Quality evaluation methods for Transdermal Drug Delivery System (TDDS) pharmaceutical with crystal reservoir system using microscopic Raman, near infrared and terahertz spectroscopy and imaging technique, were developed. The crystal reservoir system that contains an active substance as crystalline form is one of useful release-rate controlling systems for active substances which have high skin-penetration such as tulobuterol (TBR). The conversion of TBR from crystalline form to non-crystalline form in a matrix has important role for a release-rate control. Therefore, crystallization of TBR in a matrix is one of the critical quality factors of this type of TDDS tapes. However, confirmation and/or detection of crystalline TBR in a matrix would be difficult because visual test methods such as a microscopy could not apply through an opaque liner and a supporting board. In this case, non-destructive and high penetrate-able spectroscopic imaging methods would be useful for analyzing it. The authors examined applicability of microscopic spectroscopic imaging methods using laser Raman, near-infrared and terahertz electro-magnetic waves as quality analytical tools for confirming of crystalline TBR in the model tapes and the commercial tapes.
The Electronic Records and Electronic Signatures Committee of PDA Japan Chapter, which is abbreviated to be ERES Committee as follows, started with examining and discussing the effect of 21 CFR Part11 which is US regulation about the electronic record/e-signature and the correspondence of the Japanese relevant regulation in November, 2001. Thereafter, the ERES committee has been assuming activities as a main target to hold translation/the publication of the references, as well as seminars on ERES so that the pharmaceutical industry could be developed through our efforts to make the most use of the sane corporate development by the electronic technique. The committee has approximately 40 members registered now, and it leads and holds some subcommittees, which perform the information sharing between committees, the examination of the measures in the guide and guidelines along with the regulations. We hereunder show the achievement of the inspection subcommittee which gave a presentation by the 16th annual PDA Japan Chapter Meeting conducted in November, 2009, as the partial introduction of the ERES committee activity concerned.