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Development and application of methodologies of DT-NMR rapid non-destructive and for polymorphism identification and quantification of APIs in solid drugs

Abstract

Nuclear magnetic resonance in the time domain (DT-NMR) typically uses benchtop appliances that have low cost. The DT-NMR is used mainly in the analysis of homogeneous and heterogeneous materials, process control, agricultural products and by-products, quality of food, oil and oil products, cosmetics. The analysis of solid components in foods, polymers and other organic materials are much less studied, have difficult-to-detect signals. A way to improve the acquisition of solid signs was developed by the author of this project during your doctorate, which is the acquisition of 1H signals from a new pulse sequence called Rhim and Radiofrequency Kessemeier Optimized Solid-Echo (RK-ROSE). This sequence features efficiency superior to most sequences used for characterization of solid samples, for example, the Solid-Echo (SE) and "Magic Sandwich Echo" (MSE). The applications of this new string are several, among them the development of a methodology for determination of polymorphic substances in pharmaceuticals and quantification of solid mixture by relaxatometria of 1H and 19F. The characterization and quantification of shape of active pharmaceutical ingredients (APIs) play a central role in the pharmaceutical industry from the preliminary development of medicine to manufacturing. The APIs can take different forms, polymorphic form solvatos and hydrates, as well as having amorphous portion. So it is very important to determine the presence of these structures in the APIs once each Polymorph can have different characteristics that affect the pharmacodynamic properties of the medicinal product. Therefore, it is necessary to quantify accurately the polymorphism. The MRI-DT began to be evaluated as an alternative method that provides several advantages, the analyses are conducted in bench instruments, low cost, requires no sample preparation and is a non-destructive and quick measure. The present project aims at the development of DT-NMR equipment and an efficient methodology for determination of polymorphism in pharmaceuticals (development of methods for quality control) and quantification of APIs in mixtures solid medicines. The project will be developed in the company FIT-Fine Instrument Technology, one that develops equipment and applications in MRI-DT in Brazil, which has become agribusiness market and technical-scientific. The development of this methodology will be a great opportunity for the company to enter the market of pharmaceutical industries extremely large and lucrative. It is hoped that with this new application is possible for market research and development of new drugs. (AU)

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