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Review
. 2020 May;15(3):292-310.
doi: 10.1016/j.ajps.2019.05.003. Epub 2019 Jul 8.

Sprinkle formulations-A review of commercially available products

Han Sol Lee  1 , Jeong-Jun Lee  1 , Myeong-Gyu Kim  2 , Ki-Taek Kim  3 , Cheong-Weon Cho  1 , Dae-Duk Kim  4 , Jae-Young Lee  1
Affiliations
Review

Sprinkle formulations-A review of commercially available products

Han Sol Lee et al. Asian J Pharm Sci. 2020 May.

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.

Keywords: Dysphagia; Geriatric; Guidance for industry; Pediatric; Soft food; Sprinkle formulation.

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Figures

Image, graphical abstract
Graphical abstract
Fig 1
Fig. 1
General administration methods for the sprinkle drug products in various dosage forms including tablets, powder, granules, immediate-release (IR) capsules, extended-release (ER) capsules, delayed-release (DR) capsules, and multiparticulate drug delivery system (MDDS).
Fig 2
Fig. 2
The number of approved New Drug Applications (NDAs) for sprinkle drug products since 1941. A total of sixty-five original sprinkle products are available on the US pharmaceutical market.
Fig 3
Fig. 3
Schematic illustration of SODASⓇ technology. The spherical bead has a multilayered structure, of which the drug-containing core is coated with the layers of release-controlling polymers.
Fig 4
Fig. 4
Approximate pH ranges of commonly used soft foods and liquids.(Adapted from Appendix A of Ref. .
See this image and copyright information in PMC

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