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Microwave-Assisted Development of Orally Disintegrating Tablets by Direct Compression
Authors:Kishor V. Kande  Darsheen J. Kotak  Mariam S. Degani  Dmitry Kirsanov  Andrey Legin  Padma V. Devarajan
Affiliation:1.Department of Pharmaceutical Sciences and Technology,Institute of Chemical Technology, Deemed University, Elite Status and Centre of Excellence (Maharashtra),Mumbai,India;2.Institute of Chemistry,St. Petersburg State University,St. Petersburg,Russia;3.Laboratory of Artificial Sensory Systems,ITMO University,St. Petersburg,Russia
Abstract:Orally disintegrating tablets (ODTs) are challenged by the need for simple technology to ensure good mechanical strength coupled with rapid disintegration. The objective of this work was to evaluate microwave-assisted development of ODTs based on simple direct compression tableting technology. Placebo ODTs comprising directly compressible mannitol and lactose as diluents, super disintegrants, and lubricants were prepared by direct compression followed by exposure to >97% relative humidity and then microwave irradiation for 5 min at 490 W. Placebo ODTs with hardness (>5 kg/cm2) and disintegration time (<60 s) were optimized. Palatable ODTs of Lamotrigine (LMG), which exhibited rapid dissolution of LMG, were then developed. The stability of LMG to microwave irradiation (MWI) was confirmed. Solubilization was achieved by complexation with beta-cyclodextrin (β-CD). LMG ODTs with optimal hardness and disintegration time (DT) were optimized by a 23 factorial design using Design Expert software. Taste masking using sweeteners and flavors was confirmed using a potentiometric multisensor-based electronic tongue, coupled with principal component analysis. Placebo ODTs with crospovidone as a superdisintegrant revealed a significant increase in hardness from ~3 to ~5 kg/cm2 and a decrease in disintegration time (<60 s) following microwave irradiation. LMG ODTs had hardness >5 kg/cm2, DT?
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