Problem-solving ingredients for complex drugs

Published: 18-Jan-2013

Around 40% of new chemical entities fall into class II – low solubility drugs, making them difficult to formulate. Improving the bioavailability of these compounds is a major challenge but the technologies involved could help to extend the lifecycle of many medicines. Manufacturers are also looking to improve palatability and diversify drug delivery routes to increase patient compliance.

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Scientific advancements may be leading to more effective drugs, but the requirement for solubility-enhancing technology, palatability improvements and life-cycle extenders is greater than ever. Susan Birks looks at ingredient trends.

Drug developers around the world are facing a new set of challenges. Not only are the new active ingredients poorly soluble and site-specific, requiring complex delivery systems, but development costs are rising. Add to this the cost of new initiatives such as QbD and the Falsified Medicines Directive and the profitability of new drugs takes a dive. In addition a high failure rate of new drugs and growing use of generics makes lifecycle extensions a priority.

Topping the list of needs for most drug developers, however, is improving solubility and bioavailability. As one ingredient supplier put it, now that all the easy (small) therapeutic molecules have been discovered, the new molecules coming through are much more complex and suffer from solubility and bioavailability issues. As a result, ingredient suppliers and CMOs are focusing their offerings on improving solubility and bioavailability of actives, through either chemical or mechanical methods, or in terms of enhanced delivery vehicles.

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