1. Pullulan based oral thin film formulation of zolmitriptan: Development and optimization using factorial design
- Author
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Pankaj M. Maheriya, Anita M. Chaudhari, Abhishek K. Gandhi, and Vipul D. Prajapati
- Subjects
Sucralose ,Materials science ,Administration, Oral ,Zolmitriptan ,02 engineering and technology ,030226 pharmacology & pharmacy ,Biochemistry ,03 medical and health sciences ,Mouthfeel ,chemistry.chemical_compound ,0302 clinical medicine ,Drug Stability ,Structural Biology ,Tensile Strength ,Spectroscopy, Fourier Transform Infrared ,Ultimate tensile strength ,medicine ,Humans ,Glucans ,Molecular Biology ,Oxazolidinones ,PEG 400 ,Analysis of Variance ,Chromatography ,Plasticizer ,Reproducibility of Results ,Pullulan ,General Medicine ,Factorial experiment ,Hydrogen-Ion Concentration ,021001 nanoscience & nanotechnology ,Tryptamines ,Molecular Weight ,Drug Liberation ,chemistry ,0210 nano-technology ,medicine.drug ,Nuclear chemistry - Abstract
The goal of study was to formulate and characterize pullulan based oral thin film (OTF) of zolmitriptan by solvent casting method. Based on preliminary trials, glass, PEG 400 and sucralose were selected as casting surface, water-miscible plasticizer and sweetener for OTF, respectively. A 32 factorial design was used to study the effect of amount of PEG 400 (X1) and sucralose (X2) as independent variables on tensile strength (Y1), elasticity (Y2), % in-vitro drug release in phosphate buffer of pH 6.8 at 5min (Q5min, Y3) and overall taste of OTF (Y4) as responses. OTF of batch F4 (PEG 400, 200mg; sucralose, 12mg) was identified as an optimized batch showing in-vitro, in-vivo disintegration time 20.70 and 21.58s, respectively; 95.53% Q5min; satisfactory thickness, strength, % elongation, ease of handling, smooth mouthfeel, excellent overall taste; even distribution of all ingredients in pullulan OTF (SEM study); and stable film at specified conditions concluding that pullulan, PEG 400 and sucralose are used in combination to make palatable, stable OTF of zolmitriptan.
- Published
- 2018
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