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Erythropoietin： From a Biosimilar to Innovative Products Protected by Industrial Property Assets

Journal of Pharmacy and Pharmacology 2017年第9期5卷 681-687页

作者： Lien Lopez Matilla pedro barzaga Fernandezt Sonia Gonzalez Blanco Patent Office Centro de Inmunologia Molecular Havana 11300 Cuba Patent Office Center for Pharmaceutical Research and Drug Development Havana 10600 Cuba Patent Office Center for Genetic Engineering and Biotechnology Havana 11300 Cuba

Aim： EPO （erythropoietin） is a hormone that stimulates the erythropoiesis and is mainly produced by the kidneys. In the early 1990s among the emerging biotech drugs, the recombinant human EPO （rhEPO） was the best-selling product worldwide, reaching nearly three billion dollars annually. The CIM （center of molecular immunology） produced and sold the rhEPO as commercial strategy to recover the investment made in its new facilities. This work summarizes the inventions that protect the innovative products developed by three Cuban institutions, starting from rhEPO, and the industrial property strategy followed by them. Methods： The information was obtained from the United States Patent, Trademark Office （USPTO） database, Patentscope, Espacenet, patent databases of Center for Pharmaceutical Research and Drug Development （CIDEM） and Cuban Industrial Property Office. Conclusions： The manufacturing process of CIM＇s EPO has its own patent family. From a manufacturing by product an innovative formulation protected by patent was obtained. There is a patent family around the nasal formulation and it continues enlarging. From a biosimilar pharmaceutical innovative products impacting on human health have been obtained.

关键词： Erythropoietin ataxia pegylated EPO biosimilar.

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Healing effect on gastric and oral ulcers of tannic extract obtained from Pinus caribaeae Morelet bark and preclinical toxicology tests

Healing effect on gastric and oral ulcers of tannic extract ...

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第十五届国际药理学大会

作者： Alicia Lagarto pedro barzaga Viviana Bueno Jorge Luis Santana Isbel Guerra Sara Agüero Odalys Valdés Drag Research and Development Center. Biologic Control Laboratory. Ave. 26 No.1605. Nuevo Vedado. Plaza. Havana. Cuba. CP 10600 MSc. Drag Research and Development Center. Biologic Control Laboratory. Ave. 26 No.1605. Nuevo Vedado. Plaza. Havana. Cuba. CP 10600 Lic. Drag Research and Development Center. Biologic Control Laboratory. Ave. 26 No.1605. Nuevo Vedado. Plaza. Havana. Cuba. CP 10600 Dra. Drag Research and Development Center. Biologic Control Laboratory. Ave. 26 No.1605. Nuevo Vedado. Plaza. Havana. Cuba. CP 10600 Dr. Drag Research and Development Center. Biologic Control Laboratory. Ave. 26 No.1605. Nuevo Vedado. Plaza. Havana. Cuba. CP 10600 Téc. Drag Research and Development Center. Biologic Control Laboratory. Ave. 26 No.1605. Nuevo Vedado. Plaza. Havana. Cuba. CP 10600 Téc. Drag Research and Development Center. Biologic Control Laboratory. Ave. 26 No.1605. Nuevo Vedado. Plaza. Havana. Cuba. CP 10600 Téc.

＜正＞ The study examines the healing effect on gastric and oral ulcers of tannic extract obtained from Pinus caribaeae Morelet and preclinical toxicology tests. The protective effect on gastric mucous was evaluated in lesions induced by ethanol in Wistar rats at dose of 5 mg/kg. Oral mucous healing effect was evaluated in lesions induced by acetic acid in Golden Syrian hamster at 3 dose levels:64,80 and 100 mg/ml. Oral acute toxicity was conduced at dose of 2000 mg/kg and subchronic doses of 1,2.5 and 5 mg/kg/day were used for 90 days exposure in Wistar rats. Tannic extract causes significant decrease of gastric lesions. Ulcers number and lesions index decreased in 47 and 35 % respectively. Oral mucous dosing causes significant acceleration of scaring. Epithelial regeneration and own sheet maturation were accelerate in treated group. There were no mortality and signs of toxicity in acute toxicity assay. In subchronic exposure signs of toxicity were observed and body weight gain was significantly increased. Some of the blood and biochemical elements were affected. The histopathological examination showed abnormalities in liver, kidney, stomach and nasal cavity organs at doses of 1.0 and 5.0 mg/kg/day.

关键词： gastric and oral mucous healing oral acute toxicity oral subchronic toxicity

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