Technological development of sodium heparin injection in solution of 5.000 IU/mL
Keywords:
sodium heparin, injectable, developmentAbstract
Objective: Developing a new formulation of heparin sodium injection in solution of 5.000 IU/mL.
Methods: Three variants of formulations were tested and three batches were prepared at laboratory scale. Three pilot batches were also scaled up with stability checking for 12 months of shelf life and 6 months accelerated.
Results: The formulation composed of heparin sodium (5.000 IU/mL), chlorobutanol as preserve, two buffers (monobasic sodium phosphate/dibasic sodium phosphate) and water for injection, as a vehicle; 6R bulbs, transparent and colorless, met the quality requirements. Biological potency and pH control were stable in the three batches prepared at laboratory scale.
Conclusions: The results obtained in the latter demonstrated the feasibility of the technological development of this medicine, fulfilling the quality characteristics of the injectables.
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References
Grand B. Historia del descubrimiento de los agentes antitrombóticos clásicos: aspirina, heparina y anticoagulantes orales. Una serendipia con perseverancia. Hematología. 2018;22(1):95-102.
Prospecto: información para el usuario HEPARINA SÓDICA SALA 5.000 UI/mL [Internet]. Barcelona (España) Agencia Española de Medicamentos y Productos Sanitarios (AEMPS); [actualizado junio 2009; citado 10 septiembre 2019]. Disponible en: http://www.aemps.es.
Medicines Complete: Martindale: The Complete Drug Reference. Heparin [Internet]. The Pharmaceutical Press. Royal Pharmaceutical Society; [actualizado 10 noviembre 2015; citado 10 septiembre 2019]. Disponible en: https://www.medicinescomplete.com/.
Trejo C. Anticoagulantes: Farmacología, mecanismos de acción y usos clínicos. Cuadernos de Cirugía. 2004; 18(1):83-90. García DA, Baglin TP, Weitz JI, Samama MM. Parenteral Anticoagulants: Antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. CHEST. 2012;141 Suppl 2:24-43. DOI: 10.1378/chest.11-2291
Mulloy B, Hogwood J, Gray E, Lever R, Page CP. Pharmacology of Heparin and Related Drugs. Pharmacol Rev. 2016; 68:76-141. http://dx.doi.org/10.1124/pr.115.011247
Onishi A, St Ange K, Dordick JS, Linhardt RJ. Heparin and anticoagulation. Front Biosci (Landmark Ed). 2016; 21:1372-1392.
Junqueira DR, Zorzela LM, Perini E. Unfractioned heparin versus low molecular weight heparins for avoiding heparininduced thrombocytopenia in postoperative patients. Cochrane Database Syst Rev. 2017; 4:1-46. DOI: 10.1002/14651858. CD007557.pub3.
Kaciulyte J, Losco L, Maruccia M, et al. Postsurgical antithrombotic therapy in microsurgery: our protocol and literatura review. Eur Rev Med Pharmacol Sci. 2019; 23:4448-4457.
DailyMed: HEPARIN SODIUM- heparin sodium injection, solution [Internet]. National Library of Medicine (US); [actualizado 21 marzo 2017; citado 22 de agosto de 2019]. Disponible en: https://dailymed.nlm.nih.gov/.
Remington JP, editor. The Science and Practice of Pharmacy. 22nd ed. London-Philadelphia: Pharmaceutical Press; 2013. 2724 p.
British Pharmacopoeia. London: The Stationery Office; 2015.
MedlinePlus®: Heparina inyectable [Internet]. Bethesda (MD): National Library of Medicine(US); [actualizado 15 septiembre 2017; citado 15 julio 2019]. Disponible en: https://medlineplus.gov/spanish/.
McEvoy GK, editor. Handbook on Injectable Drugs. 18th ed. Bethesda: American Society of Helth-System Pharmacists;2015. 5690
Vila JL, editor. Tecnología Farmacéutica. Madrid: Síntesis;2001. 591 p.
Niazi SK. Part II Manufacturing Formulations. En: Handbook of Pharmaceutical Manufacturing Formulations. Second ed. New York-London: Informa Healthcare USA, Inc.; 2009.
Ficha Técnica: HEPARINA SÓDICA CHIESI 5.000 UI/mL [Internet]. Madrid (España) Agencia Española de Medicamentos y Productos Sanitarios (AEMPS); [actualizadojunio 2009; citado 10 septiembre 2019]. Disponible en: http://www.aemps.es.
Rowe RC, Sheskey PJ, Quinn ME, editors. Handbook of Pharmaceutical Excipients. Sixth ed. London-Chicago: Pharmaceutical Press; 2009. 888 p.
DailyMed: HEPARIN SODIUM- heparin sodium injection, solution [Internet]. National Library of Medicine (US); [actualizado 16 mayo 2014, citado 22 agosto 2019]. Disponible en: https://dailymed.nlm.nih.gov/.
Ficha Técnica: HEPARINA HOSPIRA 5 %, solución inyectable [Internet]. Madrid (España) Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) [actualizado junio 2007, citado 10 septiembre 2019]. Disponible en: http://www.aemps.es.
Farmacopea de los Estados Unidos de América (USP 40/2017 NF 35). Rockville(MD): The United States Pharmacopeial Convention; 2017. 8565 p.
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Copyright (c) 2020 Nancy Burguet-Lago, Yenilen Troche-Concepción, Alen Nils Baeza-Fonte, Griset Toledo-Carrabeo, Yamilka Herrera-Ledezma
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