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Article

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Title

The Use of Hot Melt Extrusion to Prepare a Solid Dispersion of Ibuprofen in a Polymer Matrix

Authors

[ 1 ] Instytut Technologii i Inżynierii Chemicznej, Wydział Technologii Chemicznej, Politechnika Poznańska | [ D ] phd student | [ P ] employee

Scientific discipline (Law 2.0)

[7.6] Chemical sciences

Year of publication

2023

Published in

Polymers

Journal year: 2023 | Journal volume: vol. 15 | Journal number: iss. 13

Article type

scientific article

Publication language

english

Keywords
EN
  • hot melt extrusion
  • Eudragit
  • ibuprofen
  • amorphous solid dispersion
Abstract

EN In this work, we report the use of the hot melt extrusion method in harsh extrusion conditions, i.e., screw rotation speed of 250 rpm, temperature above 100 °C, and two mixing zones, in order to obtain an amorphous dispersion of an active pharmaceutical ingredient (API) that is sparingly soluble in water. As a polymer matrix Eudragit EPO (E-EPO) and as an API ibuprofen (IBU) were used in the research. In addition, the plasticizer Compritol 888 ATO (COM) was tested as a factor potentially improving processing parameters and modifying the IBU release profile. In studies, 25% by weight of IBU, 10% of COM and various extrusion temperatures, i.e., 90, 100, 120, 130, and 140 °C, were used. Hot melt extrusion (HME) temperatures were selected based on the glass transition temperature of the polymer matrix (Tg = 42 °C) and the melting points of IBU (Tm = 76 °C) and COM (Tm = 73 °C), which were tested by differential scanning calorimetry (DSC). The thermal stability of the tested compounds, determined on the basis of measurements carried out by thermogravimetric analysis (TGA), was also taken into account. HME resulted in amorphous E-EPO/IBU solid dispersions and solid dispersions containing a partially crystalline plasticizer in the case of E-EPO/IBU/COM extrudates. Interactions between the components of the extrudate were also studied using infrared spectroscopy (FTIR-ATR). The occurrence of such interactions in the studied system, which improve the stability of the obtained solid polymer dispersions, was confirmed. On the basis of DSC thermograms and XRPD diffractograms, it was found that amorphous solid dispersions were obtained. In addition, their stability was confirmed in accelerated conditions (40 °C, 75% RH) for 28 days and 3 months. The release profiles of prepared tablets showed the release of 40% to 63% of IBU from the tablets within 180 min in artificial gastric juice solution, with the best results obtained for tablets with E-EPO/IBU extrudate prepared at a processing temperature of 140 °C.

Date of online publication

30.06.2023

Pages (from - to)

2912-1 - 2912-15

DOI

10.3390/polym15132912

URL

https://www.mdpi.com/2073-4360/15/13/2912

Comments

Article number: 2912

License type

CC BY (attribution alone)

Open Access Mode

open journal

Open Access Text Version

final published version

Release date

30.06.2023

Date of Open Access to the publication

at the time of publication

Full text of article

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Access level to full text

public

Ministry points / journal

100

Impact Factor

4,7

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