Quality by design approach for optimizing the formulation and physical properties of extemporaneously prepared orodispersible films

International Journal of Pharmaceutics
J Carolina VisserHerman J Woerdenbag

Abstract

The quality by design (QbD) approach was applied for optimizing the formulation of extemporaneously prepared orodispersible films (ODFs) using Design-Expert® Software. The starting formulation was based on earlier experiments and contained the film forming agents hypromellose and carbomer 974P and the plasticizer glycerol (Visser et al., 2015). Trometamol and disodium EDTA were added to stabilize the solution. To optimize this formulation a quality target product profile was established in which critical quality attributes (CQAs) such as mechanical properties and disintegration time were defined and quantified. As critical process parameters (CPP) that were evaluated for their effect on the CQAs the percentage of hypromellose and the percentage of glycerol as well as the drying time were chosen. Response surface methodology (RMS) was used to evaluate the effects of the CPPs on the CQAs of the final product. The main factor affecting tensile strength and Young's modulus was the percentage of glycerol. Elongation at break was mainly influenced by the drying temperature. Disintegration time was found to be sensitive to the percentage of hypromellose. From the results a design space could be created. As long as the formulation and ...Continue Reading

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Citations

Nov 13, 2015·Expert Opinion on Drug Delivery·Raphael KrampeMaren Preis
Jan 3, 2016·International Journal of Biological Macromolecules·Priti GirotraGaurav Kumar
Apr 6, 2016·AAPS PharmSciTech·J Carolina VisserHenderik W Frijlink
Apr 18, 2016·International Journal of Pharmaceutics·Leena Kumari PrasadRobert O Williams
Jul 7, 2016·International Scholarly Research Notices·Yoshifumi MurataChieko Maida
Jun 28, 2016·Pharmaceutical Development and Technology·Ana Filipa BorgesSérgio Simões
Jul 29, 2016·Expert Opinion on Drug Delivery·Ana Filipa BorgesSérgio Simões
Jun 21, 2017·International Journal of Pharmaceutics·Branca M A SilvaSérgio Simões
Mar 7, 2020·Drug Development and Industrial Pharmacy·Ting-Ting YanYan-Zhong Chen
Dec 19, 2017·Drug Development and Industrial Pharmacy·Ga-Hui OhYoung-Joon Park
Mar 19, 2020·Pharmaceutics·Yu TianJ Carolina Visser
Nov 30, 2018·The Journal of Pharmacy and Pharmacology·Ajinkya M BhagurkarMichael A Repka
Dec 11, 2020·Drug Development and Industrial Pharmacy·Maram Suresh Gupta, Tegginamath Pramod Kumar
Dec 18, 2019·International Journal of Pharmaceutics·Ewelina ŁyszczarzRenata Jachowicz
Sep 15, 2020·International Journal of Pharmaceutics·Yoshiko TakeuchiHirofumi Takeuchi
Nov 27, 2020·Drug Design, Development and Therapy·Anita KovácsSzilvia Berkó
Mar 3, 2018·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Lu ZhangRajesh N Davé
Nov 5, 2016·International Journal of Pharmaceutics·Leena Kumari PrasadJames W McGinity
Jul 2, 2019·Acta Pharmaceutica : a Quarterly Journal of Croatian Pharmaceutical Society and Slovenian Pharmaceutical Society, Dealing with All Branches of Pharmacy and Allied Sciences·Katarzyna Wasilewska, Katarzyna Winnicka

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