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Stream/Area:
-
Subject:
-
Paper ID:
IJSREM66688
Volume:
10 |
8 |
Aug 2026
Pages:
1-3
Publication Frequency:
Monthly (12 issues per year)
License:International Journal of Scientific Research in Engineering and Management follows the Creative Commons Attribution 4.0 (CC BY 4.0) License, allowing free use and distribution with proper attribution.
pharmaceutics
Sri Vijay Vidyalaya College of Pharmacy, Dharmapuri, Tamil Nadu, India
pharmaceutics
Sri Vijay Vidyalaya College of Pharmacy, Dharmapuri, Tamil Nadu, India
pharmaceutics
Sri Vijay Vidyalaya College of Pharmacy, Dharmapuri, Tamil Nadu, India
pharmaceutics
Sri Vijay Vidyalaya College of Pharmacy, Dharmapuri, Tamil Nadu, India
Nicotine replacement therapy (NRT) delivers controlled doses of nicotine to reduce craving and withdrawal during smoking cessation while avoiding the combustion toxicants of cigarette smoke. Among available NRT dosage forms, fast-dissolving oral films (FDOFs) offer rapid onset, ease of administration without water, and improved patient compliance. In the present work, nicotine was isolated from Nicotiana tabacum L. leaves by an acid-base (liquid-liquid) extraction procedure and confirmed by Dragendorff's, Mayer's, Wagner's, Hager's and iodine alkaloid tests. The purified extract was incorporated into fast-dissolving films by the solvent casting technique using hydroxypropyl methylcellulose (HPMC E15) as the film-forming polymer, with glycerol as plasticizer and sorbitol, citric acid and peppermint oil as sweetening, saliva-stimulating and flavouring agents, respectively. Three batches (F1-F3) containing 2 mg nicotine per film were prepared by varying HPMC concentration (100-140 mg) and evaluated for physical appearance, thickness, weight variation, folding endurance, surface pH and drug content uniformity. All batches yielded transparent, smooth and flexible films with thickness of 0.16-0.20 mm, folding endurance above 250, near-neutral surface pH (6.7-6.9) and drug content of 97-99%. Formulation F2 showed the most balanced mechanical and release characteristics and was selected as the optimized batch. The study demonstrates that nicotine extracted by a simple liquid-liquid technique can be successfully formulated into a stable, patient-friendly fast-dissolving film suitable for further development as an NRT product.
KEYWORDS
Nicotine was successfully extracted from Nicotiana tabacum leaves by a simple, low-cost liquid-liquid (acid-base) extraction method and confirmed by standard alkaloid identification tests. The extracted nicotine was formulated into fast-dissolving oral films by solvent casting using HPMC E15, glycerol, sorbitol, citric acid and peppermint oil. The prepared films were transparent, flexible, of acceptable thickness and weight, near-neutral in surface pH, and showed uniform drug content with rapid disintegration and release. Formulation F2 offered the best overall balance of properties and represents a promising, patient-friendly candidate for nicotine replacement therapy, warranting further in vivo pharmacokinetic and clinical evaluation before commercial development.
[1] Pawar SD, Shinde N, Ravi G, Kalyankar TM. Formulation and evaluation of mouth dissolving oral film of nicotine using Quality by Design approach. Int J Appl Pharm. 2025. [2] Nuntawong P, et al. Extraction of nicotine from tobacco leaves and development of fast-dissolving films. 2021. [3] Kheawfu K, Kaewpinta A, Chanmahasathien W, et al. Extraction of nicotine from tobacco leaves and development of fast dissolving nicotine extract film. Membranes. 2021;11(6):403. [4] Khan A, et al. Fast-dissolving nicotine oral films for smoking cessation. 2018. [5] Hu RS, Wang J, Li H, et al. Simultaneous extraction of nicotine and solanesol from waste tobacco materials. Sep Purif Technol. 2015. [6] Preis M. Oromucosal film preparations. Expert Opin Drug Deliv. 2015. [7] Kishioka S, Kiguchi N, Kobayashi Y, Saika F. Nicotine effects and the endogenous opioid system. J Pharmacol Sci. 2014. [8] Bala R, Sharma S, et al. Fast dissolving oral films: a review. Int J Pharm Investig. 2013;3(2):50-58. [9] Stead LF, Perera R, Bullen C, et al. Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev. 2012. [10] Hoffmann EM, et al. Evaluation of solvent-cast oral films. Drug Dev Ind Pharm. 2011.
Publication Date
8/12/2026
Peer Review Type
Double-Blind Peer Review
Review Rounds: 2
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The authors declare no conflict of interest related to this research work.
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