It is common to have a limited amount of API in the early phase of drug development, which often impedes the rapid progression of the drug development. This article describes a new approach that enables the use of industrial-scale machines from the very beginning that has resulted in high-quality output for cGMP processes and also optimized the yield of small-batch size production.
Salmon Calcitonin is a peptide with poor oral bioavailability. To assess its potential for oral delivery parallel screenings were conducted with two different technologies targeting duodenal and sublingual biological barriers respectively. Subsequently, based on the animal pharmacokinetic (PK) study data, the optimal formulation and dose form was identified, which shows the oral bioavailability of Salmon Calcitonin was increased by more than 20 times.
A commercial-stage medical technology company created a way to noninvasively monitor adherence to oral medications. The system is based on detecting 2-butanol, a metabolite of the adherence marker, in patients’ breath, and therefore it can be used to definitively verify, monitor, and report in real time how and when study participants are taking their medication.
With the Better Treatments by Design process, Catalent aims to achieve optimal outcomes for innovators, prescribers, and patients. By applying advanced dose design principles early on we can help you achieve optimal absorption profiles, as well as improve patient adherence and compliance, leading to greater payer acceptance, more scripts, and potentially better patient outcomes.