Search results for "Solid oral dosage form"
showing 3 items of 3 documents
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Levetiracetam.
2015
Literature and experimental data relevant for the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing levetiracetam are reviewed. Data on solubility and permeability suggest that levetiracetam belongs to class I of the biopharmaceutical classification system (BCS). Levetiracetam's therapeutic use, its wide therapeutic index, and its favorable pharmacokinetic properties make levetiracetam a valid candidate for the BCS-based biowaiver approach. Further, no BE studies with levetiracetam IR formulations in which the test formulation failed to show BE with the comparator have been reported in the open lit…
A novel soft robotic pediatric in vitro swallowing device to gain insights into the swallowability of mini-tablets Authors
2022
Paediatric solid oral dosage forms for combination products: Improving in vitro swallowability of minitablets using binary mixtures with pellets
2023
There is a growing interest in determining and improving the acceptability of solid oral dosage forms (SODF) in paediatric populations. Combination products can be an interesting solution to combine two active pharmaceutical ingredients. This study shows that binary mixture of paediatric SODF could enhance formulation swallowability and palatability. Using the Paediatric Soft Robotic Tongue (PSRT) – an in vitro device inspired by the anatomy and physiology of 2-year-old children – we investigated the oral phase of swallowing of multi-particulate formulations, i.e., pellets (350 and 700 µm particles), minitablets (MTs, 1.8 mm), and their binary mixtures (BM), by measuring the oral swallowing…