Development of generic drug product by pharmaceutical industry is a scientific and technical approach which is totally different from developing a reference or innovator product. Most of the developing countries focus...Development of generic drug product by pharmaceutical industry is a scientific and technical approach which is totally different from developing a reference or innovator product. Most of the developing countries focus on developing the generic drug products because huge amount of investment is required for innovation and to develop reference product. The generic medicine has to be bioequivalent to the innovator drug and ensure the same biological effect with proper safety and efficacy. Nowadays, the pharmaceutical industries focus on the development of generic product as this does not require that much time and cost compared to the innovator company. But development of generic product is also difficult as it contains the same therapeutic efficacy as innovator. The development approach is based on the target market, i.e. US market, EU market. If a manufacturer targets the US market, then all excipients should be USP grade, analysis should be conducted by USP method or in-house method and stability studies as well. Prior and during the development of generic drug product API selection, dosage form selection, reference product selection and characterization, formulation development, analytical method development, tech transfer or submission batch are prime concern. Then again, bioequivalence study, drug registration procedure and commercialization of the generic product considering regulatory guidance of respective regulatory agencies and the approaches taken by the regulatory agencies for the development of registration of generic medicines are also crucial as well for the development of generic drug product. The aim of this study was to review the entire stage of a generic drug development by a generic pharmaceutical company.展开更多
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
文摘Development of generic drug product by pharmaceutical industry is a scientific and technical approach which is totally different from developing a reference or innovator product. Most of the developing countries focus on developing the generic drug products because huge amount of investment is required for innovation and to develop reference product. The generic medicine has to be bioequivalent to the innovator drug and ensure the same biological effect with proper safety and efficacy. Nowadays, the pharmaceutical industries focus on the development of generic product as this does not require that much time and cost compared to the innovator company. But development of generic product is also difficult as it contains the same therapeutic efficacy as innovator. The development approach is based on the target market, i.e. US market, EU market. If a manufacturer targets the US market, then all excipients should be USP grade, analysis should be conducted by USP method or in-house method and stability studies as well. Prior and during the development of generic drug product API selection, dosage form selection, reference product selection and characterization, formulation development, analytical method development, tech transfer or submission batch are prime concern. Then again, bioequivalence study, drug registration procedure and commercialization of the generic product considering regulatory guidance of respective regulatory agencies and the approaches taken by the regulatory agencies for the development of registration of generic medicines are also crucial as well for the development of generic drug product. The aim of this study was to review the entire stage of a generic drug development by a generic pharmaceutical company.
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.
