CF001 – Ethics and Bioethics
T:30 P:0 E:0 C:2 P:0
Summary: Constant biomedical science advances have introduced ethical dilemmas of high complexity and importance to society in the last decades. The research with embryonic stem cells, with genetically modified organisms, the use of laboratory animals in research, research with children and the disabled, are some examples. Therefore, the course will discuss the many ethical subjects from biomedical research involving human beings, laboratory animals, embryos, organ and blood donation, abortion, euthanasia, as well as ethical aspects related to the pharmaceutical industry.
Bibliography:
Angell, M. (2004) The truth about the drug companies. Random House Trade Paperbacks, New York; Caplan, A.L. (1992). Quando a medicina enlouqueceu. A bioética e o holocausto. Instituto Piaget, Lisboa; Guilhen, D e Zicker, F. (2007). Ética na pesquisa em saúde: avanços e desafios; Segre, M e Cohen, C. (2008). Bioética. 3ª.ed.rev. Edusp – Editorada Universidade de São Paulo; Vázquez, A.S. (2012). Ética. 34ª.ed.Civilização Brasileira, Rio de Janeiro; Veatch, R.M. (2014). Bioética. 3ª. ed. Pearson Education do Brasil, São Paulo.
CF002 – Applied Statistics
T:60 P:0 E:0 C:4 P:0
Summary: Position and dispersion measures: average, median, mode, standard deviation, coefficient of variation; significance numbers and round offs; Types of errors: crass, systematic and random; Detection of anomalous samples: Grubb and Dixon’s Tests; Normal Distribution, Normal standardized Distribution (z), t-Student Distribution and F Distribution: properties, application and use of tables; confidence intervals for an average value of a random variable employing the z and t distributions; Statistics inference: hypothesis tests using z, t and F distributions for average comparisons and variances; Analysis of Variance (ANOVA) for the comparison of more than two averages; Regression Analysis: Minimum squares Method, coefficient calculation of regression and confidence intervals, determination and correlation coefficients, assessment of residues and standardized residues, normality and homoscedasticity; Introduction to methods validation: the main merit figures: linearity, precision, accuracy, sensitivity, detection limit, quantification limit and robustness. The discipline will have a theoretical part, followed by exercises, and a practical part conducted using Excel software, where it will be used the tool “Data Analysis” for the resolution of problems from the pharmaceutical area, such as: anomalous sample detection on a dissolution study, comparison of results from two analytical methods (NIR vs HPLC) for the quantification of a drug in a medicine, bio-equivalence result analysis of an innovative medicine vs generic medicine; elaboration of analytical curve for the quantification of a drug.
Bibliografia: Miller, J.C. e Miller, J. N. Statistics and Chemometrics for Analytical Chemistry, 6th ed., Pearson, England, 2010. Bolton, S. Pharmaceutical Statistics: practical and clinical applications, 3rd ed., Marcel Dekker Inc., New York, 1997.Skoog D. A, West D. M, Holler FJ, Crouch S. R. Fundamentos de Química Analítica, Cengage Learning, São Paulo, 2006Harris, D. C. Análise Química Quantitativa, LTC Livros Técnicos e Científicos Editora S.A., Rio de Janeiro, 2008.Bruns, R., E., Scarminio, I., S., de Barros Neto, B. Como fazer experimentos: aplicações na ciência e na indústria, 4ª ed., Bookman, SP, 2010.Box, G. E. P., Hunter, J. S., Hunter, W. G. Statistics for Experimenters, John Wiley and Sons, New Jersey, 2005.Draper, N. e Smith.H. Applied Regression Analysis, 3rd ed., Wiley, EUA, 1998.
CF003 – General Seminars
T:60 P:0 E:0 C:4 P:0
Summary: External guests, professors and the course students will present seminars on their research.
CF004 – Transition from postgraduate programs to the labor market
T:45 P:0 E:0 C:3 P:0
Summary: Offer support to facilitate the career placement process (Education Institutions, private sector, etc) for program alumni. CV preparation and logging, CV adequacy for insertion in private companies, notice analysis for public tenders, main points to be evaluated in public tenders for employment as a professor (subsidies for didactic test, presentation of work plan, defense test), organizational management before and during a public tender, guidelines on the preparation of scientific projects for research funding. Theoretical and Practical classes, debates and workshops with the presence of the following professionals: phonoaudiologist, headhunter, psychologist and renowned researchers/professors.
Bibliography: Jansen, R.C. (2011) Developing a Talent for Science, Cambridge University Press isbn: 9780521149617; Texts recommended by the professor
CF005 – Preparation and Dissertation of Scientific Papers and Scientific Investigation Methodology
T:60 P:0 E:0 C:4 P:0
Summary: The construction of scientific knowledge: value and reality judgments, the scientific method, science paradigms, influence of the activity of the scientist in the society. The scientific work: summary and presentation in congresses, symposiums and similar events. The types of scientific monographs: Master’s Degree (dissertation) and for Doctorate (thesis). Reports. Offer the postgraduate program students tools for the preparation, dissertation and publication of scientific articles, as well as assisting them in observing, thinking, planning, organizing, reviewing, and transmitting their ideas. Stimulating the reading of articles, results discussion and publications of results obtained during the development of thesis and dissertations.
CF006 – Development of pharmaceutical forms
T:60 P:0 E:0 C:4 P:0
Summary: To deepen the knowledge on the relation between the route of use of medicines and its development (biopharmacotechnics), considering quality, efficiency and safety. For such, the class will discuss the aspects of drug delivery, absorption and bioavailability from the pharmaceutical form; bio-equivalence; therapeutic equivalence and interchangeability among medicines, according to the scientific criteria internationally accepted and which governs the sanitary regulation in the medicine area in Brazil and abroad. Aggregate principles of the Pharmacotechnics and Pharmaceutical Technology related to the development of pharmaceutical forms, as well as their positive and negative possible impacts. Theoretical-practical fundamentals for the development of formulations, packaging and stability from the main pharmaceutical forms.
