Edit Hirsch
Title: High-speed electrospinning of aqueous polymer solutions for the solid formulation of biopharmaceuticals
Biography
Biography: Edit Hirsch
Abstract
The application of biopharmaceuticals for oral administration is a topic of great interest in the pharmaceutical industry due to the inherent advantages of oral delivery. Electrospinning is a promising drying technology providing a rapid and gentle drying at ambient temperature due to the large surface area. Considering the sensitivity of biopharmaceuticals, the use of aqueous solutions during electrospinning is preferred. The commonly used single needle electrospinning equipment does not have adequate productivity, thus in order to satisfy the industrial requirements the scale-up of electrospinning is necessary. High-speed electrospinning (HSES) is a suitable technology for mass production of fibres in the sub-micron range. The scaled up electrospinning of water-soluble polymers such as polyvinyl polypyrrolidone (PVP) K17, PVP K90, polyvinyl alcohol (PVA), hydroxypropyl β-cyclodextrin (HPβCD), and hydroxypropyl methylcellulose (HPMC) were achieved using HSES. Simultaneously the optimization of these systems were accomplished considering the feasibility of downstream processing (e.g. grinding) of the nanofibrous mat. High molecular weight polyethylene oxide (PEO) was added to enhance fiber formation of PVA and HPMC while sugar type “grindability-aiding” excipients were used to improve grindability of the dried product. PVA and PEO based samples containing sugar type excipients (glucose, mannitol, lactose, saccharose, trehalose) were ground and characterized. The physical state of the polymers and excipients impacts the properties of the nanofibers such as downstream processability and in addition it could affect the biomolecule stability. The results demonstrate the successful scale-up process to HSES which is a suitable production method for formulations of water-soluble polymers for oral delivery of biopharmaceuticals.