There is a growing trend towards co-formulating drugs in the same tablet or capsule in order to reduce the number of pills a patient has to take and, hopefully, increase patient compliance with therapy. For example, the US Food and Drug Administration has just implemented a programme to increase R&D into combination tablets for HIV, where compliance with therapy is critical to retain its effectiveness and stop resistant strains of the virus developing.
Meanwhile, Schering-Plough and Merck & Co received approval last year for a single-dose combination product for cholesterol lowering, called Vytorin in the US and Inegy in Europe. The drug combines S-P's Zetia (ezetimibe) with Merck's Zocor (simvastatin) and is tipped to achieve sales in excess of $1 billion (€823m), according to analysts.
But in many cases it is difficult to formulate two drugs into a single dose, because they may react with each other or need to be formulated in a different carrier. For example, it is hard to combine insoluble and water-soluble actives in a singe dosage form.
Innercap's Novacaps delivery system can handle incompatible pharmaceutical agents, either solid or liquid, via an oral or a suppository capsule. The technology is based on the use of 'mixed phase' capsules, in which a capsule is engineered with a number of compartments.
For example, a combination example pictured below shows a high potency insoluble active in a lipid emulsion sustained release tablet and a cocktail of two crystalline active materials, all delivered in the same primary capsule.
Aside from allowing different compounds to be delivered in tandem, the technology also makes it possible to time the release of each individual compound, tailoring treatment to a specific application.
The company notes that another key application of the Novacaps technology will be to lengthen the lifespan of mature pharmaceuticals, by repackaging and reformulating them into combination products that will extend patent protection for the franchise.