Bibliography: Basic:1) Gennaro, AR. Remington: A ciência e a prática da farmácia. A partir da vigésima edição, em inglês ou português; 2) Ansel, HC; Allen, LV; Popovich, NG. Formas farmacêuticas e sistemas de liberação de fármacos (Ansel’s pharmaceutical dosage forms and drug delivery systems). A partir da 8a edição, em Inglês ou português; 3) Aulton, ME. Delineamento de formas farmacêuticas. A partir da 2a edição; 4) Prista, LN et al. Tecnologia Farmacêutica. 6a ou 7a edição. Lisboa, Fundação Calouste Kubekian; 5) Essential articles, updated at the start of each semester, will be made available in pdf format to students at the start of the class; Complementary: 1) Farmacopéia Brasileira, 5 ed, Brasília, Anvisa Fundação Oswaldo cruz, 2010; 2) United States Pharmacopeia, USP 37: The National Formulary NF 32. Rockville, The United States Pharmacopeia Convention, 2014; 3) European Pharmacopeia. 8th Edition. Strasbourg, Council of Europe, 2013 e suplemento 8.1 (2013) e 8.2. (2014); 4) Rowe, RC. Handbook of Pharmaceutical excipients. A partir da 6a edição. Pharmaceutical Press.
CF009 – Biocatalysis in the development of New Drugs
T:60 P:0 E:0 C:4 P:0
Summary: Application of the green chemistry principles within the pharmaceutical area in order to obtain the reduction of toxic residues, solvents and more efficient synthesis requirements. Advantages and disadvantages of Biocatalysis and the principles of Green chemistry. Enzymes or intact cells? Searching for new biocatalysts in the biodiversity. Types of reaction, classification, immobilization, artificial enzymes, semi-synthetic enzymes. Chemical enzymatic processes and multi-enzymatic processes
Bibliography:
[1] K.Faber “Biotransformation in Organic Chemistry” ISBN 3-540-66334-7 Springer -Verlag Berlin; [2] Richard Sillverman “The Organic Chemistry of Enzyme catalyzed Reactions 2000 Elsevier Science; [3] S. Roberts – Biocatalysts for fine Chemical Synthesis
CF011 – Formulation of Cosmetic Products and Cosmeceuticals
T:30 P:0 E:0 C:2 P:0
Summary: Concepts, fundamentals and evolution of the Cosmetic Science. Presentation and discussion of cosmetic forms. Extended delivery systems for the cosmetic application.
Bibliography:
KE, C. Recents advances in nanotechnology. Apple Academic Press. December 14th 2011; DUMITIU, S.; POPA, V. Polymeric Biomaterials. Medicinal and Pharmaceutical applications. CRC Press. January 16th 2013; Leonardi, G. R.; Spers, V. R. E. (Org.). Cosmetologia e Empreendedorismo: Perspectivas para a Criação de Novos Negócios. 1. ed. São Paulo: Pharmabooks, 2015. v. 1; Costa, A. Tratado Internacional de Cosmecêuticos, GUANABARA KOOGAN, 2012; Periódicos: Anais Brasileiros de Dermatologia, International Journal of Cosmetic Science, Journal of Cosmetic Science, Journal of Drugs in Dermatology
CF013 – Emergency Toxicological Analysis
T:60 P:0 E:0 C:4 P:0
Summary: Introduction to toxicological analysis, its characteristics and singularities within the different areas in toxicology; Structure of the Information Centers and Toxicological Assistance. Role of the reference toxicology laboratory in the emergency and urgency network; Choice, collection, transportation and storage of samples for emergency toxicology; Main interest intoxicants in emergency toxicology; Preparation of samples for toxicological analysis; Main analytical techniques used in emergency toxicology analysis: colorimetrics, immunoassays, thin layer chromatography, gas chromatography, high performance liquid chromatography, capillary electrophoresis, UV/visible spectrophotometry, masses spectrometry; Validation of methods in toxicological analysis; Clinical interpretation of laboratory findings, emission of results/reports; Discussion of cases. Justification: The emergency toxicology, sometimes referred to as hospital toxicology (given the location where it is usually carried out) may be defined as a toxicology aspect which main objective is to provide useful information that may assist in the diagnosis and consequent treatment of intoxication, representing a link between analytical and clinical toxicology [1, 2]. The necessity for quick and reliable analytical results is the most remarkable characteristic from the emergency toxicological analysis. In some situations, the intoxication diagnosis may be done based on clinical and circumstantial evidences (patients and/or relatives reports, medicine vials or pesticides found next to the patient), with no need of urgency or even need of toxicological exams conduction. However, when the patient is unconscious, unaccompanied, in critical health state, or if the diagnosis can not be concluded with the necessary confidence to start the treatment, the screening laboratory toxicological test must be carried out immediately, being of extreme importance that the clinical body has quick access to toxicological results that may possibly be of great use in order to start the adequate treatment for that intoxication [3, 4]. In this discipline, of theoretical and practical content, it will be covered the main topics related to emergency toxicological analysis, its context within the multidisciplinary team from the Toxicological and Assistance Information Centers and its importance to public health.
Bibliography:
1. Flanagan, R. J. et al. Analytical toxicology: overview. In: undamentals of analytical toxicology. John Wiley & Sons, Ltd., 2008. p.1-18; 2. Uges, D. R. A. Hospital toxicology. In: Moffat, A. C.; Osselton, M. D., et al (Ed.). In: Clarke’s analysis of drugs and poison. 4a. ed. Pharmaceutical Press, v.1, 2011. p.3-58; 3. Maurer, H. H. How can analytical diagnostics in clinical toxicology be successfully performed today? Ther. Drug Monit., v. 34, n. 5, p. 561-564, 2012; 4. Meyer, M. R. et al. Development, validation, and application of a fast and simple GC-MS method for determination of some therapeutic drugs relevant in emergency toxicology. Ther. Drug Monit., v. 33, n. 5, p. 649-53, 2011.
