Jeff Worthington and David Tisi, Senopsys LLC03.09.16
Oral solids—tablets and capsules—continue to comprise the bulk of the market. However, many patients have difficulty swallowing tablets and capsules and most oral solid dosage forms are not suitable for infants and children, or facilitate dose titration. Due to these limitations, liquids, powders, orally disintegrating tablets, and chewable tablets are often the dosage forms of choice for pediatric, geriatric and other special patient populations. One challenge for these dosage forms is the increased oral cavity residence time, which makes palatability a major challenge. Increasingly, FDA and EMA are requiring sponsors to demonstrate due diligence during development by ensuring the palatability of age-appropriate pediatric products as a condition for review (i.e., Pediatric Study Plans and Paedriatric Investigation Plans). This often represents a difficulty for pharma companies and their contract development partners for a number of reasons.
First, as these alternative dosage forms represent a small fraction of the market, for most organizations, even large ones, their development is a rare event and therefore relevant formulation experience is diff
First, as these alternative dosage forms represent a small fraction of the market, for most organizations, even large ones, their development is a rare event and therefore relevant formulation experience is diff
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