Assessment of Residual Solvent and Drug in PLGA Microspheres by Derivative Thermogravimetry

Thermogravimetry does not give specific information on residual organic solvents in polymeric matrices unless it is hyphenated with the so-called evolved gas analysis. The purpose of this study was to apply, for the first time, derivative thermogravimetry (DTG) to characterize a residual solvent and...

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Main Authors: Hyunjin Shim, Hongkee Sah
Format: Article
Language:English
Published: MDPI AG 2020-07-01
Series:Pharmaceutics
Subjects:
Online Access:https://www.mdpi.com/1999-4923/12/7/626
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author Hyunjin Shim
Hongkee Sah
author_facet Hyunjin Shim
Hongkee Sah
author_sort Hyunjin Shim
collection DOAJ
description Thermogravimetry does not give specific information on residual organic solvents in polymeric matrices unless it is hyphenated with the so-called evolved gas analysis. The purpose of this study was to apply, for the first time, derivative thermogravimetry (DTG) to characterize a residual solvent and a drug in poly-<i>d,l</i>-lactide-<i>co</i>-glycolide (PLGA) microspheres. Ethyl formate, an ICH class 3 solvent, was used to encapsulate progesterone into microspheres. DTG provided a distinct peak, displaying the onset and end temperatures at which ethyl formate started to evolve from to where it completely escaped out of the microspheres. DTG also gave the area and height of the solvent peak, as well as the temperature of the highest mass change rate of the microspheres. These derivative parameters allowed for the measurement of the amount of residual ethyl formate in the microspheres. Interestingly, progesterone affected not only the residual solvent amount but also these derivative parameters. Another intriguing finding was that there was a linear relationship between progesterone content and the peak height of ethyl formate. The residual solvent data calculated by DTG were quite comparable to those measured by gas chromatography. In summary, DTG could be an efficient and practical quality control tool to evaluate residual solvents and drugs in various polymeric matrices.
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spelling doaj.art-65f9abe15cc942878eb9b761a4bfb6162023-11-20T05:50:51ZengMDPI AGPharmaceutics1999-49232020-07-0112762610.3390/pharmaceutics12070626Assessment of Residual Solvent and Drug in PLGA Microspheres by Derivative ThermogravimetryHyunjin Shim0Hongkee Sah1College of Pharmacy, Ewha Womans University, 52 Ewhayeodaegil, Seodaemun-gu, Seoul 03760, KoreaCollege of Pharmacy, Ewha Womans University, 52 Ewhayeodaegil, Seodaemun-gu, Seoul 03760, KoreaThermogravimetry does not give specific information on residual organic solvents in polymeric matrices unless it is hyphenated with the so-called evolved gas analysis. The purpose of this study was to apply, for the first time, derivative thermogravimetry (DTG) to characterize a residual solvent and a drug in poly-<i>d,l</i>-lactide-<i>co</i>-glycolide (PLGA) microspheres. Ethyl formate, an ICH class 3 solvent, was used to encapsulate progesterone into microspheres. DTG provided a distinct peak, displaying the onset and end temperatures at which ethyl formate started to evolve from to where it completely escaped out of the microspheres. DTG also gave the area and height of the solvent peak, as well as the temperature of the highest mass change rate of the microspheres. These derivative parameters allowed for the measurement of the amount of residual ethyl formate in the microspheres. Interestingly, progesterone affected not only the residual solvent amount but also these derivative parameters. Another intriguing finding was that there was a linear relationship between progesterone content and the peak height of ethyl formate. The residual solvent data calculated by DTG were quite comparable to those measured by gas chromatography. In summary, DTG could be an efficient and practical quality control tool to evaluate residual solvents and drugs in various polymeric matrices.https://www.mdpi.com/1999-4923/12/7/626poly-<i>d,l</i>-lactide-<i>co</i>-glycolidemicrospheresderivative thermogravimetryresidual solventethyl formate
spellingShingle Hyunjin Shim
Hongkee Sah
Assessment of Residual Solvent and Drug in PLGA Microspheres by Derivative Thermogravimetry
Pharmaceutics
poly-<i>d,l</i>-lactide-<i>co</i>-glycolide
microspheres
derivative thermogravimetry
residual solvent
ethyl formate
title Assessment of Residual Solvent and Drug in PLGA Microspheres by Derivative Thermogravimetry
title_full Assessment of Residual Solvent and Drug in PLGA Microspheres by Derivative Thermogravimetry
title_fullStr Assessment of Residual Solvent and Drug in PLGA Microspheres by Derivative Thermogravimetry
title_full_unstemmed Assessment of Residual Solvent and Drug in PLGA Microspheres by Derivative Thermogravimetry
title_short Assessment of Residual Solvent and Drug in PLGA Microspheres by Derivative Thermogravimetry
title_sort assessment of residual solvent and drug in plga microspheres by derivative thermogravimetry
topic poly-<i>d,l</i>-lactide-<i>co</i>-glycolide
microspheres
derivative thermogravimetry
residual solvent
ethyl formate
url https://www.mdpi.com/1999-4923/12/7/626
work_keys_str_mv AT hyunjinshim assessmentofresidualsolventanddruginplgamicrospheresbyderivativethermogravimetry
AT hongkeesah assessmentofresidualsolventanddruginplgamicrospheresbyderivativethermogravimetry