Ophthalmic Nanoemulsions: From Composition to Technological Processes and Quality Control

• Published in: Molecular pharmaceutics Vol. 18; no. 10; pp. 3719 - 3740
• Main Authors: Gawin-Mikołajewicz, Agnieszka, Nartowski, Karol P, Dyba, Aleksandra J, Gołkowska, Anna M, Malec, Katarzyna, Karolewicz, Bożena
• Format: Journal Article
• Language: English
• Published: United States American Chemical Society 04.10.2021
• Subjects: Administration, Ophthalmic; Emulsions - administration & dosage; Emulsions - chemical synthesis; Emulsions - chemistry; Emulsions - standards; Eye Diseases - drug therapy; Humans; Nanoparticle Drug Delivery System - administration & dosage; Nanoparticle Drug Delivery System - chemical synthesis; Nanoparticle Drug Delivery System - chemistry; Nanoparticle Drug Delivery System - standards; Quality Control; Review; ocular drug delivery; emulsification; nanoemulsion; high-energy methods; ophthalmic nanoemulsion; low-energy methods
• ISSN: 1543-8384; 1543-8392; 1543-8392
• DOI: 10.1021/acs.molpharmaceut.1c00650

Nanoemulsions are considered as the most promising solution to improve the delivery of ophthalmic drugs. The design of ophthalmic nanoemulsions requires an extensive understanding of pharmaceutical as well as technological aspects related to the selection of excipients and formulation processes. This Review aims at providing the readers with a comprehensive summary of possible compositions of nanoemulsions, methods for their formulation (both laboratory and industrial), and differences between technological approaches, along with an extensive outline of the research methods enabling the confirmation of in vitro properties, pharmaceutical performance, and biological activity of the obtained product. The composition of the formulation has a major influence on the properties of the final product obtained with low-energy emulsification methods. Increasing interest in high-energy emulsification methods is a consequence of their scalability important from the industrial perspective. Considering the high-energy emulsification methods, both the composition and conditions of the process (e.g., device power level, pressure, temperature, homogenization time, or number of cycles) are important for the properties and stability of nanoemulsions. It is advisible to determine the effect of each parameter on the quality of the product to establish the optimal process parameters’ range which, in turn, results in a more reproducible and efficient production.