Original paper
Quality by design (QbD) approach for design and development of drug-device combination products: a case study on flunisolide nasal spray
Volume: 23, Issue: 10, Pages: 1077 - 1087
Published: Sep 10, 2016
Abstract
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. viscosity (cp) (Y1) and D50 droplet size distribution (DSD) (μm) (Y2) were identified. Potential risk factors were identified using a fish bone diagram and failure mode...
Paper Details
Title
Quality by design (QbD) approach for design and development of drug-device combination products: a case study on flunisolide nasal spray
Published Date
Sep 10, 2016
Volume
23
Issue
10
Pages
1077 - 1087