PAEDIATRICS
Traditional oral solid dosage forms leverage the most established manufacturing technologies with control costs, have long-term stability, do not require dosage measurement and are relatively easy and effective to taste mask via coating. They can, however, be difficult or young children to swallow and do not afford and dose flexibility. Fast-dissolving tablets allow absorption of the tablets in 60 seconds or less. They are appropriate for smaller molecule weight of APIs with no bitter taste that are delivered at doses of less than 20 mg and can diffuse into the epithelium of the upper GI tract and permeate oral mucosal tissues. However, they do not work for APIs that have a bitter taste, short half-lives and for formulations requiring sustained or controlled release. Chewable tablets provide fast absorption and better bioavailability through bypass disintegration and tend to have high paediatric patient acceptance. They also offer convenience to caregivers because no water is required for swallowing. On the other hand, these formulations contain sorbitol, which can cause diarrhea and flatulence. Due to their hygroscopicity, they must be kept dry and may require specialised packaging and storage conditions. The formulation must also have the right flow, lubrication, disintegration organoleptic and compressibility properties. Multiparticulate formulations are popular for paediatric populations because as a solid dosage form they have long-term stability; several options are available; they provide maximum dose flexibility; modified release formulations are possible; and taste masking is generally effective. Mini-tablets are small tablets averaging 1.5-3mm in diameter that can be filled into capsules, compressed into bigger tablets or loaded into sachets or stick packs. They not only provide
flexible dosing (by simply increasing the number of mini-tabs) and sustained/timed release options with coating but are easy to swallow, can be effectively taste-masked and allow different incompatible APIs to be formulated into a single dosage form. If APIs are unstable in liquid forms, mini-tablets can also be reconstituted and dosed as a suspension. Modified feeding bottles allow delivery of medication while the baby drinks its formula. Dose-sipping technology, which consists of a specially designed straw, enables the delivery of a single dose of small-sized pellets. SPECIALISED EXPERTISE IS OFTEN REQUIRED The choice of formulation type for paediatric patients is often dictated by the physiochemical properties and the taste of the active drug substance, along with the intended dose for different age groups. Each formulation must be appropriate for the child in terms of dose, convenience and acceptability to ensure compliance. Expertise in the wide range of possible oral dosage forms is essential for ensuring the most age-appropriate, efficacious and costeffective option is selected for any given API. Collaboration with contract development and manufacturing organisations with longterm experience and demonstrated success developing and producing right-sized dosage forms tailored for children from infants to teens at clinical to commercial scale can provide competitive advantage, reduce time to launch and ensure market success.
The choice of formulation type for paediatric patients is often dictated by the physiochemical properties and the taste of the active drug substance.
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