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Design,optimization,and characterization of an in-situ pore-forming system for controlled delivery of paliperidone

Medicine in Novel Technology and Devices 2024年第1期21卷 71-79页

作者： Priya Pate bhumi ladani Gayatri Patel Ramanbhai Patel College of Pharmacy Charotar University of Science and TechnologyCHARUSAT–CampusChanga388421AnandGujaratIndia

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 *** helps to achieve the greatest therapeutic benefit with the fewest side *** the purpose of identifying various formulation attributes,preliminary trials were *** 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 *** 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 *** optimized batch,both core and coated tablets showed acceptable pharmaco-technical *** release profile of the optimized batch tablets was found to be similar to that of reference product with good zero-order release *** release was observed through the channels formed by in-situ pores on tablet surface performed using *** 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.

关键词： Controlled release pH-independent release Similarity factor Pharmaceutical equivalent Reference product

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