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These were the proportion of the active pharmaceutical ingredients (APIs) in a tablet and the aqueous solubility of the active substance in relation to the intended concentration after dispersing the tablet in water according to a frequently used paediatric medicine preparation technique. Abbreviation API active pharmaceutical ingredients Providing medicines for children with different ages, body weights and capacities poses clinical challenges. [Extracted from the article]

Introduction: To investigate the dosing accuracy using split tablets in paediatric patients. Methods: Five brands of tablets (Alvedon®(paracetamol), Catapresan®(clonidine), Hydrocortone®(hydrocortisone), Prednisolon® (prednisolon) and Tavegyl®(clemastine) were split into halves and quarters by hand or by using a tablet splitter. The resulting halves and quarters were weighed. Results: Three out of the five tablet brands passed the test in the Ph. Eur. (European Pharmacopoeia) for subdivision of tablets when split once and when split twice to yield quarters only one of the tablets passed the test. When also applying the limit for relative standard deviation (RSD) from the US Pharmacopoeia only one of the tablet halves passed and the other two was just outside the limit. None of the tablet quarters passed the RSD limit. Conclusion: Our results indicate that tablets larger than 8 mm might be split once. Tablets should not be split more than once, due to uncertainty in dose accuracy. There is a need for more commercially available age-appropriate formulations. Extemporaneously prepared formulations should be considered as an alternative to the use of split tablets. [ABSTRACT FROM AUTHOR]

The aim of the study was to determine and compare the degree of swelling and the swelling kinetics of poly(ethylene oxide) (PEO) hydrophilic matrix tablets without any additives for matrixes with different molecular weight polydispersities. A wide range of “mixed” polydisperse PEO tablets were obtained by mixing two PEO batches with average molecular weights of 105 and 2 × 106, respectively. These were compared with “single-batch” tablets with narrower mono-modal molecular weight distributions. A texture analyzer (TA) was used to determine, during the entire dissolution process, the thickness of the “gel” layer, the height of the dry tablet core and the total height of the tablet. The release of polymer from the tablet was also measured using a chromatographic method. Both the swelling histories and the polymer release rates varied strongly with molecular weight and agitation rate, whereas the rate of dissolution of the solid core varied much less with molecular weight. For single-batch and mixed tablets, tuned to give the same release rate, the swelling process was found to be very similar, regardless of the molecular polydispersity (between 1.2 and 8.8). These results support a previously proposed dissolution model with the key assumption of a constant critical viscosity, independent of time or polymer molecular weight, at the surface of the gel layer of a dissolving tablet. © 2009 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 99: 1225–1238, 2010 [ABSTRACT FROM AUTHOR]