The step-wise dissolution method: An efficient DSC-based protocol for verification of predicted API-polymer compatibility
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22340%2F23%3A43928104" target="_blank" >RIV/60461373:22340/23:43928104 - isvavai.cz</a>
Result on the web
<a href="https://www.sciencedirect.com/science/article/pii/S0378517323010256?via%3Dihub" target="_blank" >https://www.sciencedirect.com/science/article/pii/S0378517323010256?via%3Dihub</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.ijpharm.2023.123604" target="_blank" >10.1016/j.ijpharm.2023.123604</a>
Alternative languages
Result language
angličtina
Original language name
The step-wise dissolution method: An efficient DSC-based protocol for verification of predicted API-polymer compatibility
Original language description
The development of an amorphous solid dispersion (ASD) is a promising strategy for improving the low bioavailability of many poorly water-soluble active pharmaceutical ingredients (APIs). The construction of a temperature-composition (T-C) phase diagram for an API-polymer combination is imperative as it can provide critical information that is essential for formulating stable ASDs. However, the currently followed differential scanning calorimetry (DSC)-based strategies for API solubility determination in a polymer at elevated temperatures are inefficient and, on occasions, unreliable, which may lead to an inaccurate prediction at lower temperatures of interest (i.e., T = 25 degrees C). Recently, we proposed a novel DSC-based protocol called the "step-wise dissolution" (S-WD) method, which is both cost-and time-effective. The objective of this study was to test the applicability of the S-WD method regarding expeditious verification of the purely-predicted API-polymer compatibility via the perturbed chain-statistical associating fluid theory (PC-SAFT) equation of state (EOS). Fifteen API-polymer T-C phase diagrams were reliably constructed, with three distinct API-polymer case types being identified regarding the approach used for the S-WD method. Overall, the PC-SAFT EOS provided satisfactory qualitative descriptions of the API-polymer compatibility, but not necessarily accurate quantitative predictions of the API solubility in the polymer at T = 25 degrees C. The S-WD method was subsequently modified and an optimal protocol was proposed, which can significantly reduce the required experimental effort.
Czech name
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Czech description
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Classification
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
10403 - Physical chemistry
Result continuities
Project
<a href="/en/project/GA22-07164S" target="_blank" >GA22-07164S: Rational design of drug delivery systems based on tailored biodegradable polymers using an iterative in silico and experimental approach</a><br>
Continuities
P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)
Others
Publication year
2023
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
INTERNATIONAL JOURNAL OF PHARMACEUTICS
ISSN
0378-5173
e-ISSN
1873-3476
Volume of the periodical
648
Issue of the periodical within the volume
prosinec 2023
Country of publishing house
US - UNITED STATES
Number of pages
14
Pages from-to
123604
UT code for WoS article
001125162800001
EID of the result in the Scopus database
2-s2.0-85178174698