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Published on: August 18, 2023
Age-Appropriate Formulations Including Pharmaceutical Excipients in Neonatal Medicines
Karin Kogermann1, Jana Lass2,3, Georgi Nellis4
1Institute of Pharmacy, Faculty of Medicine, University of Tartu, Tartu, Estonia.
Insights
Developing age-appropriate pharmaceutical formulations for neonates is crucial. Novel drug delivery systems aim to reduce medication errors and improve safety and efficacy in neonatal care.
Area of Science:
- Neonatal Pharmacology
- Pharmaceutical Sciences
- Drug Delivery Systems
Background:
- Neonatal drug formulation presents unique challenges due to developmental immaturity.
- Extemporaneous compounding is common but lacks standardization, leading to medication errors and safety concerns.
Purpose of the Study:
- To review challenges in neonatal drug formulation and excipient exposure.
- To explore novel drug delivery approaches for improved neonatal care.
Main Methods:
- Literature review of recent formulations and pharmaceutical excipients.
Main Results:
- Identified issues with age-inappropriate formulations and harmful excipient exposure in neonates.
- Discussed strategies to minimize excipient risks and challenges in designing neonatal dosage forms.
- Summarized emerging drug delivery technologies for neonates.
Conclusions:
- Novel age-appropriate drug delivery systems are needed to enhance medicine quality and reduce neonatal treatment errors.
- Further research into new technologies, formulations, and excipients, supported by rigorous testing, is essential for safe and effective neonatal drug delivery.
Background:
The development of appropriate pharmaceutical formulations for routine neonatal practice is challenging because of the developmental characteristics and the need for it to be specifically ageappropriate. This has led to wide use of extemporaneous formulations, which lack standardized procedures that can result in medication errors in clinical practice resulting in suboptimal efficacy and safety concerns.
Methods:
We have reviewed the most recent literature on formulations and pharmaceutical excipients.
Results:
We present the issues related with the lack of age-appropriate formulations, discuss the importance and extent of exposure to pharmaceutical excipients known to be harmful to neonates, indicate ways that can reduce exposure to excipients of concern, and review challenges of the design of age-appropriate drug formulations and dosage forms/drug delivery systems for neonates. Finally, we summarize novel approaches regarding drug delivery for neonates.
Conclusion:
Novel approaches in age-appropriate drug delivery should overcome the present obstacles and improve the quality of medicines, thus avoiding errors in treatment and improving the management of neonates. Further basic researches on discovering new technologies and modern formulations, using in vitro testing systems as well as preclinical and clinical trials, are needed to improve the feasibility, practicality and safety of new formulations, including research on pharmaceutical excipients.
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