The purpose of the current investigation was to develop a pharmaceutical equivalent osmotic drug delivery formulation of Paliperidone(PLD)in the form of controlled porosity osmotic pump tablets(CPOT)in order to keep t...The purpose of the current investigation was to develop a pharmaceutical equivalent osmotic drug delivery formulation of Paliperidone(PLD)in the form of controlled porosity osmotic pump tablets(CPOT)in order to keep the drug's steady state concentration in the body.This helps to achieve the greatest therapeutic benefit with the fewest side effects.For the purpose of identifying various formulation attributes,preliminary trials were conducted.Taguchi design was used to study the influence of seven input factors namely drug to polymer ratio,polymer 1(HPMC K100 M)to polymer 2(HPMC K15M),drug to total osmogens,coating level,amount of pore former,concentration of ethyl cellulose and amount of plasticizer on dependent variable similarity factor(f2).Utilizing the Minitab 17,data analysis was done.The similarity factor(f2)was computed using the osmotic tablet reference product INVEGA®.The findings demonstrate that each of the seven independent variables significantly affects the similarity factor.For optimized batch,both core and coated tablets showed acceptable pharmaco-technical parameters.The release profile of the optimized batch tablets was found to be similar to that of reference product with good zero-order release pattern.Drug release was observed through the channels formed by in-situ pores on tablet surface performed using SEM.From the results it can be concluded that prepared CPOT of PLD was found pharmaceutical equivalent with commercial product which is cost effective and fully compliance with cGMP.展开更多
Passive sampling technology has good application prospects for monitoring trace pollutants in aquatic environments.Further research on the sampling mechanism of this technology is essential to improve the measurement ...Passive sampling technology has good application prospects for monitoring trace pollutants in aquatic environments.Further research on the sampling mechanism of this technology is essential to improve the measurement accuracy and extend the application scope of this approach.In this study,adsorption and permeation experiments were performed to investigate the sorption and mass transfer properties of five chiral pharmaceuticals at the enantiomeric level on polyethersulfone(PES)and polytetrafluoroethylene(PTFE)membranes used in a polar organic chemical integrative sampler.Batch adsorption experiments showed that the PES membrane had an adsorption phenomenon for most selected pollutants and an insignificant sorption behavior was observed for all selected pharmaceuticals on the PTFE membrane except for R(S)-fluoxetine.The diffusion coefficients of selected pharmaceuticals onto the PTFE membrane were approximately one order of magnitude higher than those onto the PES membrane.The permeation experiment indicated that under different hydraulic conditions,the change of the relative pollutant concentration through the PTFE membrane for the composite pollutant system was more obvious than that for the single pollutant system,and mass transfer hysteresis exists for both contaminant systems through PES membranes.Using the first-order equation or 3-component model to estimate the overall mass transfer coefficients,the results showed that the overall mass transfer coefficient values of pollutants in the composite pollutant system onto both membranes were higher than those in the single pollutant system.This parameter was mainly influenced by the synergistic effects of the multi-analyte interaction and diminished water boundary layers during the mass transfer process.展开更多
文摘The purpose of the current investigation was to develop a pharmaceutical equivalent osmotic drug delivery formulation of Paliperidone(PLD)in the form of controlled porosity osmotic pump tablets(CPOT)in order to keep the drug's steady state concentration in the body.This helps to achieve the greatest therapeutic benefit with the fewest side effects.For the purpose of identifying various formulation attributes,preliminary trials were conducted.Taguchi design was used to study the influence of seven input factors namely drug to polymer ratio,polymer 1(HPMC K100 M)to polymer 2(HPMC K15M),drug to total osmogens,coating level,amount of pore former,concentration of ethyl cellulose and amount of plasticizer on dependent variable similarity factor(f2).Utilizing the Minitab 17,data analysis was done.The similarity factor(f2)was computed using the osmotic tablet reference product INVEGA®.The findings demonstrate that each of the seven independent variables significantly affects the similarity factor.For optimized batch,both core and coated tablets showed acceptable pharmaco-technical parameters.The release profile of the optimized batch tablets was found to be similar to that of reference product with good zero-order release pattern.Drug release was observed through the channels formed by in-situ pores on tablet surface performed using SEM.From the results it can be concluded that prepared CPOT of PLD was found pharmaceutical equivalent with commercial product which is cost effective and fully compliance with cGMP.
基金supported by the National Natural Science Foundation of China (No.41977377)。
文摘Passive sampling technology has good application prospects for monitoring trace pollutants in aquatic environments.Further research on the sampling mechanism of this technology is essential to improve the measurement accuracy and extend the application scope of this approach.In this study,adsorption and permeation experiments were performed to investigate the sorption and mass transfer properties of five chiral pharmaceuticals at the enantiomeric level on polyethersulfone(PES)and polytetrafluoroethylene(PTFE)membranes used in a polar organic chemical integrative sampler.Batch adsorption experiments showed that the PES membrane had an adsorption phenomenon for most selected pollutants and an insignificant sorption behavior was observed for all selected pharmaceuticals on the PTFE membrane except for R(S)-fluoxetine.The diffusion coefficients of selected pharmaceuticals onto the PTFE membrane were approximately one order of magnitude higher than those onto the PES membrane.The permeation experiment indicated that under different hydraulic conditions,the change of the relative pollutant concentration through the PTFE membrane for the composite pollutant system was more obvious than that for the single pollutant system,and mass transfer hysteresis exists for both contaminant systems through PES membranes.Using the first-order equation or 3-component model to estimate the overall mass transfer coefficients,the results showed that the overall mass transfer coefficient values of pollutants in the composite pollutant system onto both membranes were higher than those in the single pollutant system.This parameter was mainly influenced by the synergistic effects of the multi-analyte interaction and diminished water boundary layers during the mass transfer process.
