Disperse pharmaceutical systems. The biopharmaceutical classification system as a tool in development and formulation. Stability studies. Pharmaceutical forms, elaboration, and control: immediate-release oral and sublingual administration methods (1) capsules, tablets, orodispersible.
Galenic Pharmacy is the science and art of preparing, preserving and presenting medications in order to find for each active substance drug presentations best suited to the treatment of a particular disease. Since 1845 is part of the curriculum of the Degree of Pharmacy.
Competencies and learning outcomes
- Hypothesize, assess information, and promote viable solutions to cases and professional situations.
- Ability to analyze, evaluate, and assess individual and group situations, identify problems, interpret data, and formulate solutions to individual and/or group problems.
- Assess information critically and apply the scientific method to improve the profession.
- Ability to update, consolidate, and integrate new knowledge to improve the profession using continuous self-learning techniques and critical analysis.
- Capability to use and promote innovation and creativity to solve professional problems.
- Identify, design, obtain, analyze, control, and produce drugs and medicines, as well as other products and raw materials with a health interest for human and/or veterinary use.
- Know how to apply the scientific method and acquire skills to handle legislation, information sources, bibliographies, the development of protocols, and other aspects considered necessary for the design and critical assessment of preclinical and clinical trials.
- Perform standard laboratory procedures, including the use of scientific equipment for synthesis and analysis, including proper instrumentation.
- Know the physical and chemical characteristics of the substances used to manufacture medicine.
- Know the origin, nature, design, acquisition, analysis, and control of medications and health products.
- Design, optimize, and develop pharmaceutical forms that ensure their quality, including the formulation and quality control of medications, the development of master formulas and products prepared in a pharmacy.
- Apply quality control to health products, dermo-pharmaceuticals and cosmetics and packaging material.
- Understand the processes of liberation, absorption, distribution, metabolism, and excretion of drugs and factors that condition absorption and disposition according to the administration routes.
- Understand the physical, chemical, and biopharmaceutical properties of the primary active ingredients and excipients and the possible interactions between them.
- Understand the stability of active ingredients and pharmaceutical forms as well as the methods of study.
- Understand the basic operations and technological processes related with the production and control of medication.
- Develop master formulas and medicinal preparations.
Objectives (Learning outcomes)
- 01Explain the different processes of degradation of drugs
- 02Degradation processes relate to the period of validity of a drug
- 03To compare the stability of the same drug under different conditions
- 04List the technological resources used to stabilize a drug
- 05To indicate physical modification affecting drugs and affecting release and hence their bioavailability.
- 06To explain the rules on stability testing
- 07To schedule a stability test of a compressed
- 08To distinguish and classify the HS according to the nature of the phases
- 09To interpret the concepts of surface tension and interfacial tension
- 010To identify the parts of surfactant and differentiate
- 011To list the characteristics of surfactants
- 012To apply the characteristics of surfactants on formation of HS
- 013Interpreting various types of wetting
- 014Instability factors explain the HS dependent droplet size
- 015To explain the mechanisms of stabilization of HS
- 016To classify and interpret the attraction between distinct particles of an HS
- 017To interpret distinct models of electric double layer
- 018To explain how affect the potential electrokinetics in the comportment and estabilidad of an HS
- 019Establishing the stability of a HS based on the changes that occur by the movement of particles in an HS
- 020To describe the methods of steric and electrostatic stabilization of the HS
- 021To distinguish the different types of rheological behavior of the HS
- 022To explain the relationship between the viscosity of a HS and the rate and time of application of a force.
- 023To identify each of the phases of an emulsion
- 024to explain the stabilization of emulsions affecting on interfacial tension, and the electrostatic modification of the reologics characteristics
- 025To relate the type of emulsifier with HLB value in the range
- 026To apply the concept of HLB in fabrications of emulsions
- 027To classify and distinguish the more common emulsifiers in emulsions preparations
- 028To prepare emulsions using different methods
- 029To chose adjuvants necessary for each type of stabilization in the manufacture of emulsions
- 030Determining the sign of the emulsion droplet size and rheology properties for application in the manufacture of a medicament.
