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Oligonucleotide Formulations Prepared by High-Speed Electrospinning: Maximizing Loading and Exploring Downstream

Edit Hirsch1, Márió Nacsa1, Eszter Pantea1

  • 1Department of Organic Chemistry and Technology, Budapest University of Technology and Economics, Müegyetem rkp. 3, 1111 Budapest, Hungary.

Pharmaceutics
|March 29, 2023
PubMed
Summary
This summary is machine-generated.

High-speed electrospinning successfully created antisense oligonucleotide (ASO) tablet formulations using hydroxypropyl-beta-cyclodextrin (HPβCD). This method offers a scalable solution for ASO drug delivery, demonstrating stability and potential for high drug loading.

Keywords:
antisense oligonucleotidebiopharmaceutical formulationdownstream processingelectrospinninghigh-drug-loaded fibersoral deliverysolvent optimization

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Area of Science:

  • Pharmaceutical Technology
  • Biomaterials Engineering
  • Drug Delivery Systems

Background:

  • Antisense oligonucleotides (ASOs) are a promising class of therapeutics requiring effective delivery systems.
  • Electrospinning offers potential for creating novel drug delivery matrices but faces challenges in scale-up and processing.
  • Hydroxypropyl-beta-cyclodextrin (HPβCD) is explored as a stabilizer and matrix for electrospun formulations.

Purpose of the Study:

  • To develop antisense oligonucleotide (ASO) tablet formulations utilizing high-speed electrospinning.
  • To optimize electrospinning parameters for fiber morphology and productivity.
  • To assess the stability and processability of the developed ASO-loaded HPβCD fibers for direct compression tableting.

Main Methods:

  • Electrospinning of HPβCD with ASO using various solvents (water, methanol/water, methanol) to optimize fiber morphology.
  • Utilization of high-speed electrospinning technology to achieve high production rates (~330 g/h).
  • Formulation development for high drug loading (up to 50%) and subsequent processing including grinding, excipient addition, and direct compression tableting.

Main Results:

  • Methanol as a solvent facilitated fiber formation with lower viscosity, enabling higher potential drug loading.
  • High-speed electrospinning successfully produced HPβCD fibers containing 9.1% ASO at a high rate.
  • Formulations with 50% drug loading were achieved; fibers exhibited good grindability but poor flowability, which was improved by excipient addition for successful tableting.
  • The ASO-HPβCD formulations demonstrated excellent physical and chemical stability over a 1-year study period.

Conclusions:

  • High-speed electrospinning is a viable and scalable technology for producing ASO-loaded HPβCD fibers for oral tablet formulations.
  • HPβCD serves as a suitable matrix for stabilizing ASO and enabling high drug loading.
  • The study provides solutions for electrospinning scale-up and downstream processing challenges, paving the way for biopharmaceutical manufacturing.