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Background <p>The advantages of oral disintegrating films (ODFs) are convenience for patients who have difficulty taking medication and compliance with regulatory production, and their development is actively underway.</p> Area covered <p>In this article we review the ODF pharmaceuticals currently available on the market and examine the active ingredients and excipients used in film formulation, and how the films are developed. We also discuss how quality was assessed during ODF development and how quality-by-design (QbD) could be applied to pharmaceutical ODF development.</p> Expert opinion <p>ODFs are a patient-friendly dosage formulation and a useful drug delivery system. This article provides a basic understanding of ODFs and discusses their advantages and limitations, together with information on how to evaluate the quality of ODFs and the application of QbD, to help ensure the safety and effectiveness of ODFs. However, there are currently no standardized quality regulations for ODFs, so further research and regulation are required.</p>

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A comprehensive review of oral disintegrating film products, and their quality assessment and development

  • 期刊论文

  • 发表日期：

    2025年1月22日

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  • Jae-hyun Nam,
  • Byeong-hyeon Kim,
  • Azam Sharif Mohammed Shafioul,
  • Minki Jin,
  • Cheong-Weon Cho

摘要

Background

The advantages of oral disintegrating films (ODFs) are convenience for patients who have difficulty taking medication and compliance with regulatory production, and their development is actively underway.

Area covered

In this article we review the ODF pharmaceuticals currently available on the market and examine the active ingredients and excipients used in film formulation, and how the films are developed. We also discuss how quality was assessed during ODF development and how quality-by-design (QbD) could be applied to pharmaceutical ODF development.

Expert opinion

ODFs are a patient-friendly dosage formulation and a useful drug delivery system. This article provides a basic understanding of ODFs and discusses their advantages and limitations, together with information on how to evaluate the quality of ODFs and the application of QbD, to help ensure the safety and effectiveness of ODFs. However, there are currently no standardized quality regulations for ODFs, so further research and regulation are required.