Factor analysis in optimization of formulation of high content uniformity tablets containing low dose active substance

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F68081731%3A_____%2F17%3A00480607" target="_blank" >RIV/68081731:_____/17:00480607 - isvavai.cz</a>
Alternative codes found
RIV/62157124:16370/17:43875569
Result on the web
<a href="http://dx.doi.org/10.1016/j.ejps.2017.09.017" target="_blank" >http://dx.doi.org/10.1016/j.ejps.2017.09.017</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.ejps.2017.09.017" target="_blank" >10.1016/j.ejps.2017.09.017</a>

Result language
angličtina
Original language name
Factor analysis in optimization of formulation of high content uniformity tablets containing low dose active substance
Original language description
Warfarin is intensively discussed drug with narrow therapeutic range. There have been cases of bleeding attributed to varying content or altered quality of the active substance. Factor analysis is useful for finding suitable technological parameters leading to high content uniformity of tablets containing low amount of active substance. The composition of tabletting blend and technological procedure were set with respect to factor analysis of previously published results. The correctness of set parameters was checked by manufacturing and evaluation of tablets containing 1-10mg of warfarin sodium. The robustness of suggested technology was checked by using worst case scenario and statistical evaluation of European Pharmacopoeia (EP) content uniformity limits with respect to Bergum division and process capability index (Cpk). To evaluate the quality of active substance and tablets, dissolution method was developed (water, EP apparatus II, 25rpm), allowing for statistical comparison of dissolution profiles. Obtained results prove the suitability of factor analysis to optimize the composition with respect to batches manufactured previously and thus the use of metaanalysis under industrial conditions is feasible.
Czech name
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Czech description
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Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
20602 - Medical laboratory technology (including laboratory samples analysis; diagnostic technologies) (Biomaterials to be 2.9 [physical characteristics of living material as related to medical implants, devices, sensors])

Project
Result was created during the realization of more than one project. More information in the Projects tab.
Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year
2017
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

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