PMID- 12672617 OWN - NLM STAT- MEDLINE DCOM- 20030916 LR - 20190910 IS - 0378-5173 (Print) IS - 0378-5173 (Linking) VI - 255 IP - 1-2 DP - 2003 Apr 14 TI - A new model for predicting moisture uptake by packaged solid pharmaceuticals. PG - 217-25 AB - A novel mathematical model has been developed for predicting moisture uptake by packaged solid pharmaceutical products during storage. High density polyethylene (HDPE) bottles containing the tablet products of two new chemical entities and desiccants are investigated. Permeability of the bottles is determined at different temperatures using steady-state data. Moisture sorption isotherms of the two model drug products and desiccants at the same temperatures are determined and expressed in polynomial equations. The isotherms are used for modeling the time-humidity profile in the container, which enables the prediction of the moisture content of individual component during storage. Predicted moisture contents agree well with real time stability data. The current model could serve as a guide during packaging selection for moisture protection, so as to reduce the cost and cycle time of screening study. FAU - Chen, Y AU - Chen Y AD - Abbott Laboratories, Global Pharmaceutical R&D, R4P7, 1401 Sheridan Road, North Chicago, IL 60064, USA. yisheng.chen@abbott.com FAU - Li, Y AU - Li Y LA - eng PT - Journal Article PL - Netherlands TA - Int J Pharm JT - International journal of pharmaceutics JID - 7804127 RN - 0 (Tablets) RN - 059QF0KO0R (Water) RN - 9002-88-4 (Polyethylene) SB - IM MH - Absorption MH - Algorithms MH - Desiccation MH - *Drug Packaging MH - Drug Storage MH - Humidity MH - *Models, Chemical MH - Permeability MH - *Polyethylene/chemistry MH - Tablets MH - Temperature MH - Water EDAT- 2003/04/04 05:00 MHDA- 2003/09/17 05:00 CRDT- 2003/04/04 05:00 PHST- 2003/04/04 05:00 [pubmed] PHST- 2003/09/17 05:00 [medline] PHST- 2003/04/04 05:00 [entrez] AID - S0378517303000899 [pii] AID - 10.1016/s0378-5173(03)00089-9 [doi] PST - ppublish SO - Int J Pharm. 2003 Apr 14;255(1-2):217-25. doi: 10.1016/s0378-5173(03)00089-9.