Stability of Monoclonal Antibodies as Solid Formulation for Auto-Injectors: A Pilot Study

Author:

Garcia-Villen Fatima123ORCID,Gallego Idoia123ORCID,Sainz-Ramos Myriam123ORCID,Ordoyo-Pascual Jorge123,Ruiz-Alonso Sandra123,Saenz-del-Burgo Laura123ORCID,O’Mahony Conor4ORCID,Pedraz Jose Luis123ORCID

Affiliation:

1. NanoBioCel Group, Laboratory of Pharmaceutics, Faculty of Pharmacy, University of the Basque Country UPV/EHU, 01006 Vitoria-Gasteiz, Spain

2. Biomedical Research Networking Centre in Bioengineering, Biomaterials and Nanomedicine (CIBER-BBN), Institute of Health Carlos III, 01006 Vitoria-Gasteiz, Spain

3. Bioaraba, NanoBioCel Resarch Group, 01009 Vitoria-Gasteiz, Spain

4. Tyndall National Institute, University College Cork, T12 R5CP Cork, Ireland

Abstract

Drug adherence is a significant medical issue, often responsible for sub-optimal outcomes during the treatment of chronic diseases such as rheumatoid or psoriatic arthritis. Monoclonal antibodies (which are exclusively given parenterally) have been proven to be an effective treatment in these cases. The use of auto-injectors is an effective strategy to improve drug adherence in parenteral treatments since these pen-like devices offer less discomfort and increased user-friendliness over conventional syringe-based delivery. This study aims to investigate the feasibility of including a monoclonal antibody as a solid formulation inside an auto-injector pen. Specifically, the objective was to evaluate the drug stability after a concentration (to reduce the amount of solvent and space needed) and freeze-drying procedure. A preliminary screening of excipients to improve stability was also performed. The nano-DSC results showed that mannitol improved the stability of the concentrated, freeze-dried antibody in comparison to its counterpart without it. However, a small instability of the CH2 domain was still found for mannitol samples, which will warrant further investigation. The present results serve as a stepping stone towards advancing future drug delivery systems that will ultimately improve the patient experience and associated drug adherence.

Funder

ECSEL Joint Undertaking

Basque Country Government

Ph.D fellowship

Publisher

MDPI AG

Subject

Pharmaceutical Science

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