Obiekt
Tytuł: Technological aspects of preparation of orodispersible films containing aripiprazole and assessment of their quality
Abstrakt:
The aim of this study was the development and optimization of the composition of orodispersible films (ODFs) and the process of their preparation with various methods, i.e. solvent casting, electrospinning and 3D printing, as well as the assessment of their quality. For this purpose, 40 series of the ODF films including 14 placebo formulations and 26 series containing raw aripiprazole or in the form of solid dispersion, were prepared and assessed. The results of the studies show that the properties of the ODF films depended on their composition and the applied production technology. Due to the poor water solubility of aripiprazole, the solid dispersions with polymeric carriers such as Poloxamer® 407, Kollidon® VA64, mannitol, Macrogol 6000, or Soluplus® were prepared using a ball milling method. Among the analyzed carriers, the Poloxamer 407 had the best properties. Therefore, the aripiprazole-Poloxamer® 407 (1:1) solid dispersions were prepared for further studies. The next stage of the research included optimization of the ODFs composition and the process of their preparation. In the case of ODF films prepared by the casting method, the PVA-based films with 15% glycerol addition were the most suitable for the preparation of ODF films, due to their better mechanical properties and shorter disintegration time. Moreover, ODFs with solid dispersion showed a smoother films surfa ; ce, favorable mechanical properties, faster disintegration time (<20 s) and higher drug amount released (>95% after 15 min) as compared to films containing raw aripiprazole. Based on the results of the analysis, it was shown that the ODF films containing PVA as the film-forming polymer, glycerol as a plasticizer (15%) and solid dispersion were characterized by the best properties among all tested cast films. The ODF films prepared with the electrospinning method, using PVA as the film-forming polymer, were characterized by good mechanical properties and the shortest disintegration time (1 s) among all tested formulations. Moreover, the increased surface area and partial amorphization of the drug substance had a positive effect on the drug substance release profile. The mechanical properties of the PVA-based ODF films obtained by 3D printing were similar to the films produced by the casting method. However, their disintegration time was more than two times longer. What is more, the aripiprazole in printed films was in an amorphous form which positively influenced its dissolution profile. Stability studies of the ODF films packed into ALU / ALU sachets in a climate chamber of 25℃/60%RH showed changes in the amount of aripiprazole released. The results of the tests carried out in the conditions of 40℃/75% RH indicated that the stability studies should be performed using a more ; barrier packaging material to ensure better dosage form stability. The results of the performed research indicate that the three applied methods, i.e. casting, electrospinning and 3D printing, are suitable in the preparation of ODFs with aripiprazole. Among them, the most preferable is the electrospinning method due to the shortest disintegration time of the electrospun films. However, the problematic issue is obtaining films of uniform mass and thickness.
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Instytucja nadająca tytuł:
Rada Dyscypliny Nauki farmaceutyczne
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Data ostatniej modyfikacji:
8 kwi 2024
Data dodania obiektu:
1 cze 2022
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8
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http://dl.cm-uj.krakow.pl:8080/publication/4721
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| Nazwa wydania | Data |
|---|---|
| ZB-135317 | 8 kwi 2024 |
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