There are many recent examples, such as ZANTAC® (ranitidine) and PROZAC® (fluoxetine), where generic products have entered the market very soon after the basic patent protection expired.

Whilst it may be possible to develop a single isomer to replace a racemic original product, in the way that AstraZeneca has substituted esomeprazole (NEXIUM®) for omeprazole (LOSEC®), this is not always possible. Reformulating the original product with a new and innovative technology can be very successful. The classic example of this was Pfizer’s billion-dollar product PROCARDIA XL®, a once-daily formulation of the established but ageing nifedipine. Enhanced convenience and resulting improved compliance may result from these technology or formulation switches.

Another form of Improved Delivery Systems is to develop a product with an improved pharmacokinetic profile which leads to advantages in the therapy and is a benefit to the patients.

It is never too early to start implementing a life cycle management strategy, particularly with the long lead-times for the development of a pharmaceutical product.

The SOLIQS drug delivery technologies can help you to extend your product’s life by providing:

• enhanced bioavailability and therefore reduced drug load
• unique pharmacokinetic profiles from fast release to once-daily sustained release
• unique and difficult to copy (prevent counterfeiting) solid dosage forms, such as caplets, lentil shapes and sometimes even transparent ones!
• molecular dispersions (“Solid Solutions”) to overcome bioavailability and other problems related to polymorphism.