Development of a Pediatric Mini-Tablet Formulation for Expedited Preclinical Studies

Lavan, Monika; Wang, Xueqi; McCain, Robyn; Jannasch, Amber; Cooper, Bruce R.; Hostetler, Scott; Byrn, Stephen R.; Knipp, Gregory T.

doi:10.1208/s12249-020-01891-x

Cited by 2 publications

(1 citation statement)

References 62 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…To date, only one study has regarded preclinical investigations [61]. The anticancer agent lapatinib, a tyrosine kinase inhibitor, has been approved for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer.…”

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

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

confidence: 99%