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Study of excipients' influence on the drug dissolution from tablets
Ouzký, Miroslav ; Šklubalová, Zdeňka (advisor) ; Mužíková, Jitka (referee)
Charles University, Faculty of Pharmacy in Hradec Králové Department of: Pharmaceutical Technology Supervisor: Consultants: Assoc. Prof. PharmDr. Zdeňka Šklubalová, Ph.D. Mgr. Jana Brokešová, Mgr. Daniel Pěček Student: Miroslav Ouzký Title of Thesis: Study of excipientsʼ influence on the drug dissolution from tablets The aim of this work was to study the influence of excipients on the dissolution of the high-dose active substance from tablets. The tablets were compressed from the granules prepared by wet-granulation method. 11 batches of tablets which contained two different fillers: either lactose or microcrystalline cellulose, respectively; and extragranularly added disintegrant: either croscarmellose or crospovidone, respectively, in three concentration levels of 2 %, 3,7 % or 5,4 % were prepared. Tablets were packed into aluminium/PVC blisters. The paddle dissolution test was used to determine the release of the active substance into phospate buffer pH 7,2 at the time of preparation (time 0) and at the time points 1.5, 3 and 6 months of stability assay at 40 řC and 75 % relative air humidity. The results show that the drug release from tablets containing microcrystalline celulose was generally faster than from those containing lactose. The same was true for tablets to which croscarmellose was...
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