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Related Concept Videos

Inhaled Medications01:23

Inhaled Medications

486
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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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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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...
553
Bioavailability Enhancement: Drug Solubility Enhancement01:16

Bioavailability Enhancement: Drug Solubility Enhancement

22
Body:Bioavailability is a critical factor in determining a drug's effectiveness. It refers to the proportion of a drug that enters the circulation when introduced into the body and is, as a result, able to have an active effect. Enhancing bioavailability is essential for drugs with poor solubility, as it can significantly impact their therapeutic efficacy. Various methods are employed to increase the solubility of drugs, thereby enhancing their bioavailability.Micronization and nanonization are...
22
Drug Product Performance: In Vitro–In Vivo Correlation01:20

Drug Product Performance: In Vitro–In Vivo Correlation

47
In pharmaceutical development, it's crucial to establish a predictive in vitro–in vivo correlation (IVIVC) for two or more formulations to gain a comprehensive understanding of release properties. IVIVC reduces the need for costly in vivo studies and facilitates the establishment of meaningful dissolution specifications with significant cost savings and decreased regulatory burden. Furthermore, a meaningful IVIVC should predict Cmax and AUC within 20%, aligning with FDA guidance while...
47
Bioavailability Enhancement: Drug Permeability Enhancement01:27

Bioavailability Enhancement: Drug Permeability Enhancement

29
Body:After oral administration, poor permeability often limits the rate at which drugs are absorbed through the intestinal epithelium. Enhancing drug permeability is crucial for effective therapy, and several strategies have been developed to overcome this challenge.One effective strategy involves the use of lipid-based formulations. These formulations enhance dissolution and solubility, targeting physiological mechanisms to increase drug absorption. This includes stimulating bile salt...
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Development of a Preclinical Inhalation Model to Test Vaporized Cannabis Distillates
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Improved Bioavailability with Dry Powder Cannabidiol Inhalation: A Phase 1 Clinical Study.

Orrin Devinsky1, Kelly Kraft2, Lorraine Rusch3

  • 1Department of Neurology, Comprehensive Epilepsy Center, New York University School of Medicine, New York, NY, United States.

Journal of Pharmaceutical Sciences
|August 17, 2021
PubMed
Summary

Inhaled cannabidiol (CBD) offers faster absorption and higher bioavailability than oral CBD. This dry-powder inhaler formulation shows promise for acute indications, improving therapeutic potential.

Keywords:
BioavailabilityClinical pharmacokineticsFirst-pass metabolismInhalationPulmonary drug delivery

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Area of Science:

  • Pharmacology
  • Drug Delivery Systems
  • Cannabinoid Therapeutics

Background:

  • Oral cannabidiol (CBD) formulations are FDA-approved for specific seizure disorders but face limitations.
  • Extensive first-pass hepatic metabolism of oral CBD reduces its therapeutic efficacy and increases inactive metabolite levels.
  • Inhalation offers a potential alternative route to bypass hepatic metabolism and improve systemic CBD delivery.

Purpose of the Study:

  • To compare the pharmacokinetics (PK) of a novel dry-powder inhaler (DPI) CBD formulation against the oral solution Epidiolex® in healthy participants.
  • To evaluate the safety and tolerability of inhaled CBD via a DPI compared to oral administration.

Main Methods:

  • A Phase 1 clinical study involving healthy participants.
  • Single-dose administration of DPI CBD (2.1 mg) and oral CBD (50 mg Epidiolex®).
  • Pharmacokinetic analysis of CBD concentrations and time to maximum concentration (Tmax) in plasma.

Main Results:

  • Inhaled DPI CBD achieved a 71-fold higher peak CBD concentration than oral Epidiolex®.
  • The mean time to reach maximum CBD concentration was significantly faster with DPI CBD (3.8 min) versus oral CBD (122 min).
  • DPI CBD administration resulted in a 24-fold lower dose compared to oral CBD for these outcomes.

Conclusions:

  • Dry-powder inhaler CBD demonstrates significantly enhanced bioavailability and a more rapid onset of action compared to oral CBD formulations.
  • The DPI CBD formulation is safe and well-tolerated, supporting its potential for treating acute conditions.
  • Further research into DPI CBD is warranted for acute indications requiring rapid therapeutic effects.