QbD APPROACH IN THE DEVELOPMENT OF ORAL
LYOPHILISATES WITH IBUPROFEN FOR PAEDIATRIC USE
ȘTEFANA SUCIU 1, SONIA IURIAN 1*, CATĂLINA BOGDAN 2, RAREȘ IOVANOV 1, LUCIA RUS 3, MIRELA MOLDOVAN 2, IOAN TOMUȚĂ 1
“Iuliu Hațieganu” University of Medicine and Pharmacy, Faculty of Pharmacy, Cluj-Napoca, Romania
1Department of Pharmaceutical Technology and Biopharmacy, 41 V. Babeș Street, 400012
2Department of Dermatology and Cosmetics, 12 I. Creangă Street, 400010
3Department of Drug Analysis, 6 L. Pasteur Street, 400349
*corresponding author: iuriansonia@yahoo.com
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Abstract:
Quality-by-Design (QbD) concept in drug formulation and development was introduced in order to achieve and ensure an
adequate product quality through a good process understanding. By identifying the variability sources that influence the
product features, the quality of the product can be built from the development phase. Applying the concept, in the current
work it was intended to develop and characterize orodisperable lyophilisates (OLs) for paediatric use. The drug model used
was ibuprofen and following risk assessment evaluation, twenty-five experimental formulations were prepared. With a Doptimal
experimental design with six factors and two levels, the influence of the formulation factors on the desired quality
target product profile was assessed (QTPP, the quality characteristics of a product that is intended to be achieved considering
the aspects related to the safety and efficacy of the product): disintegration time, wetting time, mean dissolution time, texture
and bio-adhesive features of the OLs were studied. During this experiment, it was observed that the type of the matrix
forming and bio-adhesive agent influenced the disintegration time. All formulation factors influenced the wetting time, while
no significant influence was observed for the bio-adhesive properties of the OLs. The hardness and rigidity of the OLs was
increased by gelatine, while the methylcellulose and xanthan gum conducted to opposite results. The fracturability of the OLs
was influenced only by the quantitative factors, respectively the percentage of the matrix forming agent and the bio-adhesive
agent. The dissolution profile was slightly influenced by the type of bio-adhesive agent. The design space has been defined
based on the obtained results. The QbD approach was successfully applied within this study and OLs with ibuprofen for
paediatric use with desired pharmaceutical characteristics may be successfully obtained by lyophilisation.

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