CF014 – Toxicology and Forensic Chemistry
T:60 P:0 E:0 C:4 P:0
Summary: Presentation of important definitions and concepts in toxicology and forensic chemistry; Structure of the Forensic laboratories in Brazil and comparisons with other countries; Chain of custody; Biological samples for analysis in forensic toxicology; Post mortem forensic toxicology; Main intoxicants involved in criminal situations; Main analytical and sample preparation techniques used in toxicology and forensic chemistry; Validation of methods used in forensic analysis; Analysis of evidences associated to combustion (fire residues, residues from fire weapons firing, explosives); Forensic analysis of inks and paints. Analysis of how recent are documents; Analysis of drugs of abuse and confiscated medications; Chemical profile of drugs of abuse and their use in police intelligence; Interpretation of the laboratory findings; Emission of results and preparation of investigative reports. In the last years, the interest for forensic sciences has grown considerably in Brazil. Within these sciences, two areas of great importance are: toxicology and forensic chemistry. These areas represent clear manifestations of how science and legislation can overlap each other. The term forensic is immediately related to the legal system, police forces and courts, providing a different vision and application to toxicology and chemistry sciences. The forensic toxicology operates in the identification of toxic agents in biological material which produces harmful effects in a situation that requires legal clarification, as in death investigations (specially in suicide and homicide cases), in civil and criminal matters which involve the use of drugs of abuse (driving under the influence of psychoactive substances, crimes facilitated by the use of toxic agents, among others) and in situations which involve crimes related to the environment. The application of knowledge of analytical chemistry and toxicology (specially toxicokinetics and toxicodynamics) in the execution of laboratory exams and in the interpretation of the findings gives the forensic toxicology a multidisciplinary aspect. Forensic chemistry, on the other hand, works with physical evidences (non-biological), usually collected in crime scenes or in locations where there is a suspicion that a crime has occurred. It is an application of the chemical science where the nature of the sample and the knowledge in analytical chemistry are of great importance in order for the expert to choose properly the analytical essays for the conduction of their investigation. Among the exam objects, there may be various types of materials, such as drugs of abuse, medications, paints, fire residues, fuels, fire weapons firing residues, explosives, polymers, glass, etc. In this discipline, it will be approached the fundamental concepts and aspects of these areas from forensic sciences, and to contextualize the state of the art of these areas in Brazil and in other countries. This approach will be made through the presentation and discussion of forensic cases, and the presentation of the most used analytical techniques in forensic analysis, discussing their applications and limitations.
Bibliography:
1. Bell, S. Forensic Chemistry. New Jersey: Pearson Education, 2006. 671 p.; 2. Osselton, M. D., et al (Ed.). Clarke’s analysis of drugs and poison. 4th. ed. Pharmaceutical Press, v.1, 2011. p.3-58; 3. SWGTOX. Scientific Working Group for Forensic Toxicology – Standard Practices for Method Validation in Forensic Toxicology. 2013. Available at: < http://www.swgtox.org/documents/Validation3.pdf >. Access in: 17th Feb 2016; 4. UNODC. United Nations Office on Drug and Crime – Guidance for the validation of analytical methodology and calibration of equipment used for testing of illicit drugs in seized materials and biological specimens. 2009. Available at: < https://www.unodc.org/documents/scientific/validation_E.pdf>. Access in: 17th Feb 2016; 5. SWGDRUG. Scientific Working Group for the Analysis of Seized Drugs. Available at: <http://swgdrug.org>. Access in: 17th Feb 2016.
CF015 – Biomembranes
T:60 P:0 E:0 C:4 P:0
Summary: Introduction to biomembranes: membranes records and models; composition; properties; components movement; functions; phenomena that occur in biomembranes: phase transition, fusion and lipid domains formation, interaction with bioactive molecules, physical techniques applied to the study of membranes (Calorimetry; molecular dynamics on bilayers; RMN; X-rays; electron paramagnetic resonance; atomic force microscopy); technological applications; membrane proteins; lipidrafts; unilamellar vesicles.
Discipline structure: Expository lectures, discussion of articles previously selected (proposed by professors and available on the site Teleduc) and presentation of seminars from scientific articles.
Bibliography: Yeagle, P.L. (2012) The Structure of cell membranes, 3rd ed. CRC Press (2nd. Ed. = on line version). R. B. Gennis (1989) Biomembranes, Springer-Verlag, New York. (lab. Biomembranes). R.C. Warren (1987) Physics and architecture of cell membranes, Adam-Hilger, Bristol and Philadelphia, (lab. Biomembranes). R.R.C. New (1990) Liposomes: a practical approach. IRL Press, Oxford, lab. Biomembranes) D.D. Lasic& D. Papahajlopoulos (1998). Medical applications of Liposomes, Elsevier, Amsterdam-Lausanne (BIB). M.K. Jain (1988) Introduction to Biological Membranes, John Wiley & Sons, New York. (BIB) D.B. Datta. (1987) A Comprehensive Introduction to Membrane Biochemistry, Floral Pub., Madison. (BIB) R. Prasad (1995) Manual on membrane lipids, Springer, Berlin. (BIB) S. Papa & J.M. Tager (1995) Biochemistry of cell membranes, BirkhäuserVerlag, Basel. (BIB)
CF016 – Planning and Experimental Optimization applied to pharmaceutical development.
T:60 P:0 E:0 C:4 P:0
Summary: Introduction: Why use multivariate methods? The concept of interaction among variables; ICH Q8 guide and the concepts of Qualityby Design and Design Space; factorial design planning in two levels: how to set the planning, effects calculation of the factors, errors and confidence intervals; construction of the statistic model; Normal probability chart; variance analysis (ANOVA), diagnosis tools, construction and interpretation of the response surface; curvature evaluation. Fractional factorial design planning for the screening of factors: how to select the experiments, generating relation, fractions; resolution; how to select a fractional without losing information; how to complete the fractional design planning; Central composed design planning (3 levels): construction and evaluation of the quadratic model; construction, evaluation and shifting on the response surface; Use of the model for prediction of the interest properties: how to find the experimental conditions that lead to a determined response value (target value); response maximization and minimization; Design Space definition; Simultaneous optimization of more than one response: overlapping of contour maps and procedure based on the Derringer and Suich functions. Mixture design planning: why are there different methods for the optimization of mixtures, important concepts, experimental domain representation and the mixture models.
Justification: Currently, one may observe the growing use of multivariate methods within the pharmaceutical area, due mainly to encouragement from Europe and US regulatory agencies, which have launched guidelines highlighting the relevance of these methods and ensuring the regulatory flexibility related to their use. The objective of the regulatory agencies is to update the pharmaceutical development, the production and quality assurance by means of the innovation based on the scientific knowledge. The Quality by Design’s (QbD) initiative opened the doors to the introduction of design planning and experimental optimization methods (DOE, Design of Experiments) in the development of medicines and has become very important around the globe. In Brazil, the adoption of these methodologies is still incipient within the pharmaceutical area, being necessary the diffusion of the theoretical principles and practical applications. This discipline’s main objective is to teach students the main design planning methods and experimental optimization applied to the development of products, processes and analytical methods within the pharmaceutical area, according to the Quality by Design principles. The discipline will have the duration of 02 hours a week and it is constituted of theory and practice, which will take place in the end with the use of the software Design Expert® (StatEase).
