title: An observational study of the effect of vibration on the caking of suspensions in oily vehicles.
abstract: An oily suspension of penethamate (PNT) that was physically stable on storage, caked solidly during road/air transport. This paper reports on the caking behaviour of PNT oily suspension formulations exposed to vibrations in a lab-based test designed to simulate road/air transport. The lab-test was used to study the effects of container type (glass v PET) and formulation (oil, surfactant type and concentration) on the physical stability of suspension under vibration. Redispersibility of the sediment was lower at longer vibrations times and at higher intensity of vibration. Caking on vibration was strongly influenced by the type of container (caking in glass but not in PET) possibly due to tribo-charging of particles. Caking on vibration was dependent on the formulation: type and concentration of surfactant; type of oil. The physical stability of oily suspensions, and the effect of vibration are two areas which have been largely neglected in the pharmaceutical literature. This paper discusses some potential mechanisms for the observations but studies using fully characterised materials are required. Finally we conclude that static testing of physical stability of oily suspensions is not sufficient and that a vibrational stress test is required.
authors.affiliation: School of Pharmacy, University of Otago, P.O. Box 56, Dunedin, 9010, New Zealand.
authors.forename: Rohit
authors.initials: R
authors.lastname: Jain
authors.affiliation: School of Pharmacy, University of Otago, P.O. Box 56, Dunedin, 9010, New Zealand.
authors.forename: Olaf
authors.initials: O
authors.lastname: Bork
authors.affiliation: APAC Development Centre, Bayer New Zealand Limited, 3 Argus Place, Hillcrest, Auckland 0627, New Zealand.
authors.forename: Fadil
authors.initials: F
authors.lastname: Alawi
authors.affiliation: APAC Development Centre, Bayer New Zealand Limited, 3 Argus Place, Hillcrest, Auckland 0627, New Zealand.
authors.forename: Karthigeyan
authors.initials: K
authors.lastname: Nanjan
authors.affiliation: School of Pharmacy, University of Otago, P.O. Box 56, Dunedin, 9010, New Zealand. Electronic address: ian.tucker@otago.ac.nz.
authors.forename: Ian G
authors.initials: IG
authors.lastname: Tucker
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods*; D004339:Drug Compounding / Q000379:methods*; D004355:Drug Stability; D005079:Excipients / Q000737:chemistry*; D009821:Oils / Q000737:chemistry*; D010400:Penicillin G / Q000031:analogs & derivatives* / Q000737:chemistry; D013501:Surface-Active Agents / Q000737:chemistry; D013535:Suspensions / Q000737:chemistry; D014732:Vibration
chemical_list: D005079:Excipients; D009821:Oils; D013501:Surface-Active Agents; D013535:Suspensions; C008780:penethamate hydroiodide; D010400:Penicillin G
keywords: Caking; Oil; Physical; Suspension; Tribocharging; Vibration