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Compression-coated pulsatile chronomodulated therapeutic system: QbD assisted optimization
Pulsatile drug delivery systems have drawn attention in contemporary research for designing chronotherapeutic systems. The current work aims to design pulsatile ketorolac tromethamine tablets using compression coating for delayed delivery with a lag time suitable for the treatment of morning stiffne...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Taylor & Francis
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9477481/ https://www.ncbi.nlm.nih.gov/pubmed/35838522 http://dx.doi.org/10.1080/10717544.2022.2094500 |
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author | Aldawsari, Hibah M. Naveen, N. Raghavendra Alhakamy, Nabil A. Goudanavar, Prakash S. Rao, GSN Koteswara Budha, Roja Rani Nair, Anroop B. Badr-Eldin, Shaimaa M. |
author_facet | Aldawsari, Hibah M. Naveen, N. Raghavendra Alhakamy, Nabil A. Goudanavar, Prakash S. Rao, GSN Koteswara Budha, Roja Rani Nair, Anroop B. Badr-Eldin, Shaimaa M. |
author_sort | Aldawsari, Hibah M. |
collection | PubMed |
description | Pulsatile drug delivery systems have drawn attention in contemporary research for designing chronotherapeutic systems. The current work aims to design pulsatile ketorolac tromethamine tablets using compression coating for delayed delivery with a lag time suitable for the treatment of morning stiffness in arthritis. Rapidly disintegrating core tablets of ketorolac tromethamine were formulated using super-disintegrants, and the optimized formulation was compression using PEO WSR coagulant and Eudragit RLPO for delaying the release. The central composite design and response surface methodology were employed to optimize the formulation and process parameters namely PEO WSR Coagulant (X(1)), Eudragit RLPO (X(2)), and Hardness (X(3)). The dependent variables optimized were lag time and time required for 95% drug release. Analysis using response surface graphs and mathematical modeling of the results allowed identifying and quantifying the formulation variables active on the selected responses. A polynomial equation fitted to the data was used to predict the composition with optimum responses. Compression-coated pulsatile tablets’ optimized composition exhibited a lag time of 9 h and released 95% of the ketorolac tromethamine in 17.42 h. Validation of the mathematical model assured the reliability of QBD in formulation design. In vivo X-ray imaging and pharmacokinetic studies established a strong relationship between the coated polymers maintaining the desired lag time for delayed delivery of the active to coincide with the chronobiology for enhanced bioavailability at the right time when needed. |
format | Online Article Text |
id | pubmed-9477481 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Taylor & Francis |
record_format | MEDLINE/PubMed |
spelling | pubmed-94774812022-09-16 Compression-coated pulsatile chronomodulated therapeutic system: QbD assisted optimization Aldawsari, Hibah M. Naveen, N. Raghavendra Alhakamy, Nabil A. Goudanavar, Prakash S. Rao, GSN Koteswara Budha, Roja Rani Nair, Anroop B. Badr-Eldin, Shaimaa M. Drug Deliv Research Article Pulsatile drug delivery systems have drawn attention in contemporary research for designing chronotherapeutic systems. The current work aims to design pulsatile ketorolac tromethamine tablets using compression coating for delayed delivery with a lag time suitable for the treatment of morning stiffness in arthritis. Rapidly disintegrating core tablets of ketorolac tromethamine were formulated using super-disintegrants, and the optimized formulation was compression using PEO WSR coagulant and Eudragit RLPO for delaying the release. The central composite design and response surface methodology were employed to optimize the formulation and process parameters namely PEO WSR Coagulant (X(1)), Eudragit RLPO (X(2)), and Hardness (X(3)). The dependent variables optimized were lag time and time required for 95% drug release. Analysis using response surface graphs and mathematical modeling of the results allowed identifying and quantifying the formulation variables active on the selected responses. A polynomial equation fitted to the data was used to predict the composition with optimum responses. Compression-coated pulsatile tablets’ optimized composition exhibited a lag time of 9 h and released 95% of the ketorolac tromethamine in 17.42 h. Validation of the mathematical model assured the reliability of QBD in formulation design. In vivo X-ray imaging and pharmacokinetic studies established a strong relationship between the coated polymers maintaining the desired lag time for delayed delivery of the active to coincide with the chronobiology for enhanced bioavailability at the right time when needed. Taylor & Francis 2022-07-15 /pmc/articles/PMC9477481/ /pubmed/35838522 http://dx.doi.org/10.1080/10717544.2022.2094500 Text en © 2022 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Aldawsari, Hibah M. Naveen, N. Raghavendra Alhakamy, Nabil A. Goudanavar, Prakash S. Rao, GSN Koteswara Budha, Roja Rani Nair, Anroop B. Badr-Eldin, Shaimaa M. Compression-coated pulsatile chronomodulated therapeutic system: QbD assisted optimization |
title | Compression-coated pulsatile chronomodulated therapeutic system: QbD assisted optimization |
title_full | Compression-coated pulsatile chronomodulated therapeutic system: QbD assisted optimization |
title_fullStr | Compression-coated pulsatile chronomodulated therapeutic system: QbD assisted optimization |
title_full_unstemmed | Compression-coated pulsatile chronomodulated therapeutic system: QbD assisted optimization |
title_short | Compression-coated pulsatile chronomodulated therapeutic system: QbD assisted optimization |
title_sort | compression-coated pulsatile chronomodulated therapeutic system: qbd assisted optimization |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9477481/ https://www.ncbi.nlm.nih.gov/pubmed/35838522 http://dx.doi.org/10.1080/10717544.2022.2094500 |
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