The Recent Combination Products Boom

Renewed interest in fixed dose combination products is at an all time high, with new combination products being announced almost weekly. Combination drugs that target the same indication (polypharmacy) are not a new concept, having demonstrated their use in diseases like diabetes, and now expanding their reach into areas such as hypertension, hyperlipidemia, AIDS, depression and even to address enlarged prostate.

What’s New?

What is new are combination products being developed to treat different ailments in the same patient (co-morbidity), at the same time and with one pill. Driven by factors such as an increase in obesity and the aging of baby boomers we are seeing larger and larger patient populations suffering from a multitude of ailments, for example, industry estimates put the number of Americans suffering from both hypertension and elevated cholesterol at 30 million. Added to this are new research and recommendations, like that from the American Diabetes Association, recommending that certain diabetics take cholesterol and blood pressure lowering drugs in complement to their oral diabetic medications. All of this leads to the co-prescription of a multitude of medications, increased costs and an increased pill burden for the patient.  Add to this aging blockbuster drugs, side effects issues and slim discovery pipelines, and you have the current boom in new combination drug therapies.

The MicroDose Fixed-Dose Combination approach

MicroDose has developed a proprietary approach that enables the combination of two or more fixed dosage drugs into a single pill or capsule, but separated by a physical barrier. The approach requires no special processing of the powders which, along with the physical barrier between the two drugs, allows for more rapid development timelines and lower regulatory requirements. 

The advantages of the MicroDose technology are:

• Shorter time-to-market
  • No new formulation work required,  uses existing, marketed formulations
  • Time-to-market for combination products can be less than 2 years
    
    
• Lower development cost
  
  
• Easier to manufacture
  • Provides independent control of dose strength of the active ingredients to more easily support multiple dose strength combinations

The MicroDose combination approach supplies an effective means to implement life-cycle-management strategies, produces new products for a fraction of the cost it takes to bring a traditional combination product to market, with a lower risk of both technical and regulatory failure.

MicroDose Combination Products

MicroDose has identified and is developing several combination products for its own use in the high growth areas of hypertension, hyperlipidemia and Type II diabetes based on its proprietary technology.

Can The Microdose Approach Help You?

MicroDose will license and co-develop this approach with interested pharmaceutical partners for drugs in their portfolio. 

If you think you might have an interest in licensing any of our products in development, or have any pipeline products that could benefit from the MicroDose approach, please contact us and we will give you a free assessment of feasibility. 

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