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Related Concept Videos

Inhaled Medications01:23

Inhaled Medications

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Inhaled medications are crucial for managing chronic obstructive pulmonary disease (COPD) and asthma. They are essential for effective treatment and control, ensuring optimal respiratory health and well-being. Inhaled medication delivers drugs directly to the lungs, providing a rapid onset of action and reducing systemic side effects compared to oral or injectable medications. Three primary types of inhalation devices are used to administer these medications: nebulizers, metered-dose inhalers...
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Biopharmaceutics and Pharmacokinetics: Overview01:28

Biopharmaceutics and Pharmacokinetics: Overview

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Understanding drugs, drug products, and their performance in pharmaceutical science is pivotal. Drugs, whether simple molecules or complex compounds, are designed to interact with the body's biological systems to diagnose, treat, or prevent diseases. Drug products include various delivery systems such as tablets, capsules, injections, and inhalers. The performance of these drug products is gauged by their ability to deliver the active ingredient to the desired site of action at the...
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Drug Delivery: Miscellaneous Routes01:22

Drug Delivery: Miscellaneous Routes

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Drug delivery methods like oral inhalation, nasal sprays, transdermal patches, eye drops, intravitreal injection,  and rectal administration provide localized effects with reduced toxicity.
Oral inhalation and nasal sprays swiftly transfer drugs across the respiratory epithelium's mucosal layer. Inhaled glucocorticoids and bronchodilators directly target lung conditions such as asthma, while fluticasone nasal spray mitigates allergic rhinitis.
Transdermal patches transport drugs...
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Additional Routes of Drug Administration01:18

Additional Routes of Drug Administration

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Choosing the appropriate route of drug administration is significantly influenced by two key factors: the therapeutic objectives and the inherent properties of the drug being used.
Administering drugs via inhalation allows for the direct delivery of gaseous, volatile substances or droplets to different parts of the respiratory tract. One of the advantages of the inhalation route is the rapid absorption of drugs into the circulatory system, which is possible because of the large surface area of...
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Drugs Used in Lower Respiratory Disorders: Overview01:17

Drugs Used in Lower Respiratory Disorders: Overview

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Lower respiratory tract disorders present challenges that often require skilled and nuanced approaches for effective management. Common ailments, such as asthma and chronic obstructive pulmonary disease (COPD), have prompted the development of intricate treatment strategies involving bronchodilators and anti-inflammatory drugs, each tailored to ease breathing and revitalize the lungs.
Bronchodilators, the first step of respiration enhancement, come in various forms, each with its own mechanism...
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Asthma-IV: Diagnostic and Management01:30

Asthma-IV: Diagnostic and Management

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The diagnosis and management of asthma are comprehensive, encompassing clinical assessments, lung function tests, and pharmacological interventions. Here's an overview:
Clinical Assessment for Asthma:
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Related Experiment Video

Updated: May 15, 2025

Dry Powder and Nebulized Aerosol Inhalation of Pharmaceuticals Delivered to Mice Using a Nose-only Exposure System
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Inhalable and Nasal Biologics: Analytical, Formulation, Development, and Regulatory Considerations.

David Cipolla1, Christopher J Gruenloh2, Nani Kadrichu3

  • 1Research Department, Insmed Incorporated, Bridgewater, New Jersey, USA.

Journal of Aerosol Medicine and Pulmonary Drug Delivery
|April 8, 2025
PubMed
Summary

Inhalable and nasal biologics (INBs) offer advantages over injections, but require careful development. This report guides INB development by discussing Chemistry, Manufacturing, and Controls (CMC) and bioequivalence (BE) considerations.

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biologicsinhaledlarge moleculenasalregulatoryrespiratory

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Area of Science:

  • Pharmaceutical Sciences
  • Biotechnology
  • Regulatory Science

Background:

  • Inhalation and intranasal delivery of large molecules and biologics offer direct targeting, bypass metabolism, and convenience.
  • Significant growth in research and development for inhalable and nasal biologics (INBs) is observed.
  • Challenges in formulation, manufacturing, analytical testing, and regulatory review must be addressed for INB market entry.

Purpose of the Study:

  • To summarize expert discussions on applying Chemistry, Manufacturing, and Controls (CMC) and bioequivalence (BE) principles to INB development.
  • To review applicable literature and regulatory guidelines for INBs in the absence of explicit guidance.
  • To explore the balance between INB requirements and established medical aerosol techniques.

Main Methods:

  • Review of existing US FDA and EMA guidelines for biologics and small-molecule inhalation/nasal products.
  • Synthesis of discussions from the 2023 International Society for Aerosols in Medicine (ISAM) and International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) workshop.
  • Inclusion of recent developments and case studies on generic peptides, inhaled biologics, and viral-based products.

Main Results:

  • Description of regulatory expectations for INB development.
  • Guidance on selecting delivery systems and formulation types for INBs.
  • Overview of analytical techniques for assessing INB product quality attributes.

Conclusions:

  • INBs hold promise for treating diseases with unmet needs and reducing injection burden.
  • Continued collaboration among researchers, developers, and regulators is crucial for advancing INB therapies.
  • Successful development and regulatory approval of INBs will ultimately benefit patients and improve health outcomes.