Quantitative Estimation of Avicel Polymer and its Impact on Spray Pattern, Plume Geometry and Droplet Size in Nasal Spray Products

Abstract

Throughout the world, the regulatory agencies like US FDA, MHRA, Health Canada recommend that during the development of generic products like Nasal sprays, Ophthalmic solutions, the inactive ingredients in the generic product formulation must be qualitatively (Q1) and quantitatively (Q2) similar to the reference listed drug product. This requires a careful deformulation/reverse engineering study of the reference listed drug product or innovator product for all the listed inactive ingredients. Avicel is one of the most important ingredients primarily used in various Nasal spray and ophthalmic suspension products as a suspending agent. It is a mixture of microcrystalline cellulose and carboxy methyl cellulose. The aim of this study is to develop a simple yet robust analytical method for the accurate quantitative estimation of this polymer for generic product development to regulatory markets. We have not found any reported method for the accurate quantitation of this polymer from any of the pharmaceutical dosage forms. Hence, this article will certainly accelerate the generic development of different pharmaceutical dosage forms for regulatory markets. Due to its non chromophoric nature, Avicel polymer is derivatized to a readily quantifiable compound by using diphenylamine reagent. The complex is measured at wavelength 635 nm without any interference. The polymer can be successfully quantified at concentration of 0.26 μg/ml and above from various pharmaceutical products such as tablets, nasal spray suspensions, ophthalmic products etc. This paper gives a simple yet accurate and precise method for the quantitative estimation of Avicel by derivatized spectrophotometry from various pharmaceutical products.