Compatibility studies between nebicapone, a novel COMT inhibitor, and excipients using stepwise isothermal high sensitivity DSC method

被引：12

作者：

Silva, J. P. Sousa e ^{[1
]}

Lobo, J. M. Sousa ^{[1
]}

机构：

[1] Univ Porto, Fac Pharm, Dept Pharmaceut Technol, P-4050047 Oporto, Portugal

来源：

JOURNAL OF THERMAL ANALYSIS AND CALORIMETRY | 2010年 / 102卷 / 01期

关键词：

Nebicapone; HSDSC; Incompatibility; Drug-excipient interaction; DIFFERENTIAL SCANNING CALORIMETRY; EXTENDED-RELEASE FORMULATIONS; CATECHOL-O-METHYLTRANSFERASE; DRUG; MIXTURES; DISEASE;

D O I：

10.1007/s10973-010-0807-8

中图分类号：

O414.1 [热力学];

学科分类号：

070201 [理论物理];

摘要：

Study of excipients incompatibility with drugs in an early phase of pharmaceutical development is still a persistent difficulty within the pharmaceutical industry. We examine here the compatibility between an experimental drug (nebicapone) and common excipients using differential scanning calorimetry (DSC), high sensitivity DSC (HSDSC) and a conventional heat stress test. The results obtained indicate that nebicapone may be compatible with lactose monohydrate and sodium croscarmellose but is incompatible with magnesium stearate. This study concludes that HSDSC, in stepwise isothermal mode, may be used as a potential tool for detecting excipient incompatibilities.

引用

页码：317 / 321

页数：5

共 17 条

[1]

Characterization of venlafaxine hydrochloride and compatibility studies with pharmaceutical excipients [J].

Bernardi, L. S. ;

Oliveira, P. R. ;

Murakami, F. S. ;

Silva, M. A. S. ;

Borgmann, S. H. M. ;

Cardoso, S. G. .

JOURNAL OF THERMAL ANALYSIS AND CALORIMETRY, 2009, 97 (02) :729-733

[2]

Catechol-O-methyltransferase and its inhibitors in Parkinson's disease [J].

Bonifacio, Maria Joao ;

Palma, P. Nuno ;

Almeida, Luis ;

Soares-da-Silva, Patricio .

CNS DRUG REVIEWS, 2007, 13 (03) :352-379

[3]

Thermal analyses of commercial magnesium stearate pseudopolymorphs [J].

Bracconi, P ;

Andrès, C ;

N'diaye, A ;

Pourcelot, Y .

THERMOCHIMICA ACTA, 2005, 429 (01) :43-51

[4]

Degradation of components in drug formulations: a comparison between HPLC and DSC methods [J].

Ceschel, GC ;

Badiello, R ;

Ronchi, C ;

Maffei, P .

JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 2003, 32 (4-5) :1067-1072

[5]

Ferreira JJ, 2008, CLIN NEUROPHARMACOL, V31, P2, DOI [10.1097/WNF.0B013E3180645CB0, 10.1097/wnf.0b013e3180645cb0]

[6]

Ford J.L., 1989, PHARM THERMAL ANAL T

[7]

Potential applications of microcalorimetry for the study of physical processes in pharmaceuticals [J].

Gaisford, S ;

Buckton, G .

THERMOCHIMICA ACTA, 2001, 380 (02) :185-198

[8]

Gibson M., 2001, PHARM PREFORMULATION

[9]

Drug-excipient compatibility studies by physico-chemical techniques - The case of atenolol [J].

Marini, A ;

Berbenni, V ;

Pegoretti, M ;

Bruni, G ;

Cofrancesco, P ;

Sinistri, C ;

Villa, M .

JOURNAL OF THERMAL ANALYSIS AND CALORIMETRY, 2003, 73 (02) :547-561

[10]

Further investigations into the use of high sensitivity differential scanning calorimetry as a means of predicting drug-excipient interactions [J].

McDaid, FM ;

Barker, SA ;

Fitzpatrick, S ;

Petts, CR ;

Craig, DQM .

INTERNATIONAL JOURNAL OF PHARMACEUTICS, 2003, 252 (1-2) :235-240

← 1 2 →