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
Within the public health sector of Hong Kong(China),there is a consensus around the important role of traditional Chinese medicines.For Hong Kong(China)to play a bridging role to bring Chinese medicines to the global ...Within the public health sector of Hong Kong(China),there is a consensus around the important role of traditional Chinese medicines.For Hong Kong(China)to play a bridging role to bring Chinese medicines to the global market requires a concerted effort from the government,academic institutes and industries.The release of the final version of the European Medicines Agencies guidance document,which details the acceptance of minimum requirements to nonclinical package in bibliographical applications,grants the opportunity for well-established and traditional herbal medicines to demonstrate an‘acceptable safe’status for registration in the European Union.It is anticipated that this minimum nonclinical package can be applied to demonstrate the safe use of many traditional Chinese medicines regardless of their eligibility to be registered under the simplified procedure within the European Union.This paper conceptualizes an integration of a simplified evaluation route for eligible proprietary Chinese medicines(pCm)with long history of use into the existing drug regulatory framework in Hong Kong(China).Such integration utilizing the minimum nonclinical package,based on bibliographical data or expert report,as proof of evidence to demonstrate safety for pCm with long history of use requires less demand in scientific resources.With Hong Kong(China)conducting‘first hand’review for eligible pCm,it provides an option for overseas and local pharmaceutical companies to register their products in Hong Kong(China)without the need to rely on issuance of Certificate of Pharmaceutical Product from other countries.This could bring eligible pCm with long history of use to reach international risk-based standard and to be marketed globally as‘medicines’to reach their full therapeutic potential.An important process to positioning Hong Kong(China)to compete with other countries in promoting importation and exportation of pCm to better serve the global health.展开更多
Emerging contaminants(ECs)have aroused great concerns due to their widespread presence as well as their potential health and ecological risks.Currently monitoring data about ECs in Chinese rural areas are still limite...Emerging contaminants(ECs)have aroused great concerns due to their widespread presence as well as their potential health and ecological risks.Currently monitoring data about ECs in Chinese rural areas are still limited.In this study,Taige Canal basin was selected as a typical rural area for a pilot study.The occurrence of ECs,including pharmaceutical and personal care products(PPCPs),pesticides,plasticizers and flame retardants,in surface water and aquaculture ponds,as well as in wastewater treatment facilities,was comprehensively investigated.The effectiveness of rural decentralized wastewater treatment facilities and centralized wastewater treatment plant(WWTP)in removing ECs was also analyzed.Among 126 commonly used pesticides for target analysis,25 compounds were detected in surface water with high frequency of>80%.Besides,55 PPCPs,21 pesticides and 18 other industrial products were identified by non-target analysis using high resolution mass spectrometry(HRMS).Totally 18 compounds were detected in surface water with a frequency of>60%and 6 of them were found in all samples,including irbesartan,valsartan,propazine,buprofezin,bis(2-ethylhexyl)phthalate(DEHP)and tri-(2-chloroisopropyl)phosphate(TCPP),with mean concentrations of 3022,195,125,218,3738 and 545 ng/L,respectively.There are 29 compounds(11 PPCPs,8 pesticides and 10 other industrial products)detected in water samples from the aquaculture ponds,of which 13 compounds were found in all three ponds.The removal efficiencies of ECs in wastewater treatment facilities are generally limited,except valsartan(82%–86%),nobiletin(100%)and diisodecylphthalate(100%)were found to be significantly removed.展开更多
Objective This study is aimed to investigate the differences in pharmaceutical quality and therapeutic efficacy of calcipotriol ointments between the original product and the generics.Methods We evaluated the pharmace...Objective This study is aimed to investigate the differences in pharmaceutical quality and therapeutic efficacy of calcipotriol ointments between the original product and the generics.Methods We evaluated the pharmaceutical quality of the original product and the generics including pH,content and related substance,and calcipotriol stability in the matrix.Intradermal retention of calcipotriol ointments in vitro was investigated using skin of Bama miniature pig.The pharmacodynamics study was performed in psoriasis guinea pig models.Results The matrix of original product is better than the generics,and influenced the drug diffusion,stability and in vitro retention,thus resulted in the difference in pharmacodynamics.The retention amount of calcipotriol in the original product was significantly higher than that of generic B,and approximately 4 folds higher than that of generic A.All of the three ointments improved pathological indexed in psoriasis guinea pigs,and there was a significant difference between the preparation group and the model group (P =0.001).Guinea pigs in the original group had the lowest interleukin-17 level (35.7 ± 1.13 μg/ml) and Baker Score (2.70 ± 0.97) compared with generic A (37.9 ±3.3 μg/ml,3.10 ± 0.22,respectively) and generic B (39 ± 4.6μg/ml,3.80 ± 0.57,respectively),but no statistical difference was found among the three groups (all P ＞ 0.05).Conclusions Difference occurs in the internal quality between the original product and the generics.The original preparation owns suitable balance between matrix stability and transdermal ability so that showes superiority in pharmaceutical properties,intradermal retention and therapeutic effect in vitro and in vivo,which suggests that more attention should be paid to the formulation and process during the research and development of the generics.The original product is recommended with priority for treatment especially at emergency.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.
