Cho, Dae Duk Kim, Jae Young Lee

Research output: Contribution to journalReview articlepeer-review

7 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)292-310
Number of pages19
JournalAsian Journal of Pharmaceutical Sciences
Volume15
Issue number3
DOIs
StatePublished - May 2020

Keywords

  • Dysphagia
  • Geriatric
  • Guidance for industry
  • Pediatric
  • Soft food
  • Sprinkle formulation

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