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Formulation Development and Optimization of Extended Release Pellets of Dexketoprofen Trometamol
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| Author:
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BHUPENDRA G.PRAJAPATI, ALPESH PATEL
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| Abstract:
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The aim is to prepare extended release multi-particulates dosage form of Dexketoprofen trometamol which is the pharmacologically active isomer of ketoprofen. Utilization of active enantiomer with minimal dose and administration frequency, extended release multi-particulates dosage form is explored. Drug loaded pellets were prepared by Extrusion spheronization technique while extended release coating of these drug pellets were done by wurster coating process.
Lactose and Microcrystalline cellulose as diluents, glycerin as plasticizer and Povidone as binder were selected during drug loaded pellets development by extrusion-spheronization. Kollicoat SR 30D was used as sustained release polymer during extended release coating by wurster coating process. Triethyl citrate and Talc were used as plasticizer and anti-adherent during extended release coating process respectively. Wurster coating process parameters for sustained release were further statistically optimized for agglomerates formation, process efficiency and drug release profile using central composite design (CCD). Results shows that 1.0 to 1.2 bar atomisation air pressure, 7.8 to 10.0 gm/min spray rate and 29-34°C product bed temperature gave desired drug product quality attributes. Extended release multi-particulates were successfully developed for dexketoprofen trometamol which may be explore to manufacture various dosage forms like capsules, compressed tablets, pellets in sachet for ease of patient administration.
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| Keyword:
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Dexketoprofen Trometamol, pellets, Extrusion-spheronization, Fluid Bed Technology
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.01.016
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| Download:
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