Physical characterization of polymorphic drugs: an integrated characterization strategy

被引:132
作者
Yu, L [1 ]
Reutzel, SM [1 ]
Stephenson, GA [1 ]
机构
[1] Eli Lilly & Co, Lilly Res Labs, Indianapolis, IN USA
来源
PHARMACEUTICAL SCIENCE & TECHNOLOGY TODAY | 1998年 / 1卷 / 03期
关键词
D O I
10.1016/S1461-5347(98)00031-5
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
The potential impact of changing crystal forms during late-stage drug development, in terms of cost and product delay, justifies systematic and early characterization of polymorphism. A thorough understanding of polymorph characteristics also allows selection of the best form to market. The authors review the key elements of polymorph characterization (identification and quantitation, structures, properties and structure-property relationships). The emphasis is on recent developments and an integrated characterization strategy for different types of polymorphs using crystallographic, spectroscopic, microscopic and thermal techniques.
引用
收藏
页码:118 / 127
页数:10
相关论文
共 114 条
[1]   ON TEMPERATURE DEPENDENCE OF COOPERATIVE RELAXATION PROPERTIES IN GLASS-FORMING LIQUIDS [J].
ADAM, G ;
GIBBS, JH .
JOURNAL OF CHEMICAL PHYSICS, 1965, 43 (01) :139-&
[2]   THE MOLECULAR-BASIS OF MOISTURE EFFECTS ON THE PHYSICAL AND CHEMICAL-STABILITY OF DRUGS IN THE SOLID-STATE [J].
AHLNECK, C ;
ZOGRAFI, G .
INTERNATIONAL JOURNAL OF PHARMACEUTICS, 1990, 62 (2-3) :87-95
[3]   Near-IR detection of polymorphism and process-related substances [J].
Aldridge, PK ;
Evans, CL ;
Ward, HW ;
Colgan, ST ;
Boyer, N ;
Gemperline, PJ .
ANALYTICAL CHEMISTRY, 1996, 68 (06) :997-1002
[4]   SYSTEMATIC ANALYSIS OF STRUCTURAL DATA AS A RESEARCH TECHNIQUE IN ORGANIC-CHEMISTRY [J].
ALLEN, FH ;
KENNARD, O ;
TAYLOR, R .
ACCOUNTS OF CHEMICAL RESEARCH, 1983, 16 (05) :146-153
[5]   Molecular mobility of supercooled amorphous indomethacin, determined by dynamic mechanical analysis [J].
Andronis, V ;
Zografi, G .
PHARMACEUTICAL RESEARCH, 1997, 14 (04) :410-414
[6]   RELAXATION IN LIQUIDS, POLYMERS AND PLASTIC CRYSTALS - STRONG FRAGILE PATTERNS AND PROBLEMS [J].
ANGELL, CA .
JOURNAL OF NON-CRYSTALLINE SOLIDS, 1991, 131 :13-31
[7]  
[Anonymous], 1996, Modern techniques in Raman spectroscopy
[8]   CHARACTERIZATION OF POLYMORPHISM OF GEPIRONE HYDROCHLORIDE [J].
BEHME, RJ ;
BROOKE, D ;
FARNEY, RF ;
KENSLER, TT .
JOURNAL OF PHARMACEUTICAL SCIENCES, 1985, 74 (10) :1041-1046
[9]   DETERMINATION OF DRUG POLYMORPHS BY LASER RAMAN-SPECTROSCOPY .1. AMPICILLIN AND GRISEOFULVIN [J].
BELLOWS, JC ;
CHEN, FP ;
PRASAD, PN .
DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, 1977, 3 (05) :451-458
[10]   CONFORMATIONAL INFLUENCES ON ELECTRONIC-SPECTRA AND STRUCTURE - POLYMORPHS OF N-(P-CHLOROBENZYLIDENE)-P-CHLOROANILINE [J].
BERNSTEIN, J ;
ANDERSON, TE ;
ECKHARDT, CJ .
JOURNAL OF THE AMERICAN CHEMICAL SOCIETY, 1979, 101 (03) :541-545