title: A mechanistic model for the prediction of in-use moisture uptake by packaged dosage forms.
abstract: A mechanistic model for the prediction of in-use moisture uptake of solid dosage forms in bottles is developed. The model considers moisture transport into the bottle and moisture uptake by the dosage form both when the bottle is closed and when it is open. Experiments are carried out by placing tablets and desiccant canisters in bottles and monitoring their moisture content. Each bottle is opened once a day to remove one tablet or desiccant canister. Opening the bottle to remove a tablet or canister also causes some exchange of air between the bottle headspace and the environment. In order to ascertain how this air exchange might depend on the customer, tablets and desiccant canisters are removed from the bottles by either carefully removing only one or by pouring all of the tablets or desiccant canisters out of the bottle, removing one, and pouring the remaining ones back into the bottle. The predictions of the model are found to be in good agreement with experimental data for moisture sorption by desiccant canisters. Moreover, it is found experimentally that the manner in which the tablets or desiccant canisters were removed does not appreciably affect their moisture content.
authors.affiliation: Pharmaceutical Development, AstraZeneca R&D, Mölndal, Sweden. johan.remmelgas@astrazeneca.com
authors.forename: Johan
authors.initials: J
authors.lastname: Remmelgas
authors.forename: Anne-Laure
authors.initials: AL
authors.lastname: Simonutti
authors.forename: Asa
authors.initials: A
authors.lastname: Ronkvist
authors.forename: Lubomir
authors.initials: L
authors.lastname: Gradinarsky
authors.forename: Anders
authors.initials: A
authors.lastname: Löfgren
mesh_terms: D003890:Desiccation; D004349:Drug Packaging; D004355:Drug Stability; D004356:Drug Storage; D006813:Humidity; D008956:Models, Chemical; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D013607:Tablets; D014867:Water / Q000737:chemistry
chemical_list: D004364:Pharmaceutical Preparations; D013607:Tablets; D014867:Water