Gulshan Bansal - Academia.edu (original) (raw)

Papers by Gulshan Bansal

Research paper thumbnail of Physicochemical evaluation and in vitro release studies on itraconazolium sulfate salt

Asian Journal of Pharmaceutical Sciences, 2014

Solubility Dissolution Cyclodextrins BCS Class II Antifungal a b s t r a c t To counter the poor ... more Solubility Dissolution Cyclodextrins BCS Class II Antifungal a b s t r a c t To counter the poor aqueous solubility of itraconazole (ITC), its sulfate salt (ITCSUL) was synthesized and characterized by 1 H NMR, MS, FTIR, DSC, XRPD, DLS and SEM. Antifungal properties of ITCSUL were confirmed against different fungal pathogens by broth microdilution method. Enhanced solubility of the salt in various pharmaceutical solvents was observed. Approximately 5.5 fold increase in percentage drug release from ITCSUL than that of ITC in 3 h was observed. Further, the physical mixtures of ITCSUL with two cyclodextrins; b-cyclodextrin (b-CD) and HP-b-cyclodextrin (HP-b-CD) were prepared in 3 M ratios. The in vitro release studies of CD mixtures of ITC and ITCSUL exhibited markedly enhanced dissolution in comparison to ITC and ITCSUL respectively. The promising in vitro performance of ITCSUL and ITCSUL CD mixtures along with advantage of expedient preparation suggest their potential applications in designing a better oral drug delivery system.

Research paper thumbnail of Ditosylate Salt of Itraconazole and Dissolution Enhancement Using Cyclodextrins

AAPS PharmSciTech, 2012

Salt formation has been a promising approach for improving the solubility of poorly soluble acidi... more Salt formation has been a promising approach for improving the solubility of poorly soluble acidic and basic drugs. The aim of the present study was to prepare the salt form of itraconazole (ITZ), a hydrophobic drug to improve the solubility and hence dissolution performance. Itraconazolium ditolenesulfonate salt (ITZDITOS) was synthesized from ITZ using acid addition reaction with p-toluenesulfonic acid. Salt characterization was performed using 1 H NMR, mass spectrometry, Fourier transform infrared spectroscopy, differential scanning calorimetry, and X-ray diffraction. The particle size and morphology was studied using dynamic light scattering technique and scanning electron microscopy, respectively. The solubility of the salt in water and various pharmaceutical solvents was found multifold than ITZ. The dissolution study exhibited 5.5-fold greater percentage release value in 3 h of ITZDITOS (44.53%) as compared with ITZ (8.54%). Results of in vitro antifungal studies using broth microdilution technique indicate that ITZDITOS possessed similar antifungal profile as that of ITZ when tested against four fungal pathogens. Furthermore, the physical mixtures of ITZDITOS with two cyclodextrins, βcyclodextrin (β-CD), and 2-hydroxypropyl-β-cyclodextrin (HP-β-CD) were prepared in different molar ratios and were evaluated for in vitro release. It was observed that in only 30 min of dissolution study, about 74 and 81% of drug was released from 1:3 molar ratios of ITZDITOS with β-CD and ITZDITOS with HP-β-CD, respectively, which was distinctly higher than the drug released from ITZ commercial capsules (70%). The findings warrant further preclinical and clinical studies on ITZDITOS so that it can be established as an alternative to ITZ for developing oral formulations.

Research paper thumbnail of Thermal characterization and compatibility studies of norfloxacin for development of extended release tablets

Journal of Thermal Analysis and Calorimetry, 2009

... 744 PR Oliveira et al ... Tita B, Marian E, Tita D, Vlase G, Doca N, Vlase T. Compar-ative ki... more ... 744 PR Oliveira et al ... Tita B, Marian E, Tita D, Vlase G, Doca N, Vlase T. Compar-ative kinetic study of decomposition of some diazepine deriva-tives under isothermal and non-isothermal ... 20. Santos AFO, Basılio ID Jr, de Souza FS, Medeiros AFD, Pinto MF, de Santana DP, et al ...

Research paper thumbnail of Forced Degradation Study on Gliclazide and Application of Validated Stability-Indicating HPLC-UV Method in Stability Testing of Gliclazide Tablets

Forced degradation study on gliclazide was conducted under the conditions of hydrolysis, oxidatio... more Forced degradation study on gliclazide was conducted under the conditions of hydrolysis, oxidation, dry heat and photolysis and an isocratic stability-indicating HPLC-UV method was developed and validated. All the seven degradation products (I-VII) formed under different conditions were optimally resolved on a C 18 column with mobile phase composed of 40% acetonitrile and 60% ammonium acetate solution (0.025 M, pH 3.5) at a flow rate of 0.25 mL min À1 using 235 nm as detection wavelength. The method was linear between 5-500 lg mL À1 drug concentrations. The %RSD of intra-and inter-day precision studies was <1 and <2% respectively. Excellent recoveries (99.81-100.97%) proved the method sufficiently accurate. Each peak resolved always with a resolution of >1.90 indicating the method to be rugged enough. The method was used to study the drug degradation behaviour under the forced conditions. Four degradation products (I-IV) were formed in 0.1 N HCl and water whereas only I and III were formed in 3% H 2 O 2 . Two new products V and VI in addition to I, III and IV were formed in 0.1 N NaOH. The drug was stable to thermal and photolytic decomposition. The degradation behaviour in water and 0.1 N NaOH was similar under dark and light conditions but a new product VII was formed in 0.01 N HCl in light. In general, the rate of degradation was accelerated by the light. The method was applied successfully in stability testing of gliclazide tablets.

