The increasing need to deliver medication to patients efficiently with fewer side effects and improved compliance has accelerated the pace of invention of new drug delivery systems. Revolutionary drug delivery technologies can improve the efficacy of a drug and provide pharmaceutical companies with a means of developing new products, as well as extending the life of existing patent franchises.

While medication can be delivered to a patient through various delivery systems, oral administration remains the preferred route. However, today's capsules and tablets have limited effectiveness in providing controlled drug delivery. They frequently result in drug release that is too rapid, causing incomplete absorption of the drug, gastro-intestinal irritation and other side effects. In addition, the need for frequent dosing of many drugs administered by capsules and tablets also can impede patient compliance with the prescribed regimen costing the healthcare system billions of dollars due to less than optimal therapeutic outcomes.

Most oral drug delivery technology involves a shell or coating around the proven and effective medication. The properties of that shell control the timed-release characteristics of the system. Current drug delivery technologies rely on specialized and expensive production of the shell, including laser boring and multiple membrane layering methodologies. Prior to the advent of Controlled Delivery Technology (CDT®), the required expertise and custom fabrication infrastructure have made these technologies costly and difficult to transfer to alternate third parties for manufacturing.

SCOLR Pharma's patented CDT® technology delivers Active Pharmaceutical Ingredients ("API") over an extended time period and is comparatively very easy to manufacture. Specifically, the CDT® system is founded on the art of the dynamics of matrix erosion, changes in gel thickness, electrolyte ionization as a marker of water mobility, and ionic interactions. This novel technology is a new generation of molecular scaffolding (or lattices) comprised of a matrix composed of a combination of polymers and electrolytes in a closed microenvironment. A progressive inward hardening between the Matrix and the dissolution medium controls outward diffusion of the drug. This causes a precision timed erosion and predictable, programmable release of the medicinal core not previously achievable with first-generation systems. In addition, these three technologies provide the capability of successfully formulating with three different drug classifications: class I (high permeability/high solubility), class II (low solubility/high permeability), and class III drugs (high solubility/low permeability). Historically, class III drugs have exhibited difficulties with conventional release technologies because of their unique characteristics.

The Biopharmaceutical Classification Scheme (BCS)

• Amidon et al, Pharm. Res. 12, 413-420, (1995)
• Guidance for Industry: FDA 1995
• Table compiled by R. Fassihi (2001)
• Sustained Release / Controlled Release = only applies to drugs that qualify in terms of Pharmacokinetics and Pharmacodynamics for controlled release development

Important factors which influence the absorption process:

• Release rate from the delivery system
• Drug degradation within the GI tract, GI content, pH, enzymes and amphiphilic bile secretions
• Poor permeability across gut mucosa, preferential absorption capacity of different GI sites
• Delivery system transit time through the GI Tract
• First pass metabolism and potential exsorption into the GI Tract
• Dose to Solubility [D/S] Ratio as a function of pH under Fed & Fasted State