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. Simultaneous Spray Drying For Combination Dry Powder Inhaler Formulations 7/12/2022

    Three combination case studies are demonstrated, in which bevacizumab is paired with erlotinib, cisplatin, or paclitaxel in a dry powder inhaler formulation.

  4. 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.

  5. 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.

  6. Advances In Spray Drying For Enhanced Bioavailability And Improved Formulation Control

    In a recent webinar, Lonza discussed the process it uses to develop a spray dried powder formulation and scale from early feasibility studies to manufacturing.

  7. Simultaneous Spray Drying For Large/Small Mol Combinations 8/9/2022

    Gain insights into a “simul-spray” process pioneering for combining small and large molecules into a single, atomized drug product for inhalation administration.

  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. Engineering Approaches To Respiratory Drug Delivery 5/27/2022

    Explore the material and performance properties of spray-dried and jet-milled mannitol for respiratory delivery of crystalline mannitol.