PHRC 4110 Pharmaceutics I

Transcription

1 CO01: Use interpretive tools for proper data handling CO01.01: Describe basic mathematics and statistic to interpret pharmaceutical data CO01.02: Work with exponents, powers, roots, logarithms, and antilogarithms CO01.03: Interpret straight line equations CO01.04: Convert units CO01.05: Perform dimensional analysis CO01.06: Describe significant figures CO01.07: 07: Calculate equivalent weight CO01.08: Describe basic statistics including mean, median, mode, and standard deviation, precision and accuracy CO02: Define the states of matter and forces in materials determining the property and performance of the CO02.01: Define differences between the states of matter CO02.02: Describe how states of matter change CO02.03: Describe difference between intensive and extensive properties CO02.04: Discuss phase diagrams for a pure substance and a binary system CO02.05: Discuss crystal, amorphous, liquid crystals and polymorphism CO02.06: Describe basic concepts of pressure, temperature, volume and their relationships CO02.07: Define ionic and covalent bonding, intra and intermolecular forces CO02.08: Differentiate the role of intermolecular forces and their roles in defining material property, drug stability, degradation, interaction CO02.09: Differentiate the solution and solid state properties of the materials CO02.10: Discuss factors affecting properties of the material in solution and solid states CO02.11: Describe Van der Waals forces, and their importance in drug product preparation and stability CO02.12: Describe permanent dipoles, induced dipoles, hydrogen bonding, and their importance in drug products CO02.13: Correlate material structure and its intermolecular forces CO03: Describe the basics of thermodynamics, and its application in pharmaceutical dosage forms CO03.01: Define concepts, including internal energy, heat, work, system, surrounding, universe, and apply them to pharmaceutical examples CO03.02: Describe thermodynamic terms and thermodynamic laws CO03.03: Differentiate exothermic and endothermic reactions CO03.04: Define process enthalpies, spontaneous and non-spontaneous reactions or process, entropy and Gibbs free energy CO03.05: Discuss how all processes in relation to drug formulation and development are governed by thermodynamics CO04: Describe electrolyte/non-electrolyte properties of materials, and the effect of ph on drug solubility CO04.01: Describe electrolyte, non-electrolyte, weak and strong electrolytes, and correlate the concept to drug active ingredient CO04.02: Calculate concentrations by molality, molarity, normality, fraction and percent CO04.03: Describe the difference between ideal and non-ideal solutions, the importance of Raoult's and Henry's laws CO04.04: Describe colligative properties, lowering vapor pressure, boiling point elevation, freezing point depression, osmotic pressure CO04.05: 05: Use colligative properties for material characterization (e.g., molecular weight) CO04.06: Define dissociation, association, activity and, ionic strength, and how drug properties may change with the surrounding environment CO04.07: Describe theories of acids and bases, and conjugate pairs CO04.08: Define weak and strong acids and bases with drug examples CO04.09: Calculate ph of strong acids and bases CO04.10: Calculate ph of weak acids and bases on drug examples CO04.11: Discuss the importance of Ka, Kb, pka and pkb, acidity and basicity, and use them in calculations

