Pediatric Dispersible Tablets: a Modular Approach for Rapid Prototyping

Buck, Jonas; Huwyler, Jörg; Kühl, Peter; Dischinger, Angela

doi:10.1007/s11095-016-1946-9

Cited by 3 publications

(3 citation statements)

References 25 publications

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“…ODTs are required to disintegrate in less than 30 s by USP disintegration test and 3 min by Ph. Eur.8.2 disintegration test. , However, quantifying disintegration time using the pharmacopeia methods is questionable for ODT tablets because the test conditions are far from that of the human oral cavity.…”

Section: Resultsmentioning

confidence: 99%

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Expedited Development of Diphenhydramine Orally Disintegrating Tablet through Integrated Crystal and Particle Engineering

Wang

Sun

2017

Mol. Pharmaceutics

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A palatable direct compression (DC) orally disintegrating tablet (ODT) product of a bitter drug, diphenhydramine (DPH), was developed using an integrated crystal and particle engineering approach. A DPH salt with a sweetener, acesulfame (Acs), DPH-Acs, was synthesized and its solid state properties were comprehensively characterized. Tablet formulation composition and compaction parameters were optimized by employing material sparing techniques. In vivo disintegration time, bitterness, and grittiness of the final ODT product, were evaluated by a taste panel. Physical stability of the ODT tablets was assessed to identify appropriate storage conditions. Phase-pure DPH-Acs exhibited significantly better tabletability and palatability than DPH-HCl. A DC formulation was designed and optimized to obtain a new ODT product with good manufacturability and excellent product characteristics, including fast in vivo disintegration, and acceptable bitterness and grittiness. A new ODT product of DPH with excellent pharmaceutical properties was successfully developed using 15 g of DPH and in two months. This example shows that integrated crystal and particle engineering is an effective approach for developing high quality ODT products using the DC process.

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Section: Resultsmentioning

confidence: 99%

“…Eur.8.2 disintegration test. 38,39 However, quantifying disintegration time using the pharmacopeia methods is questionable for ODT tablets because the test conditions are far from that of the human oral cavity.…”

Section: Molecular Pharmaceuticsmentioning

confidence: 99%

Expedited Development of Diphenhydramine Orally Disintegrating Tablet through Integrated Crystal and Particle Engineering

Wang

Sun

2017

Mol. Pharmaceutics

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“…The additional constituents of these coprocessed excipients are MCC (for both) and corn starch (in CombiLac). Starch, as a viscosity-modifying excipient, is often used to promote physical stability of dispersions while enhancing their organoleptic profile by creating a smooth, creamy mouth-feel [36]. In contrast, CombiLac performed worse than MicroceLac, despite the inclusion of starch in the former compared to the latter.…”

Section: Individual Analysis Of Co-processed Excipients Based On the mentioning

confidence: 99%

Co-Processed Excipients for Dispersible Tablets—Part 2: Patient Acceptability

et al. 2018

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Palatability and patient acceptability are critical attributes of dispersible tablet formulation. Co-processed excipients could provide improved organoleptic profile due to rational choice of excipients and manufacturing techniques. The aim of this study was to identify the most suitable co-processed excipient to use within directly compressible dispersible tablet formulations. Nine excipients, selected based on successful manufacturability, were investigated in a randomised, preference and acceptability testing in 24 healthy adult volunteers. Excipients were classified in order of preference as follows (from most preferred): SmartEx QD100 > F-Melt Type C > F-Melt Type M > MicroceLac > Ludiflash > CombiLac > Pharmaburst 500 > Avicel HFE-102 > Avicel PH-102. Broad differences were identified in terms of acceptability, with SmartEx QD100 being 'very acceptable', F-Melt Type C, F-Melt Type M and MicroceLac being 'acceptable', Ludiflash, CombiLac and Pharmaburst 500 being 'neutral' and Avicel products being 'very unacceptable' based on ratings using five-point hedonic scales. Organoleptic differences were ascribed to different composition and physical properties of excipients, resulting in dissimilar taste and mouth-feel. Excipients with particle size in water larger than 200-250 μm were considered poorly acceptable, which supports the use of this value as a threshold for maximum particle size of dispersible formulation. The most promising co-processed excipients for directly compressible dispersible tablets were successfully identified.

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