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Sprinkle formulations-A review of commercially available products.

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.

SUBMITTER: Lee HS

PROVIDER: S-EPMC7327757 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Sprinkle formulations-A review of commercially available products.

Lee Han Sol HS Lee Jeong-Jun JJ Kim Myeong-Gyu MG Kim Ki-Taek KT Cho Cheong-Weon CW Kim Dae-Duk DD Lee Jae-Young JY

Asian journal of pharmaceutical sciences 20190708 3

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 picke ...[more]

PMID: 32636948

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Project description:ObjectivesMap the current landscape of commercially available artificial intelligence (AI) software for radiology and review the availability of their scientific evidence.MethodsWe created an online overview of CE-marked AI software products for clinical radiology based on vendor-supplied product specifications ( www.aiforradiology.com ). Characteristics such as modality, subspeciality, main task, regulatory information, deployment, and pricing model were retrieved. We conducted an extensive literature search on the available scientific evidence of these products. Articles were classified according to a hierarchical model of efficacy.ResultsThe overview included 100 CE-marked AI products from 54 different vendors. For 64/100 products, there was no peer-reviewed evidence of its efficacy. We observed a large heterogeneity in deployment methods, pricing models, and regulatory classes. The evidence of the remaining 36/100 products comprised 237 papers that predominantly (65%) focused on diagnostic accuracy (efficacy level 2). From the 100 products, 18 had evidence that regarded level 3 or higher, validating the (potential) impact on diagnostic thinking, patient outcome, or costs. Half of the available evidence (116/237) were independent and not (co-)funded or (co-)authored by the vendor.ConclusionsEven though the commercial supply of AI software in radiology already holds 100 CE-marked products, we conclude that the sector is still in its infancy. For 64/100 products, peer-reviewed evidence on its efficacy is lacking. Only 18/100 AI products have demonstrated (potential) clinical impact.Key points• Artificial intelligence in radiology is still in its infancy even though already 100 CE-marked AI products are commercially available. • Only 36 out of 100 products have peer-reviewed evidence of which most studies demonstrate lower levels of efficacy. • There is a wide variety in deployment strategies, pricing models, and CE marking class of AI products for radiology.

Dataset Information

Sprinkle formulations-A review of commercially available products.

Publications

Sprinkle formulations-A review of commercially available products.

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