2 CO04.12: Discuss the importance of water ionization, Kw and pkw, effect of temperature, and use them in calculations CO04.13: Discuss the Le Chateliers' Principle CO04.14: Describe Titration curves CO04.15: Define equivalence points CO04.16: Describe acidic and basic buffers CO04.17: Calculate buffer capacity and maximum buffer capacity CO04.18: Calculate ph of buffered systems CO05: Describe basic concepts of solubility, partitioning, and diffusion CO05.01: Describe the difference between solubility and dissolution rate CO05.02: Define factors affecting solubility and melting CO05.03: Describe solvents and their dielectric constants CO05.04: Discuss the correlation between ph, ionization and solubility CO05.05: Describe approaches to improve solubility or permeability CO05.06: Define BCS Classification, I-IV IV CO05.07: Discuss solvent-solvent, solute-solute, solvent-solute interaction CO05.08: Discuss the correlation between temperature, heat of solution, solubility CO05.09: Define partitioning, partition coefficient ans solubility, partition coefficient and permeability, distribution coefficient CO05.10: Describe diffusion concepts, and factors affecting diffusion CO05.11: Apply Noyes-Whitney equation CO06: Describe drug stability and factors affecting the drug degradation, as well as the rate (kinetics) at CO06.01: 01 Describe stability and factors affecting drug stability CO06.02: Define drug degradation through hydrolysis, oxidation, photolysis, racemization, adsorption, absorption CO06.03: Describe how to maintain drug stability CO06.04: Discuss the importance of excipients in stability and degradation of drug products CO06.05: Describe the importance of reaction law and rate, activation energy CO06.06: Discuss the effect of temperature, ionic strength, catalyst, H, OH, and buffers on reaction rate CO06.07: Define the difference between zero, first and second order reactions CO06.08: Differentiate and identify various reactions CO06.09: Calculate Half-life and shelf life (expiration) CO06.10: Discuss the correlation between Conc. vs time, Rate vs conc. CO06.11: Define rate equations CO07: Define interfacial phenomena, and its role in preparation of dispersed systems, and describe the CO07.01: Identify a dispersed system CO07.02: Describe fundamental differences between solution and dispersion systems CO07.03: Define different dispersed systems, W/O or O/W dispersion systems CO07.04: Define the role of dispersed phase size and how it correlates to Gravity and Brownian forces CO07.05: Discuss the correlation between particle size and charge CO07.06: Define the importance of zeta potential on dispersion stability CO07.07: Describe the differences between Lyophilic, Lyophobic, and association colloids CO07.08: 08: Describe Protective colloids and Gold number CO07.09: Identify sedimentation in suspension and emulsion systems, and suspension flocculation CO07.10: Define emulsions and emulsion instability via coalescence, sedimentation, creaming, Ostwald ripening, and breaking CO07.11: Discuss the effect of temperature and composition on emulsion phase inversion CO07.12: Define surfactants, their structures and their differences CO07.13: Calculate surfactant HLBs CO07.14: Correlate surfactant HLB, O/W and W/O dispersed systems CO08: Learn basic concepts of viscosity and rheology of liquid to semi-solid pharmaceutical dosage forms

3 CO08.01: Describe Newtonian and non-newtonian fluids and dispersed systems CO08.02: Apply Newtonian and non-newtonian principles to suspension, emulsion, diluted dispersed systems and concentrated dispersed systems CO08.03: Discuss why certain fluids display a non-newtonian behavior CO08.04: Define factors that affect fluid flow, such as temperature, shear rate and time CO08.05: Discuss pseudoplastics, dilatants, thixotropy and rheopexy, plastic flow, and hysteresis loop CO08.06: 06: Differentiate laminar and turbulent conditions and their effects on viscosity measurements CO08.07: Describe viscoelasticity, and the effect of time on flow property CO09: Define basic physical pharmacy of polymers and macromolecules used in preparation of CO09.01: Describe polymer applications in pharmaceutical products CO09.02: Define mono-dispersed, and polydispersed polymer systems CO09.03: Discuss molecular weight and molecular weight distribution of a polymer, average molecular weights and how these affect polymer properties CO09.04: Describe glass transition temperature, Tg, and factors affecting Tg CO09.05: Define different polymer structures such as topology, isomerism, crosslinking, linear, branched, cis, and trans CO09.06: Discuss how polymer structure contributes to its role in pharmaceutical application CO09.07: Describe protein structures CO09.08: Define protein stability and formulation CO10: Learn basic concepts of protein binding and complexation, and its role in drug bioavailability CO10.01: 01 Define different classes of complexes and identify pharmaceutical examples CO10.02: Describe chelates, their physical properties, and what differentiates them from organic molecular complexes CO10.03: Describe the forces involved in polymer-drug complexes with pharmaceutical drug delivery applications CO10.04: Discuss the ways that protein binding can influence drug action CO11: Correlate property and application of materials with the focus on controlled drug delivery systems CO11.01: Describe physicochemical principles of materials in traditional and advanced pharmaceutical dosage forms CO11.02: Describe structure-property relationship of materials and how to utilize them in different pharmaceutical applications CO11.03: Describe how material properties are utilized to design different drug release systems including immediate, sustained, delayed, pulsatile, and targeted CO11.04: Discuss material properties in developing modern delivery technologies and systems based on microparticles, nanoparticles, modern polymers, liposomes for traditional and new actives such as proteins and peptides CO12: Describe the biopharmaceutics principles in developing pharmaceutical dosage forms CO12.01: Describe bioequivalence and bioavailability terminology CO12.02: Explain how blood levels versus time curves are used to assess bioavailability of a drug CO12.03: Outline the difference between a generic and reference drug product CO12.04: Recognize the letter code classification of the Orange Book CO12.05: Recognize the pharmaceutical reasons/considerations for a dosage from design CO12.06: Differentiate advantages and disadvantages of the routes of administration CO12.07: Identify the role of the different disciplines involved during initial drug development CO12.08: Describe the factors that influence bioavailability CO12.09: Classify and identify the differences between the four types of absorption mechanism CO12.10: Explain the factors that affect drug dissolution and absorption and stability CO12.11: Recognize the different physiological conditions found in the gastrointestinal tract CO13: Describe biopharmaceutical and analytical aspects of pharmaceutical dosage forms

