Incremental Innovation of Combination Products

N. D. Patel, Dr. J.K.Patel, P.V.Patel, A. A. Ajmera

Abstract: There are numerous strategies that can be applied when developing combination products with soluble compounds. However, new strategies will have to be used when considering combinations with soluble and insoluble compounds. INNERCAP Technologies, Inc., a drug delivery company, offers an advanced patent pending multi-phased, multi-compartmentalized capsular-based delivery system. The system can be used to enhance the value and benefits of pharmaceutical and biopharmaceutical products. It is a very effective way to deliver multiple active chemical compounds in different physical phases with controlled release profiles. Each compartment is sealed to prevent the medicaments from escaping and coming into contact with one another. This approach maximizes bioavailability and, at the same time, addresses patient compliance problems

Combination pharmaceutical products are defined as being able to treat the same disease state, multiple disease states, or counteract the negative side-effects.

  • Additivity’ is combining two or more drugs with complementary modes of action to gain the desired therapeutic effect without the side-effects;

  • Potentiation’ is the synergistic effect on drug A by adding a dose of drug B without a therapeutic effect;

  • Cancellation’ is when effects of one drug are nullified by the addition of a second.

A combination product may contain pharmaceuticals, biopharmaceuticals, or nutraceuticals. They can also incorporate several, different controlled-release profiles, such as immediate, pulse, chronotherapy, targeted and sustained.Cocktail drugs means a number of drugs face the fear of extinction as they fall prey to resistance. Combination drugs counter this problem and offer a higher level of efficacy as well.
Combination products are composed of two or more regulated components – drugs, medical devices, or biologics, combined through physical or chemical means. These include drug coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.Combination products are also being marketed or developed for orthopedics (eg, protein-coated implants to encourage bone regeneration), cancer (eg, a tumor ablation system), infection control (surgical mesh with antibiotic coating), and diabetes care (integrated glucose meter and insulin pump). Future combination product applications are expected to include implantable, closed loop insulin pumps, steroid-eluting electrodes, or even novel “physical solutions,” such as drug-coated surgical screws, catheters, sutures, and wire. 


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