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Research ArticleResearch

A Predictive Modeling Approach to Support the Overfill Volume Definition of Liquid-in-Vial Drug Products

Sébastien Dasnoy, Laura Simonin, Soizic Radulovic, Andy White, Jean-François Decoster and Laurence Denis
PDA Journal of Pharmaceutical Science and Technology September 2022, 76 (5) 384-394; DOI: https://doi.org/10.5731/pdajpst.2021.012658
Sébastien Dasnoy
1UCB Pharma, Chemin du Foriest, 1420 Braine-l'Alleud, Belgium; and
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  • For correspondence: sebastien.dasnoy@ucb.com
Laura Simonin
1UCB Pharma, Chemin du Foriest, 1420 Braine-l'Alleud, Belgium; and
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Soizic Radulovic
1UCB Pharma, Chemin du Foriest, 1420 Braine-l'Alleud, Belgium; and
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Andy White
2UCB Celltech, 638 Ajax Avenue, Slough, Berkshire, SL1 4BG, United Kingdom
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Jean-François Decoster
1UCB Pharma, Chemin du Foriest, 1420 Braine-l'Alleud, Belgium; and
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Laurence Denis
1UCB Pharma, Chemin du Foriest, 1420 Braine-l'Alleud, Belgium; and
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Abstract

Liquid-in-vial drug products are typically overfilled to meet the label claim volume specification while taking into account losses in the container-closure system and withdrawal device. Any overfill volume setting requires justification. The aim of this study was to estimate the overfill volume required for a liquid drug product in a vial using a prediction model. Glass vials sized from 2R to 20R capacity were filled with sorbitol-based aqueous solutions having a viscosity at 20°C ranging from 1 to 40 mPa·s. Viscosity and vial neck diameter were shown to be the main contributors to the hold-up volume of sorbitol-based aqueous solutions in vial and withdrawal syringe. The hold-up volume of various molecules of therapeutic interest was successfully estimated using a model built from sorbitol-based aqueous solutions data. A total variability approach is proposed for estimating the overfill volume of liquid-in-vial drug products, taking into account the product hold-up volume in vial and withdrawal syringe, the filling variability, and the extractable volume test variability. This prediction model could provide a first guess of the fill volume range to be tested to support overfill volume definition.

  • Drug product filling
  • Glass vial
  • Overfill volume
  • Hold-up volume
  • Extractable volume
  • Viscosity
  • © PDA, Inc. 2022
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PDA Journal of Pharmaceutical Science and Technology: 76 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 76, Issue 5
September/October 2022
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A Predictive Modeling Approach to Support the Overfill Volume Definition of Liquid-in-Vial Drug Products
Sébastien Dasnoy, Laura Simonin, Soizic Radulovic, Andy White, Jean-François Decoster, Laurence Denis
PDA Journal of Pharmaceutical Science and Technology Sep 2022, 76 (5) 384-394; DOI: 10.5731/pdajpst.2021.012658

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A Predictive Modeling Approach to Support the Overfill Volume Definition of Liquid-in-Vial Drug Products
Sébastien Dasnoy, Laura Simonin, Soizic Radulovic, Andy White, Jean-François Decoster, Laurence Denis
PDA Journal of Pharmaceutical Science and Technology Sep 2022, 76 (5) 384-394; DOI: 10.5731/pdajpst.2021.012658
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Keywords

  • Drug product filling
  • Glass vial
  • Overfill volume
  • hold-up volume
  • Extractable volume
  • Viscosity

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