Universidade Federal do Rio Grande do Norte Natal, 20 de Maio de 2024

Resumo do Componente Curricular

Dados Gerais do Componente Curricular
Tipo do Componente Curricular: MÓDULO
Unidade Responsável: PROGRAMA DE PÓS-GRADUAÇÃO EM DESENVOLVIMENTO E INOVAÇÃO TECNOLÓGICA EM MEDICAMENTOS (15.95.01)
Código: DIT0010
Nome: ESTUDO DE ESTABILIDADE DE MEDICAMENTOS
Carga Horária Teórica: 15 h.
Carga Horária Prática: 0 h.
Carga Horária de Ead: 0 h.
Carga Horária Total: 15 h.
Pré-Requisitos:
Co-Requisitos:
Equivalências:
Excluir da Avaliação Institucional: Não
Matriculável On-Line: Sim
Horário Flexível da Turma: Não
Horário Flexível do Docente: Sim
Obrigatoriedade de Nota Final: Sim
Pode Criar Turma Sem Solicitação: Não
Necessita de Orientador: Não
Exige Horário: Sim
Permite CH Compartilhada: Não
Quantidade de Avaliações: 1
Ementa/Descrição: A disciplina visa relacionar temas avançados aplicados ao estudo de estabilidade de medicamentos. Abordando aspectos relacionados com as interações e incompatibilidades em fármacos-excipientes, reações de degradações, cinética e modelos matemáticos aplicados ao estudo de estabilidade de produtos farmacêuticos. Além de avaliar a aplicação deste estudo na regulamentação, registro e comercialização dos medicamentos
Referências: BALTEZOR, M. Physico-chemical criteria for the stability and stability forecast of solid dosage forms. In. GRIMM, W.; THOMAE, K. eds. Stability testing of pharmaceutical products. Sttutgart: Wissenschaftliche Verlagsgesellschaft, 1987. 238p. Bhalekar M, Madgulkar A, Patel B, et al. Complexes: Role in pharmaceutical formulation. ASIAN JOURNAL OF CHEMISTRY. V.19, Issue: 4. p 2615- 2622. 2007. CARSTENSEN, J.T. Drug stability: principles and practices. v.43. New York: Marcel Dekker, 1990. CASADIO, S. Tecnologia farmacêutica. 2.ed. Milano: Cisalpino- Goliardica, 1972. Chow, S. and Liu, J. (1995). Statistical Design and Analysis in Pharmaceutical Science: Validation, Process Controls, and Stability. New York: Marcel Dekker, Inc. CONNORS, K.A.; AMIDON, G.L.; STELLA, V.L. Chemical stability of pharmaceuticals: a handbook for pharmacists. New York: John Wiley, 1986. 847p. CPMP, 2003. CPMP/QWP/122/02, rev 1, 2003. Guideline on stability testing: stability testing of existing active substances and related finished products. Committee for proprietary medicinal products, London, UK. CPMP, 2003. CPMP/QWP/609/96/Rev 1, 2003. Note for guidance on declaration of storage conditions: A: in the product information of medicinal products, B: for active substances. Committee for proprietary medicinal products, London, UK. D.L. Hertzog, J.F. McCafferty, X. Fang, R.J. Tyrell and R.A. Reed, Development and validation of a stability-indicating HPLC method for the simultaneous determination of losartan potassium, hydrochlorothiazide, and their degradation products, J. Pharm. Biomed. Anal. 30 (2002), pp. 747?760. DAGAR, V.D. Factors affecting the stability of pharmaceutical products. East. Pharm., New Delhi, n.6, p.41-42, 1990. FDA Guidance for Industry (Draft), 1998. Drug Stability Testing of Drug Substances and Drug Products. ICH Q1A(R2), 2003. Stability testing guidelines: stability testing of new drug substances and products. ICH Steering Committee. ICH. Stability Testing Of New Drug Substances And Products Q1A (R2), 2003. Disponível em http://www.ich.org/Media Server.jser?@_ID=419&@_MODE=GLB. INTERNATIONAL CONFERENCE ON HARMONIZATION. Stability testing of new drug substances and products. Disponível em: http://www.ich.org. K.E. McCarthy, Q. Wang, E.W. Tsai, R.E. Gilbert, D.P. Ip and M.A. Brooks, Determination of losartan and its degradates in Cozaar® tablets by reversed-phase high-performance thin-layer chromatography, J. Pharm. Biomed. Anal. 17 (1998), pp. 671?677. Khawam A, Flanagan DR. Basics and applications of solid-state kinetics: A pharmaceutical perspective.JOURNAL OF PHARMACEUTICAL SCIENCES. v.95, 3, p. 472-498. 