Oral Drug Delivery Resources

1. Managing Poor Solubility With Cutting-Edge Formulation Approaches 8/24/2022

   An increasing number of poorly soluble APIs are the cornerstone of cutting-edge therapies, necessitating equally complex formulation technologies to maintain or improve solubility and, ultimately, bioavailability.

2. A Phase I Study Allowing Clinical Screening Of Multiple Solubility-Enhancement Formulation Technologies 3/7/2022

   The study was designed to assess the clinical performance of prototype formulations, assess food effect and dose linearity of a selected formulation, and the impact on exposure in subjects taking proton pump inhibitors (PPI).

3. Innovative Formulation Technologies By 505(b)(2) Regulatory Pathway 1/24/2022

   Revitalization of older marketed drugs using innovative drug delivery technologies can provide new marketing exclusivity and patent protection, offering an effective tool for product life cycle management.

4. Sophisticated Formulation Approaches For Insoluble Drug Candidates 1/24/2022

   A sophisticated drug delivery approach involves collaboration, technical experience, and years of working knowledge in drug development at different stages of the process.

5. Solutions For Accelerated Pharmaceutical Development

   Explore an integrated service package designed to simplify and accelerate the development pathway, even for APIs with challenging properties such as low aqueous solubility and poor bioavailability.

6. Harness High-Quality PBPK Modeling To Enhance Clinical Readiness

   Physiologically based pharmacokinetic (PBPK) modeling advancements are helping drug sponsors mitigate risk in preclinical and clinical studies through early identification of poor absorption properties.

7. 10 Ways To Align Your Medical Device With Human Factors Industry Best Practices 3/1/2024

   Discover how patient-centric design principles can improve the development of medical devices. By focusing on user needs and behaviors, manufacturers can ensure that products align with expectations.

8. Engineering Advances In Needle Geometry To Accommodate Viscous Biologics 2/1/2023

   Explore the challenges faced in administering highly viscous biologics to patients via subcutaneous injection and how new special thin-wall needles are able to tackle them.

9. Oral Controlled Delivery Of Poorly Water-Soluble Drugs 1/27/2022

   Various drug delivery nanotechnologies, such as nano-suspensions, lipid microemulsions, nano-emulsions, and amorphous solid dispersions, have been critical in overcoming bioavailability challenges.

10. Drug Formulation Development: Quick Reference Guide 7/11/2022

    This guide shares the steps involved in formulation development, considerations during formulation, and how partnering with an experienced CDMO can lead to a successful commercial product.