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Related Concept Videos

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.
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Drug Delivery: Miscellaneous Routes01:22

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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.
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Methods for Studying Drug Absorption: In situ01:09

Methods for Studying Drug Absorption: In situ

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In situ experiments, such as the Doluisio method and Single-Pass Perfusion technique, provide critical insights into drug uptake by simulating in vivo conditions for drug absorption.
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Non-Oral Extravascular Drug Absorption Routes

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Non-oral extravascular routes, which encompass sublingual, buccal, topical, intramuscular, and inhalation methods, primarily utilize passive diffusion to transport drugs into the systemic circulation. The absorption rates and effectiveness of these routes depend on the drug's physicochemical properties, as well as the patient's anatomical and pathophysiological state.
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The enteral drug administration involves three primary routes: oral, sublingual, and buccal. Oral ingestion is the most prevalent, safe, economical, and convenient method for drug administration. However, it has certain drawbacks, including limited absorption due to the drug's low water solubility or poor membrane permeability, possible emesis from GI mucosa irritation, destruction of drugs by digestive enzymes or low gastric pH, and irregular absorption along with food or other drugs.
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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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Related Experiment Video

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Using Lung Regional Deposition Modeling as Model-Integrated Evidence for Locally Acting Orally Inhaled Drug Products.

Ross L Walenga1, Steven G Chopski2, Jae H Lee2

  • 1Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, U. S. Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. Ross.Walenga@fda.hhs.gov.

Pharmaceutical Research
|November 6, 2025
PubMed
Summary

Lung regional deposition modeling (RDM) offers a solution for evaluating drug delivery in orally inhaled drug products (OIDPs). This method aids in understanding region-specific lung delivery, facilitating generic product development and improving patient access.

Keywords:
Computational fluid dynamicsModel credibilityModel-integrated evidenceOrally inhaled drug productsRegional deposition modeling

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Area of Science:

  • Pharmacokinetics and Drug Delivery
  • Respiratory Medicine
  • Computational Modeling

Background:

  • Evaluating drug delivery for locally acting orally inhaled drug products (OIDPs) is challenging due to the lack of direct lung region drug concentration quantification.
  • Current in vivo regional deposition studies have limitations, including small sample sizes, long durations, and 2D result representations.

Purpose of the Study:

  • To highlight the utility of lung regional deposition modeling (RDM) for assessing region-specific drug delivery from OIDPs.
  • To explore how RDM can inform the development of in vitro-in vivo correlations for OIDPs.

Main Methods:

  • Utilizing lung regional deposition modeling (RDM) to simulate and understand physical processes influencing drug delivery in the lungs.
  • Integrating RDM with in vitro and/or in vivo data for model validation and parameter input.
  • Establishing model credibility through validation processes.

Main Results:

  • RDM provides valuable insights into region-specific drug delivery within the lungs for locally acting OIDPs.
  • The integration of RDM with experimental data can lead to the development of robust in vitro-in vivo correlations.
  • Credible RDM can be considered model-integrated evidence (MIE).

Conclusions:

  • Lung regional deposition modeling (RDM) is a powerful tool for evaluating drug delivery in orally inhaled drug products (OIDPs).
  • Model-integrated evidence (MIE) derived from RDM can facilitate the development and approval of generic OIDPs.
  • This approach can ultimately improve the accessibility of essential inhaled medications for patients.