Bioavailability Enhancement - Oral Drug Products and Intermediates

The depth of our bioavailability (BA) enhancement offering makes us a leader in addressing addressing low solubility, low bioavailability and dissolution rate issues. We work collaboratively with our customers to advance compounds, or re-purpose existing compounds, across a full range of API properties and delivery challenges. Our end-to-end solutions incorporate full capabilities in bringing a compound from concept to commercialization, thereby minimizing program complexity, timelines and risk.

Industry estimates indicate that more than 80% of new chemical entities exhibit low solubility, low bioavailability and / or low or inconsistent dissolution rate. Effectively addressing these drug solubility, bioavailability and dissolution rate problems is essential for advancing the compound and providing the desired therapeutic benefit of the drug product to patient. And ensuring that the solubility solution incorporates the ultimate manufacturability of the drug product can avoid time-consuming re-formulation and rapid advancement to market.

We recognize the core challenges of advancing the new chemical compounds in today’s biopharmaceutical pipeline. That’s why we have developed a portfolio of bioavailability enhancement technologies and services with which to address poor solubility and inadequate or inconsistent dissolution rate.

Our commitment to our customers includes a 20+ year track record across our bioavailability enhancement approaches with phase-appropriate processing in place to support non-GMP feasibility assessments through GMP clinical trials and commercial-scale manufacturing.
Proven bioavailability enhancement technologiesOur bioavailability enhancement technologies include:

Particle size reduction: micronization and nano-millingSolid dispersion technologies: hot-melt extrusion or spray dryingSpecialized nanocrystalline dispersion and spray-dried nanoadsorbate technologiesComplementary drug delivery technologies are utilized to modulate pharmacokinetics of the solubilized compound and achieve a full range of absorption profiles.

Our scientists take a data-driven approach to characterizing BA problem statement(s) and selecting the enabling technology to advance your compound.

Our integrated product design and development services provide the full range of capabilities to support the rapid advancement of compounds from concept to clinic. This range of services has been integrated in our SimpliFiH® Solutions offering designed to be phase-appropriate and to simplify your pathway to IND/IMPD studies:

• API development and supply
• API characterization
• Product design and preformulation development
• Formulation and product development
• Analytical services and quality control
• Clinical trial manufacture
• Clinical packaging and supply services