PREFORMULATION STUDY OF MOISTURE EFFECT ON THE PHYSICAL STABILITY OF PYRIDOXAL HYDROCHLORIDE

被引：3

作者：

DURIG, T ^{[1
]}

FASSIHI, AR ^{[1
]}

机构：

[1] UNIV WITWATERSRAND,SCH MED,DEPT PHARM,7 YORK RD,JOHANNESBURG 2193,SOUTH AFRICA

来源：

INTERNATIONAL JOURNAL OF PHARMACEUTICS | 1991年 / 77卷 / 2-3期

关键词：

PREFORMULATION; PYRIDOXAL HYDROCHLORIDE; MOISTURE EFFECT; PHYSICAL STABILITY; POLYMORPHIC CHANGE;

D O I：

10.1016/0378-5173(91)90333-J

中图分类号：

R9 [药学];

学科分类号：

1007 [药学];

摘要：

During a preformulation programme the effect of atmospheric moisture on pyridoxal HCl (PL) was investigated. A complete moisture sorption isotherm was derived for PL at 25-degrees-C. In addition, PL samples were stored at 11 and 75% relative humidity (RH) for 2 weeks. Changes in the samples were detected by differential scanning calorimetery (DSC), infrared spectroscopy (IR) and scanning electron microscopy (SEM). DSC and IR studies provided strong evidence of two polymorphic forms of PL. In addition, DSC thermograms of the samples stored at 75% RH showed changes indicative of a partial polymorphic transformation; further, these changes in crystal habit were observed in the SEM study. The moisture sorption isotherm shows an abrupt decrease in moisture content in the region of 57-68% RH. This may correspond to the formation of the less hygroscopic, stable polymorph. PL is physically unstable at elevated levels of moisture, however, exposure to certain levels of RH may enhance its stability due to transformation of polymorphs.

引用

页码：315 / 319

页数：5

共 16 条

[1]

PHYSICAL CHARACTERIZATION AND ACTIVITY INVIVO OF POLYMORPHIC FORMS OF 7-CHLORO-5,11-DIHYDRODIBENZ[B,E][1,4]OXAZEPINE-5-CARBOXAMIDE, A POTENTIAL TRICYCLIC ANTIDEPRESSANT [J].

GIBBS, IS ;

HEALD, A ;

JACOBSON, H ;

WADKE, D ;

WELIKY, I .

JOURNAL OF PHARMACEUTICAL SCIENCES, 1976, 65 (09) :1380-1385

[2]

GIRONFOREST D, 1984, PHARM IND, V46, P851

[3]

HUTTENRAUCH R, 1977, PHARMAZIE, V32, P240

[4]

IMAIZUMI H, 1980, CHEM PHARM BULL, V28, P2565

[5]

KRAHN FU, 1987, PHARM ACTA HELV, V62, P247

[6]

MAKOWER B, 1956, AGR FOOD CHEM, V4, P72

[7]

MAURY L, 1985, PHARM ACTA HELV, V60, P22

[8]

MIYAZAKI S, 1974, CHEM PHARM BULL, V22, P638

[9]

STABILITY ASPECTS OF PREFORMULATION AND FORMULATION OF SOLID PHARMACEUTICALS [J].

MONKHOUSE, DC .

DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY, 1984, 10 (8-9) :1373-1412

[10]

THOMA K, 1984, DTSCH APOTH ZTG, V43, P2162

← 1 2 →