DESIGN AND DEVELOPMENT OF <em>NICOTIANA TABACUM</em> FILM USING FACTORIAL DESIGN
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2016, Vol 8, Issue 8
Abstract
Objective: The objective of the present investigation was to develop and optimize Nicotiana tabacum oral dissolving films with optimized physicomechanical and chemical properties for improved patient compliance. Nicotiana tabacum oral dissolving films are used to help people stop smoking cigarettes. Methods: Nicotiana tabacum oral dissolving films were prepared by solvent casting method using hydroxymethylpropyl cellulose as film forming polymer and polyethylene glycol 6000 as a surfactant. The process was optimized using the design of experiments. Four process parameters were studied at two levels using 24 design. Further, the optimized Nicotiana tabacum oral dissolving films were evaluated for HPTLC analysis, microbial limit test, organoleptic evaluation, stability studies and clinical efficacy studies.Results: It was found that the thickness of wet film and viscosity of solution has a significant influence on thickness as well as disintegration time. Folding endurance and tensile strength of the film was influenced by the thickness of the wet film, machine speed and viscosity of the solution. Drying temperature does not have any significant influence on the selected response. By controlling the thickness of wet film 0.5 mm, the viscosity of the solution 5000 cps and machine speed 15 min, disintegration time, folding endurance and tensile strength of this formulation can be controlled.Conclusion: It was noted that Nicotiana tabacum oral dissolving films are being accepted by patients in general and showed a marked reduction in craving for smoking. Prepared formulation was stable for 6 mo stability as per ICH guidelines.
Authors and Affiliations
Anwar Daud, Ashok Peepliwal, Minal Bonde, Nidhi Sapkal, Naresh Gaikwad, C. B. Gunawardena
Keywords
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