Microspheres are widely used as drug delivery systems, owing to their higher therapeutic and diagnostic performance compared to conventional drug delivery systems. Lactide and Glycolide (L:G) polymers are specifically used as microspheres for the sustained and targeted delivery of hydrophobic or hydrophilic drugs, as well as biological therapeutic macromolecules, including peptide and protein drugs. These polymers need extensive characterization to determine the LG ratio, end group, viscosity, Molecular Weight and other tests. The new USP General Chapter ( <1156> will focus on the various critical quality attributes and performance characteristics like universal tests, specific tests, performance tests and intended to provide guidance on acceptance limits.
Iron Colloidal products are formulations containing nanomaterials or nanocolloidal complexes for intravenous (IV) therapy for the treatment of Iron deficiency and Iron deficiency anemia. The purpose of this new USP chapter ( <1155>) is to provide information and guidance regarding how to determine various physicochemical properties of iron complexes, including particle size and morphology, viscosity, colloidal nature, molecular weight, surface charge, chemical nature of the carbohydrate shell, total iron content, and labile iron content, using several sophisticated analytical instrumentation. Discussion of these methods will be presented.
Drug-device combination products (DDCP) are innovative, therapeutic products that include both a drug and a device. Common examples include pre-filled syringes (PFS), drug eluting stents (DES), drug coated balloons (DCB), and others. The new USP General Chapter ( <1157>) is intended to provide lists of common product quality test requirements for the drug component of a DDCP. The focus of the chapter will be solely on testing the drug component by providing universal tests, specific tests and intended to provide acceptance limits wherever applicable.
Learning Objectives:
The attendees will understand the specific analytical methods, required tests and their acceptance criteria for the various Microsphere based pharmaceutical products.
The attendees will understand the use of various analytical methodologies for the charectyerization of the LG (Lactide:Glycolide) polymers.
The attendees will understand the complexity of the Iron colloidal formulations and the use of various analytical techniques for the charecterization whole iron, iron core and carbohydrate shell.
.jpg "Prabhakar R. Gruddanti, MS, PhD (he/him/his) photo")