PMID- 18448285
OWN - NLM
STAT- MEDLINE
DCOM- 20080926
LR  - 20131121
IS  - 0378-5173 (Print)
IS  - 0378-5173 (Linking)
VI  - 358
IP  - 1-2
DP  - 2008 Jun 24
TI  - Determination of water vapor transmission rate (WVTR) of HDPE bottles for 
      pharmaceutical products.
PG  - 137-43
LID - 10.1016/j.ijpharm.2008.02.031 [doi]
AB  - The objective of this study was to investigate the effects of experimental 
      conditions for measuring the water vapor transmission rate (WVTR) of high-density 
      polyethylene (HDPE) bottles using a steady-state sorption method. Bottles were 
      filled with desiccant, closed with caps and heat induction sealed, and then 
      stored in stability chambers at controlled temperature and relative humidity. 
      Weight gain of the bottles was determined every 1 or 2 weeks until a linear 
      weight gain profile was obtained. WVTR of the bottles was determined from the 
      slope of the linear portion of the weight gain versus time profile. The effects 
      of desiccants and temperature/humidity were studied. Results show that, with a 
      sufficient amount of anhydrous calcium chloride in bottles, a negligibly low and 
      sufficiently constant headspace humidity is maintained, and a steady-state 
      permeation rate is achieved. For all 8 sizes of bottles used in this study, 
      steady-state was achieved in 1 or 2 weeks after the experiment was started. This 
      method provided reproducible WVTR data for HDPE bottles. Apparent moisture 
      permeability of all 8 sizes of bottles was (2.3+/-0.3)x10(-7), 
      (2.6+/-0.2)x10(-7), and (3.4+/-0.2)x10(-7)cm(2)/s at 25 degrees C, 30 degrees C, 
      40 degrees C, respectively. Moisture permeability determined from the current 
      study was similar to data reported in the literature, indicating that the 
      steady-state weight gain method can be used to obtain reliable WVTR of containers 
      for pharmaceutical products.
FAU - Chen, Yisheng
AU  - Chen Y
AD  - Abbott Laboratories, Global Pharmaceutical R&D, 1401 Sheridan Road, North 
      Chicago, IL 60064, USA.
FAU - Li, Yanxia
AU  - Li Y
LA  - eng
PT  - Journal Article
DEP - 20080315
PL  - Netherlands
TA  - Int J Pharm
JT  - International journal of pharmaceutics
JID - 7804127
RN  - 0 (Excipients)
RN  - 0 (Polyethylenes)
RN  - 059QF0KO0R (Water)
RN  - M4I0D6VV5M (Calcium Chloride)
SB  - IM
MH  - Algorithms
MH  - Calcium Chloride/chemistry
MH  - Drug Packaging
MH  - Excipients
MH  - Humidity
MH  - Permeability
MH  - Polyethylenes/*chemistry
MH  - Water/*chemistry
EDAT- 2008/05/02 09:00
MHDA- 2008/09/27 09:00
CRDT- 2008/05/02 09:00
PHST- 2007/09/07 00:00 [received]
PHST- 2008/02/25 00:00 [revised]
PHST- 2008/02/27 00:00 [accepted]
PHST- 2008/05/02 09:00 [pubmed]
PHST- 2008/09/27 09:00 [medline]
PHST- 2008/05/02 09:00 [entrez]
AID - S0378-5173(08)00174-9 [pii]
AID - 10.1016/j.ijpharm.2008.02.031 [doi]
PST - ppublish
SO  - Int J Pharm. 2008 Jun 24;358(1-2):137-43. doi: 10.1016/j.ijpharm.2008.02.031. 
      Epub 2008 Mar 15.