Bibliography: Bruns, R., E., Scarminio, I., S., de Barros Neto, B., How to make experiments: applications in science and industry, 4ª ed., Bookman, SP,2010.Food and Drug Administration, Center of Drug Evaluation and Research (CDER). Guidance for Industry: PAT: A framework for Innovative pharmaceutical development, manufacturing and quality assurance, Rockville, 2004. International Conference of Harmonization of technical requirements for registration of pharmaceuticals for human use (ICH), Guideline Q8 (R1): Pharmaceutical development, 2005.Box, G. E. P., Hunter, J. S., Hunter, W. G., Statistics for Experimenters, John Wiley and Sons, New Jersey, 2005.Cornell, J. A. Experiments with mixtures: Designs, Models and the analysis of Mixture Data, 3ª ed, John Wiley & Sons, New York, 2002.Draper, N. e Smith. H., Applied Regression Analysis, 3ª ed., Wiley, EUA, 1998.Myers, R., Montgomery, D., Cook, C.M.A., Response Surface Methodology: Process and Product Optimization Using Designed Experiments, 3ª ed., John Wiley and Sons, New Jersey, 2009.
CF017 – Molecular Biology: From fundamentals to applications within the pharmaceutical area
T:60 P:0 E:0 C:4 P:0
Summary: Cloning and expression strategies, hetorologous expression systems, recombinant protein purification, fusion proteins, reporter essays, reporter proteins, oligonucleotides design, knock out and gene knockdown, DNA manipulation in vitro, expression vectors, gene amplification methods, mutagenesis, hybridization, monoclonal antibodies, therapeutic recombinant antibodies, biodrugs, molecular diagnosis, gene therapy, molecular-cellular therapy, vaccines, molecular screening, transgenic animals, systems biology; synthetic biology, bioinformatics. Conduction of the discipline: theoretical lectures, directed studies and presentations of the students about selected subjects.
Justification: The growing importance of biopharmaceutical products, gene and cellular therapies and the growing impact of the molecular biology methods in the health sector and on the understanding of biological processes.
Main objective of the discipline: Offer subsidies to the students in order for them to understand the molecular mechanisms and the molecular biology methodologies and its application in the discovery area and the development of pharmaceutic products and diagnosis processes.
Bibliography: Book: Watson et al., 2007; Recombinant DNA – Genes and Genomes – A short course, 3rd edition, Cold Spring Harbour Lab. press, Freeman Co.; Texts recommended by the professor: review articles and primary articles.
CF018 – Mechanism of cellular signaling in health and disease
T:60 P:0 E:0 C:4 P:0
Summary: Molecular target concept, immune system signaling, ligands and receptors, mediators and secondary messengers, hormones, horizontal and vertical receptors, channels, adapters, scaffold proteins, multidomain proteins, G-proteins, phospholipase, kinases, phosphatase, adenylylcyclase, Ca2+ bond, transcription factors, nuclear receptors, enzymes, proteolysis, multimerization di-e, proteins isoforms, proteins post translational modifications, cellular cycle regulation, oncoproteins, suppressive tumors, cancer signaling, alternative splicing, apoptosis signaling, virus regulation proteins, protein-protein interaction, signaling channels, channel integration, identification of molecular targets, characterization of molecular targets, high performance screening, high content screening, development of bioassays, drugs rational design. Conduction of the discipline: theoretical lectures, directed studies and presentations of the students on selected subjects.
Justification: The growing importance of cellular signaling mechanisms for the identification and characterization of specific molecular targets for the disease treatment.
Main objective of the discipline: To offer subsidies to the students in order for them to understand the cellular signaling molecular mechanisms and allow them to discuss their possibilities within the area of discovery and the development of new drugs.
Bibliography: Ralph Bradshaw and Edward Dennis (Editors), Handbook of cell signaling, 2010, second edition
Texts recommended by the professor: review articles and primary articles.
CF020 – Ingredient standardization bases from natural products
T:60 P:0 E:0 C:4 P:0
Summary: Study the main metabolic pathways used by vegetable cells in the biosynthesis of natural products with therapeutic application and strategies that may be used for the production of phytopharmaceuticals. The bio-synthetic pathways and their intersections and the restriction points and/or factors of pathways regulation related to the formation of a target metabolite, to be used in the metabolic engineering for the production of vegetable origin drugs. Extraction and separation methods and technological and analytical strategies used in the research and development of phytopharmaceuticals.
Bibliography: Leland J. Cseke, Ara Kirakosyan, Peter B. Kaufman, Sara L. Warber, James A. Duke, and Harry L. Brielm N; Natural Products from plants, 2o edition, Taylor & Francis Group, 2006; Michael Heinrich, Joanne Barnes, Simon Gibbons, and Elizabeth M. Williamson, Fundamentals of Pharmacognosy and Phytotherapy, Chuchill Livingston, 2007; Garrg G et.al. Journal of Chinese Integrative Medicine, 10(10), 2012, 1077; Manuchair Ebadi, Pharmacodynamic Basis of Herbal Medicine, 2o edition, 2006, Taylor & Francis Group; Periodicals Scientific Articles
CF021 – Isolation and Identification of active ingredients
T:90 P:0 E:0 C:6 P:0
Summary: Present the students current methods and techniques applied to the extraction, purification and identification of bioactive molecules. It will be covered: 1. The importance and the impact of non-conventional separation processes (different biotechnology sectors, bioprocesses characterization); 2. Liquid-solid separation (cell breaking, filtration, centrifugation); 3. Concentration of Products from diluted mixtures (Precipitation, Extraction, membrane Processes); 4. Bioactive Molecules Purification (Ion Exchange Chromatography, hydrophobic and affinity interaction; chiral Chromatography; preparative Chromatography); 5. Hyphenated techniques and spectroscopic methods (IV, UV, RMN and mass) applied to the identification of bio-active molecules.
