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Published on: March 23, 2016
Unmet technological demands in orodispersible films for age-appropriate paediatric drug delivery
Indhu Annie Chacko1, Gayathri Ramachandran1, M S Sudheesh2
1Department of Pharmaceutics, Amrita School of Pharmacy, AIMS Health Sciences Campus, Amrita Vishwa Vidyapeetham, 682041, Ponekkara, Kochi, India.
Insights
Developing age-appropriate formulations for children is crucial for safe medication delivery and adherence. Orodispersible films (ODF) show promise in addressing challenges in pediatric drug delivery, improving patient acceptance.
Area of Science:
- Pharmaceutical Sciences
- Paediatric Drug Delivery
- Formulation Development
Background:
- Paediatric drug delivery faces significant challenges, including unknown excipient safety, lack of age-appropriate formulations, poor taste-masking, and limited pharmacokinetic data.
- Ensuring age-appropriateness is vital for improving medical adherence and reducing medication errors in children.
- Predicting the biopharmaceutical performance of paediatric formulations based on age remains an unmet need.
Purpose of the Study:
- To review the challenges and potential solutions in developing age-appropriate paediatric formulations.
- To explore the role of orodispersible films (ODF) as a promising age-appropriate formulation technology for paediatric drug delivery.
- To discuss technological advancements that can enhance the acceptance and efficacy of ODF in paediatric patients.
Main Methods:
- Review of current literature on paediatric drug delivery challenges.
- Analysis of orodispersible film (ODF) technology and its potential applications in paediatrics.
- Discussion of technological improvements such as taste masking, solubility enhancement, and 3D printing for ODF preparation.
Main Results:
- Orodispersible films (ODF) are identified as a promising technology for age-appropriate paediatric drug delivery.
- Technological advancements in taste masking, drug solubility, dissolution rate, and flexible dosing enhance ODF suitability.
- 3D printing in a Good Manufacturing Practices (GMP) setting offers customisation and extemporaneous preparation of ODF.
Conclusions:
- ODF technology offers a viable solution to address the critical need for age-appropriate formulations in paediatric medicine.
- Improvements in ODF technology can significantly enhance patient acceptance and medical adherence in the paediatric population.
- Further development and implementation of ODF, particularly with 3D printing, hold great potential for advancing paediatric drug delivery.
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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