The aim of the PhD dissertation was to evaluate the application of three, new co-spray dried excipient systems F-Melt® type C, F-Melt® type M and Pharmaburst® to form fast disintegrating tablet matrix by direct compression method. The analysis of tablets was carried out on 18 formulations placebo as well as on 140 formulations containing ibuprofen, diclofenac sodium, or diltiazem hydrochloride. On the base of the results such as disintegration time, mechanical resistance and texture analysis using the porosimetry of mercury, or nitrogen adsorption the influence of the excipient, the drug and its amount on the quality of the tablets was stated. Since Pharmaburst® was used as a matrix forming agent, the tablets disintegrating within 1 min of adequate mechanical resistance, containing 50 mg and 100 mg of ibuprofen, or diclofenac sodium and 50 mg of diltiazem hydrochloride were prepared. Similar results were shown in case of tablets containing F-Melt® type C and 50 mg of diltiazem hydrochloride. The study involved not only the measurements of the disintegration time according to the pharmacopoeial method but also wetting time was determined, MRI technique and a rotating shaft apparatus were used. The analysis of in vivo disintegration time was performed. The study aimed also the preparation of ODTs containing solid dispersions of ibuprofen. The application of spray-dried magnesium ; aluminometasilicate (Neusilin® US2) as a carrier improved the drug solubility. Disintegration time below 1 min 20 s and friability below 0,3 % had tablets containing both Pharmaburst® and solid dispersion of ibuprofen with Neusilin® US2.
Uniwersytet Jagielloński – Collegium Medicum
Mar 8, 2023
Nov 21, 2012
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http://dl.cm-uj.krakow.pl:8080/publication/778
Edition name | Date |
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ZB-111790 | Mar 8, 2023 |
Krupa, Anna
Brniak, Witold
Kurek, Mateusz
Antosik-Rogóż, Agata
Woyna-Orlewicz, Krzysztof
Niwiński, Krzysztof