Bibliography:
BIDLINGMEYER, B. A. Practical HPLC methodology and applications John Willey R. Sons. Inc., 1992. 2- CIENFUEGOS, F.; VAITSMAN, D. Analise Instrumental. Editora Interciência, 2000, 606 p. 3- CIOLA, R, Fundamentos da Cromatografia a líquido de alto desempenho. Editora Edgard Blucher, Ltda,1998, 179p. 4– COLLINS, C.H., BRAGA, G.L. Introdução a Métodos Cromatográficos. 3.ed., Editora da UNICAMP, 1997, 279p. 5- FUNG, D.Y.C., MATTHEWS, R.F. Instrumental Methods for Quality Assurance in Foods, Marcell Dekker, Inc., 1991. 6- GROB, R.L. Modern Practice of gas chromatography. 2a ed. John Wiley & Sons,1985. 7- HELRICH, K, Official Methods of Analysis, v.1 e 2, 15ed. Association of Official Analytical Chemists, Inc., vol. 1 e 2, 1995. 8- LANÇAS, F.M. Cromatografia em Fase Gasosa. ACTA, São Carlos, 1993, 269p. 9- LINDAYS, S., KEALEY, D. High. Performance liquid chromatography (analytical chemistry by open learning) John Wily & Sons. Inc. 1990. 10- MATISSE, R. (ed). High performance liquid chromatogrephy in food. Technomic Publishing Co. Inc. 1992. 11- SMIDER, L.R., GLAYCH, J.L., WIRKLAND, J.J. Practical HPLC methodo development. John Wiley & Sons, 1988. 12- SADEK, P.C. The HPLC Solvent Guide. 2ª edição, 2002, 641p. 13- SOARES, L.V. Curso Básico de Instrumentação para Analistas de Alimentos e Fármacos, Editora Manole, 2006, 352p. 14- KOOG, D,A; HOLLER, F.J.; NIEMAN, T.A Princípios de Análise Instrumental, 5ª edição, Editora Bookman, 2002, 838p. 15- LANÇAS, F.M. Validação de Métodos Cromatográficos de Análise, Editora Rima, 2002, 62p. 16- RADLER, F; NUNES, D. Cromatografia Princípios Básicos e Técnicas Afins. Editora Interciência, 2003. 188p. Amala Soumyanath, Tradicional Medicines for Modern Times, 2006, Taylor and Francis Group Mark. S. Meskin et.al., Phytochemical Aging and Health, 2006. Taylor & Francis Group, Herbal Medicine Biomoleculae and Clinical Aspects, 2o edition,2010, Taylor & Francis group, Scientific papers from journals
CF022 – Validation of extraction methods & chromatographic analysis
T:60 P:0 E:0 C:4 P:0
Summary: Present the main chromatographic methods used to separate interest compounds from vegetable, ingredients and medicines matrices. Discuss the applications and restrictions of the most used chromatographic methods for their identification. Discuss the development of extraction methods and validation for the confirmation of recovery, respectability, accuracy parameters among others.
Bibliography: RESOLUTION-RE Nº 899, OF MAY 29, 2003; Scientific papers from journals
CF023 – UV, IV, RMN1H, RMN13C Analysis Spectrometric Methods and mass spectrometry
T:60 P:0 E:0 C:4 P:0
Summary: Introduction: Spectroscopy in the control of drugs and medicines analysis. Differentiation and application of the spectrometric techniques: EM, UV-VIS, IV and RMN; Spectroscopy on UV-VIS and IV: Principles, theoretical basis, instrumentation and most usual techniques, correlation between chemical structure and functional groups absorption, quantitative and qualitative analysis of organic compounds; Mass Spectrometry: Main techniques and instrumentation, ion reactions, fragmentation and rearrangement. Organic compounds analysis with characteristic fragmentation in the EM; Nuclear Magnetic Resonance: Principles of continuous and pulsed RMN, instrumentation, theoretical basis, coupling constant of chemical shift, qualitative analysis of pharmaceutical interest compounds; Joint application of spectrometric methods on UV-VIS, IV, masses, RMN 13C and RMN 1H in the analysis of drugs and medicines.
Bibliography:
Roger G. Linington, Philip G. Williams and John B. MacMillan, Problems in Orgsnic Structure Determination, A pratical approach to NMR spectroscopy, 2016, Taylor & Francis Group; SILVERSTEIN, R. M.; BASSLER, G. C. e MORRILL, T. C. Spectrometric identification of organic compounds, 5. ed., New York: John Wiley and Sons, 1991; Periodical Scientifical Articles
CF024 – Mass Spectrometry applied in the elucidation of Biomarkers in the Medical, Pharmaceutical and Food areas
T:60 P:0 E:0 C:4 P:0
Summary: Introduction to Mass Spectrometry. Ionizing Sources. Mass Analyzers. Chemical Imaging Coupling and applications with separation techniques. Liquid Chromatography. Gas Chromatography. Application in the Medical, Pharmaceutical and Food areas.
Bibliography:
1. Dowward, K., Mass Spectrometry – A Foundation Course, RSC Publishing, 2007; 2. Gross, J. H., Mass Spectrometry – A textbook, Springer, 2004. 3. Rubakhin, S. S. e Sweedler, J. V. (eds.), Mass spectrometry imaging – principles and protocols, Springer, 2010. 4. Cass, Q. Cromatografia Líquida, Novas tendências e Aplicações – Elsevier 2015
CF025 – Preformulation and medicine stability studies
T:45 P:0 E:0 C:3 P:0
Summary: Introduction to the preformulation of medicines; physical and physical-chemical characteristics and properties of the drugs and their influence on the technological process and bioavailability, Pharmaceutical excipient compatibility studies, polymorphism, salts, co-crystals, characterization methods used in preformulation, solubility and development of mean of Dissolution, Introduction to the medicines stability, monitoring of drugs decomposition reactions, qualitative analysis methods applicable on the decomposition kinetics, order of reaction and for the determination of medicine lifespan duration, Study of degradation products.
Justification: Currently, one may notice the growing concern in ensuring the medicine quality, from the beginning of the active pharmaceutical ingredient evaluation (IFA), the production process until the finished product. In order to achieve this, it is necessary to observe factors such as the ingredient physical and chemical stability, the presence of polymorphism, solubility and possible interactions between the drug and excipient, as well as to evaluate factors related to the medicine stability, such as content and dissolution, formation of degradation products, adequacy of packaging, proper conservation against cross and microbial contamination, uniformity of the ingredient used and acceptance by user. The preformulation study aims through analytical tools and literature studies to obtain a stable pharmaceutical formulation according to acceptable quality criteria. The standards for the study of degradation products are still recent in Brazil, these can be formed during the medicine stability study, being necessary a more profound evaluation with theoretical and practical principles for their identification, through analytical methodology such as mass spectrometry and spectroscopic methods. The objective of the discipline is to propose a rational discussion of a pharmaceutical formulation through the preformulation study and discuss parameters related to the medicine stability.
