Pre and post characterization of ODTs with emphasis on compression force and quality of super-disintegrants: In vivo analysis in healthy volunteers

Oral dispersible tablets (ODTs) are patient compliant dosage forms which rapidly disintegrate in the mouth following active absorption with rapid onset of action. The current study was designed to resolve compression problems used for ODTs, as high compression force exhibited hardness and drug relea...

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Published in:Pakistan journal of pharmaceutical sciences 2023-11, Vol.36 (6), p.1767-1775
Main Authors: Ayub, Shagufta, Hanif, Sana, Ul Huq, Umar Inzamam, Irfan, Muhammad, Ali, Ijaz, Madkhali, Osama A, Farzana, Kalsom, Ali Syed, Muhammad, Shahid, Nariman, Aftab, Tayyaba, Asmatullah, Maliha
Format: Article
Language:English
Subjects:
Chemical properties
Chemistry, Pharmaceutical - methods
Compressibility
Drug Compounding - methods
Excipients
Healthy Volunteers
Humans
Mechanical properties
Oral medication
Pharmaceutical research
Tablets
Tablets (Medicine)
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container_end_page 1775
container_issue 6
container_start_page 1767
container_title Pakistan journal of pharmaceutical sciences
container_volume 36
creator Ayub, Shagufta
Hanif, Sana
Ul Huq, Umar Inzamam
Irfan, Muhammad
Ali, Ijaz
Madkhali, Osama A
Farzana, Kalsom
Ali Syed, Muhammad
Shahid, Nariman
Aftab, Tayyaba
Asmatullah, Maliha
description Oral dispersible tablets (ODTs) are patient compliant dosage forms which rapidly disintegrate in the mouth following active absorption with rapid onset of action. The current study was designed to resolve compression problems used for ODTs, as high compression force exhibited hardness and drug release problems. Formulations, F1-F9 were compressed at three different forces 44, 54 and 64 kN using cross-carmellose sodium (CCS) and sodium starch glycolate (SSG) and evaluated for pre and post compression. Formulations F1, F4 and F7 which were compressed at 44 kN showed hardness ranges between 5.09-6.15 with lowest DT (less than 15 s) and better LTZ release. While F2, F5 and F8 (compressed at 54 kN) demonstrated hardness in between 6.90-7.02. Similarly, F3, F6 and F9 compressed at 64 kN showed hardness values between 8.70-8.98 with increased DT and slow LTZ release. Friability results for all the formulations were within United States Pharmacopeial (USP) specifications (
doi_str_mv 10.36721/PJPS.2023.36.6.REG.1767-1775.1
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All formulations depicted t-test value &lt;0.5, hence it found that all formulations showed significant statistical value within limits, however best compression force 44 kN showed low p value. 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All formulations depicted t-test value &lt;0.5, hence it found that all formulations showed significant statistical value within limits, however best compression force 44 kN showed low p value. 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All formulations depicted t-test value &lt;0.5, hence it found that all formulations showed significant statistical value within limits, however best compression force 44 kN showed low p value. It was concluded that optimized compression force for ODTs was 44 kN among all employed forces that exhibited desirable drug release.</abstract><cop>Pakistan</cop><pub>Pakistan Journal of Pharmaceutical Sciences</pub><pmid>38124417</pmid><doi>10.36721/PJPS.2023.36.6.REG.1767-1775.1</doi><tpages>9</tpages></addata></record>
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subjects Chemical properties
Chemistry, Pharmaceutical - methods
Compressibility
Drug Compounding - methods
Excipients
Healthy Volunteers
Humans
Mechanical properties
Oral medication
Pharmaceutical research
Tablets
Tablets (Medicine)
title Pre and post characterization of ODTs with emphasis on compression force and quality of super-disintegrants: In vivo analysis in healthy volunteers
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