COMPARABILITY STUDY OF BOVINE HEPARINs

Heparin is a drug with several effects, among them, we have the anticoagulant that is commonly used in the clinic. Belonging to the glycosaminoglycan family, it can be obtained exclusively from animal sources, which can be of ovine, bovine or porcine origin. Currently, pork intestine is the main source of heparin extraction, with China responsible for 50% of its world production. This scenario of production from a single type of herd and concentrated in a single country generates insecurity in its supply, leading to the search for new sources. Brazil is the largest producer of unfractionated heparin (UFH) obtained from bovine intestine, and this product has an anticoagulant activity 50-60% of the UFH from swine intestine, so its pharmaceutical formulations exhibit higher mass content to reach the same potential anticoagulant of porcine intestine preparations. Given this scenario, it is necessary to use tools in order to expand the heparin options present in the consumer market. One of the tools that can be used for this purpose is the comparability of biological products, which is based on an ANVISA manual and is based on a study between an innovative product and a reference product already available in the pharmaceutical market. Techniques will be applied to verify the structural, physical-chemical and biological activity likelihood between the analyzed preparations. Nuclear magnetic resonance is one of the spectroscopic techniques that can be used to verify the structure, as it makes it possible to explore the magnetic properties of atomic nuclei and verify the properties of where they are contained. The study will contribute to the knowledge of possible discrepancies, particularities or similarities with the preparations obtained from a national industry and another from an Argentine industry.