Bibliography:
[1]GIBSON, M. Pharmaceutical preformulation and formulation, CRC Press 2001, 596 p.; [2]Mark, Gibson Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form, 2a Ed., Informa, 2009, 234p.; [3] TENNESEN, H.H. Photostability of Drugs and Drug Formulations. Taylor & Francis, 435p. 2004; [4] NETZ, P..A.; ORTEGA, G.G. Fundamentos de Físico-química. Uma abordagem para ciências farmacêuticas, Artmed, Porto Alegre, 2002; [5] CARSTENSEN, J.T.; RODES, C.T.; Drug stability. Principles and practices, 3ed., Marcel Dekker, New York, 2000.
CF026 – Modern Analytical Methods Applied to pharmaceutical product Analysis
T:30 P:0 E:0 C:2 P:0
Ementa: Introdução aos Métodos Analíticos Modernos Aplicados à Análise de produtos farmacêuticos, Avanços recentes em Métodos cromatográficos, Novas fases estacionárias aplicadas ao estudo de insumos farmacêuticos e medicamentos, Desenvolvimento de métodos, Eletroforese capilar aplicada ao estudo de insumos farmacêuticos e medicamentos, Análise Térmica aplicada ao estudo ao estudo de insumos farmacêuticos e medicamentos; Avanços na análise de metais em amostras de medicamentos, Espectrometria de Massas aplicada ao estudo de insumos farmacêuticos, medicamentos
Justificativa: Apresentar os principais métodos analíticos recentes para análise de insumos e medicamentos em diferentes formas farmacêuticas avaliando o efeito de matrizes, interferentes e respostas através de discussões sobre a adequabilidade do método com os limites de concentração estabelecidos. Apresentar protocolo para desenvolvimento e validação de métodos e discutir aplicações de métodos de análise térmica, cromatográficos e espectroscópicos em insumos farmacêuticos e medicamentos.
Bibliografia:
[1] Collins, G.L.Braga, P.S.Bonato, Fundamentos de Cromatografia, Editora da UNICAMP, Campinas-SP, 2006; [2] D.L.Paiva, G.M.Lampman, G.S.Kriz, J.R.Vyvyan, Introdução à espectroscopia, Cengage Learning, São Paulo, 2012; [4] NETZ, P..A.; ORTEGA, G.G. Fundamentos de Físico-química. Uma abordagem para ciências farmacêuticas, Artmed, Porto Alegre, 2002; [5] E.Hoffman, V.Stroobant, Mass Spectrometry: Principles and Applications, Ed. John Wiley & Sons, 2005; [6] O. McPolin, An Introduction for HPLC for Pharmaceutical Analysis, Mourne Training Services, United Kingdon, 2009; [7] D.G.Watson, Pharmaceutical Analysis, Third Edition. Churchill Livingstone, 2012; [8] D.Q.M.Craig, M.Reading, Thermal Analysis of Pharmaceutical, CRC Press, Florida, 2007; [9] S. Ahuja, S. Scypinski, Handbook of Modern Pharmaceutical Analysis, Academic Press, 2001; [10] S. HANSEN, S. PEDERSEN-BJERGAARD, K. RASMUSSEN, Introduction to Pharmaceutical Chemical Analysis, John Wiley & Sons. 2012
Periodicals:
CF027 – Biosafety and Laboratory Good Practices
T:60 P:0 E:0 C:4 P:0
Summary: Introduction to Biosafety. Evaluation and management of risks in laboratories: chemical, biological and physical risks of accidents, ergonomics related to the manipulation of chemical products and genetically modified organisms, manipulation of medicines, food, clinical analysis, cosmetics and similar. Use of personal protective equipment. Management and disposal of chemical, biological and radioactive residues. Notions of first aid. Laboratory environment. Laboratory Good Practices. Correct use of glassware and equipment. Calculation and preparation of solutions. OBJECTIVES: The discipline has as objective, to introduce the biosafety concepts, aiming for the operator safety as well as the population and environment, by means of the correct management and disposal of biological, chemical and radioactive materials. Present the concepts and exercise biosafety practices, with actions aimed at the prevention of risks related to research, lecturing and production activities. Know good laboratory practices, performing safe and quality practices in the manipulation of instruments, biological samples, animals and chemical substances. Programmatic Content: Biosafety: Biosafety Principles, The lecturing and research laboratories and their risks, Personal and collective protective equipment, Handling, control and disposal of biological products, Handling of chemical products and the disposal of their residues, Biosafety in medicines, cosmetics and related products, Occupational risks due to chemical agents, Biosafety in bioterium, Biosafety in industrial biotechnology, Biosafety in microbiology laboratory, Biosafety in molecular biology laboratories, Notions in first aid and preventions and actions related to fire in health environments. Laboratory Good Practices: Structure and organization in the laboratory: Work planning, organization, standardization and registry, Types of glassware and material cleaning, Reagents: preparation, labelling and storage, Purification processes and water quality control, Calculations and dilutions, Disinfection and sterilization methods, Good practices in the use of equipment: Scale handling, micropipette, greenhouse, autoclaves, water bath, centrifuge, agitators, microscopes and spectrophotometers.
Bibliography:
Almeida M F. Boas Práticas de Laboratório. São Caetano do Sul: editora Difusão, 2009 p. 434; Hirata MH, Crespo Hirata R, Mancini Filho J. Manual de biossegurança – 2ª edição. São Paulo: Manole, 2012. 384 p.; Mastroeni MA. Biossegurança aplicada a laboratórios e serviços de saúde. 2ª ed, Atheneu, São Paulo, 2005, 338p.; Richmond JY, Mckinney RW, organizado por Santos AR, Millington MA, Althoff MC. Biossegurança em laboratórios biomédicos e de microbiologia. Editado por Brasília: 290 p.; UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR). Handbook of Good Laboratory Practice. US epartment of Health and Human Services. Biosafety in Microbiological and Biomedical Laboratories. U.S. Government Printing Office, Washington, 2008.
