Oral Drug Delivery Resources

1. Optimizing Formulations With Bioavailability Enhancement Technologies

   API-sparing development techniques and identifying the appropriate scalable formulation technology to improve drug solubility and enhance oral bioavailability can help increase your chances of success.

2. Crystallization Process Dev: Ramping Up Bench-Scale Control 1/20/2022

   Since physical structure and biological activity are directly linked, controlling the physical form of a compound is paramount to a final drug product’s quality and effectiveness.

3. 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).

4. Overcoming Limitations To Achieve Uniform Dosing 1/24/2022

   An immediate need for lower dose capsules in the clinic posed several challenges in blend formulation with very tight timelines for delivery.

5. A Clinical Assessment Of Delayed-Release Coated Capsule Compositions For Regional Gastrointestinal Delivery Using Gamma Scintigraphy 3/7/2022

   Gamma scintigraphy was used to evaluate GI transit and release from 3 capsule prototypes with different coating systems; data on pH, temperature and pressure during GI transit was obtained and correlated.

6. Combination Products: Market Trends And Regulatory Considerations 1/17/2024

   Combination products provide significant avenues for increasing patient adherence and overall efficacy. This collection outlines the opportunity and identifies strategies for gaining regulatory approval.

7. Integrated Strategies for Achieving Regulatory Milestones Faster 10/12/2023

   Learn how an innovative formulation platform reduced development timelines and allowed a sponsor to find the optimal nafamostat formulation without adding unnecessary delays.

8. Improve Solubility And Spray Drying Throughput For Brick Dust Compounds

   This paper presents three approaches to address poor solubility in organic solvents for spray drying as well as case studies outlining their successful application during development.

9. Spray Drying For Improved Solubility 11/15/2022

   Gain expert insights into how to develop a spray dried powder formulation and scale it from early feasibility studies to commercial manufacturing.

10. Improved Bioavailability In 12 Weeks 2/26/2018

    A lead compound showed clinical promise but had limited bioavailability owing to low solubility. Learn about the challenges, including the molecular characterization and limited budget, and the structured 3-step approach.