Application of spectroscopic imaging for characterizing API: polymer systems as a screening tool for the development of potential amorphous solid dispersions

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11160%2F17%3A10374955" target="_blank" >RIV/00216208:11160/17:10374955 - isvavai.cz</a>

Výsledek na webu

<a href="http://www.ptfarm.pl/wydawnictwa/czasopisma/acta-poloniae-pharmaceutica/110/-/27117" target="_blank" >http://www.ptfarm.pl/wydawnictwa/czasopisma/acta-poloniae-pharmaceutica/110/-/27117</a>

DOI - Digital Object Identifier

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Jazyk výsledku

angličtina

Název v původním jazyce

Application of spectroscopic imaging for characterizing API: polymer systems as a screening tool for the development of potential amorphous solid dispersions

Popis výsledku v původním jazyce

Raman and infrared mapping techniques were employed in this study for the characterization of drug-polymer films cast on glass plates and for finding good amorphous solid dispersion formulation candidates containing dabigatran etexilate. To verify the results obtained from this approach, two common solvent evaporation-based solid dispersion processes were used for the preparation of samples and those samples were analyzed conventionally, with solid state NMR and modulated DSC. Solid solutions containing amorphous dabigatran etexilate with a low probability of crystallization were identified, using mapping techniques in samples with 75% of drug dissolved in Kollidon K30 and in 50% of drug dissolved in Kollidon VA64 and Soluplus. On the contrary, all samples prepared by spray drying were characterized as solid solutions which may lead to crystallization of the API in certain concentrations. This was shown to be valid in materials containing Kollidon VA64 and Soluplus, respectively, and more than 50% of the API when prepared by solvent evaporation. The experimental data obtained in this study proved that spectral mapping-based screening methods are able to identify potential candidates for amorphous solid dispersion formulations which are less prone to crystallization.

Název v anglickém jazyce

Application of spectroscopic imaging for characterizing API: polymer systems as a screening tool for the development of potential amorphous solid dispersions

Popis výsledku anglicky

Raman and infrared mapping techniques were employed in this study for the characterization of drug-polymer films cast on glass plates and for finding good amorphous solid dispersion formulation candidates containing dabigatran etexilate. To verify the results obtained from this approach, two common solvent evaporation-based solid dispersion processes were used for the preparation of samples and those samples were analyzed conventionally, with solid state NMR and modulated DSC. Solid solutions containing amorphous dabigatran etexilate with a low probability of crystallization were identified, using mapping techniques in samples with 75% of drug dissolved in Kollidon K30 and in 50% of drug dissolved in Kollidon VA64 and Soluplus. On the contrary, all samples prepared by spray drying were characterized as solid solutions which may lead to crystallization of the API in certain concentrations. This was shown to be valid in materials containing Kollidon VA64 and Soluplus, respectively, and more than 50% of the API when prepared by solvent evaporation. The experimental data obtained in this study proved that spectral mapping-based screening methods are able to identify potential candidates for amorphous solid dispersion formulations which are less prone to crystallization.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

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OECD FORD obor

30104 - Pharmacology and pharmacy

Projekt

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Návaznosti

S - Specificky vyzkum na vysokych skolach<br>I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2017

Kód důvěrnosti údajů

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

Název periodika

Acta Poloniae Pharmaceutica

ISSN

0001-6837

e-ISSN

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Svazek periodika

74

Číslo periodika v rámci svazku

6

Stát vydavatele periodika

PL - Polská republika

Počet stran výsledku

8

Strana od-do

1851-1858

Kód UT WoS článku

000430449500025

EID výsledku v databázi Scopus

2-s2.0-85037704499