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Preparation of solid pharmaceutical forms of celecoxib with immediate-release and sustained-release by using wet granulation techniques and evaluation of their in vitro characteristics

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Journal of Chinese Pharmaceutical Sciences 2022年第7期31卷 536-544页

作者： Ahmed Alkhodri Svetlana Suslina Department of General Pharmaceutical and Biomedical Technology Medical InstitutePeoples’Friendship University of RussiaStreet Miklukho-Maklaya 6Moscow 117198Russia

In the present study,we aimed to formulate matrix tablets of celecoxib with immediate-release(IR)and sustained-release(SR)and evaluate the influence of different types and concentrations of polymers on drug release characteristics in *** formulations were prepared by using the wet granulation *** formulation(F5)with the traditional release was composed without release-control *** contrast,four formulations(F1–F4)with prolonged action were designed by using different cellulosic polymers,such as hydroxypropyl methylcellulose polymers(HPMC-K100M and HPMC-Е6),hydroxypropyl cellulose with high viscosity grade(HPCh),carboxymethyl cellulose(CMC),and ethylcellulose(EC-10 cps).All tablet formulations contained sodium lauryl sulfate(SLS),polyvinylpyrrolidone(PVP-k30),microcrystalline cellulose(MCC),and lactose *** MCC and PVP-k30 were used in a fixed quantity in all formulations except for formulation F5,which contained 10%and 2.7%of them,*** effects of polymer viscosity grade and its quantity on celecoxib release from two formulations containing the same polymer were *** release in vitro was evaluated in phosphate buffer(pH=7.4).The amount of celecoxib released in phosphate medium was calculated by preparing a standard *** vitro profile indicated that formulations F1(HPMC-K100M)and F2(HPMC-E6)extended the drug release for 18 h(82%)and 10 h(96.001%),*** F3and F4 released 72.09%and 59.8%of their contents during 18 h,respectively,and thus their effects could last for more than a ***,IR formulation(F5)released more than 90%of its content within 1–2 *** Excel was used to analyze the dissolution profile data for drug release kinetics,such as first-order,Zero-order,Higuchi,and Korsmeyer-Peppas *** release mechanism of all formulations was CaseⅡrelaxation *** study showed that cellulosic derivative polymers could successfully prolong IR of matrix tablet formulation.

关键词： Immediate release Sustained release Celecoxib HPMC wet granulation Dissolution profile

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Coating powder beds with liquids and foams based on viscous formulations using a twin screw mixer: A continuous process study

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PARTICUOLOGY 2024年第10期93卷 364-376页

作者： Manga, Mohamed S. Kontziampasis, Dimitrios Al-Maqdad, Mustafa Clifford, Sean Bakalis, Serafim York, David W. Univ Leeds Fac Engn & Phys Sci Sch Chem & Proc Engn Leeds LS2 9JT England Univ Leeds Sch Mech Engn Fac Engn & Phys Sci Leeds LS2 9JT England Univ Dundee Sch Sci & Engn Dundee DD1 4HN Scotland Cent South Univ Dundee Int Inst Tongzipo Rd Changsha 410013 Hunan Peoples R China Univ Newcastle Sch Engn Dept Chem Engn Newcastle Upon Tyne NE1 7RU England Univ Birmingham Sch Chem Engn Birmingham B15 2TT England Univ Nottingham Fac Engn Dept Chem Engn Nottingham NG7 2RD England

Coating with viscous formulations has been essential in numerous industries as it can be a means for providing functionalization, additional properties, as well as other benefits. However, there have been scarce studies that have investigated and proposed methodologies in literature. Continuous coating of powders with viscous liquids poses as a promising technology, which has been mentioned in some studies, but has not yet been thoroughly investigated. This paper employs the use of image processing and analysis, in combination with statistical analysis of particles to evaluate the effectiveness of foams and liquids as a means of coating powder beds. Two different sizes of twin screw mixers that are working in continuous operation are employed, and a new continuous foaming device is fabricated and used for the experiments of coating. The effect of materials and process parameters (as for example rotational speed, and flowrate) on the quality of coating are investigated. Image analysis is used to assess the coating quality. The results clearly showcase the potential of using twin screw mixers for coating purposes and not only for mixing. The hypothesis that using large bubble foams to improve the coating of viscous liquids on particles is proven correct, as they provide higher quality coatings compared to their equivalent liquids, when used in the twin screw mixer. Surprisingly, using a larger scale twin screw mixer, does not show a substantial effect on the mixing, regarding quality, however there is still a requirement for mix optimization for achieving scale-up of this process. These results provide a new pathway for coating powders with viscous formulations in industrial applications, requiring less energy and effort in this process, and can pave the way towards introducing more sustainable industrial methodologies for coating. (c) 2024 Chinese Society of Particuology and Institute of Process Engineering, Chinese Academy of Sciences. Published by Elsevier B.V. Thi

关键词： Powder coating Continuous processing Viscous liquid Foam Image analysis Positron emission particle traking (PEPT) EMISSION PARTICLE TRACKING GROWTH REGIME MAP wet granulation ENCAPSULATION PENETRATION NUCLEATION

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Process optimization for the enhanced stability of diclofenac potassium granules and capsules

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Journal of Chinese Pharmaceutical Sciences 2018年第2期27卷 82-91页

作者： Jiangyan Liu Xiunan Li Xiaoxue Zhang Haoyan Huang Liqing Chen Jinghao Cui Qingri Cao College of Pharmaceutical Sciences Soochow University Suzhou 215123 China Department of Pharmacy Yanji City Hospital Yanji 133000 China

This study aimed to investigate the effects of different process parameters on the physical properties, in vitro dissolution rate, and short and long-term stability of diclofenac potassium（DFP） granules and capsules. DFP granules exhibited low total amounts of impurities when prepared through the wet granulation method using a granulating solvent with a low water/ethanol ratio. The impurities of the wet DFP mass dried at 70 ℃ were higher than those dried at 50 ℃ or 60 ℃. DFP granules were stable under strong light exposure during preparation. DFP granules prepared using a granulating solvent with a 1：4 water/ethanol ratio had a relatively smaller particle size and higher angle of repose than those prepared using granulating solvents with other water/ethanol ratios. The dissolution rate of DFP capsules prepared using four different water/ethanol ratios was less than 2% after 10 min of dissolution and increased to 95% within 30 min of dissolution. The total amount of drug impurities of DFP capsules prepared using a granulating solvent with 1：4 water/ethanol ratio was considerably lower than those of DFP capsules prepared using a granulating solvent with a 1：0 water/ethanol solvent ratio. Regardless of the water/ethanol ratio, the capsules showed poor stability when exposed to high temperature（60 ℃） and strong light（4500±500 Lux） for 10 days, but were relatively stable at high humidity（92.5% RH）. The results of the long-term stability（25±2 ℃ and 60%±10% relative humidity） study showed that DFP granules were more stable than DFP capsules, and were stable for 12 months. The type of encapsulating material did not affect the 2-month stability of DFP. DFP granules are sensitive to granulating solvent and drying temperature and DFP capsules should be stored away from high temperature and strong light.

关键词： Diclofenac potassium wet granulation Physical properties Stress test Long-term stability

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