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Unmet technological demands in orodispersible films for age-appropriate paediatric drug delivery

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Abstract

Age-appropriateness of a formulation is the ability to deliver variable but accurate doses to the paediatric population in a safe and acceptable manner to improve medical adherence and reduce medication errors. Paediatric drug delivery is a challenging area of formulation research due to the existing gap in knowledge. This includes the unknown safety of excipients in the paediatric population, the need for an age-appropriate formulation, the lack of an effective taste-masking method and the lack of paediatric pharmacokinetic data and patient acceptability. It is equally important to establish methods for predicting the biopharmaceutical performance of a paediatric formulation as a function of age. Overcoming the challenges of existing technologies and providing custom-made solutions for the development of age-appropriate formulation is, therefore, a daunting task. Orodispersible films (ODF) are promising as age-appropriate formulations, an unmet need in paediatric drug delivery. New technological improvements in taste masking, improving solubility and rate of dissolution of insoluble drugs, the flexibility of dosing and extemporaneous preparation of these films in a hospital good manufacturing practises (GMP) setup using 3D printing can increase its acceptance among clinicians, patients and caregivers. The current review discusses the problems and possibilities in ODF technology to address the outstanding issues of age-appropriateness, which is the hallmark of patient acceptance and medical adherence in paediatrics.

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Adapted from reference [36]

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Acknowledgements

The authors are grateful to Dr. Shantikumar V Nair, Dean and Dr. Sabitha M, Principal for their support.

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  1. Indhu Annie Chacko and Gayathri Ramachandran contributed equally to this work.

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  1. Department of Pharmaceutics, Amrita School of Pharmacy, AIMS Health Sciences Campus, Amrita Vishwa Vidyapeetham, 682041, Ponekkara, Kochi, India

    Indhu Annie Chacko, Gayathri Ramachandran & M.S. Sudheesh

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All authors contributed to the study conception and design. The first draft of the manuscript was written by IAC and GR. All authors read and approved the final manuscript.

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Chacko, I.A., Ramachandran, G. & Sudheesh, M. Unmet technological demands in orodispersible films for age-appropriate paediatric drug delivery. Drug Deliv. and Transl. Res. 14, 841–857 (2024). https://doi.org/10.1007/s13346-023-01451-3

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