Minitablets enabling dosing and dose individualization in oral solid dosage forms: a case study with atomoxetine
DOI:
https://doi.org/10.56782/pps.921Keywords:
minitablets, atomoxetine, wallowing difficulties, dose flexibility, calcium phosphateAbstract
Minitablets represent a promising oral solid dosage form that allows for a wide range of doses within a single formulation. They are particularly suitable for pediatric and geriatric patients. Their small size facilitates administration by improving swallowability, making them an effective alternative for patients who have difficulty swallowing conventional tablets or capsules. This study describes the composition and manufacturing method of minitablets containing atomoxetine hydrochloride as a model drug. The minitablets were prepared using a direct compression method, utilizing the synergistic action of two fillers/diluents with different deformation properties: plastic microcrystalline cellulose and brittle anhydrous dibasic calcium phosphate. The resulting minitablets demonstrated satisfactory mechanical strength and met the required dosage unit uniformity. They also achieved dissolution rates consistent with the relevant monograph. Comparison with commercially available reference products in the form of hard capsules filled with a powder mixture confirmed the potential of minitablets as an effective alternative form of the drug.
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