CF028 – Ingredient and Pharmaceutical Product Quality Control
T:60 P:0 E:0 C:4 P:0
Summary: Quality control of pharmaceutical, cosmetics and related products. Main types of microbial contamination. Pharmaceutical grade water and methods of obtaining and microbiological control. Quality control of sterile and non-sterile products. Preservatives efficiency and antibiotics potency. OBJECTIVES: Providing the student with theoretical and practical knowledge on the activities of medicine, cosmetics and related products biological control. Knowing the main types and sources of microbiological contamination. Developing microbiology techniques applied to control. Knowing the legislation and current protocols on the microbiological quality control. PROGRAMMATIC CONTENT: Total control and quality assurance of pharmaceutic, cosmetics and related products, Current legislation and guidelines on the microbiological quality control, Microbial contamination on pharmaceutical, cosmetics and related products, Quality control of pharmaceutical grade water, Microbial quality analysis of non-sterile products, Sterile products control, Sterility test, Bacterial pyrogens and endotoxins, Disinfectants and sanitizers: general aspects and application, Preservative efficiency, Microbiological dosing of antibiotics and growing factors
Bibliography:
Farmacopeia Brasileira 5ª Edição – 2010 – Anvisa.Jorge, Antonio Olavo Cardoso. Microbiologia: atividades práticas. 2. ed.Ano 2008. Pinto, Terezinha de Jesus Andreoli; Kaneko, Telma Mary; Pinto, Antonio F. Controle biológico de qualidade de produtos farmacêuticos, correlatos e cosméticos. 4. Ed. São Paulo, SP: Atheneu, 2015. 416 p.; Ribeiro, Mariangela Cagnoni. Microbiologia prática: aplicações de aprendizagem de microbiologia básica: bactérias, fungos e vírus. 2. ed. Ano 2011; British Pharmacopoeia. London: Her Majesty’s Stationary Office, 2012. 5v.; European Pharmacopoeia. 7 ed. Strasbourg: Europen Directorate for the quality medicines, 2010; Japanese Pharmacopoeia. 13 ed. Tokyo: Society of Japanese Pharmacopoeia. 2011; United States Pharmacopoeia. 37 ed. Rockivlle: United States Pharmacopeia Convention, 2014
CF029 – Antimicrobial and bacterial resistance mechanisms
T:60 P:0 E:0 C:4 P:0
Summary: Main classes of antimicrobials Operating mechanism of the main microbials used in therapeutics: antimicrobials which operate on the cell wall biosynthesis; antimicrobials which block the protein biosynthesis; antimicrobials which block the DNA replication; antimicrobials which operate in other targets in the bacterial cell. Pharmacokinetics/Pharmacodynamics concepts (PK/PD) for antimicrobials. Bacterial resistance mechanisms: Permeability alteration, Operating site alteration, efflux pump, enzymatic mechanism. Emerging mechanisms of resistance to antimicrobials. Global scenario of the microbial resistance. Methods and trends in the research of new antimicrobials.
Objectives: Knowing the main antimicrobials and their operating mechanisms. Understanding the Bacterial resistance mechanisms. Knowing methodologies applied to the study of antimicrobials (practical lectures). Understanding the rational use of antimicrobials.
Programmatic Content: Antimicrobials which operate on the cell wall; antimicrobials which operate on the protein synthesis; antimicrobials which block the DNA replication; antimicrobials which operate on the folic acid metabolism and which operate on the cellular membrane, Mechanisms of bacterial resistance: Permeability alteration, Operating site alteration, efflux pump, enzymatic mechanism, Pharmacokinetics/pharmacodynamis (PK/PD) concepts for antimicrobials, Rational use of antimicrobials, Microbial resistance and global scenario, Methodologies for the study of antimicrobial activity (minimum inhibitory concentration, zone of inhibition, tests on bacterial biofilm), Seminars in research for the discovery of new antimicrobials
Bibliography:
Martinez JL, Baquero F. Antibiotics and Bacterial Resistance. Chichester:John Wiley and sons. 2013; Madigan MT; Martinko JM; Dunlap PV; Clark DP. Brock’s Microbiology 12 ed. Sao Paulo: Artmed, 2010. 1160 p.; Reese, Richard E. Antibiotics Handbook. Rio de Janeiro: Guanabara Koogan, 2001; Tortora GJ, Funke BR, Case CL. Microbiology. 10 ed. Sao Paulo: Artmed, 2012. 964 p.; World Health Organization. The evolving threat of antimicrobial resistance – Options for action. 2012. 120 p.
CF030 – Rational Approaches for Drug Planning
T:60 P:0 E:0 C:4 P:0
Summary: General concepts applied to the Rational planning of drugs. Physical-chemical properties, drug metabolism. Strategies for Prototype Optimization. Virtual Selection.
Programmatic Content: Part 1: General Concepts, Factors which affect the drugs efficiency, Drugs origin, Pharmacophore groups, Biological operation Phases, The Pharmaceutical market; Part 2: Drugs physical-chemical properties, their parameters and biological activity, acidity and basicity, Partition, Solubility, Electronic parameters, Stearic Parameters, Properties Calculations using computer software. Part 3: Drugs metabolism and Latency: Biotransformation – phase 1 reactions; Conjugation – phase 2 reactions; Prodrugs and latency. Part 4: Drug-receptors interactions: types of bioreceptors, Forces involved in the drug interaction with their bioreceptor, Drugs stereo-chemistry: bioactive configurations and conformations. Part 5: Discovery and Rational planning of Drugs: Prototypes Optimization. Virtual Selection.
Bibliography: Patrick, G. An Introduction to Medicinal Chemistry, 5th ed., 2013, Oxford University Press; Lemke, Williams, *Roche e Zito. Foye´s Principles of Medicinal Chemistry. 6th ed., 2008, Lippincott, Williams & Wilkins, London. Sites and scientific papers presented by the professor.
CF031 – Special topics in particulate drugs delivery systems
T:60 P:0 E:0 C:4 P:0
Summary: General concepts: drugs administration routes, focusing on the relevant particularities to the medicine formulation; types of delivery; particulate pharmaceutical forms; conventional and innovative excipients. Pharmacotechnical development of formulations (theoretical/practical): excipients and their interactions; preformulation studies; drugs dosing; physical-chemical characterization of particulate formulations, incorporation rate and drugs delivery profile. Application of the concepts in the experimental development of nanoparticles as carriers.
