Inhalation Drug Delivery Resources

1. Application Of A Novel Temperature Shift Process For Particle Engineering

   Spray drying of amorphous dispersions improves solubility and bioavailability, enabling supersaturation in the intestine and driving higher absorption rates when compared to crystalline drug forms.

2. Formulation Development From Preclinical To First-In-Human 1/24/2022

   A compound with poor biopharmaceutical properties or improper formulation design could lead to a delay in the project or even program termination.

3. Using 505(B)(2) To Streamline Approval Of Combination Products 2/2/2023

   In recent years, the quantity of approvals for products and 505(b)(2) applications has risen, causing developers to map out their regulatory strategy as early as possible.

4. 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.

5. Mitigating Hidden Risks: Extractables And Leachables 1/24/2022

   Everything from glass or plastic bottles to the ink used in labels can leach unwanted contaminants. The first challenge chemists address is to narrow the focus on the most likely suspects.

6. Complex Molecules, Complex Problems

   The support of an experienced CDMO is critical to overcoming complexity when working with highly potent APIs and when solving solubility challenges.

7. Precision Powder-In-Capsule Micro-Dosing Accelerates Drug Development 6/1/2022

   Precision powder microdosing makes it possible to quickly get formulations to the clinic, saving time, money, and use of limited APIs.

8. Procuring Packaging And Delivery Systems: Single Versus Dual Sourcing 6/2/2026

   In this article, Fran DeGrazio examines the trend toward dual sourcing of products, components, and materials for drug delivery packaging and systems. She outlines the key differences between single and dual sourcing and makes recommendations about using one versus the other while mitigating supply chain and product quality risk. 

9. Simultaneous Spray Drying For Innovative Dry Powder Inhaler Combination Formulations

   Dr. Kimberly Shepard, a principal R&D engineer at Lonza, offered insights on recent innovations pioneered in spray drying. Shepard also discussed spray drying technologies capable of combining small-molecule APIs with biotherapeutic molecules.

10. Formulation Research Strategy For Discovery- Stage New Drug Candidates 1/24/2022

    Early stage formulation studies, which should support the emerging target product profile, will often yield important experimental results to aid subsequent development of clinically relevant dosage forms.