Evaluation of dissolution techniques for orally disintegrating mini-tablets

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.

Highlights

Similar dissolution profiles were obtained with mini-paddle and standard-paddle.

Experiments can be scaled down without losing reliability and predictability.

Paddle rotation speed affected the dissolution profiles.

Choosing an appropriate filter will aid in obtaining reliable dissolution results.

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.

Download the full article here: Evaluation of dissolution techniques for orally disintegrating mini-tablets

or continue reading here: Emma Hellberg, Journal of Drug Delivery Science and Technology, https://doi.org/10.1016/j.jddst.2020.102191 Evaluation of dissolution techniques for orally disintegrating mini-tablets

Keywords: Paediatric drug delivery, Orally disintegrating mini-tablet, Drug dissolution, Paddle rotation speed, Membrane filter, mannitol (Parteck® ODT),croscarmellose-sodium, Magnesium stearate

Conclusions
The mini-paddle apparatus proved useful for dissolution testing of mini-tablets. Similar dissolution profiles were obtained with both the mini-paddle and standard size paddle equipment and the results showed that the standard paddle experiments could be scaled down without losing the reliability and the predictability of the standard method. The paddle rotation speed affected the drug dissolution profiles in both equipment types. At low paddle speed, coning was visually observed. Coning can affect the release profile, especially for poorly soluble drugs, and a suitable paddle speed should be chosen carefully to avoid coning. The effect of rotation speed has to be investigated further for more precise recommendations. Choosing an appropriate inert filter membrane can have a significant effect on the dissolution results. The mini-tablets produced in this study showed suitable properties regarding weight and dose homogeneity, disintegration, tensile strength and friability irrespective of the particle size of the filler. In addition, the particle size of the filler did not affect the dissolution profile. An appropriately designed dissolution test using mini-paddle apparatus is required prior to further implementation in quality control procedures.

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