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In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets.
Drug Dev Ind Pharm. 2017 May; 43(5):723-731.DD

Abstract

CONTEXT

Considering that bitter taste of drugs incorporated in orally disintegrating tablets (ODTs) can be the main reason for avoiding drug therapy, it is of the utmost importance to achieve successful taste-masking. The evaluation of taste-masking effectiveness is still a major challenge.

OBJECTIVE

The objective of this study was to mask bitter taste of the selected model drugs by drug particle coating with Eudragit® E PO, as well as to evaluate taste-masking effectiveness of prepared ODTs using compendial dissolution testing, dissolution in the small-volume shake-flask assembly and trained human taste panel.

MATERIALS AND METHODS

Model drugs were coated in fluidized bed. Disintequik™ ODT was used as a novel co-processed excipient for ODT preparation. Selected formulations were investigated in vitro and in vivo using techniques for taste-masking assessment.

RESULTS AND DISCUSSION

Significantly slower drug dissolution was observed from tablets with coated drug particles during the first 3 min of investigation. Results of in vivo taste-masking assessment demonstrated significant improvement in drug bitterness suppression in formulations with coated drug. Strong correlation between the results of drug dissolution in the small-volume shake-flask assembly and in vivo evaluation data was established (R ≥ 0.970).

CONCLUSION

Drug particle coating with Eudragit® E PO can be a suitable approach for bitter taste-masking. Strong correlation between in vivo and in vitro results implicate that small-volume dissolution method may be used as surrogate for human panel taste-masking assessment, in the case of physical taste-masking approach application.

Authors+Show Affiliations

a Department of Pharmaceutical Technology and Cosmetology, Faculty of Pharmacy , University of Belgrade , Belgrade , Serbia.a Department of Pharmaceutical Technology and Cosmetology, Faculty of Pharmacy , University of Belgrade , Belgrade , Serbia.a Department of Pharmaceutical Technology and Cosmetology, Faculty of Pharmacy , University of Belgrade , Belgrade , Serbia.a Department of Pharmaceutical Technology and Cosmetology, Faculty of Pharmacy , University of Belgrade , Belgrade , Serbia.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

27494420

Citation

Drašković, Milica, et al. "In Vitro and in Vivo Investigation of Taste-masking Effectiveness of Eudragit E PO as Drug Particle Coating Agent in Orally Disintegrating Tablets." Drug Development and Industrial Pharmacy, vol. 43, no. 5, 2017, pp. 723-731.
Drašković M, Medarević D, Aleksić I, et al. In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets. Drug Dev Ind Pharm. 2017;43(5):723-731.
Drašković, M., Medarević, D., Aleksić, I., & Parojčić, J. (2017). In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets. Drug Development and Industrial Pharmacy, 43(5), 723-731. https://doi.org/10.1080/03639045.2016.1220572
Drašković M, et al. In Vitro and in Vivo Investigation of Taste-masking Effectiveness of Eudragit E PO as Drug Particle Coating Agent in Orally Disintegrating Tablets. Drug Dev Ind Pharm. 2017;43(5):723-731. PubMed PMID: 27494420.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets. AU - Drašković,Milica, AU - Medarević,Djordje, AU - Aleksić,Ivana, AU - Parojčić,Jelena, Y1 - 2016/08/21/ PY - 2016/8/6/pubmed PY - 2017/6/16/medline PY - 2016/8/6/entrez KW - Taste-masking KW - drug particle coating KW - in vitro–in vivo correlation KW - small-volume shake-flask assembly KW - trained human taste panel SP - 723 EP - 731 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 43 IS - 5 N2 - CONTEXT: Considering that bitter taste of drugs incorporated in orally disintegrating tablets (ODTs) can be the main reason for avoiding drug therapy, it is of the utmost importance to achieve successful taste-masking. The evaluation of taste-masking effectiveness is still a major challenge. OBJECTIVE: The objective of this study was to mask bitter taste of the selected model drugs by drug particle coating with Eudragit® E PO, as well as to evaluate taste-masking effectiveness of prepared ODTs using compendial dissolution testing, dissolution in the small-volume shake-flask assembly and trained human taste panel. MATERIALS AND METHODS: Model drugs were coated in fluidized bed. Disintequik™ ODT was used as a novel co-processed excipient for ODT preparation. Selected formulations were investigated in vitro and in vivo using techniques for taste-masking assessment. RESULTS AND DISCUSSION: Significantly slower drug dissolution was observed from tablets with coated drug particles during the first 3 min of investigation. Results of in vivo taste-masking assessment demonstrated significant improvement in drug bitterness suppression in formulations with coated drug. Strong correlation between the results of drug dissolution in the small-volume shake-flask assembly and in vivo evaluation data was established (R ≥ 0.970). CONCLUSION: Drug particle coating with Eudragit® E PO can be a suitable approach for bitter taste-masking. Strong correlation between in vivo and in vitro results implicate that small-volume dissolution method may be used as surrogate for human panel taste-masking assessment, in the case of physical taste-masking approach application. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/27494420/In_vitro_and_in_vivo_investigation_of_taste_masking_effectiveness_of_Eudragit_E_PO_as_drug_particle_coating_agent_in_orally_disintegrating_tablets_ L2 - http://www.tandfonline.com/doi/full/10.1080/03639045.2016.1220572 DB - PRIME DP - Unbound Medicine ER -