Bibliography: Basic:1) Gennaro, AR. Remington: A ciência e a prática da farmácia. A partir da vigésima edição, em inglês ou português; 2) Ansel, HC; Allen, LV; Popovich, NG. Formas farmacêuticas e sistemas de liberação de fármacos (Ansel’s pharmaceutical dosage forms and drug delivery systems). A partir da 8a edição, em Inglês ou português; 3) Aulton, ME. Delineamento de formas farmacêuticas. A partir da 2a edição; 4) Prista, LN et al. Tecnologia Farmacêutica. 6a ou 7a edição. Lisboa, Fundação Calouste Kubekian; 5) Essential articles, updated at the start of each semester, shall be made available in pdf to students at the start of classes; Complementary: 1) Farmacopéia Brasileira, 5 ed, Brasília, Anvisa Fundação Oswaldo cruz, 2010; 2) United States Pharmacopeia, USP 37: The ttNational Formulary NF 32. Rockville, The United States Pharmacopeia Convention, 2014; 3) European Pharmacopeia. 8th Edition. Strasbourg, Concil of Europe, 2013 e suplemento 8.1 (2013) e 8.2. (2014); 4) Rowe, RC. Handbook of Pharmaceutical excipients. A partir da 6a edição. Pharmaceutical Press.
CF033 – Update in Pharmacotherapy
T:30 P:0 E:0 C:2 P:0
Summary: The course will discuss the use of medicines for the treatment of various diseases and disorders which affect the main organism systems, always focusing on the pathophysiological process.
Bibliography:
DiPiro, J.T.; Talbert, R.L.; Yee, G.C.; Matzke, G.R.; Wells, B.G.; Posey, L.M. (2014). Pharmacotherapy: a pathophysiologic approach. 9th.ed. McGraw-Hill Education, New York.
Updating through literature review.
CF034 – Molecular targets for the development of drugs
T:30 P:0 E:0 C:2 P:0
Summary: Drugs, their targets, nature and number of therapeutic targets. Proteins Structure. Enzymes as therapeutic targets. Receptors as therapeutic targets. Ion channels as therapeutic targets. Transport proteins as therapeutic targets. Organ-selective approaches of therapeutic targets. Molecular targets involved in adverse reactions.
Bibliography:
Gu, J.; Bourne, P. E. Structural bioinformatics. 2nd ed. Hoboken, N.J.: Wiley-Liss, 2009; Palfreyman, M. G.; McCann, P. P.; Lovenberg, W. M.; Temple, J. G.; Sjoerdsma A. Enzymes as targets for drug design. London: Academic Press, 1989; Seifert, R.; Wieland, T. G protein-coupled receptors as drug targets: analysis of activation and constitutive activity. Weinheim, Germany: Wiley-VCH Verlag GmbH, 2009; Ottow, E.; Weinmann, H. Nuclear receptors as drug targets. Weinheim, Germany: Wiley-VCH Verlag GmbH, 2008; Gonzalez, J. E.; Termin, A. P.; Wilson, D. M. Voltage-gated ion channels as drug targets. Weinheim, Germany: Wiley-VCH Verlag GmbH, 2006; Amidon, G. L.; Wolfgang Sadée, W. Membrane transporters as drug targets. New York: Kluwer Academic Publishers, 2002; Molema, G.; Meijer, D. K. F. Drug targeting: organ-specific strategies. Weinheim, Germany: Wiley-VCH Verlag GmbH, 2001; Urbán, L.; Patel, V. F.; Vaz, R. J. Antitargets and drug safety. Weinheim, Germany: Wiley-VCH Verlag GmbH, 2015.
CF035 – Stability of pharmaceutical products and cosmetics
T:60 P:0 E:0 C:4 P:0
Summary: The discipline will approach stability essays conducted for pharmaceutical and cosmetic products, as well as their importance in relation to the products quality assurance, efficiency and toxicity. It studies the different types of stability essays conducted as instrumentals (physical-chemical, chemical and microbiological), clinical and sensory, which must be conducted on the various stages of fabrication of medicines and cosmetics
Bibliography:
ERIC S. GIL. Controle físico-químico de qualidade de medicamentos. 3ed., São Paulo: PHARMABOOKS EDITORA, 2010, 512p.; PINTO, T.J.A.; KANEKO, T.M.; PINTO, A.F. Controle biológico de qualidade de produtos farmacêuticos, correlatos e cosméticos. 3.ed. São Paulo: Atheneu, 2010; THE UNITED STATES Pharmacopeia. 33th. ed. Rockville: The United States Pharmacopeial Convention, 2010; EUROPEAN Pharmacopoeia. Saint-Ruffine, Maisonneuve, 2006; ANSEL, H.C. et al. Formas Farmacêuticas e Sistema de Liberação de Fármacos. 9.ed., São Paulo: Artmed, 2013. 568 p.; CORREA, M.A. Cosmetologia – Ciência e Técnica. São Paulo: Livraria e Editora Medfarma, 2012. 492 p.; HANDBOOK of pharmaceutical excipients. Washington: American Pharmaceutical Association, 1994. 672 p. http://files.rushim.ru/books/lekarstva/handbook-of-pharmaceutical-excipients2009.pdf; Farmacopeia Brasileira. 5.ed. ANVISA, 2010. http://www.anvisa.gov.br/hotsite/cd_farmacopeia/index.htm; BRASIL. Agência Nacional de Vigilância Sanitária. Resolução RE nº899, 29 de maio de 2003. Guia para validação de métodos analíticos e bioanalíticos. Diário Oficial da União, Brasília, 02 jun. 2003a. Disponível em: http://www.anvisa.gov.br; BRITISH Pharmacopoeia. London, Her Majesty’s Stationary Office, 2001; THE INDEX MERCK. An encyclopedia of chemicals, drugs and biologicals. 13 ed. White Station, Mecek, 2001.
CF036 – Microbial Analysis of Food and Nutraceutics
T:60 P:0 E:0 C:4 P:0
Summary: Food sampling, analysis and profile of food microbiological quality, bacteria and fungus analysis, mesophile, psychrophile and thermophile microorganisms on food, degradation of food and quality control.
Bibliography:
Texts recommended by the professor: review articles and scientifical articles in the area. Co. Pte. Ltd., 2007. 210 p. ISBN: 978-9-8127-0144-2. Strunk Jr., W. The elements of style. New York: Tribeca Books, 2011. 52 p. ISBN: 978-1-6129-3110-4.