Critical Quality Attributes of Topical Semi-solid Dosage Forms: Solvent Activity
type: CreativeWork
description: Critical quality attribute has been defined as “a physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality”. Deviations from preset quality metrics may potentially result in drug products with inferior therapeutic efficacy and unacceptable clinical safety profile. Topical cream formulations may possess numerous quality attributes that can affect the permeation of the drug through skin and consequently therapeutic efficacy. CQAs of topical formulations are often aimed at characterizing either the physicochemical properties of APIs or bulk characteristics of the formulation itself. Solvent systems constitute a major proportion of semisolid cream type formulations and its inclusion is critical to overall product performance (drug delivery to skin). A majority of the commercially available dermatological formulations contain solvent systems (water, ethanol, propylene glycol, glycerol and liquid chemical permeation enhancers) but the significance of solvent activity (thermodynamic solvent properties) on product performance has not been investigated so far, to be translated into a quality metric system (CQA). Water was utilized as a model solvent in order to link thermodynamic solvent activity and drug delivery performance of topical semi-solid cream systems. The overall aim of the research investigation is to evaluate water activity as a critical quality attribute of topical semi-solid dosage forms. Primary goal of this study was to investigate the mechanistic effects of water activity on drug release properties of formulation and drug permeation across the skin. A related objective was to investigate the mechanistic effects of water activity on skin hydration and barrier properties. For mechanistic investigation, a simple topical vehicle of varied aw (0.97 - 0.42) was formulated using deionized water with caffeine (model drug). Drug transport stud…
abstract: Critical quality attribute has been defined as “a physical, chemical, biological or microbiological property or characteristic that should be within an appropriate limit, range, or distribution to ensure the desired product quality”. Deviations from preset quality metrics may potentially result in drug products with inferior therapeutic efficacy and unacceptable clinical safety profile. Topical cream formulations may possess numerous quality attributes that can affect the permeation of the drug through skin and consequently therapeutic efficacy. CQAs of topical formulations are often aimed at characterizing either the physicochemical properties of APIs or bulk characteristics of the formulation itself. Solvent systems constitute a major proportion of semisolid cream type formulations and its inclusion is critical to overall product performance (drug delivery to skin). A majority of the commercially available dermatological formulations contain solvent systems (water, ethanol, propylene glycol, glycerol and liquid chemical permeation enhancers) but the significance of solvent activity (thermodynamic solvent properties) on product performance has not been investigated so far, to be translated into a quality metric system (CQA). Water was utilized as a model solvent in order to link thermodynamic solvent activity and drug delivery performance of topical semi-solid cream systems. The overall aim of the research investigation is to evaluate water activity as a critical quality attribute of topical semi-solid dosage forms. Primary goal of this study was to investigate the mechanistic effects of water activity on drug release properties of formulation and drug permeation across the skin. A related objective was to investigate the mechanistic effects of water activity on skin hydration and barrier properties. For mechanistic investigation, a simple topical vehicle of varied aw (0.97 - 0.42) was formulated using deionized water with caffeine (model drug). Drug transport stud…
author: Angamuthu, Muralikrishnan
keywords: Critical Quality Attributes, Drug Release, Manufacturing Variabilities, Percutaneous Absorption, Solvent Activity, Topical Semi-Solid Dosage Forms, Pharmacy and Pharmaceutical Sciences
date published: 2016-01-01T08:00:00Z
date modified: 2026-07-24T03:06:53Z
provider: University of Mississippi
publisher: Networked Digital Library of Theses and Dissertations
type: WebPage
source organization: University of Mississippi