Analytical Method Development for Paediatric Oral Dose Products

Formulating paediatric medicines comes with many challenges. Due to the unique physiological and developmental characteristics of young patients, it is essential that pharmaceutical companies tailor their approaches to meet the specific needs of each patient.

As members of the European Paediatric Formulation Initiative (EUPFI), Almac takes pride in sharing deep expertise and contributing to improving access of medicines for paediatric patients. Below are some of the key challenges to consider when developing paediatric treatments.

Dosing Accuracy & Precision
Younger patients such as toddlers and infants require precise dosing to ensure a safe and effective consumption of the drug product. Because of this, analytical methods must be highly sensitive and precise, therefore formulations must be check weighed throughout the manufacturing process to ensure dosage forms are accurate.

Almac specialises in manufacturing oral dose forms such as granules, tablets and mini-tablets in stick packs and sachets as well as liquid or powder in bottles for the correct dosage specifically for paediatric patients.

Taste and Palatability
Paediatric medications must be palatable as it affects a patient’s willingness to take the treatment. By taking these challenges into consideration, our development experts focus on the taste, texture, dosage form and ease of administration for effective and well-tolerated treatments for paediatric patients.

However, extra ingredients such as taste-mask agents and other excipients can make it harder to isolate and measure drug dosage accurately. To accurately measure small doses required for paediatric oral dose products, we offer advanced analytical methods including HPLC, MS, UPLC and Fluorescence Spectroscopy.

Formulation Stability
Paediatric medications must remain stable under environmental conditions to maintain their safety and efficacy. Analytical methods must accurately assess the stability of these formulations over time. That’s why we work with our clients using our fully integrated stability services to fully understand the shelf life of their drug formulation. This data also helps us offer innovative packaging solutions tailored to paediatric medications to maintain its efficacy.

Regulatory Requirements
Analytical methods for paediatric medications must demonstrate bioequivalence and bioavailability in paediatric populations to ensure developed formulations are both effective and well-tolerated by
paediatric patients.

At Almac, we have a wealth of experience in making sure drug development programmes meet the highest standard of quality and safety for your patients.

Age-Appropriate Formulations
Our formulation development scientists specialise in creating age-appropriate and palatable drug formulations that are safe and efficient. As younger patients have unique physiological profiles, analytical methods must cater to these differences to ensure optimal absorption and metabolism in paediatric patients.

It is evident that developing analytical methods for paediatric drug development programmes is a complex process that requires deep knowledge on the unique needs of each patient. By partnering with an experienced CDMO who will ensure analytical methods are accurate, adaptable to age-specific patients and compliant to regulatory standards, pharmaceutical companies can ensure their paediatric patients receive safe, effective and high-quality treatments.