Formulation and evaluation of Paliperidone HCl mouth dissolving tablet by QbD approach

Santosh D. Borde, Sadhana R. Shahi, Kiran V. Kale, Ajit C. Jadhav, Durgesh R. Parakh

Abstract


Objective: The aim of present study was to prepare the mouth dissolving tablet of Paliperidone HCl by QbD approach with increasing its rate of dissolution of formulation prepared by Direct Compression method.

Methods: Oral drug delivery system has been regarded as the most expedient and cost-effective method of drug administration with good patient compliance. MDTtechnology makes tablet dissolve or disintegrate quickly on the tongue without additional water intake. The present study was focused on formulation of mouth dissolving tablet by QbD approach. Risk assessment of critical material attributes (CMA’s) and critical process parameters (CPP’s) are concomitant to critical quality attributes (CQA’s) of the product to achieve quality targeted product profile (QTPP).  A 32 full factorial design was applied to inspect the association effect of 2 formulation variables: Avicel PH 102 concentration and Indion 234 concentration with their effect on disintegration time and percentage drug release were studied as dependent parameter. Tablets were evaluated for powder flow properties, hardness, content uniformity, Disintegration test, wetting time, % drug release, etc. Multiple regression analysis and ANOVA were employed to recognize and estimate the effect of important parameters and launch their relationship with CQA’s and to achieve design space for optimization purpose.

Results: The optimized formulation showed percentage drug content of 98.60 ± 1.21%, disintegration time of 12.00 ± 0.27 seconds and wetting time of 16.00 ± 0.53 seconds. In-vitro drug release was 98.00 ± 1.22 %.

Conclusions: The developed formulation led to enhanced rate of dissolution of Paliperidone HCl due to the decreased disintegration time.


Keywords


Paliperidone HCl, mouth dissolving tablets, QbD approach, full factorial design, % drug release

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