CAMPIÑEZ , María Dolores

The current regulatory environment based on the ICH guidelines encourages a systematic and science-based approach in the pharmaceutical development, required by the "Quality by design" concept. This methodology implies that the quality of a product must be designed instead of assayed in the final dosage form. For this purpose, a deep knowledge...

The main objective of the present paper has been the development and study of two new biodegradable polyurethanes, PU(dithiodiethanol-DTDI) and PU[(iPr)Man-DTDI], to be used as sustained matrix forming excipients. Furthermore, their capacity to act as excipient for colon drug delivery systems has been evaluated. Thus, SeDeM diagrams have been...