International Journal of Research in Pharmacy and Allied Science

ISSN: 2583-6544   |  Issues per year: Monthly  |   Indexed In: Google Scholar, CORE, ScienceOpen, Researchgate

ISSN:2583-6544

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Artificial Intelligence-Enabled Quality by Design and Regulatory Science for Apixaban Orodispersible Tablets: A Critical Review of Clinical Rationale, Formulation Strategy, and Submission-Ready Documentation for Stroke Prevention

Author(s): Gururaj S Kulkarni¹1, Mithun N²2, Anna Balaji³3

Email(s): 1tocpceutics@gmail.com

Address:

    ¹Department of Pharmaceutics (HOD), The Oxford College of Pharmacy, Bengaluru, Karnataka, India ²Department of Pharmaceutics (PG Student), The Oxford College of Pharmacy, Bengaluru, Karnataka, India ³Principal, The Oxford College of Pharmacy, Bengaluru, Karnataka – 560068, India

Published In:   Volume - 5,      Issue - 3,     Year - 2026

DOI: https://doi.org/10.71431/IJRPAS.2026.5307  

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ABSTRACT:
Stroke is a leading global cause of death and acquired disability, affecting millions annually. Among post-stroke patients, 36–51% experience oropharyngeal dysphagia, rendering conventional film-coated tablets of apixaban – a direct factor Xa inhibitor – difficult or unsafe to administer. This review critically examines the evidence base for developing an apixaban Orodispersible Tablet (ODT) formulation across three converging domains: (1) global stroke burden and dysphagia-related adherence barriers in dysphagic, geriatric, and paediatric populations; (2) apixaban's biopharmaceutical constraints – particularly poor aqueous solubility (~40 µg/mL) and BCS Class II/IV designation – mapped onto ODT manufacturing approaches (direct compression, lyophilisation, sublimation) and excipient selection strategies; and (3) the integration of Artificial Intelligence (AI) within a formal Quality by Design (QbD) framework, detailing how Artificial Neural Networks (ANNs) and Genetic Algorithms (GAs) can optimise Critical Quality Attributes and resolve multi-objective formulation trade-offs. The review further maps AI-generated data streams onto eCTD Modules 2, 3, and 5 in alignment with FDA, EMA, and ICH requirements for data integrity (ALCOA+), model lifecycle management, and audit trail compliance.

Keywords:

Cite this article:
Gururaj S Kulkarni, Mithun N, Anna Balaji. Artificial Intelligence-Enabled Quality by Design and Regulatory Science for Apixaban Orodispersible Tablets: A Critical Review of Clinical Rationale, Formulation Strategy, and Submission-Ready Documentation for Stroke Prevention. IJRPAS, March 2026; 5(3): 87-112DOI: https://doi.org/https://doi.org/10.71431/IJRPAS.2026.5307


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