Quality by Design-Based Preformulation Studies of Dual Drug-Loaded Electrospun Nanofibers for Rheumatoid Arthritis

Varsha M. Gaikwad¹, Omprakash G. Bhusnure²

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ABSTRACT

Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disorder requiring long-term pharmacotherapy, often involving combination drug therapy to enhance efficacy and reduce adverse effects. Nanofiber-based drug delivery systems have gained significant attention for their high surface area, tunable drug release, and potential for localized or controlled delivery. The present study aims to conduct a Quality by Design (QbD)–guided preformulation investigation for the development of a dual drug-loaded nanofiber system intended for rheumatoid arthritis. A systematic QbD framework was applied to define the Quality Target Product Profile (QTPP), identify Critical Quality Attributes (CQAs), and perform risk assessment to determine Critical Material Attributes (CMAs) & Critical Process Parameters (CPPs). Preformulation studies included physicochemical characterization, solubility analysis, drug–drug compatibility, drug–polymer compatibility, thermal behavior and evaluation of solution properties relevant to nanofiber formulation. The findings demonstrate that a QbD-based preformulation approach enables systematic risk reduction for development of dual drug-loaded nanofibers for rheumatoid arthritis management.

Keywords: Quality by Design, Preformulation, Dual drug delivery, Nanofibers, Rheumatoid arthritis.

How to cite this article: Gaikwad VM, Bhusnure OG. Quality by Design-Based Preformulation Studies of Dual Drug-Loaded Electrospun Nanofibers for Rheumatoid Arthritis. Int J Drug Deliv Technol. 2026;16(6s): 768-779; DOI: 10.25258/ijddt.16.6s.104

Source of support: None

Conflict of interest: None