文摘Within the public health sector of Hong Kong(China),there is a consensus around the important role of traditional Chinese medicines.For Hong Kong(China)to play a bridging role to bring Chinese medicines to the global market requires a concerted effort from the government,academic institutes and industries.The release of the final version of the European Medicines Agencies guidance document,which details the acceptance of minimum requirements to nonclinical package in bibliographical applications,grants the opportunity for well-established and traditional herbal medicines to demonstrate an‘acceptable safe’status for registration in the European Union.It is anticipated that this minimum nonclinical package can be applied to demonstrate the safe use of many traditional Chinese medicines regardless of their eligibility to be registered under the simplified procedure within the European Union.This paper conceptualizes an integration of a simplified evaluation route for eligible proprietary Chinese medicines(pCm)with long history of use into the existing drug regulatory framework in Hong Kong(China).Such integration utilizing the minimum nonclinical package,based on bibliographical data or expert report,as proof of evidence to demonstrate safety for pCm with long history of use requires less demand in scientific resources.With Hong Kong(China)conducting‘first hand’review for eligible pCm,it provides an option for overseas and local pharmaceutical companies to register their products in Hong Kong(China)without the need to rely on issuance of Certificate of Pharmaceutical Product from other countries.This could bring eligible pCm with long history of use to reach international risk-based standard and to be marketed globally as‘medicines’to reach their full therapeutic potential.An important process to positioning Hong Kong(China)to compete with other countries in promoting importation and exportation of pCm to better serve the global health.
基金supported by the Major Science and Technology Program for Water Pollution Control and Treatment in China(No.2017ZX07202004).
文摘Emerging contaminants(ECs)have aroused great concerns due to their widespread presence as well as their potential health and ecological risks.Currently monitoring data about ECs in Chinese rural areas are still limited.In this study,Taige Canal basin was selected as a typical rural area for a pilot study.The occurrence of ECs,including pharmaceutical and personal care products(PPCPs),pesticides,plasticizers and flame retardants,in surface water and aquaculture ponds,as well as in wastewater treatment facilities,was comprehensively investigated.The effectiveness of rural decentralized wastewater treatment facilities and centralized wastewater treatment plant(WWTP)in removing ECs was also analyzed.Among 126 commonly used pesticides for target analysis,25 compounds were detected in surface water with high frequency of>80%.Besides,55 PPCPs,21 pesticides and 18 other industrial products were identified by non-target analysis using high resolution mass spectrometry(HRMS).Totally 18 compounds were detected in surface water with a frequency of>60%and 6 of them were found in all samples,including irbesartan,valsartan,propazine,buprofezin,bis(2-ethylhexyl)phthalate(DEHP)and tri-(2-chloroisopropyl)phosphate(TCPP),with mean concentrations of 3022,195,125,218,3738 and 545 ng/L,respectively.There are 29 compounds(11 PPCPs,8 pesticides and 10 other industrial products)detected in water samples from the aquaculture ponds,of which 13 compounds were found in all three ponds.The removal efficiencies of ECs in wastewater treatment facilities are generally limited,except valsartan(82%–86%),nobiletin(100%)and diisodecylphthalate(100%)were found to be significantly removed.
文摘Objective This study is aimed to investigate the differences in pharmaceutical quality and therapeutic efficacy of calcipotriol ointments between the original product and the generics.Methods We evaluated the pharmaceutical quality of the original product and the generics including pH,content and related substance,and calcipotriol stability in the matrix.Intradermal retention of calcipotriol ointments in vitro was investigated using skin of Bama miniature pig.The pharmacodynamics study was performed in psoriasis guinea pig models.Results The matrix of original product is better than the generics,and influenced the drug diffusion,stability and in vitro retention,thus resulted in the difference in pharmacodynamics.The retention amount of calcipotriol in the original product was significantly higher than that of generic B,and approximately 4 folds higher than that of generic A.All of the three ointments improved pathological indexed in psoriasis guinea pigs,and there was a significant difference between the preparation group and the model group (P =0.001).Guinea pigs in the original group had the lowest interleukin-17 level (35.7 ± 1.13 μg/ml) and Baker Score (2.70 ± 0.97) compared with generic A (37.9 ±3.3 μg/ml,3.10 ± 0.22,respectively) and generic B (39 ± 4.6μg/ml,3.80 ± 0.57,respectively),but no statistical difference was found among the three groups (all P ＞ 0.05).Conclusions Difference occurs in the internal quality between the original product and the generics.The original preparation owns suitable balance between matrix stability and transdermal ability so that showes superiority in pharmaceutical properties,intradermal retention and therapeutic effect in vitro and in vivo,which suggests that more attention should be paid to the formulation and process during the research and development of the generics.The original product is recommended with priority for treatment especially at emergency.
