Mar 20, 2013

Biopharmaceutical formulations for pre-filled delivery devices

Expert Opinion on Drug Delivery
Jan JezekIain Simpson

Abstract

Pre-filled syringes are becoming an increasingly popular format for delivering biotherapeutics conveniently and cost effectively. The device design and stable liquid formulations required to enable this pre-filled syringe format are technically challenging. In choosing the materials and process conditions to fabricate the syringe unit, their compatibility with the biotherapeutic needs to be carefully assessed. The biothereaputic stability demanded for the production of syringe-compatible low-viscosity liquid solutions requires critical excipient choices to be made. The purpose of this review is to discuss key issues related to the stability aspects of biotherapeutics in pre-filled devices. This includes effects on both physical and chemical stability due to a number of stress conditions the product is subjected to, as well as interactions with the packaging system. Particular attention is paid to the control of stability by formulation. We anticipate that there will be a significant move towards polymer primary packaging for most drugs in the longer term. The timescales for this will depend on a number of factors and hence will be hard to predict. Formulation will play a critical role in developing successful products in the pr...Continue Reading

  • References89
  • Citations21

References

  • References89
  • Citations21

Citations

Mentioned in this Paper

Drug Delivery Systems
Drug Formulation Process
Natural Products
Hypodermic Syringes
Syrinx Formation
Microencapsulation
Drug Stability
Drug Packaging
Pharmaceutical Excipient
Blood Viscosity Examination

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