Journal of Thermal Analysis and Calorimetry
Volume/Issue:
Volume 68: Issue 2
Thermal Behavior of Paracetamol-Polymeric Excipients Mixtures
Authors:
F. Giordano Università di Parma Dipartimento Farmaceutico Viale delle Scienze 27A 43100 Parma Italy Viale delle Scienze 27A 43100 Parma Italy

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A. Rossi Università di Parma Dipartimento Farmaceutico Viale delle Scienze 27A 43100 Parma Italy Viale delle Scienze 27A 43100 Parma Italy

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R. Bettini Università di Parma Dipartimento Farmaceutico Viale delle Scienze 27A 43100 Parma Italy Viale delle Scienze 27A 43100 Parma Italy

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A. Savioli Università di Parma Dipartimento Farmaceutico Viale delle Scienze 27A 43100 Parma Italy Viale delle Scienze 27A 43100 Parma Italy

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A. Gazzaniga Università di Milano Istituto Chimico Farmaceutico Viale Abruzzi 42 20132 Milano Italy Viale Abruzzi 42 20132 Milano Italy

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Cs. Novák Budapest University of Technology and Economics Research Group for Technical Analytical Chemistry of the Hungarian Academy of Sciences & Institute of General and Analytical Chemistry H-1111 Budapest Szent Gellért tér 4 Hungary H-1111 Budapest Szent Gellért tér 4 Hungary

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Pages:
575–590
Online Publication Date:
03 Nov 2004
Publication Date:
01 May 2002
Article Category:
Research Article
DOI:
https://doi.org/10.1023/a:1016004206043
Keywords:
DSC; excipient; HSM; MFTIR; paracetamol; polymorphism; SEM
Restricted access

Abstract  

The thermal behavior of binary mixtures of paracetamol and a polymeric excipient (microcrystalline cellulose, hydroxypropylmethylcellulose and cross-linked poly(vinylpyrrolidone)) was investigated. The physical mixtures, ranging from 50 to 90% by mass of drug, were submitted to a heating-cooling-heating program in the 35–180C temperature range. Solid-state analysis was performed by means of differential scanning calorimetry (DSC), hot stage microscopy (HSM), micro-Fourier transformed infrared spectroscopy (MFTIR), and scanning electron microscopy (SEM). The polymeric excipients were found to address in a reproducible manner the recrystallization of molten paracetamol within the binary mixture into Form II or Form III. The degree of crystallinity of paracetamol in the binary mixtures, evaluated from fusion enthalpies during the first and second heating scans, was influenced by the composition of the mixture, the nature of the excipient and the thermal history. In particular, DSC on mixtures with cross-linked poly(vinylpyrrolidone) and hydroxypropylmethylcellulose with drug contents below 65 and75%, respectively, evidenced the presence only of amorphous paracetamol after the cooling phase. Microcrystalline cellulose was very effective in directing the recrystallization of molten paracetamol as Form II.

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Cover Journal of Thermal Analysis and Calorimetry
Journal of Thermal Analysis and Calorimetry
Print ISSN:
1388-6150
Online ISSN:
1572-8943

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Journal of Thermal Analysis and Calorimetry
Language English
Size A4
Year of
Foundation		 1969
Volumes
per Year		 1
Issues
per Year		 24
Founder Akadémiai Kiadó
Founder's
Address		 H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
Publisher Akadémiai Kiadó
Springer Nature Switzerland AG
Publisher's
Address		 H-1117 Budapest, Hungary 1516 Budapest, PO Box 245.
CH-6330 Cham, Switzerland Gewerbestrasse 11.
Responsible
Publisher		 Chief Executive Officer, Akadémiai Kiadó
ISSN 1388-6150 (Print)
ISSN 1588-2926 (Online)

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