Aripiprazole active substance is a white crystalline powder and is practically insoluble in water and its solubility is pH dependent. Therefore, a particle size effect on dissolution of the tablets can be expected.
The product development has taken into consideration the physicochemical characteristics of the active drug substance such as poor aqueous solubility, hygroscopic properties, stability, particle size, polymorphism, and biopharmaceutical issues such as dissolution rate.
The formulation contains stable, milled crystalline aripiprazole because of the limited solubility in water and the hydrophobic nature of the active substance. Fluid bed wet granulation process was developed as the manufacturing process for the tablets. The excipients included in the formulation were chosen and adjusted in order to achieve a dosage form with an accurate therapeutic onset.
The formulation shows a good bioavailability and the results of pharmacokinetic and in vitro studies support the bioequivalence between clinical and commercial tablets.
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