Scaled-Up production and tableting of grindable electrospun fibers containing a protein-type drug

Panna Vass, Edit Hirsch, Rita Kóczián, Balázs Démuth, Attila Farkas, Csaba Fehér, Edina Szabó, Áron Németh, Sune K. Andersen, Tamás Vigh, Geert Verreck, István Csontos, G. Marosi, Zsombor K. Nagy

Research output: Contribution to journalArticle

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.

Original languageEnglish
Article number329
JournalPharmaceutics
Volume11
Issue number7
DOIs
Publication statusPublished - Jul 1 2019

Fingerprint

Galactosidases
Tablets
Mannitol
Polyvinyl Alcohol
Pharmaceutical Preparations
Proteins
Excipients
Crystallization
X-Ray Diffraction
Powders
Needles
Hot Temperature
Temperature
Water

Keywords

  • Biopharmaceuticals
  • Electrospinning
  • Grinding
  • Oral dosage form
  • Processability
  • Scale-up

ASJC Scopus subject areas

  • Pharmaceutical Science

Cite this

Vass, P., Hirsch, E., Kóczián, R., Démuth, B., Farkas, A., Fehér, C., ... Nagy, Z. K. (2019). Scaled-Up production and tableting of grindable electrospun fibers containing a protein-type drug. Pharmaceutics, 11(7), [329]. https://doi.org/10.3390/pharmaceutics11070329

Scaled-Up production and tableting of grindable electrospun fibers containing a protein-type drug. / Vass, Panna; Hirsch, Edit; Kóczián, Rita; Démuth, Balázs; Farkas, Attila; Fehér, Csaba; Szabó, Edina; Németh, Áron; Andersen, Sune K.; Vigh, Tamás; Verreck, Geert; Csontos, István; Marosi, G.; Nagy, Zsombor K.

In: Pharmaceutics, Vol. 11, No. 7, 329, 01.07.2019.

Research output: Contribution to journalArticle

Vass, P, Hirsch, E, Kóczián, R, Démuth, B, Farkas, A, Fehér, C, Szabó, E, Németh, Á, Andersen, SK, Vigh, T, Verreck, G, Csontos, I, Marosi, G & Nagy, ZK 2019, 'Scaled-Up production and tableting of grindable electrospun fibers containing a protein-type drug', Pharmaceutics, vol. 11, no. 7, 329. https://doi.org/10.3390/pharmaceutics11070329
Vass, Panna ; Hirsch, Edit ; Kóczián, Rita ; Démuth, Balázs ; Farkas, Attila ; Fehér, Csaba ; Szabó, Edina ; Németh, Áron ; Andersen, Sune K. ; Vigh, Tamás ; Verreck, Geert ; Csontos, István ; Marosi, G. ; Nagy, Zsombor K. / Scaled-Up production and tableting of grindable electrospun fibers containing a protein-type drug. In: Pharmaceutics. 2019 ; Vol. 11, No. 7.
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