Inhalation Drug Delivery Resources

  1. Application Of Nano-Emulsion Technology To Address Unmet Medical Needs: A Case Study Of Clopidogrel IV By 505(b)(2) Pathway 1/26/2022

    Review a process where the insoluble and unstable free-base form of clopidogrel is converted to a form with acceptable drug loading and is protected from chemical degradation.

  2. 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.

  3. The Gateway Delivery To The Brain 1/30/2026

    Nose‑to‑brain delivery enables targeted neurological treatment by using direct neural pathways to boost precision and limit systemic exposure, with new formulations and devices driving rapid progress.

  4. 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.

  5. 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.

  6. 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.

  7. Streamlining The Path To Market For Generic Drug-Device Combinations 9/18/2024

    Developing g-DDCPs is a complex and time-consuming process. By using a risk-based approach, manufacturers can streamline the development process and bring g-DDCPs to market more quickly.

  8. Spray Drying For Innovative Dry Powder Inhaler Combination Formulations

    Combination therapies delivered directly to the lung by dry powder inhalants are an effective means of reducing patient burden. Read about case studies that illustrate the potential for improving care.

  9. 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.

  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.