Partially hydrolyzed polyvinyl alcohol as functional excipient in oral solid dosage forms prepared via extrusion

Formulators are constantly looking for novel excipients which provide specific properties to a formulation and which (preferably) can be used for a broad range of drug products. Although partially hydrolyzed polyvinyl alcohol (PVA), a water-soluble synthetic polymer, is already used as viscosity-enhancing or stabilizing agent in liquid dosage forms, its use as pharmaceutical excipient in oral solid dosage forms has been limited. Since several grades of PVA are available (e.g. different degree of hydrolysis (DH) and polymerization, which influences the water solubility and viscosity of the polymer), this polymer can be a potential excipient in different applications of solid dosage forms and/or to impart a broad range of characteristics to a specific drug product. Based on the introduction of continuous manufacturing techniques in the pharmaceutical industry (extrusion being one of them) and the search for novel pharmaceutical excipients, this doctoral thesis evaluates the use of partially hydrolyzed PVA in solid dosage forms processed via HME and via extrusion/spheronization. The aim of the first part of this project is to evaluate partially hydrolyzed PVA with different DH as carrier in HME, focusing on its effect on processing of poorly water-soluble drugs. As tableting of a hot-melt extruded polymeric formulation is a possible downstream processing technique in order to formulate the final dosage forms, this research was extended to evaluate the impact of HME on the mechanical properties of PVA-based tablets. The second part of this project evaluated partially hydrolyzed PVA as pelletisation aid in extrusion/spheronization, aiming to formulate pellets with a high drug load (> 70%), evaluating pellets with a single drug as well as pellets containing two drugs (e.g. suitable for combination therapy using a single drug product).

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Promovendus/aWesley De Jaeghere
FaculteitFaculteit Farmaceutische Wetenschappen
VakgroepVakgroep Geneesmiddelenleer
Curriculum2015 – 2015 Master after Master in Industrial Pharmacy (Inter-Universiy programme – UGent, KUL,UA,VUB) 2005 – 2010 Master in Pharmaceutical Sciences – Drug Development (UGent) 1999 – 2005 Biotechnische Wetenschappen, TS0, Vrij Agro-en Biotechnisch Instituut (VABI, Roeselare)
Academische graadDoctor in de Farmaceutische Wetenschappen
TaalEngels
Promotor(en)Prof. Chris Vervaet UGent FFW – Prof. Jean Paul Remon UGent FFW
ExamencommissieProf. Thomas De Beer UGent FFW – Prof. Katrien Remaut UGent FFW – Prof. Sandra Van Vlierberghe Fac. Wetenschappen, UGent – Prof. Filip Kiekens Universiteit Antwerpen – Prof. Juergen Siepmann Université de Lille 2, France
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