Journal of Pharmaceutical Investigation

, Volume 47, Issue 3, pp 183–201 | Cite as

Orally disintegrating films focusing on formulation, manufacturing process, and characterization

Review

Abstract

Orally disintegrating films (ODF) has recently become one of the most popular forms of drug administration due to its excellent patient convenience and compliance. The main advantage of the dosage form arises from rapid disintegration: it can be placed on the tongue without the need of water. Compared to conventional oral dosage forms, ODFs usually result in enhanced bioavailability with faster onset of action. In addition, ODFs are flexible. Unlikely to orally disintegrating tablets, they do not require any special packaging for protection during transportation and storage. The critical quality attributes (CQAs) of ODFs should be carefully considered during the development process. These properties are not only inherent to the formulation but are also significantly influenced by the manufacturing processes. This review provides a brief overview of the advantages, formulation considerations, critical manufacturing processes and methods, characterization, and CQAs of ODFs, which might be beneficial to understand the dosage form better in a comprehensive way.

Keywords

Orally disintegrating film Formulation Quality attributes Manufacturing process Film characterization 

Notes

Acknowledgements

This work was supported by the Korea and Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Education (2016R1D1A1B03931513).

Compliance with ethical standards

Conflict of interest

All authors (Y. Lee, K. Kim, M. Kim, D.H. Choi, S.H. Jeong) declare that they have no conflict of interest.

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Copyright information

© The Korean Society of Pharmaceutical Sciences and Technology 2017

Authors and Affiliations

  1. 1.Department of Pharmaceutical EngineeringInje UniversityGyeongnamRepublic of Korea
  2. 2.College of PharmacyPusan National UniversityBusanRepublic of Korea
  3. 3.College of PharmacyDongguk University-SeoulGoyangRepublic of Korea

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