Pharmacy and Pharmaceutical Sciences Commons^™

Critical Quality Attributes Of Topical Semi-Solid Dosage Forms: Solvent Activity, Muralikrishnan Angamuthu

Electronic Theses and Dissertations

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 …