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Critical Reviews on Pediatric Dosage Form Developments and Medical Devices
Gurkirat Kaur1, Dheeraj Nagpal1, Kalpana Nagpal1
1Amity Institute of Pharmacy, Amity University Uttar Pradesh, Noida, U.P., India.
Insights
Pediatric drug dosing requires specialized approaches beyond adult standards. Novel formulations and medical devices like oral pens and Medibottles improve pediatric medication administration, reducing errors and toxicity.
Area of Science:
- Pediatric Pharmacology
- Drug Delivery Systems
- Biopharmaceutical Sciences
Background:
- Pediatric patients are not simply
- miniature adults
- due to distinct physiological differences affecting drug pharmacokinetics and pharmacodynamics.
- Current pediatric dosing practices, often based on age, weight, or reduced adult doses, are frequently inadequate.
- Organ development and body composition variations in children necessitate tailored pharmaceutical strategies.
Purpose of the Study:
- To review the challenges in designing pediatric dosage forms.
- To highlight advancements in medical devices for pediatric drug administration.
- To emphasize the need for customized solutions to improve medication safety and efficacy in children.
Main Methods:
- Literature review of pediatric drug formulation and delivery systems.
- Analysis of novel medical devices designed for pediatric use.
- Synthesis of information on challenges and innovations in pediatric pharmacotherapy.
Main Results:
- Customized formulations like mini-tablets and oro-dispersible films address administration difficulties.
- Innovative medical devices, including oral solid dosage pens, Nipple Shield Delivery Systems (NSDS), and Medibottles, facilitate accurate dosing.
- These advancements offer flexibility and convenience, overcoming barriers to effective drug delivery in pediatric patients.
Conclusions:
- Specialized dosage forms and medical devices are crucial for safe and effective pediatric drug administration.
- Addressing unique pediatric physiological parameters is essential for optimizing therapeutic outcomes.
- Innovations in drug delivery systems can significantly reduce medication errors, incomplete absorption, and toxicity in children.
Abstract:
The pediatric population is generally considered as "miniature adults," but they actually differ from adults due to their different body compositions and varied stages of organ development, which alter essential biopharmaceutical parameters. The physiological differences between the pediatric population and the adult population alter the essential kinetics and dynamics of the same drug administered at the same dose. For pediatric patients, the drug dose is generally calculated using different formulas based on age, body surface area, or weight, or is simply reduced to half of adult dose. This, however, is not the correct practice. New approaches have emerged for designing customized formulations and medical devices for the pediatric population. Examples of customized formulations are "mini-tablets" and "oro-dispersible films," which attempt to ease the administration of solid oral dosage forms. These specially designed medical devices have shown the ability to overcome many challenges in dose administration to children. One such medical device is the "oral solid dosage pen," which allows for dose adjustment by cutting a tablet-like drug carrier at a predefined height and offers flexibility and convenience for dose administration to the pediatric population. Other medical devices, such as the Nipple Shield Delivery System (NSDS) and Medibottle also aid in efficient drug delivery to pediatrics. This review summarizes the challenges in dosage form design and advances in suitable medical devices for better administration to the pediatric population to overcome accidents due to medical errors, incomplete absorption, and toxicity.
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