Abstract
Mini-tablets are suitable for paediatric as well as geriatric use since they may provide flexible and accurate dosing and administration. Due to the minute tablet size, there is a need for new standardized quality evaluation procedures and conventional techniques may have to be adopted. The main objective of the study was to evaluate different dissolution techniques for orally disintegrating mini-tablets. Dissolution tests using mini-paddle apparatus were compared with standard size paddle apparatus, and the effect of paddle rotation speed was evaluated. Also, the filter choice, and its impact on dissolution, was considered. Sodium salicylate was used as a model drug substance and was mixed with different size fractions of mannitol. The powder mixtures were compacted into 2 mm flat faced tablets. The mini-tablets were characterized regarding weight and content uniformity, tensile strength, friability, disintegration and dissolution. Similar dissolution profiles were obtained with both mini and standard equipment. The paddle rotation speed affected the dissolution profiles; a low paddle speed resulted in a slower dissolution. Furthermore, choosing a chemically inert filter will increase the likelihood of obtaining reliable and accurate results. An appropriately designed dissolution test using mini-paddle apparatus is required prior to further implementation in quality control procedures.
Highlights
There has been an increasing demand for research and development of age-appropriate dosage forms in order to improve drug treatment of children
The scanning electron microscopy (SEM) pictures confirmed that the particle size of sodium salicylate was substantially smaller than the particle size of the fillers, which was expected considering the performed sieving of the materials
The mini-paddle apparatus proved useful for dissolution testing of mini-tablets
Summary
There has been an increasing demand for research and development of age-appropriate dosage forms in order to improve drug treatment of children. Previous studies have shown that mini-tablets are well accepted by children of different ages, and children as young as six months demonstrated high swallowability of mini-tablets [3,4,5,6,7,8,9,10]. In a cross-over study Spoomer et al [8], showed that mini-tablets were highly accepted in children 6–12 months of age, and comparable with a sweet liquid formulation [3]. Stoltenberg and Breitkreutz have shown that orally disintegrating mini-tablets could be a suitable dosage form for children [3]. Mini-tablets can be regarded as a suitable dosage form for young children and used as an alternative to liquid formulations
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