Adaptation of the quality by design concept in early pharmaceutical development of an intranasal nanosized formulation

Edina Pallagi, Rita Ambrus, Piroska Szabó-Révész, Ildikó Csóka

Research output: Contribution to journalArticle

44 Citations (Scopus)


Regulatory science based pharmaceutical development and product manufacturing is highly recommended by the authorities nowadays. The aim of this study was to adapt regulatory science even in the nano-pharmaceutical early development. Authors applied the quality by design (QbD) concept in the early development phase of nano-systems, where the illustration material was meloxicam. The meloxicam nanoparticles produced by co-grinding method for nasal administration were studied according to the QbD policy and the QbD based risk assessment (RA) was performed. The steps were implemented according to the relevant regulatory guidelines (quality target product profile (QTPP) determination, selection of critical quality attributes (CQAs) and critical process parameters (CPPs)) and a special software (Lean QbD Software®) was used for the RA, which represents a novelty in this field. The RA was able to predict and identify theoretically the factors (e.g. sample composition, production method parameters, etc.) which have the highest impact on the desired meloxicam-product quality. The results of the practical research justified the theoretical prediction. This method can improve pharmaceutical nano-developments by achieving shorter development time, lower cost, saving human resource efforts and more effective target-orientation. It makes possible focusing the resources on the selected parameters and area during the practical product development.

Original languageEnglish
Pages (from-to)384-392
Number of pages9
JournalInternational Journal of Pharmaceutics
Issue number1-2
Publication statusPublished - Jul 17 2015


  • Early development QbD
  • Meloxicam nanoparticles
  • Nasal administration
  • Quality by design
  • Regulatory pharmacy
  • Risk assessment

ASJC Scopus subject areas

  • Pharmaceutical Science

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