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Related Concept Videos

Factors Influencing Drug Absorption: Pharmaceutical Parameters01:28

Factors Influencing Drug Absorption: Pharmaceutical Parameters

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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...
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Drug Delivery: Overview01:16

Drug Delivery: Overview

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The selection of a drug's delivery route depends upon its physicochemical properties, including lipid or water solubility and ionization, as well as the therapeutic requirement, such as immediate or sustained effect. These routes can be divided into three primary categories: enteral, parenteral, and topical.
Enteral delivery involves administering drugs directly through swallowing, sublingual placement, or buccal application. Orally administered drugs predominantly navigate the...
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A rational dosage regimen considers a drug's pharmacokinetics, including its absorption, distribution, metabolism, and elimination from the body. By understanding these factors, the appropriate dosage can be determined, and the dosing schedule can be designed to achieve and maintain the desired therapeutic effect while minimizing adverse effects.
In most cases, drugs are administered repetitively or infused continuously to maintain a steady-state concentration in the body. At a steady...
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Factors Affecting Dissolution: Particle Size and Effective Surface Area01:23

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Dissolution kinetics, an essential aspect of oral drug delivery, is significantly influenced by the drug's particle size. According to the Noyes-Whitney dissolution model, the dissolution rate correlates directly with the drug's surface area. The larger the surface area, the higher the drug's solubility in water, leading to a faster drug dissolution rate. Reducing particle size increases the effective surface area, enhancing the dissolution process. Micronization and nanosizing are...
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Biopharmaceutics and Pharmacokinetics: Overview01:28

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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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Routes of Drug Administration: Overview01:22

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Drug administration involves delivering drugs to the body through various routes, such as enteral, parenteral, and topical.
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Corrigendum to "Reflection paper on the APV workshop on in vitro performance testing of topically applied and topically acting substances" [Eur. J. Pharm. Biopharm. 220 (2026) 114971].

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V·2026
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Reflection paper on the APV workshop on in vitro performance testing of topically applied and topically acting substances.

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V·2025
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Ceramide Profiling of Porcine Skin and Systematic Investigation of the Impact of Sorbitan Esters (SEs) on the Barrier Function of the Skin.

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Rational Design of Topical Semi-Solid Dosage Forms-How Far Are We?

Michael E Herbig1, Dirk-Heinrich Evers1, Sascha Gorissen1

  • 1RaDes GmbH, Schnackenburgallee 114, 22525 Hamburg, Germany.

Pharmaceutics
|July 29, 2023
PubMed
Summary

Rational formulation design for topical semi-solid dosage forms leverages skin penetration science and stability analysis. This approach enhances the development of innovative and robust drug delivery systems.

Keywords:
analyticschemical stabilityexcipientspre-formulationrheologysaturationsemi-solid formulationskin penetrationsolubilitytopical delivery

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Area of Science:

  • Pharmaceutical Sciences
  • Dermatology
  • Materials Science

Background:

  • Topical semi-solid dosage forms present unique challenges including skin barrier interaction, physical/chemical instability, and sensory perception.
  • Current formulation design often relies on traditional methods rather than rational, science-based approaches.
  • Advances in understanding skin penetration and formulation structure offer opportunities for improved design.

Purpose of the Study:

  • To analyze the opportunities and constraints of rational formulation design in industrial topical drug development.
  • To discuss models for drug selection based on physicochemical properties to accelerate success.
  • To review the application of skin penetration science for rational formulation design.

Main Methods:

  • Review of scientific literature on skin penetration, formulation design, and stability.
  • Discussion of theoretical and experimental models for drug candidate selection.
  • Focus on modern rheological and analytical methods for semi-solid formulation characterization and stability assessment.

Main Results:

  • Rational design requires understanding skin penetration mechanisms and formulation influences.
  • Drug selection based on favorable physicochemical properties is crucial for development speed and success.
  • Characterization should include advanced rheology and stability testing aligned with regulatory guidelines.

Conclusions:

  • Integrating scientific principles with early regulatory consideration enables successful development.
  • Innovative and robust semi-solid topical formulations benefit from rational design approaches.
  • Optimizing chemical stability and understanding skin penetration are key enablers for topical drug delivery.