Stable formulation of protein-type drug in electrospun polymeric fiber followed by tableting and scaling-up experiments

Wagner, István and Nagy, Zsombor Kristóf and Vass, P. and Fehér, Csaba and Barta, Zsolt and Vigh, Tamás and Sóti, Péter Lajos and Harasztos, Anna Helga and Pataki, Hajnalka and Balogh, Attila and Marosi, György (2015) Stable formulation of protein-type drug in electrospun polymeric fiber followed by tableting and scaling-up experiments. POLYMERS FOR ADVANCED TECHNOLOGIES, 26 (12). pp. 1461-1467. ISSN 1042-7147

Text Wagner2015_Stable_formulation_of_protein_type_drug_in_u.pdf Restricted to Registered users only Download (1MB) | Request a copy

Abstract

Suitability of electrospinning for biodrug formulation was investigated in order to develop an electrospinning-based method for producing oral dosage form of beta-galactosidase. beta-Galactosidase-loaded polymeric (polyvinyl alcohol, polyvinylpyrrolidones with two different molar masses, and polyethylene glycol) nanofibers were prepared by electrospinning in order to lengthen the shelf life of the enzyme (providing an alternative technology to drying). Based on the activity of the encapsulated beta-galactosidase, the most suitable polymer was polyvinylpyrrolidone with higher molecular weight (1,200,000 Da), because 97% of the original activity remained in this case. Kinetic behavior of beta-galactosidase did not show any alteration after encapsulation, and the pH and temperature profiles were not changed either. Time course of viability testing showed that the nanofibrous formulation can provide long-term stability for beta-galactosidase; the activity of the enzyme decreased only 4% after a year. Furthermore, scaling-up and tableting had no influence on activity and long-term stability; thus, the developed drying technology and tablets, containing enzyme-loaded nanofibers, can provide a new promising way of oral biodrug delivery. Copyright (C) 2015 John Wiley & Sons, Ltd.

Actions (login required)

Edit Item