There are a number of pharmacological and economical benefits to developing controlled and modified release drug products. Following the 505(b)(2) pathway allows companies to make modest changes to an already approved drug and get continued market exclusivity for a further three to potentially seven years via the filing of new patents for drug and delivery reformulations, such as controlled-release versions. These changes include constituting a modified-release approach via developing a controlled-release, long-acting, extended-release, or XR version of the drug. Like any approach, this does not come without controversy with drug makers being accused of artificially extending patent life.

Controlled release systems are developed in many cases to enable superior control of drug exposure over time, to assist drug in crossing physiological barriers, to shepherd drug to the desired site of action while minimizing drug exposure elsewhere, and finally to shield drug from premature elimination. These systems can also increase patient compliance by reducing frequency of administration, and add commercial value to marketed drugs by extending patent protection.

However, it should be recognized that development of a controlled-release product can be expensive. For many drugs, the extra expense may not be warranted on purely therapeutic grounds, although developers may pursue controlled release formulations for marketing, quality control, and regulatory reasons. Many larger pharmaceutical companies have in-house expertise and capabilities in controlled and modified-release techniques, but there are a wide variety of formulation and drug-delivery providers on the market to in-license technology and manufacturing expertise including the likes of Patheon, Capsugel, Depomed and Catalent Pharma Solutions to name a few.

Having organized the annual Controlled & Modified Drug Release Summit for over a number of years now, many of our industry attendees and experts believe that the future is good for modified-release technologies, given that their use can provide a clinical benefit and that the science behind the drugs supports use of modified release. Additionally, challenges around efficacy and lifecycle management make growth in the market probable. The lack of new pharmaceutical compounds in the discovery phase of drug development makes lifecycle management very important, and modified release dosage forms should become an important strategy in extending the life of established, high-revenue drugs.

The question you must ask yourselves and your organization is can you afford not to develop these products from a lifecycle management standpoint? Want to Learn More?