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Related Concept Videos

Transdermal Drug Delivery Systems01:18

Transdermal Drug Delivery Systems

126
Transdermal drug delivery systems (TDDS) enable the controlled release of drugs across the skin into systemic circulation. They are particularly advantageous for drugs with short half-lives or narrow therapeutic indices, as they maintain consistent plasma concentrations and reduce the risk of subtherapeutic or toxic levels.TDDS are categorized into monolithic, reservoir, and mixed systems. Monolithic systems embed the drug in a polymer matrix, where diffusion governs release. Reservoir systems...
126
Modified-Release Drug Delivery Systems: Site-Targeted01:24

Modified-Release Drug Delivery Systems: Site-Targeted

91
Site-targeted drug delivery systems enhance therapeutic efficacy while minimizing systemic toxicity and treatment costs. Unlike conventional methods, these systems ensure precise drug delivery, improving bioavailability and reducing side effects. Targeted drug delivery is classified into three levels. First-order targeting directs drugs to the capillary beds of specific organs or tissues. Second-order targets specific cell types, such as tumor cells, using receptor-mediated interactions.
91
Bioavailability Enhancement: Drug Permeability Enhancement01:27

Bioavailability Enhancement: Drug Permeability Enhancement

299
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 secretion,...
299
Modified-Release Drug Delivery Systems: Stimuli-Activated01:30

Modified-Release Drug Delivery Systems: Stimuli-Activated

97
Stimuli-activated drug delivery systems are designed to release drugs in response to specific physical, chemical, or biological stimuli. These systems often utilize hydrogels—three-dimensional, hydrophilic polymer networks capable of swelling in aqueous environments and retaining significant fluid volumes. Upon exposure to particular stimuli, these hydrogels undergo structural transitions that allow the embedded drug to be released. Due to this adaptive behavior, such systems are also...
97
Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

740
Solid dosage forms such as tablets and capsules undergo rigorous manufacturing processes to ensure stability and effectiveness. Their dissolution and absorption properties are influenced significantly by the choice of excipients (inactive ingredients that serve various roles in the formulation), and the methodology applied during production. The manufacturing parameters, such as compression force and granulation techniques, significantly affect dissolution rates. Elevated compression forces...
740
In Vitro Drug Dissolution: Compendial Testing Models II01:09

In Vitro Drug Dissolution: Compendial Testing Models II

498
Various dissolution methods are utilized to assess a drug’s dissolution rate, including the flow-through cell, paddle-over-disk, cylinder, and reciprocating disk methods.The flow-through cell apparatus (USP (United States Pharmacopeia) method 4) comprises a reservoir for the dissolution medium and a pump that propels the medium through the cell containing the test sample. This method is crucial for assessing modified-release dosage forms with minimally soluble active ingredients,...
498

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Navigating sticky areas in transdermal product development.

Caroline Strasinger1, Sam G Raney2, Doanh C Tran3

  • 1Office of Pharmaceutical Quality, Center for Drug Evaluations and Research (CDER), United States Food and Drug Administration (US FDA), 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA.

Journal of Controlled Release : Official Journal of the Controlled Release Society
|April 28, 2016
PubMed
Summary
This summary is machine-generated.

Transdermal delivery systems offer advantages over oral routes but face development challenges. This review outlines best practices for quality and performance to accelerate commercialization of these complex dosage forms.

Keywords:
AdhesivesBiowaiverIn-vitro permeationIn-vitro releaseQuality and performanceQuality by designResidual drug analysisSkin irritation and sensitizationTransdermal

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Delivery Systems

Background:

  • Transdermal delivery offers superior bioavailability and controlled release compared to oral administration.
  • Commercialization of transdermal systems is hindered by significant development and manufacturing challenges.
  • Existing industry approaches for transdermal system development and manufacturing remain uncertain.

Purpose of the Study:

  • To provide an overview of challenges in transdermal system development.
  • To outline industry best practices for assuring quality and performance of transdermal delivery systems (TDS) and topical patches.
  • To accelerate the commercial development of complex transdermal dosage forms.

Main Methods:

  • Review of challenges in transdermal system development.
  • Discussion of industry best practices for quality and performance evaluation.
  • Categorization of topics into product quality and product performance evaluations.

Main Results:

  • Identified common challenges in the transition from theoretical to commercial production of TDS.
  • Highlighted industry best practices for ensuring TDS quality and performance.
  • Provided a framework for evaluating both product quality and performance.

Conclusions:

  • Addressing development and manufacturing challenges is crucial for realizing the full benefits of transdermal delivery.
  • Adherence to best practices in quality and performance evaluation can accelerate commercialization.
  • This review aims to advance and improve the development of transdermal delivery systems.