2006. Khawam A, Flanagan DR. Solid-state kinetic models: Basics and mathematical fundamentals. JOURNAL OF PHYSICAL CHEMISTRY B. v. 110, 35, p. 17315-17328.2006. LACHMAN, L.; DELUCA, P.; AKERS, M.J. Testes de estabilidade e fundamentos de cinética química. In: LACHMAN, L.; LIEBERMAN, H.A.; KANING, J.L. Teoria e prática na Indústria Farmacêutica. Lisboa: Fundação Calouste Gublenkian, v.2, 2001. LUND, W. The Pharmaceutical Codex. Principles and Paractice of Pharmaceutics. 12th ed. London: The Pharmaceutical Press. 1994. Martindale?The Complete Drug Reference, 1999, 32nd ed. Pharmaceutical Press, USA. NULDEMAN, N.E.S. Estabilidad de medicamentos. Buenos Aires: El Ateneo, 1975.Perez-Maqueda LA, Criado JM, Sanchez-Jimenez PE. Combined kinetic analysis of solid-state reactions: A powerful tool for the simultaneous determination of kinetic parameters and the kinetic model without previous assumptions on the reaction mechanism. JOURNAL OF PHYSICAL CHEMISTRY A. v. 110, 45, p. 12456-12462. 2006. POPE, D.G. Accelerated stability testing for prediction of drug product stability. Drug Cosmet. Ind., New York, v.127, n.5, p.54-62, 1980. QUALITY Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials. V. 1. Geneva: World Health Organization, 1997. 238 p. RADWAN, M.A. Stability ? indicating HPLC assay of zidovudine in extemporaneous syrup. Anal. Lett., New York, v.27, n.6, p.1159- 1164, 1994. SINGH, S. Condições de estocagem no teste de estabilidade para Zonas III e IV: alguns aspectos não resolvidos. Pharm. Technol., Ed. Bras., v.3, n.6, p.34-41, 1999. Skrdla PJ, Robertson RT. Dispersive kinetic models for isothermal solid-state conversions and their application to the thermal decomposition of oxacillin. THERMOCHIMICA ACTA. v. 453, 1, p. 14-20. 2007. VADAS, E. B. Stability of pharmaceutical products. In: GENARO, A. R. Remington?s: The science and practice of pharmacy. 20.ed. Easton Pennsylvania: Mack Publishing Company, 2000. VADAS, E.B. Stability of Pharmaceutical Products. In: Remington: The Science and Practice of Pharmacy. Phila-delphia: Lippincott Williams & Wilkins. 20º ed. P. 986?994. 2000. Varhegyi G. Aims and methods in non-isothermal reaction kinetics. JOURNAL OF ANALYTICAL AND APPLIED PYROLYSIS. v. 79, 1-2, p. 278-288. 2007. W. Grimm, Extension of the international conference on harmonization tripartite guideline for stability testing of new drug substances and products to countries of climatic zones III and IV, Drug Dev. Ind. Pharm. 24 (1998), pp. 313?325. Chemical and Pharmaceutical Bulletin; European Journal of Pharmaceutical Sciences; Farmaco : An International Journal of Medicinal Chemistry and Pharmaceutical Chemistry; International Journal of Thermal Sciences; Journal of Pharmacy and Pharmaceutical Sciences; Journal of Thermal Analysis and Calorimetry; Kinetics and Catalysis; Pharmaceutical Chemistry Journal; Journal of Chemical Thermodynamics : JCT Pharmaceutical Executive; Pharmaceutical Research; Pharmaceutical Science and Technology Today; Pharmaceutical Technology Europe; Reaction Kinetics and Catalysis Letters; Thermochimica Acta : TA; Tropical Journal of Pharmaceutical Research : TJPR; Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan.

SIGAA | Superintendência de Tecnologia da Informação - (84) 3342 2210 | Copyright © 2006-2024 - UFRN - sigaa09-producao.info.ufrn.br.sigaa09-producao v4.12.21