Research paper thumbnail of Physicochemical evaluation and in vitro release studies on itraconazolium sulfate salt

Asian Journal of Pharmaceutical Sciences, 2014

Solubility Dissolution Cyclodextrins BCS Class II Antifungal a b s t r a c t To counter the poor ... more Solubility Dissolution Cyclodextrins BCS Class II Antifungal a b s t r a c t To counter the poor aqueous solubility of itraconazole (ITC), its sulfate salt (ITCSUL) was synthesized and characterized by 1 H NMR, MS, FTIR, DSC, XRPD, DLS and SEM. Antifungal properties of ITCSUL were confirmed against different fungal pathogens by broth microdilution method. Enhanced solubility of the salt in various pharmaceutical solvents was observed. Approximately 5.5 fold increase in percentage drug release from ITCSUL than that of ITC in 3 h was observed. Further, the physical mixtures of ITCSUL with two cyclodextrins; b-cyclodextrin (b-CD) and HP-b-cyclodextrin (HP-b-CD) were prepared in 3 M ratios. The in vitro release studies of CD mixtures of ITC and ITCSUL exhibited markedly enhanced dissolution in comparison to ITC and ITCSUL respectively. The promising in vitro performance of ITCSUL and ITCSUL CD mixtures along with advantage of expedient preparation suggest their potential applications in designing a better oral drug delivery system.

Research paper thumbnail of Ditosylate Salt of Itraconazole and Dissolution Enhancement Using Cyclodextrins

AAPS PharmSciTech, 2012

Salt formation has been a promising approach for improving the solubility of poorly soluble acidi... more Salt formation has been a promising approach for improving the solubility of poorly soluble acidic and basic drugs. The aim of the present study was to prepare the salt form of itraconazole (ITZ), a hydrophobic drug to improve the solubility and hence dissolution performance. Itraconazolium ditolenesulfonate salt (ITZDITOS) was synthesized from ITZ using acid addition reaction with p-toluenesulfonic acid. Salt characterization was performed using 1 H NMR, mass spectrometry, Fourier transform infrared spectroscopy, differential scanning calorimetry, and X-ray diffraction. The particle size and morphology was studied using dynamic light scattering technique and scanning electron microscopy, respectively. The solubility of the salt in water and various pharmaceutical solvents was found multifold than ITZ. The dissolution study exhibited 5.5-fold greater percentage release value in 3 h of ITZDITOS (44.53%) as compared with ITZ (8.54%). Results of in vitro antifungal studies using broth microdilution technique indicate that ITZDITOS possessed similar antifungal profile as that of ITZ when tested against four fungal pathogens. Furthermore, the physical mixtures of ITZDITOS with two cyclodextrins, βcyclodextrin (β-CD), and 2-hydroxypropyl-β-cyclodextrin (HP-β-CD) were prepared in different molar ratios and were evaluated for in vitro release. It was observed that in only 30 min of dissolution study, about 74 and 81% of drug was released from 1:3 molar ratios of ITZDITOS with β-CD and ITZDITOS with HP-β-CD, respectively, which was distinctly higher than the drug released from ITZ commercial capsules (70%). The findings warrant further preclinical and clinical studies on ITZDITOS so that it can be established as an alternative to ITZ for developing oral formulations.

Research paper thumbnail of Thermal characterization and compatibility studies of norfloxacin for development of extended release tablets

Journal of Thermal Analysis and Calorimetry, 2009

... 744 PR Oliveira et al ... Tita B, Marian E, Tita D, Vlase G, Doca N, Vlase T. Compar-ative ki... more ... 744 PR Oliveira et al ... Tita B, Marian E, Tita D, Vlase G, Doca N, Vlase T. Compar-ative kinetic study of decomposition of some diazepine deriva-tives under isothermal and non-isothermal ... 20. Santos AFO, Basılio ID Jr, de Souza FS, Medeiros AFD, Pinto MF, de Santana DP, et al ...

Research paper thumbnail of Forced Degradation Study on Gliclazide and Application of Validated Stability-Indicating HPLC-UV Method in Stability Testing of Gliclazide Tablets

Forced degradation study on gliclazide was conducted under the conditions of hydrolysis, oxidatio... more Forced degradation study on gliclazide was conducted under the conditions of hydrolysis, oxidation, dry heat and photolysis and an isocratic stability-indicating HPLC-UV method was developed and validated. All the seven degradation products (I-VII) formed under different conditions were optimally resolved on a C 18 column with mobile phase composed of 40% acetonitrile and 60% ammonium acetate solution (0.025 M, pH 3.5) at a flow rate of 0.25 mL min À1 using 235 nm as detection wavelength. The method was linear between 5-500 lg mL À1 drug concentrations. The %RSD of intra-and inter-day precision studies was <1 and <2% respectively. Excellent recoveries (99.81-100.97%) proved the method sufficiently accurate. Each peak resolved always with a resolution of >1.90 indicating the method to be rugged enough. The method was used to study the drug degradation behaviour under the forced conditions. Four degradation products (I-IV) were formed in 0.1 N HCl and water whereas only I and III were formed in 3% H 2 O 2 . Two new products V and VI in addition to I, III and IV were formed in 0.1 N NaOH. The drug was stable to thermal and photolytic decomposition. The degradation behaviour in water and 0.1 N NaOH was similar under dark and light conditions but a new product VII was formed in 0.01 N HCl in light. In general, the rate of degradation was accelerated by the light. The method was applied successfully in stability testing of gliclazide tablets.