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Evaluation between the Usability and Physicochemical Property of Acyclovir Ointments
Yutaka Inoue1, Akiho Mitsumori1, Itsuka Shinohara1
1Laboratory of Drug Safety Management, Faculty of Pharmacy and Pharmaceutical Sciences, Josai University, 1-1 Keyakidai, Sakado-shi, Saitama 3500295, Japan.
Journal of Pharmaceutics
|August 30, 2018
Summary
Additives in acyclovir (ACV) ointments affect physicochemical properties and usability. Differences in additives like macrogol influence factors such as viscosity, moisture content, and skin friction, impacting patient experience with generic and switch OTC drugs.
Area of Science:
- Pharmaceutical Sciences
- Dermatology
- Materials Science
Background:
- Many prescription drugs are now available over-the-counter (OTC), but formulations, including additives, can vary significantly between brand-name, generic, and switch OTC versions.
- These variations in additives can lead to different patient experiences and perceptions of usability, even for the same active pharmaceutical ingredient.
Purpose of the Study:
- To compare the physicochemical properties and usability (assessed via skin friction) of five acyclovir (ACV) ointments.
- To investigate how differences in additives, particularly macrogol, influence these properties in brand-name, generic, and switch OTC acyclovir formulations.
Main Methods:
- Evaluated physicochemical properties including content uniformity, water content, flattening (yield value), viscosity, viscoelasticity, and near-infrared (NIR) absorption spectroscopy.
- Measured skin friction to assess the usability and 'feeling' of the ointments upon application.
- Analyzed five ACV ointments: one brand-name (ACV-A), two generics (ACV-B, ACV-C), and two switch OTC (ACV-D, ACV-E).
Main Results:
- Acyclovir content was uniform and equivalent across all tested ointments.
- Significant differences were observed in moisture content, yield value, viscosity, and viscoelasticity among the preparations.
- Near-infrared (NIR) spectroscopy indicated broader absorption spectra for generic ointments (ACV-B, ACV-C).
- ACV-B exhibited the lowest skin friction, suggesting superior usability compared to other formulations.
Conclusions:
- Variations in ointment additives, specifically macrogol, are directly linked to differences in physicochemical properties.
- These property variations influence the usability and tactile feel of acyclovir ointments, impacting patient experience.
- Understanding additive-driven property changes is crucial for developing consistent and user-friendly topical medications, especially for generic and switch OTC products.
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