Technology: Diffucaps®
Eurand’s Diffucaps technology facilitates the development and commercialization of novel, controlled-release delivery systems for once- or twice-daily dosing of single drugs or drug combinations that exhibit extreme pH-dependent solubility profiles and/or are poorly soluble in physiological fluids
Diffucaps is a multiparticulate bead system comprised of multiple layers of drug, excipients, and release-controlling polymers. The beads contain a layer of organic acid or alkaline buffer to control the solubility of a drug by creating an optimal pH microenvironment for drugs that exhibit poor solubility in intestinal pH, in environments with pH greater than 8.0, or in physiological fluids.. Alternatively, the beads can contain a solid-solution of drug and crystallization inhibitor to enhance bioavailability by maintaining the drug in its amorphous state.
Diffucaps technology is especially suitable for drugs that traditionally require multiple daily doses or drugs needing customized release formulations. Each Diffucaps bead has an inert core surrounded by drug and coated with a functional polymer membrane to control the rate of drug release.
Diffucaps also can be combined with other proprietary Eurand technologies to optimize drug delivery. Diffucaps beads are <1.5 mm in diameter and can be filled into capsules or compressed into orally disintegrating tablets. In addition,as a multi-particulate system, Diffucaps products produced in capsules allow for the capsules to be opened and the contents used as a sprinkle on foods, providing a flexible dosage form for patients who experience difficulty swallowing tablets or capsules.
The flexibility of the Diffucaps system allows for easy adjustment of the release profile and dosing strength to achieve targeted in vivo results. For drug development partners involved in clinical testing, this flexibility simplifies dose-ranging studies because the beads can be encapsulated separately to create separate study arms.
Eurand’s Diffucaps technology is used in several currently marketed products and in novel products in clinical development.
Advantages of Diffucaps
- Ideal for drugs exhibiting poor solubility in lower intestinal pH, in environments with pH above 8.0, or in physiological fluids
- Can combine multiple drugs and/or multiple release profiles in the same dosage form
- Simple formulation of dose-proportional strengths.
- Can minimize food effect
Case Studies
More Information
For more information, contact Eurand at partners@eurand.com or +1-267-759-9340
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