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The effects of screw configuration and polymeric carriers on hot-melt extruded taste-masked formulations incorporated into orally disintegrating tablets.
J Pharm Sci. 2015 Jan; 104(1):124-34.JP

Abstract

The primary aim of this research was to produce successfully taste masked formulations of Sildenafil Citrate (SC) using hot-melt extrusion (HME) technology. Multiple screw configurations and polymeric carriers were evaluated for their effects on taste masking efficiency, which was assessed by both E-tongue analysis and in vitro dissolution in simulated salivary fluid (SSF, pH 6.8 artificial saliva). The screw configurations were further assessed for their effects on the morphology of the API using PXRD, FT-IR and mid-infrared chemical imaging. It was determined that the screw configuration had a profound effect on the taste masking efficiency of the formulations as a result of altering the physical state of the API. Selected extruded formulations using ethylcellulose (EC) with a pore former were further formulated into orally disintegrating tablets (ODTs), which were optimized by varying the grade and percentage of the superdisintegrant used. An optimized disintegration time of approximately 8 seconds was achieved. The final ODT formulation exhibited excellent taste masking properties with over 85% drug release in gastric media as well as physical tablet properties. Interestingly, friability, which tends to be a common concern when formulating ODTs, was well within the acceptable limits (<1%) for common tablets.

Authors+Show Affiliations

Department of Pharmaceutics & Drug Delivery, University of Mississippi, University, MS, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

25410968

Citation

Morott, Joseph T., et al. "The Effects of Screw Configuration and Polymeric Carriers On Hot-melt Extruded Taste-masked Formulations Incorporated Into Orally Disintegrating Tablets." Journal of Pharmaceutical Sciences, vol. 104, no. 1, 2015, pp. 124-34.
Morott JT, Pimparade M, Park JB, et al. The effects of screw configuration and polymeric carriers on hot-melt extruded taste-masked formulations incorporated into orally disintegrating tablets. J Pharm Sci. 2015;104(1):124-34.
Morott, J. T., Pimparade, M., Park, J. B., Worley, C. P., Majumdar, S., Lian, Z., Pinto, E., Bi, Y., Durig, T., & Repka, M. A. (2015). The effects of screw configuration and polymeric carriers on hot-melt extruded taste-masked formulations incorporated into orally disintegrating tablets. Journal of Pharmaceutical Sciences, 104(1), 124-34. https://doi.org/10.1002/jps.24262
Morott JT, et al. The Effects of Screw Configuration and Polymeric Carriers On Hot-melt Extruded Taste-masked Formulations Incorporated Into Orally Disintegrating Tablets. J Pharm Sci. 2015;104(1):124-34. PubMed PMID: 25410968.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effects of screw configuration and polymeric carriers on hot-melt extruded taste-masked formulations incorporated into orally disintegrating tablets. AU - Morott,Joseph T, AU - Pimparade,Manjeet, AU - Park,Jun-Bom, AU - Worley,Chelsea P, AU - Majumdar,Soumyajit, AU - Lian,Zhuoyang, AU - Pinto,Elanor, AU - Bi,Yunxia, AU - Durig,Thomas, AU - Repka,Michael A, Y1 - 2014/11/19/ PY - 2014/05/16/received PY - 2014/10/13/revised PY - 2014/10/21/accepted PY - 2014/11/21/entrez PY - 2014/11/21/pubmed PY - 2015/9/9/medline KW - Bitter API KW - Chemical Imaging KW - Crystalline Solid Dispersion KW - Disintegrating Tablets KW - Hot Melt Extrusion KW - Screw Configuration KW - Taste Masking SP - 124 EP - 34 JF - Journal of pharmaceutical sciences JO - J Pharm Sci VL - 104 IS - 1 N2 - The primary aim of this research was to produce successfully taste masked formulations of Sildenafil Citrate (SC) using hot-melt extrusion (HME) technology. Multiple screw configurations and polymeric carriers were evaluated for their effects on taste masking efficiency, which was assessed by both E-tongue analysis and in vitro dissolution in simulated salivary fluid (SSF, pH 6.8 artificial saliva). The screw configurations were further assessed for their effects on the morphology of the API using PXRD, FT-IR and mid-infrared chemical imaging. It was determined that the screw configuration had a profound effect on the taste masking efficiency of the formulations as a result of altering the physical state of the API. Selected extruded formulations using ethylcellulose (EC) with a pore former were further formulated into orally disintegrating tablets (ODTs), which were optimized by varying the grade and percentage of the superdisintegrant used. An optimized disintegration time of approximately 8 seconds was achieved. The final ODT formulation exhibited excellent taste masking properties with over 85% drug release in gastric media as well as physical tablet properties. Interestingly, friability, which tends to be a common concern when formulating ODTs, was well within the acceptable limits (<1%) for common tablets. SN - 1520-6017 UR - https://www.unboundmedicine.com/medline/citation/25410968/The_effects_of_screw_configuration_and_polymeric_carriers_on_hot_melt_extruded_taste_masked_formulations_incorporated_into_orally_disintegrating_tablets_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3549(15)30267-7 DB - PRIME DP - Unbound Medicine ER -