4 CO13.01: Explain how pharmacists utilize biopharmaceutical analysis to the benefit of the patient CO13.02: Differentiate the terms sensitivity and selectivity requirements for analysis of drug substances CO13.03: Define the term trace analysis and give the common name for drug concentrations (10-9, 10-12, g) CO13.04: Explain why the pharmaceutical analyst must be aware of the metabolism scheme for drug(s) when analyzing a biological sample containing the drug(g) CO13.05: Cite reasons for the need for biopharmaceutical analysis CO13.06: Cite and discuss considerations involved in the selection of an appropriate organic solvent for solvent extraction CO13.07: Define chromatography, mobile phase, and stationary phase CO13.08: List and define the types of chromatograph CO13.09: Define "tr" and "Rf" CO13.10: Name the essential components of gas and liquid chromatography CO13.11: Compare detectors in terms of usefulness CO13.12: Define the validation parameters CO13.13: Distinguish between external, internal and standard addition methods CO14: Describe the FDA steps involved in the drug development and approval processes CO14.01: Discuss the different stages/phases during the drug approval process CO14.02: Identify the main law and standards created from the act and amendments CO14.03: Distinguish the difference between the CFR and the FR CO14.04: Describe Title 21 CFR main requirements CO14.05: Describe the main drug discovery resources CO14.06: Differentiate among the methods of drug discovery CO14.07: Distinguish the terminology of drug nomenclature CO14.08: Describe the main responsibility of pharmaceutics CO14.09: Identify the information included in an IND CO15: Describe pre-formulation studies on drug and drug dosage forms CO15.01: Define the preformulation process and specific timing CO15.02: Identify the objectives of preformulation CO15.03: Cite reasons for molecular optimization CO15.04: Explain the different tests use for bulk characterization CO15.05: Discuss the difference between crystallinity, polymorphism and amorphous materials CO15.06: Identify the techniques use for determining polymorphism CO15.07: Distinguish between hygroscopicity and deliquescent CO15.08: Recognize the parameters and methods used for particle characterization CO15.09: Explain the difference between densities and how to calculate them CO15.10: Recognize the rationale of powder flow CO15.11: Describe the evaluation of mechanical properties of powders CO15.12: Discuss the concept of solubility analysis and why they are used CO15.13: Describe the reasons for stability analysis and the typical setup CO15.14: Relate how physicochemical properties such as solubility and crystallinity modification influence bioavailability CO16: Define the basics of good manufacturing practice in preparation of pharmaceutical dosage form CO16.01: Identify the general provisions -- scope and definition of cgmp CO16.02: Recognize the seven expectations of all GMP CO16.03: Describe reasons for the increase in preparation of patient-specific medications (compounding) CO16.04: Recognize the purpose of the specific section of the Food Drug Modernization Act (Section 127) and how it exempts pharmacy compounding from several government regulatory requirements

5 CO16.05: Describe how the USP/NF helps prepare pharmacies for compounding, what institution promulgated the Good Compounding practices, and develops documents and recommendations for these type of practices (similar to cgmp)