Effects of packaging and heat transfer kinetics on drug-product stability during storage under uncontrolled temperature conditions.

Publisher: Elsevier Country of Publication: United States NLM ID: 2985195R Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1520-6017 (Electronic) Linking ISSN: 00223549 NLM ISO Abbreviation: J Pharm Sci Subsets: MEDLINE

Publication: 2016- : New York, NY : Elsevier
Original Publication: Easton, Pa., American Pharmaceutical Assn.

Drug Packaging* ; Drug Stability* ; Drug Storage*; Pharmaceutical Preparations/*chemistry; Computer Simulation ; Diffusion ; Hot Temperature ; Models, Chemical ; Temperature ; Thermodynamics

To predict the stability of pharmaceutical preparations under uncontrolled temperature conditions accurately, a method to compute the average reaction rate constant taking into account the heat transfer from the atmosphere to the product was developed. The average reaction rate constants computed with taken into consideration heat transfer (κ(re) ) were then compared with those computed without taking heat transfer into consideration (κ(in) ). The apparent thermal diffusivity (κ(a) ) exerted some influence on the average reaction rate constant ratio (R, R = κ(re) /κ(in) ). In the regions where the κ(a) was large (above 1 h(-1) ) or very small, the value of R was close to 1. On the contrary, in the middle region (0.001-1 h(-1) ), the value of R was less than 1.The κ(a) of the central part of a large-size container and that of the central part of a paper case of 10 bottles of liquid medicine (100 mL) fell within this middle region. On the basis of the above-mentioned considerations, heat transfer may need to be taken into consideration to enable a more accurate prediction of the stability of actual pharmaceutical preparations under nonisothermal atmospheres.
(Copyright © 2013 Wiley Periodicals, Inc.)

0 (Pharmaceutical Preparations)

Date Created: 20130302 Date Completed: 20130923 Latest Revision: 20130412

20231215

10.1002/jps.23486

23450624