New orodispersible mini-tablets for paediatric use – A comparison of isomalt with a mannitol based co-processed excipient

Lura, Ard; Luhn, Oliver; Gonzales, Javier Suarez; Breitkreutz, Jörg

doi:10.1016/j.ijpharm.2019.118804

Cited by 23 publications

(6 citation statements)

References 16 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The effects of compaction pressure and the use of certain co-processed excipients on the quality profile of ODMTs have been studied several times. Lura et al conducted studies on the capacity of Ludiflash and galenIQ™ (isomalt-based co-processed excipient) to be used for the manufacturing of ODMTs [39], later optimising the process for scaleup from laboratory to industrial scale [40]. From the same research group, Kokott et al proved the capacity of Parteck ODT and Hisorad to be compressed into sturdy ODMTs that disintegrate quickly, both in a compaction simulator and on an industrial-grade tablet press [41].…”

Section: Minitablets (Odmts)mentioning

confidence: 99%

Orally Dispersible Dosage Forms for Paediatric Use: Current Knowledge and Development of Nanostructure-Based Formulations

et al. 2022

View full text Add to dashboard Cite

The paediatric population has always suffered from a lack of medicines tailored to their needs, especially in terms of accurate dosage, stability and acceptability. Orodispersible dosage forms have gone through a resurrection as an alternative to liquid formulations or fractioned solid formulations, although they are still subject to several inconveniences, among which the unpleasant taste and the low oral bioavailability of the API are the most significant hurdles in the way of achieving an optimal drug product. Nanostructures can address these inconveniences through their size and variety, owing to the plethora of materials that can be used in their manufacturing. Through the formation and functionalisation of nanostructures, followed by their inclusion in orodispersible dosage forms, safe, stable and acceptable medicines intended for paediatric use can be developed.

show abstract

Section: Minitablets (Odmts)mentioning

confidence: 99%

Orally Dispersible Dosage Forms for Paediatric Use: Current Knowledge and Development of Nanostructure-Based Formulations

et al. 2022

View full text Add to dashboard Cite

show abstract

“…They concluded that Ludiflash ® , which in addition to mannitol contains crospovidone as a disintegrant, and polyvinyl acetate as pore former, provided the best co-processed mixture. More recently, the same authors investigated the manufacturability of MTs using galenIQ™721, an agglomerated isomalt containing the two disaccharides, 6-O-α-D-glucopyranosyl sorbitol and 1-O-α-D-glucopyranosyl D-mannitol dihydrate in a ratio of 3:1 [53]. Like Ludiflash ® , galenIQ™721 is a spherical shape powder with a mean D 50 close to 130 µm, showing good flowability.…”

Section: Case Studies On Oro-dispersible Mts Obtained By Compression ...mentioning

confidence: 99%

Mini-Tablets: A Valid Strategy to Combine Efficacy and Safety in Pediatrics

et al. 2022

View full text Add to dashboard Cite

In the treatment of pediatric diseases, mass-produced dosage forms are often not suitable for children. Commercially available medicines are commonly manipulated and mixed with food by caregivers at home, or extemporaneous medications are routinely compounded in the hospital pharmacies to treat hospitalized children. Despite considerable efforts by regulatory agencies, the pediatric population is still exposed to questionable and potentially harmful practices. When designing medicines for children, the ability to fine-tune the dosage while ensuring the safety of the ingredients is of paramount importance. For these purposes solid formulations may represent a valid alternative to liquid formulations for their simpler formula and more stability, and, to overcome the problem of swelling ability, mini-tablets could be a practicable option. This review deals with the different approaches that may be applied to develop mini-tablets intended for pediatrics with a focus on the safety of excipients. Alongside the conventional method of compression, 3D printing appeared particularly appealing, as it allows to reduce the number of ingredients and to avoid both the mixing of powders and intermediate steps such as granulation. Therefore, this technique could be well adaptable to the daily galenic preparations of a hospital pharmacy, thus leading to a reduction of the common practice of off-label preparations.

show abstract

“…Since the European Medicine Authority (EMA) set up regulations for developing age-appropriate formulations, the development of orally disintegrating mini tablets (mini ODTs) has widely gained recognition (Lura et al, 2019). A mini tablet is referred to as a tablet with a diameter equal to/less than 4 mm (van Riet-Nales et al, 2016).…”

Section: Orally Disintegrating Tablets (Odts)/mini Tablets (Mini Odts)mentioning

confidence: 99%

Paediatric specific dosage forms: Patient and formulation considerations

Khan

Kirby

Bryson

et al. 2022

International Journal of Pharmaceutics

View full text Add to dashboard Cite

New orodispersible mini-tablets for paediatric use – A comparison of isomalt with a mannitol based co-processed excipient

Cited by 23 publications

References 16 publications

Orally Dispersible Dosage Forms for Paediatric Use: Current Knowledge and Development of Nanostructure-Based Formulations

Orally Dispersible Dosage Forms for Paediatric Use: Current Knowledge and Development of Nanostructure-Based Formulations

Mini-Tablets: A Valid Strategy to Combine Efficacy and Safety in Pediatrics

Paediatric specific dosage forms: Patient and formulation considerations

Contact Info

Product

Resources

About