Publication:
The bioequivalent and effect of nicotine formulation gum on smoking cessation

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Issued Date

2010

Resource Type

Article

File Type

application/pdf

ISSN

1252208

Other identifier(s)

2-s2.0-77952909091

Rights Holder(s)

Scopus

Bibliographic Citation

Journal of the Medical Association of Thailand. Vol 93, No.5 (2010), p.574-579

Suggested Citation

Tundulawessa Y., Yongchaiyud P., Chutrthong W., Tundulawessa K. The bioequivalent and effect of nicotine formulation gum on smoking cessation. Journal of the Medical Association of Thailand. Vol 93, No.5 (2010), p.574-579. Retrieved from: https://hdl.handle.net/20.500.14740/7585

Title

The bioequivalent and effect of nicotine formulation gum on smoking cessation

Author(s)

Tundulawessa Y.
 Yongchaiyud P.
 Chutrthong W.
 Tundulawessa K.

Abstract

Objective: To compare the absorption rate of nicotine in volunteer blood, and determine the clinical trial on smoking cessation. Material and Method: This method using reverse phase C18 column and buffer pH 5.05 as the mobile phase, flow rate 0.9 ml/min. The UV-visible detector found the retention time of nicotine in gum and volunteer blood was 5.0756 min. The linear calibration curves of nicotine in human blood were obtained over the concentration range of 2.0-20.0 μg/ml. The coefficient variability for Nicotine gum 6.74% (2 mg/g). Extraction recovery was over 86% in blood, correlation coefficient of determination (r2) > 0.9999 and the detection limit 0.0060 μg/ml. The 24 healthy volunteer men, 27 to 55 years of age, were habitual cigarette smokers. They were randomized into two groups,12 subjects chewed two 2 mg pieces, Nicomild-2 Sugar Free Gum (Millimed, Thailand), the other chewed two 2 mg, pieces, Nicorette Sugar Free(Pharmacia AB, Helsingborg, Sweden.)Volunteers' blood samples were withdrawn at 0, 15, 30, 40 min, concentration of nicotine in blood were measured by HPLC. The 199 subjects were openly recruited under the project of "The smoking cessation for Phor Laung" (5-December). All of them received Nicomild-2 (nicotine polyestex gum) between November 2007 and December 2007. Results: The absorption rate of nicotine in volunteers' blood Nicomild-2 and Nicorette at 0, 15, 30,40 minutes were 0, 51.84, 26.73, 21.012 and 0, 56.603, 21.83, 15.183 (ng / min). Both of them were found to have maximum absorption rate at 15 minutes. When comparing the maximum absorption rate at 15 minute of Nicomild-2 (sugar free) with Nicorette (sugar free) didn't have significant differences detected. Treatment with nicotine polyestex gum were reported 65.3% (130/199) at 4 weeks compared with failure 30.15% (60/199)[ 65.3% vs 30.15%; p = 0.005]. The authors found 9 (4.5%) subjects successfully quit smoking free nicotine replacement therapy (NRT).

Subject(s)

Nicotine gum
 Adult
 Analytic method
 Article
 Bioequivalence
 Calibration
 Clinical trial
 Controlled clinical trial
 Controlled study
 Dizziness
 Drug absorption
 Drug blood level
 Drug formulation
 Dyspepsia
 Dyspnea
 High performance liquid chromatography
 Human
 Human experiment
 Mouth pain
 Nicotine replacement therapy
 Normal human
 Randomized controlled trial
 Smoking cessation
 Tobacco dependence
 Adult
 Chewing Gum
 Chromatography, High Pressure Liquid
 Female
 Humans
 Male
 Middle Aged
 Nicotine
 Nicotinic Agonists
 Polymethacrylic Acids
 Polyvinyls
 Smoking
 Smoking Cessation
 Therapeutic Equivalency

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URI

https://hdl.handle.net/20.500.14740/7585

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Scopus: Year 1983-2021

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