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By Carla M. Caramella

Carla CaramellaIn a medical context, the term “combination product” has a broad meaning, since it may include any combination of substance, device, and additional components to fit all medical purposes. However, the most recognized usage is in “fixed-dose combination products” (formulations including two or more active pharmaceutical ingredients combined in certain respective fixed doses in a single dosage form). Among specific combination products, which combine different medical products, “drug-device combination products” are certainly the most recognized and debated.

Both fixed-dose and drug-device combination products are complex products that have already gained a regulatory status and a wide market share.

Besides the above definitions, drug delivery systems, at least in the perception of the scientific community, are considered the pioneers of the field, since they typically combine actives, excipients, polymers, and devices in a scientific and innovative/inventive way so as to exploit the functionality of each and every component at its best. Among the possible advantages of drug delivery systems are polypharmacy, personalized medicine, improved patient compliance, and adherence to the therapy, with eventual improvement of medical treatment.

The aim of the mini-symposium Combination Products and Innovation in Drug Delivery Systems at the 2014 AAPS Annual Meeting and Exposition in San Diego is to discuss the therapeutic advantages of both traditional and innovative combination products in the broad sense for any type of administration route.

The most common routes of administration that take advantage of combination products, such as oral and inhalation routes, will be the priorities of the workshop, but interventions concerning alternative routes of administration and formulation proposals will be welcome. Douwe Breimer, from Leiden University, will discuss current and future uses of medicinal combinations; Paolo Colombo, from the University of Parma, will expand on fixed-dose combinations for the oral route; and Hugh Smyth, University of Texas at Austin, will explain more about drug-device combination products for inhalation use.

Also, the workshop will present an occasion to highlight the regulatory hurdles that may arise in formulation development and evaluation procedures of combination products.

We invite you to bring your questions, comments, and suggestions on current issues related to combination products to this symposium on Tuesday, November 4, from 9 am–11 am.

Carla M. Caramella, Pharm. D, is professor of pharmaceutics at Pavia University, Italy. She is an AAPS Fellow (2001) and received the first Ralph Shangraw Memorial Award (2008). Caramella’s current research interest is wound healing.