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Rapid Particle Size Analysis of Topical Ophthalmic Formulations

Particle Characterization

Successful ophthalmic drug delivery is a combination of pre-corneal retention time, corneal permeability, effectiveness of drug absorption, and dose-to-dose consistency. Whether the drug product is a suspension or microemulsion, it is a complex application involving careful analyses, research, and development efforts.

Physicochemical attributes such as particle size and particle size distribution, in particular, are two dominating factors that influence medicinal uptake and the extent at which the active pharmaceutical ingredient (API) reaches its intended segment of the eye. Difluprednate, a topical corticosteroid, and nepafenac, a nonsteroidal anti-inflammatory drug, both used for pain management post-cataract surgery, are no exception to this discussion. This note will examine how to accurately determine particle size and size distribution, repeatability, and reproducibility of these APIs to interpret shelf life and bioavailability alongside standards given by regulatory authorities.

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Rapid Particle Size Analysis of Topical Ophthalmic Formulations
Drug particle size and distribution are key critical quality attributes that govern stability, ocular retention via solution thickness, and therapeutic release characteristics. The laser diffraction technique is an elegant method used to establish the fundamentals of ophthalmic formulations prior to pharmacokinetic or clinical studies. To fulfill the requirements set out by the FDA, our recommendation is the Partica LA-960V2 Particle Size Analyzer.
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