Additive manufacturing in pharmaceutical formulation - Development of biodegradable printed dosage forms for oral drug delivery

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22340%2F20%3A43921582" target="_blank" >RIV/60461373:22340/20:43921582 - isvavai.cz</a>

Výsledek na webu

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DOI - Digital Object Identifier

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Jazyk výsledku

angličtina

Název v původním jazyce

Additive manufacturing in pharmaceutical formulation - Development of biodegradable printed dosage forms for oral drug delivery

Popis výsledku v původním jazyce

The first step applying FDM in pharmaceutical formulation the conversion of a drug and chosen additives (FDA approved “excipients”) into solid filaments, used as feed material for the printer. To be able to print pharmaceutically relevant tablets, the components had to meet certain criteria –chemical and thermal stability of the drug during the process and storage, excipient biodegradability, drug content homogeneity, the dissolution rate had to be in a desired range, etc. In addition, the filaments had to exhibit suitable mechanical properties in order to enable reproducible printing with good resolution. Several types of additives were employed –fillers, plasticizers, glidants, desiccants and disintegrants. To determine the specific effect of the composition on the relevant properties of the filaments, mechanical stability, dynamic viscosity and composition homogeneity were analyzed and the observed trends were used to determine the ideal filament composition. Furthermore, the crystalline/amorphous structure of the drugs after the extrusion was analyzed (using X-ray diffraction and differential scanning calorimetry) and the dissolution kinetics of the tablets was measured using chromatography and UV spectroscopy. After the optimizations, tablets were produced successfully (example shown in Fig. 1). Analogically, gels for the production of fast-dissolving oro-dispersible films were prepared and printed using syringe extrusion printing. To determine, how to adjust the structures of printed dosage forms to achieve desired dissolution profiles, mathematical simulation was employed, as described in the presentation of Z. Grof (“Evolutionary algorithm for the design of 3D-printed tablets”).

Název v anglickém jazyce

Additive manufacturing in pharmaceutical formulation - Development of biodegradable printed dosage forms for oral drug delivery

Popis výsledku anglicky

The first step applying FDM in pharmaceutical formulation the conversion of a drug and chosen additives (FDA approved “excipients”) into solid filaments, used as feed material for the printer. To be able to print pharmaceutically relevant tablets, the components had to meet certain criteria –chemical and thermal stability of the drug during the process and storage, excipient biodegradability, drug content homogeneity, the dissolution rate had to be in a desired range, etc. In addition, the filaments had to exhibit suitable mechanical properties in order to enable reproducible printing with good resolution. Several types of additives were employed –fillers, plasticizers, glidants, desiccants and disintegrants. To determine the specific effect of the composition on the relevant properties of the filaments, mechanical stability, dynamic viscosity and composition homogeneity were analyzed and the observed trends were used to determine the ideal filament composition. Furthermore, the crystalline/amorphous structure of the drugs after the extrusion was analyzed (using X-ray diffraction and differential scanning calorimetry) and the dissolution kinetics of the tablets was measured using chromatography and UV spectroscopy. After the optimizations, tablets were produced successfully (example shown in Fig. 1). Analogically, gels for the production of fast-dissolving oro-dispersible films were prepared and printed using syringe extrusion printing. To determine, how to adjust the structures of printed dosage forms to achieve desired dissolution profiles, mathematical simulation was employed, as described in the presentation of Z. Grof (“Evolutionary algorithm for the design of 3D-printed tablets”).

Druh

O - Ostatní výsledky

CEP obor

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OECD FORD obor

20401 - Chemical engineering (plants, products)

Projekt

<a href="/cs/project/TJ02000383" target="_blank" >TJ02000383: Metoda výroby lékové formy, personalizované pro potřeby konkrétního pacienta za pomoci matematické simulace a 3D tisku</a><br>

Návaznosti

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Rok uplatnění

2020

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů