PMID- 11451627
OWN - NLM
STAT- MEDLINE
DCOM- 20010906
LR  - 20190910
IS  - 0378-5173 (Print)
IS  - 0378-5173 (Linking)
VI  - 223
IP  - 1-2
DP  - 2001 Jul 31
TI  - Application of sorption--desorption moisture transfer modeling to the study of 
      chemical stability of a moisture sensitive drug product in different packaging 
      configurations.
PG  - 1-13
AB  - The sorption--desorption moisture transfer (SDMT) model was used to predict the 
      effect of desiccant quantity, tablet quantity and tablet initial moisture content 
      on the relative humidity inside high density polyethylene (HDPE) bottles 
      containing a moisture sensitive drug product, roxifiban tablets. The effect of 
      these variables on the stability of roxifiban tablets in the HDPE bottles was 
      also evaluated. There was a good correlation between the calculated relative 
      humidity values inside the package and stability results. Tablet degradant 
      concentration increased with the increase in the relative humidity calculated by 
      the SDMT model. Desiccant quantity was the most important factor in controlling 
      degradation rate, which decreased as the quantity of desiccant in the bottle was 
      increased. For a given desiccant quantity, degradation rate increased with an 
      increase in the weight of tablets in the bottle. The inclusion of a desiccant in 
      the package significantly reduced the effect of initial tablet moisture content 
      on stability. Nevertheless, the effect of initial moisture content was still 
      discernible. This study demonstrated the practical utility of the SDMT model in 
      understanding the correlation between packaging variables and the stability of a 
      moisture sensitive product.
FAU - Badawy, S I
AU  - Badawy SI
AD  - DuPont Pharmaceuticals Company, Pharmaceutical R&D, Experimental Station, PO Box 
      80400, Wilmington, DE 19880-0400, USA. sherif.i.badawy@dupontpharma.com
FAU - Gawronski, A J
AU  - Gawronski AJ
FAU - Alvarez, F J
AU  - Alvarez FJ
LA  - eng
PT  - Journal Article
PL  - Netherlands
TA  - Int J Pharm
JT  - International journal of pharmaceutics
JID - 7804127
RN  - 0 (Tablets)
SB  - IM
MH  - Adsorption
MH  - *Drug Packaging
MH  - *Drug Stability
MH  - Humidity
MH  - Tablets
EDAT- 2001/07/14 10:00
MHDA- 2001/09/08 10:01
CRDT- 2001/07/14 10:00
PHST- 2001/07/14 10:00 [pubmed]
PHST- 2001/09/08 10:01 [medline]
PHST- 2001/07/14 10:00 [entrez]
AID - S0378517301006937 [pii]
AID - 10.1016/s0378-5173(01)00693-7 [doi]
PST - ppublish
SO  - Int J Pharm. 2001 Jul 31;223(1-2):1-13. doi: 10.1016/s0378-5173(01)00693-7.