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Formulation Considerations for Paediatric Populations  

Several factors must be considered to ensure safety and efficacy when developing a drug formulation for a paediatric population. 

These include:  

• Age and weight range: The formulation should be appropriate for the age and weight range of the paediatric population it is intended for. 
• Dosage form: Paediatric formulations are often available in liquid, chewable, or dissolvable forms to make them easier for children. 
• Taste and palatability: Children are more likely to accept a medication that tastes good and is easy to swallow. Taste is one of the most significant factors affecting children’s acceptability and adherence to the treatment to deliver therapeutic success. 
• Bioavailability: The bioavailability of a drug, or the amount absorbed and reaches the bloodstream, may show differences in children than adults and can be affected by the formulation selection. 
• Ease of administration: The formulation should be easy for caregivers to administer to children. Where administration through feeding tubes is used, either as a main route or as a very likely option, the feasibility of administration through the feeding tube needs to be addressed. 
• Dosing regimen: The dosing regimen should be tailored for the paediatric population. For example, smaller doses may be more appropriate for infants and young children. Careful consideration must be given to the formulation concentration to avoid the requirement for further compounding to tailor the dose for the paediatric population. 
• Excipients: The formulation of excipients may have a different effect on developing organ systems in children. Therefore, selecting excipients requires special consideration when formulating for the paediatric population. 
• Safety: The formulation should be safe for children, with minimal side effects. 
• Stability: The formulation should be stable and maintain its potency over time. 

Overall, formulations for paediatric populations should be designed with the specific needs of children in mind to ensure safety, efficacy, and ease of use. 

Paediatric Dosage Forms  

Several dosage forms are commonly used in paediatric populations, including: 

• Liquids: Liquid solutions and suspensions are a preferred dosage form for the paediatric population as these are easy to administer and can be flavored to improve taste and palatability. They are often used for younger children who cannot swallow pills. 
• Chewable tablets: Chewable tablets are designed to be easy for children to chew and swallow. They can be flavored to improve taste and palatability. 
• Dispersible tablets: Dispersible tablets are designed to dissolve quickly in liquid, making them easy to administer to children who cannot swallow pills. 
• Parenteral dosage forms: The parenteral route is the intravenous administration of nutrition and medications by bypassing the gastrointestinal system. Parenteral administration is the most commonly used route of administration for active substances for children who are seriously ill and preterm neonates.  
• Suppositories: Suppositories are solid dosage forms that are inserted into the rectum.  
• Transdermal patches: Transdermal patches are adhesive patches that are applied to the skin and release medication over time. They can be helpful for children who have difficulty swallowing pills or medications that need to be given over a long period. 
• Buccal and sublingual forms: Buccal tablets are placed between the cheek and gum, while sublingual forms are placed under the tongue. They are helpful for medication that needs to be absorbed quickly in the bloodstream and are also beneficial for children who have difficulty swallowing pills. 

It is important to note that not all medications are available in all these dosage forms. The appropriate dosage form will depend on the medication, the child’s age and weight, and their ability to swallow and follow dosing instructions. 

Bioavailability Paediatric  

Bioavailability is the extent to which a medication is absorbed into the bloodstream and reaches its target site of action. It can be influenced by various factors, including the dosage form, the child’s age and weight, and their ability to swallow and follow dosing instructions. 

In general, the bioavailability of medication may be different in paediatric populations due to their smaller body size and differences in anatomy and physiology compared to adults. 

For example, children have a higher body surface area-to-weight ratio than adults, which can affect the absorption of topically administered drugs. In addition, the pH of the stomach is different in children, which can affect the absorption of oral medications.

Also, the blood flow to the gut, liver, and kidneys is different in children, which can also affect the metabolism and elimination of drugs. 

Appropriate dosing and administration methods must ensure that a medication is bioavailable and effective in paediatric patients. This may involve using a different dosage form, adjusting the dose based on the child’s weight, or using a different route of administration.

It is also important to note that bioavailability can vary among paediatric populations, such as infants, toddlers, school-aged children, and adolescents. 

Therefore, it is essential to consider conducting appropriate pharmacokinetic and pharmacodynamic studies in these population groups before making a formulation available for paediatric use. 

Contact our experts now to learn more about our paediatric formulation capabilities and expertise.