LYOPHILIZATION OF PHARMACEUTICAL INJECTIONS - THEORETICAL PHYSICAL MODEL

被引:23
作者
HO, NFH
ROSEMAN, TJ
机构
[1] UPJOHN CO,PHARM RES,KALAMAZOO,MI 49001
[2] UNIV MICHIGAN,COLL PHARM,ANN ARBOR,MI 48109
关键词
Dosage forms; parenteral—lyophilization; physicochemical model; Lyophilization—physicochemical model; parenteral formulations; Models; physicochemical—lyophilization;
D O I
10.1002/jps.2600680930
中图分类号
R914 [药物化学];
学科分类号
100701 ;
摘要
A physical model for the lyophilization kinetics of parenteral formulations is presented. Mathematical relationships are derived, which involve the simultaneous change in the receding boundary of the ice‐vapor interface with time as well as water vapor diffusion across the dry porous matrix and boundary layer. Heat from an external heat source is transferred across the frozen solution to the receding ice surface. The model predicts that the water lost and the receding boundary distance are linearly related to the square root of time when lyophilization is matrix controlled. The mathematical descriptions are predictive of the physicochemical and transport events and can lead to the design of quantitative experiments to relate theory to formulation design. Copyright © 1979 Wiley‐Liss, Inc., A Wiley Company
引用
收藏
页码:1170 / 1174
页数:5
相关论文
共 30 条
[1]  
BIRD RB, 1960, TRANSPORT PHENOMENA, P744
[2]   LYOPHILIZATION OF PHARMACEUTICALS .4. DETERMINATION OF EUTECTIC TEMPERATURES OF INORGANIC SALTS [J].
DELUCA, P ;
LACHMAN, L .
JOURNAL OF PHARMACEUTICAL SCIENCES, 1965, 54 (10) :1411-&
[3]   LYOPHILIZATION OF PHARMACEUTICALS .I. EFFECT OF CERTAIN PHYSICAL-CHEMICAL PROPERTIES [J].
DELUCA, P ;
LACHMAN, L .
JOURNAL OF PHARMACEUTICAL SCIENCES, 1965, 54 (04) :617-&
[4]  
DeLuca P P, 1966, Bull Parenter Drug Assoc, V20, P65
[5]   INVESTIGATION OF FACTORS INFLUENCING RELEASE OF SOLID DRUG DISPERSED IN INERT MATRICES .2. QUANTITATION OF PROCEDURES [J].
DESAI, SJ ;
SINGH, P ;
SIMONELLI, AP ;
HIGUCHI, WI .
JOURNAL OF PHARMACEUTICAL SCIENCES, 1966, 55 (11) :1224-+
[6]  
DORSEY NE, 1940, PROPERTIES ORDINARY, P598
[7]  
DUSHMAN S, 1965, SCI F VACUUM TECHNIQ, P500
[8]  
DUSHMAN S, 1965, SCI F VACUUM TECHNIQ, pCH2
[9]   HEAT AND MASS TRANSFER MECHANISMS IN SUBLIMATION DEHYDRATION [J].
DYER, DF ;
SUNDERLA.JE .
JOURNAL OF HEAT TRANSFER, 1968, 90 (04) :379-&
[10]   FREEZE-DRYING OF BODIES SUBJECT TO RADIATION BOUNDARY CONDITIONS [J].
DYER, DF ;
SUNDERLA.EJ .
JOURNAL OF HEAT TRANSFER, 1971, 93 (04) :427-&