Formulating pediatric taste masked multiparticulates using CPS Technology – AAPS Poster

Developing formulations appropriate for children still remains to be a major formulation challenge for the pharmaceutical scientists as children are different than adults in many aspects of pharmacotherapy, including capabilities for drug administration, medicine-related toxicity, and taste preferences. The administration of drug, dosage accuracy, toxicity, and taste must be taken into consideration for the appropriate usage of the drug as well as the compliance and adherence to the treatment.

Currently many pediatric medicinal needs are unmet as the available adult formulations are not suitable for administration to children. Besides, development of multiple dosage forms for different age groups will rarely be commercially viable and liquid formulations, which can be given to a broad age group, however, would present particular challenges, for example masking the bitter-taste of drug and maintaining its stability throughout the shelf-life of the product. Dosage forms like orodispersibleor chewable preparations are being used but carry a significant risks of choking and chewing.

Recently, mini-tablet is gaining growing interest as a promising dosage form for pediatric population. However, due to their small size, minitabletsmay not be appropriate for patients with motor impairment or geriatric patients, unless administered by a caregiver or a dosing device. Difficulties may also be encountered when designing a minitablet-based dosage form for high-dose drugs (compounds with low potency), since the number of minitabletsper dose can be prohibitively large along with the labor-intensive manufacturing can lead to much higher production costs.
Multiparticulates are well understood dosage forms that provide a very high level of dose flexibility and can be developed to meet specific requirements of pediatric and geriatric age groups. This dosage form and its processing have a long been studied and well received and as such provide development flexibility like no others. Besides, multiparticulatescan also be the choice of formulation to avoid stability issues commonly associated with liquid formulations.

The sub-millimeter size of these multiparticulate sub-units offer 1) dose flexibility; 2) can be administered through capsules, sprinkle capsules, sachets, stick packs, straws; and 3) their small size makes them most convenience for oral administration to both the pediatric and geriatric population as they often experience troubles swallowing. Many times, the modification from the adult dosage form only requires a capsule fill adjustment. Therefore, multiparticulatesis a dosage form that meets a wide range of formulation requirements for the pediatric population. Download the poster here: 2019 AAPS Poster FORMULATING PEDIATRIC TASTE MASKED MULTIPARTICULATES

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