Applying terahertz technology for nondestructive detection of crack initiation in a film-coated layer on a swelling tablet

Publication date: 2012 Source:Results in Pharma Sciences, Volume 2 Author(s): Wataru Momose , Hiroyuki Yoshino , Yoshifumi Katakawa , Kazunari Yamashita , Keiji Imai , Kazuhiro Sako , Eiji Kato , Akiyoshi Irisawa , Etsuo Yonemochi , Katsuhide Terada Here, we describe a nondestructive approach using terahertz wave to detect crack initiation in a film-coated layer on a drug tablet. During scale-up and scale-down of the film coating process, differences in film density and gaps between the film-coated layer and the uncoated tablet were generated due to differences in film coating process parameters, such as the tablet-filling rate in the coating machine, spray pressure, and gas–liquid ratio etc. Tablets using the PEO/PEG formulation were employed as uncoated tablets. We found that heat and humidity caused tablets to swell, thereby breaking the film-coated layer. Using our novel approach with terahertz wave nondestructively detect film surface density (FSD) and interface density differences (IDDs) between the film-coated layer and an uncoated tablet. We also found that a reduced FSD and IDD between the film-coated layer and uncoated tablet increased the risk of crack initiation in the film-coated layer, thereby enabling us to nondestructively predict initiation of cracks in the film-coated layer. Using this method, crack initiation can be nondestructively assessed in swelling tablets after the film coating process without conducting accelerated stability tests, an...
Source: Results in Pharma Sciences - Category: Drugs & Pharmacology Source Type: research