Development of taste masked fexofenadine hydrochloride orodispersible tablets using hot melt extrusion
Issued Date
2019
Resource Type
Language
eng
Rights
Mahidol University
Rights Holder(s)
Faculty of Pharmacy Mahidol University
Suggested Citation
Nattawut Chareonthai, Thandar Aung, Keisuke Ueda, Kenjirou Higashi, Kunikazu Moribe, Satit Puttipipatkhachorn, สาธิต พุทธิพิพัฒน์ขจร (2019). Development of taste masked fexofenadine hydrochloride orodispersible tablets using hot melt extrusion. Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/52395
Title
Development of taste masked fexofenadine hydrochloride orodispersible tablets using hot melt extrusion
Abstract
Orodispersible tablet desired the oral solid formulations with a pleasant taste, and a
rapid disintegration in the mouth with no need of water. In this study, orodispersible tablet
formulations of fexofenadine HCl, a second generation anti-histamine drug were developed for
pediatric and geriatric patients. To improve patient compliance, bitter taste masking using hot
melt extrusion (HME) technology was studied. Fexofenadine HCl and Eudragit® EPO extruded
powder at three different drug loadings (20%, 40% and 60%) was prepared by HME at various
temperature (120°C, 150°C and 180°C). Physicochemical characterization using FT-IR
spectroscopy, powder X ray diffraction and differential scanning calorimetry revealed that the
amorphous state or molecularly dispersed state of fexofenadine HCl in HME powder was
obtained at lower drug/polymer ratio and higher temperature. The HME powder extruded at
180°C was selected to prepare orodispersible tablet formulations. The orodispersible tablets
with drug containing HME powder had physical properties conforming to pharmacopoeial
standards, including weight variation, hardness, friability, disintegration time and drug
dissolution in 0.1 N HCl. The taste masking performance using drug release test in simulated
salivary fluid indicated that the orodispersible tablets had lower drug release, thus enabling
taste masking effect in oral cavity. In conclusion, fexofenadine HCl orodispersible tablets with
desired taste masked effect were successfully prepared by using hot melt extrusion technology.
Description
The 1st Pharmaceutical Sciences Asia Conference 2019 Theme : Pharmaceutical Sciences toward Health Innovation in the Disruptive Era. Bangkok Midtown Hotel, Thailand. August 22, 2019, page 81-90