title: Transdermal nicotine mixed natural rubber-hydroxypropylmethylcellulose film forming systems for smoking cessation: in vitro evaluations.
abstract: Novel film forming polymeric dispersions for transdermal nicotine delivery were prepared from deproteinized natural rubber latex (DNRL) blended with hydroxypropylmethylcellulose (HPMC) and dibutyl phthalate (DBP) or glycerin (GLY) as plasticizer. The preliminary molecular compatibility of ingredients was observed by Fourier transform infrared spectroscopy, differential scanning calorimetry and X-ray diffractometry characterizations. All film forming polymeric dispersions were elegant in appearance and smooth in texture without agglomeration. Their pH was 7-8. In addition, their viscosity and spreadability showed good characteristics depended on HPMC and plasticizers blended. The transparent in situ dry films with good strength and elasticity were also confirmed by peeling-off. The nicotine release from them revealed an initial fast release that was similar to the release from a concentrated nicotine solution, and followed by slow release pattern from the in situ films. GLY blended formulation produced a higher amount of nicotine permeation through the in vitro pig skin than DBP blends. Ethanol mixing also enhanced nicotine permeation, but it affected the integrity of in situ films. The nicotine release and skin permeation kinetics were by a diffusion mechanism that was confirmed by the Higuchi's model. These formulations were safe without producing any severe skin irritation. However, for the stability they needed to be stored at 4 °C in tightly sealed containers.
authors.affiliation: a Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences , Prince of Songkla University , Songkhla , Thailand.|b Medical Products Innovations from Polymers in Clinical Use Research Unit, Prince of Songkla University , Songkhla , Thailand.
authors.forename: Wiwat
authors.initials: W
authors.lastname: Pichayakorn
authors.affiliation: a Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences , Prince of Songkla University , Songkhla , Thailand.|c Department of Pharmaceutical Chemistry, Faculty of Pharmacy , Rangsit University , Pathum Thani , Thailand.
authors.forename: Jirapornchai
authors.initials: J
authors.lastname: Suksaeree
authors.affiliation: a Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences , Prince of Songkla University , Songkhla , Thailand.
authors.forename: Prapaporn
authors.initials: P
authors.lastname: Boonme
authors.affiliation: d Department of Materials Science and Technology, Faculty of Science , Prince of Songkla University , Songkhla , Thailand , and.
authors.forename: Wirach
authors.initials: W
authors.lastname: Taweepreda
authors.affiliation: a Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences , Prince of Songkla University , Songkhla , Thailand.
authors.forename: Thanaporn
authors.initials: T
authors.lastname: Amnuaikit
authors.affiliation: e Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmaceutical Sciences , Chulalongkorn University , Bangkok , Thailand.
authors.forename: Garnpimol C
authors.initials: GC
authors.lastname: Ritthidej
keywords: Deproteinized natural rubber latex; film forming polymeric dispersions; hydroxypropylmethylcellulose; nicotine; transdermal drug delivery