Development and evaluation of orally disintegrating tablets (ODTs) containing Ibuprofen granules prepared by hot melt extrusion

Hot melt extrusion (HME) was used to increase the Ibuprofen (IBU) dissolution profiles and mask the bitterness of the produced dosage forms. IBU was embedded in a polymethacrylate polymer and the produced granules were incorporate in oral disintegrating tablets (ODTs). The developed dosage forms pre...

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Bibliographic Details
Published in:Colloids and surfaces, B, Biointerfaces B, Biointerfaces, 2011-09, Vol.86 (2), p.275-284
Main Authors: Gryczke, Andreas, Schminke, Silke, Maniruzzaman, Mohammed, Beck, Julien, Douroumis, Dennis
Format: Article
Language:English
Subjects:
Administration, Oral
Adolescent
Adult
Carboxymethylcellulose Sodium - chemistry
Chemistry, Pharmaceutical - methods
Chromatography, High Pressure Liquid
colloids
composite polymers
crosslinking
Disintegration
dispersions
Drug Compounding - methods
Extrusion
Female
Granular materials
Granules
Hardness
Hot Temperature
Hot-melt extrusion
Humans
Ibuprofen
Ibuprofen - chemistry
Male
Masking
melting
Orally disintegrating tablets Eudragit EPO
palatability
Polymethacrylic Acids - chemistry
polyvinylpyrrolidone
porosity
Povidone - chemistry
Pressure
sensory evaluation
Sodium
Solubility
Tablets
Tablets - chemistry
taste
Taste - physiology
Taste masking
volunteers
X-Ray Diffraction
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Summary:Hot melt extrusion (HME) was used to increase the Ibuprofen (IBU) dissolution profiles and mask the bitterness of the produced dosage forms. IBU was embedded in a polymethacrylate polymer and the produced granules were incorporate in oral disintegrating tablets (ODTs). The developed dosage forms presented excellent taste masking and increased dissolution rates. [Display omitted] ► Ibuprofen and Eudragit EPO processed by hot melt extrusion at high drug loadings. ► The produced solid dispersions showed the existence of amorphous Ibuprofen. ► Hot melt extruded products were compressed to manufacture ODTs. ► Robust ODTs presented excellent mechanical strength, friability and disintegration times. ► Ibuprofen solid dispersions showed effective taste masking and increased dissolution rates. In the current study Ibuprofen was embedded in a methacrylate copolymer (Eudragit ® EPO) matrix to produce solid dispersions by hot-melt extrusion (HME) processing. The obtained granules were incorporated in orally disintegrating tablets (ODTs). The tablets were developed by varying the ratio of superdisintegrants such as sodium croscarmellose and crosslinked polyvinylpyrrolidone grades while a direct compression process was used to compress the ODTs under various compaction forces to optimize tablet robustness. The properties of the compressed tablets which included porosity, hardness, friability and dissolution profiles were further evaluated and compared with Nurofen ® Meltlet ODTs. The taste and sensory evaluation in human volunteers demonstrated excellence in masking the bitter active and improved tablet palatability.
ISSN:0927-7765
1873-4367
DOI:10.1016/j.colsurfb.2011.04.007