Abstract

Abstract Design of experiments is used to optimize ratios between deproteinized natural rubber latex, Eudragit® NM 30 D, and pectin for nicotine buccal film with dependent variables as moisture content, moisture uptake, and swelling index in simulated saliva 3 and 5 h. Mathematical models were linear for moisture content and moisture uptake, while swelling index in simulated saliva 3 and 5 h was a quadratic model. Optimized polymer ratio was 0.319:0.362:0.319, respectively. Experimental values were 13.17 ± 0.92%, 3.96 ± 0.84%, 112.58 ± 22.63%, and 124.69 ± 8.01% for dependent variables, respectively. The buccal film showed high swelling at pH 7 and swelling–deswelling behaviors in a water/ethanol environment. The surface pH, weight, and thickness were 8.11, 63.28 ± 6.18 mg, and 219.87 ± 44.28 µm, respectively. Nicotine content was found as 10.22 ± 0.46 mg/4 cm2. Maximum cumulative nicotine release was 9.82 ± 0.94 mg/4 cm2. Kinetic model fitted to the Korsmeyer-Peppas model and release exponent was 0.36, representing that release mechanism was controlled by Fickian diffusion release.

Highlights

  • Design of experiments is used to optimize ratios between deproteinized natural rubber latex, Eudragit® NM 30 D, and pectin for nicotine buccal film with dependent variables as moisture content, moisture uptake, and swelling index in simulated saliva 3 and 5 h

  • The blending of three polymers has not been previously investigated and reported for nicotine delivery. The aim of this project was a preparation of buccal film for nicotine delivery using the blending between three polymers, Deproteinized natural rubber latex (DNRL), Eudragit® NM 30 D, and pectin, as a polymer matrix film, and glycerin was used as a plasticizer at a concentration of 30% w/w depending on the polymer amount

  • The DNRL decreased the hydrophilicity of the buccal film, while the Eudragit® NM 30 D and pectin increased the hydrophilicity of the buccal film

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Summary

Introduction

Abstract: Design of experiments is used to optimize ratios between deproteinized natural rubber latex, Eudragit® NM 30 D, and pectin for nicotine buccal film with dependent variables as moisture content, moisture uptake, and swelling index in simulated saliva 3 and 5 h. Mathematical models were linear for moisture content and moisture uptake, while swelling index in simulated saliva 3 and 5 h was a quadratic model. Experimental values were 13.17 ± 0.92%, 3.96 ± 0.84%, 112.58 ± 22.63%, and 124.69 ± 8.01% for dependent variables, respectively. The buccal film showed high swelling at pH 7 and swelling–deswelling behaviors in a water/ethanol environment. The surface pH, weight, and thickness were 8.11, 63.28 ± 6.18 mg, and 219.87 ± 44.28 μm, respectively. Nicotine content was found as 10.22 ± 0.46 mg/4 cm. Kinetic model fitted to the Korsmeyer-Peppas model and release exponent was 0.36, representing that release mechanism was controlled by Fickian diffusion release

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