the MicroDose PolyCap™
system

Combination products on the rise

Fixed-dose-combination (FDC) products targeting the same indication (polypharmacy) have been widely available for years and are rapidly expanding. And as patient populations suffering from a multitude of ailments (co-morbidity) have grown, the need to lower the pill burden for this population has increased.

But combining drugs with different chemistries can be challenging, and in some cases unfeasible. The goal, therefore, has become to create a simple, effective, and low-cost oral delivery system to deliver multiple medications at the same time with a single pill or capsule.

MicroDose solves the formulation and pill burden challenge

In response to this growing need, MicroDose has created the patented PolyCap™ System, a proprietary approach that enables the rapid development of FDC therapies in a single dose, but separated by a physical barrier. As this innovative approach relies on the proven strengths of capsules and the advantages of a barrier system, it allows for more rapid development timelines, reduced risk, and lower regulatory requirements.

Advantages

• Lower development costs
• Lower regulatory requirements
• Shorter time-to-market (potentially less than two years)
• Reduced pill burden and improved patient compliance
• Easier manufacture
• Potential for FDA Exclusivity
• Provides a barrier to generic competition

With the PolyCap™ System, the MicroDose FDC approach supplies an effective means to implement life-cycle-management strategies, minimize technical and regulatory risk, and enable new product development at a fraction of the cost it takes to bring a traditional combination product to market.

Manufacturing capability

The infrastructure for the development and commercial supply of these products has been put in place. Proof of concept has been established for multi-compartment capsule design and manufacture. Prototype high volume capsule handling and filling equipment has been manufactured and tested, and a collaboration secured with a GMP manufacturer. A preIND meeting has been held with the FDA for the first product envisioned with the PolyCap™ approach with positive outcomes. The capsule handling and filling equipment is pictured:

Applications

Applications are broad, from combination products targeting the same indication (polypharmacy) to combination products addressing the growing patient populations suffering from multiple ailments (co-morbidity).

MicroDose has identified and is developing combination products for its own use in the high growth areas of hypertension, hyperlipidemia, and Type II diabetes. In addition, the PolyCap™ strategy is focused on developing combination products with partners to address large chronic care markets and dietary needs including:

• Cholesterol reduction
• Obesity
• Dietary supplements
• Analgesics
• Oncology