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Scaled-Up Production and Tableting of Grindable Electrospun Fibers Containing a Protein-Type Drug

1
Department of Organic Chemistry and Technology, Budapest University of Technology and Economics (BME), Műegyetem rakpart 3, H-1111 Budapest, Hungary
2
Department of Applied Biotechnology and Food Science, Budapest University of Technology and Economics (BME), Műegyetem rakpart 3, H-1111 Budapest, Hungary
3
Oral Solids Development, Janssen R&D, Turnhoutseweg 30, 2340 Beerse, Belgium
*
Author to whom correspondence should be addressed.
Pharmaceutics 2019, 11(7), 329; https://doi.org/10.3390/pharmaceutics11070329
Received: 29 May 2019 / Revised: 6 July 2019 / Accepted: 9 July 2019 / Published: 11 July 2019
(This article belongs to the Special Issue Recent Development of Electrospinning for Drug Delivery)
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Abstract

The aims of this work were to develop a processable, electrospun formulation of a model biopharmaceutical drug, β-galactosidase, and to demonstrate that higher production rates of biopharmaceutical-containing fibers can be achieved by using high-speed electrospinning compared to traditional electrospinning techniques. An aqueous solution of 7.6 w/w% polyvinyl alcohol, 0.6 w/w% polyethylene oxide, 9.9 w/w% mannitol, and 5.4 w/w% β-galactosidase was successfully electrospun with a 30 mL/h feeding rate, which is about 30 times higher than the feeding rate usually attained with single-needle electrospinning. According to X-ray diffraction measurements, polyvinyl alcohol, polyethylene oxide, and β-galactosidase were in an amorphous state in the fibers, whereas mannitol was crystalline (δ-polymorph). The presence of crystalline mannitol and the low water content enabled appropriate grinding of the fibrous sample without secondary drying. The ground powder was mixed with excipients commonly used during the preparation of pharmaceutical tablets and was successfully compressed into tablets. β-galactosidase remained stable during each of the processing steps (electrospinning, grinding, and tableting) and after one year of storage at room temperature in the tablets. The obtained results demonstrate that high-speed electrospinning is a viable alternative to traditional biopharmaceutical drying methods, especially for heat sensitive molecules, and tablet formulation is achievable from the electrospun material prepared this way. View Full-Text
Keywords: electrospinning; scale-up; processability; biopharmaceuticals; oral dosage form; grinding electrospinning; scale-up; processability; biopharmaceuticals; oral dosage form; grinding
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This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited (CC BY 4.0).

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Vass, P.; Hirsch, E.; Kóczián, R.; Démuth, B.; Farkas, A.; Fehér, C.; Szabó, E.; Németh, Á.; Andersen, S.K.; Vigh, T.; Verreck, G.; Csontos, I.; Marosi, G.; Nagy, Z.K. Scaled-Up Production and Tableting of Grindable Electrospun Fibers Containing a Protein-Type Drug. Pharmaceutics 2019, 11, 329.

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