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

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....

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Bibliographic Details
Published in:Pharmaceutics 2023-07, Vol.15 (8), p.2049
Main Authors: Garcia-Villen, Fatima, Gallego, Idoia, Sainz-Ramos, Myriam, Ordoyo-Pascual, Jorge, Ruiz-Alonso, Sandra, Saenz-del-Burgo, Laura, O’Mahony, Conor, Pedraz, Jose Luis
Format: Article
Language:English
Subjects:
auto-injector pen
Compliance
Drug delivery systems
Drugs
Health care industry
mannitol
Monoclonal antibodies
monoclonal antibody
nano-DSC
Patient compliance
Pilot projects
Polyethylene glycol
Proteins
solid formulation
stability
Vehicles
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Summary: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.
ISSN:1999-4923
1999-4923
DOI:10.3390/pharmaceutics15082049