e-Polymers (Aug 2021)

Applying design of experiments (DoE) on the properties of buccal film for nicotine delivery

  • Suksaeree Jirapornchai,
  • Chaichawawut Benjarut,
  • Srichan Muntira,
  • Tanaboonsuthi Noppamon,
  • Monton Chaowalit,
  • Maneewattanapinyo Pattwat,
  • Pichayakorn Wiwat

DOI
https://doi.org/10.1515/epoly-2021-0064
Journal volume & issue
Vol. 21, no. 1
pp. 566 – 574

Abstract

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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.

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