Application of mini ODTs and coin-shaped ODTs with high performance excipients for pediatric preparation

There is strong clinical need for pediatric formulations from healthcare professionals and caregivers since the number of available pediatric formulation is limited. Currently oral administration is the main route of administration for pediatric formulations in the market. For development of pediatric oral administration, “acceptability” of “formulation” and “handling” should mainly be considered. Particularly, the formulation is the most important because it includes palatability (e.g., taste, smell and texture) and swallowability (e.g., size and shape). These two factors determine suitability for of taking medications to children (Fig. 1).

In European countries, liquid dosage forms such as syrups and suspensions are widely used as oral administrations for children. Although liquid dosage forms can be taken from the neonatal period, there are several issues. Their storage conditions and shelf-life are constrained compared with those of solid formulations. As one bottle covers the amount of medication for the number of days, it is necessary for caregivers to measure the liquid, deriving difficulty to administer a single dose accurately.1) In view of these considerations, solid dosage forms have been studied as pediatric preparations recent years. There are a variety of solid dosage forms, such as tablets, capsules and powders. Among these, orally disintegrating tablet (ODT), is a dosage form that is designed to improve swallowability of conventional tablet for increased medication adherence.

ODTs disintegrate in the oral cavity within 30 seconds by saliva, which is suitable for patients with dysphagia. Advantages of ODTs include their safety (they prevent aspiration), convenience (any time and place), and reliability (they prevent medication refusal). However, it might be considered that rapid disintegratability of conventional ODT is not enough for pediatric use. This article discusses distinctive dosage forms in order to improve the acceptability of pediatric formulations from a perspective of excipient manufacturers.

2. Overview and characteristics of co-processed excipients for ODTs

GRANFILLER-D and HiSORAD are co-processed excipients composed of several pharmaceutical excipients that comply with USP-NF, EP, and JP. They are produced with proprietary granulation methods. Their characteristics are indicated in Fig. 2. Both products provide advantages such as enhancing performance of ODT, reducing development time, and simplifying manufacturing process. Using these co-processed excipients, we developed ODTs which shape are suitable for pediatric use.