CPhI: Pre-Show Conference Report

Innovation is the cornerstone of the pharmaceutical industry. That innovation is seen not only in new drug development but also in approaches to extend the lifecycle of a given product through improved formulations and drug-delivery systems. Recent advances and trends in drug-delivery systems were highlighted at one of the sessions at the Pre-Connect Conference held at CPhI Worldwide in Madrid this week.

The value of innovation was emphasized by Catalent, which provided insight on the increasing role of drug-delivery systems in solving complex drug-development challenges, such as bioavailability problems, and improving patient outcomes. The company shared research that showed that compared with conventional formulations, advanced drug-delivery systems can potentially increase the value of existing drugs by 25–50% through patent-life extension, product differentiation, accelerated product development and market entry, better patient outcomes and compliance, and improved returns on R&D investment.

Innovation in inhalation drug delivery was discussed by Philippe Rogueda, director of emerging technologies at Watson Pharmaceuticals and adjunct senior lecturer from Monash University in Melbourne, Australia, who put forth the idea of telehealth and the use of single-dose inhalers (SDIs). These “smart” nebulizers use an adaptive technology that monitors patients’ compliance, and unlike conventional multidose inhalers, are used to administer only a single dose of drug and are then disposed of. The advantages? Discrete use, no expiration of remaining doses unlike multidose inhalers, no overdosing, no cross-contamination, and ease of use. SDIs could be designed for personalized therapies in providing treatment for respiratory conditions, pain, migraines, and cancer side-effects. As Rogueda pointed out, however, SDIs also raise some challenges, such as patient adoption and interest in using SDIs over conventional multidose inhalers and patient concerns over privacy with the data collected from “smart” inhalers. Additionally, large pharmaceutical companies may be somewhat reluctant to let go of their complex inhalation drug-delivery platforms and advance SDIs.

Strategies for tackling poor solubility of APIs was discussed by David Lyon, senior vice-president of research at Bend Research, and Conrad Winters, director of drug product development, at Hovione. They discussed the use of amphorous solid dispersions produced by spraying drying as a tool for resolving solubility issues and the various considerations in optimizing and scaling up spray-drying processes.

Insight into the development of controlled-release oral formulations was provided by Christian Seiler, senior principal scientist from Merck & Co. He discussed such approaches as matrix tablets and osmotic dosage forms in controlled-released formulations and diagnostic tools used to evaluate and optimize a formulation. These tools include the Enterion capsule (Quotient BioResearch), which is remotely activated in vivo to deliver the drug payload on reaching the target location in the gastrointenstional tract, and Medimetrics’ IntelliCap, an electronic capsule that is used to deliver a drug or therapeutic agent to a targeted location, with a user-defined dose and delivery profile.

The insights provided at this session underscore the value that drug delivery brings to the table in the pharmaceutical industry’s drive to bring innovative products to improve patient compliance and outcomes.