Development of sustained release gastro-retentive tablet formulation of nicardipine hydrochloride using quality by design (QbD) approach.

The objective of the present study was to develop a sustained release gastro-retentive (SRGR) tablet formulation of nicardipine hydrochloride (HCl) for once-a-day dosing using the quality by design (QbD) approach. The quality target product profile of nicardipine HCl SRGR tablet formulation was defined, and critical quality attributes (CQAs) were identified. Potential risk factors were identified using a fish bone diagram and failure mode effect analysis (FMEA) tool and screened by the Plackett-Burman design, and finally nicardipine HCl SRGR tablet formulation was optimized using the Box-Behnken design.

Quality by design (QbD) approach for design and development of drug-device combination products: a case study on flunisolide nasal spray.

The objective of the present study was to design and develop drug-device combination product in particular flunisolide nasal spray (FNS) using quality by design (QbD) approach. Quality target product profile (QTPP) of FNS was defined and critical quality attributes (CQAs), i.e.

Quality by design approach for development of suspension nasal spray products: a case study on budesonide nasal suspension.

The objective of this study was to provide quality by design (QbD) approach for development of suspension type nasal spray products. Quality target product profile (QTPP) of test product budesonide nasal suspension (B-NS) was defined and critical quality attributes (CQAs) were identified. Critical formulation, process and delivery device variables were recognized.