In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets
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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 (R) 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 (TM) 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 dur...ing 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 (R) 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.
Source:
Drug Development and Industrial Pharmacy, 2017, 43, 5, 723-731Publisher:
- Taylor & Francis Ltd, Abingdon
Funding / projects:
- Ministry of Education, Science and Technological Development, Republic of Serbia
Note:
- This is peer-reviewed version of the following article: Drašković, M.; Medarević, D.; Aleksić, I.; Parojčić, J. 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. https://doi.org/10.1080/03639045.2016.1220572
DOI: 10.1080/03639045.2016.1220572
ISSN: 0363-9045
PubMed: 27494420
WoS: 000395194500004
Scopus: 2-s2.0-84983549743
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PharmacyTY - JOUR AU - Drašković, Milica AU - Medarević, Đorđe AU - Aleksić, Ivana AU - Parojčić, Jelena PY - 2017 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/3429 AB - 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 (R) 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 (TM) 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 (R) 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. PB - Taylor & Francis Ltd, Abingdon T2 - Drug Development and Industrial Pharmacy T1 - In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets VL - 43 IS - 5 SP - 723 EP - 731 DO - 10.1080/03639045.2016.1220572 ER -
@article{ author = "Drašković, Milica and Medarević, Đorđe and Aleksić, Ivana and Parojčić, Jelena", year = "2017", 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 (R) 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 (TM) 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 (R) 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.", publisher = "Taylor & Francis Ltd, Abingdon", journal = "Drug Development and Industrial Pharmacy", title = "In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets", volume = "43", number = "5", pages = "723-731", doi = "10.1080/03639045.2016.1220572" }
Drašković, M., Medarević, Đ., 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. in Drug Development and Industrial Pharmacy Taylor & Francis Ltd, Abingdon., 43(5), 723-731. https://doi.org/10.1080/03639045.2016.1220572
Drašković M, Medarević Đ, Aleksić I, Parojčić J. In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets. in Drug Development and Industrial Pharmacy. 2017;43(5):723-731. doi:10.1080/03639045.2016.1220572 .
Drašković, Milica, Medarević, Đorđe, Aleksić, Ivana, Parojčić, Jelena, "In vitro and in vivo investigation of taste-masking effectiveness of Eudragit E PO as drug particle coating agent in orally disintegrating tablets" in Drug Development and Industrial Pharmacy, 43, no. 5 (2017):723-731, https://doi.org/10.1080/03639045.2016.1220572 . .