- 031To explain the problems and difficulties associated with the formulation of suspensions
- 032Use moisturizers in the formulation of suspensions
- 033To relate sedimentation of solids suspension with the stability
- 034To distinguish deflocculated and flocculated systems
- 035To explain Caking phenomena
- 036To identify the different manufacturing procedures and stabilization of emulsions
- 037To use viscosing
- 038To evaluate and control the stability of suspensions
- 039To define the concept of quality assurance
- 040To explain the different quality systems applicable to a drug
- 041To list the applicable GMP drug manufacturing
- 042To explain the concept of validation and qualification
- 043To distinguish the different types of validation
- 044To explain Validation Master Plan
- 045To distinguish the differents kinds of water used in the manufacture of drugs.
- 046To indicate water regulations applicable to the manufacture of medicinal
- 047To explain water treatment systems
- 048To list the environmental requirements for the manufacture of drugs
- 049To indicate the different regulations regarding air quality and its application in the manufacture of medicines
- 050To identify the personnel and material flow in a manufacturing plant
- 051To sort the different areas of a manufacturing plant.
- 052To describe the differents kinds of packaged and arrangements of the drugs
Association between objectives and units
|Week||Teaching units||Directed hours||Shared hours||Autonomous hours||Total hours|
- Lozano Estevan, María del Carmen / Córdoba Díaz, Damián / Córdoba, Manuel (Córdoba Díaz). "Manual de tecnología farmacéutica". Ámsterdam ; Barcelona Elsevier D.L. 2012.
- C.Faulí i Trillo. "Tratado de Farmacia Galénica". Luzán S.A. de Ediciones.
- Le Hir, Alain. "Farmacia galénica". Barcelona [etc.] Masson 1995.
- Michael E. Aulton and Kevin M.G. Taylor. "Aulton's Pharmaceutics. The design and manufacture of medicines". Churchill Livingstone Elsevier.
- Vila Jato, José Luis ed. lit. / Lastres García, José Luis ed. lit. "Tecnología farmacéutica". Madrid Síntesis D.L. 1997.
- Adobe Acrobat Reader 9.2
- Microsoft Office 2010
Methodology and grading
- Cooperative learning: Develop active learning through cooperative working strategies among students and promote shared responsibility to reach group goals.
- Lecture: Pass on knowledge and activate cognitive processes in students, encouraging their participation.
- Problem-based learning: Develop active learning strategies through problem solving that promote thinking, experimentation, and decision making in the student.
- Solving exercises and problems: Exercise, test, and apply previous knowledge through routine repetition.
- Galenica II will be evaluated using the following procedure:
1. Theoretical part.
60% of the final grade for the course. The exam consists of multiple choice questions and / or short answer.
2. Practical part.
The cualification of the practical part is 40% of the final grade and is calculated from:
- 80% of the final practices will be provided by the test score practices, to be held at the end of each group of students practices. Additionally, in the final exam of the subject (both in January and in September or December) there will be a practical exam for which they have been failed in any of the previous exams of this academic year or to raise the note has been obtained. In case you wish up your cualification, the last qualification obtained will be the final note to consider. The exam consists of multiple choice questions, short response and troubleshooting.
- 10% of the cualification of practices will be provided by the assistance and active participation in them. Attendance at practices is not mandatory. Attendance at practices is saved during an academic year, until the announcement of December 2017.
- The remaining 10% of the cualification of practices will be provided by the submission of a final report of practice in groups of two students. This work has an optional character. The cualification of practices will NOT be saved for the next academic year.
3. Attendance and participation in theoretical classes.
In addition, students can climb to 1 point at the end of the final calification if the student attends at least 80% of the theorical lessons. During the lectures, the teacher will make questions to be answered by using a software. The answers to these questions accounted assistance to them as well as the number of hits. Thus, a classification of students depending on the number of questions answered and successes will be established. The final grade to be uploaded will be the result of dividing the number of well-answered or correct questions with respect to the total of questions posed. Participation in this activity is optional and the note obtained is added to the final grade for the course, regardless of the score obtained in theory or practice. This additional note will NOT be saved for the next academic year.
To pass the course, you must achieve every single one of the following requirements:
It must pass the examination corresponding to the theoretical part (1).
It must pass the exam of the practical part (point 2).
The resulting note
(NOTA_TEORÍA x 0.60) + (NOTA_PRÁCTICA x 0.4) + (theoretical class teachings) must be equal to or greater than 5.
If some of the above requirements are not achieve, the subject will be considered failed.
Examination of September and December will be held on the subject in theory and/ or practice in the event that any of these parts is suspended in any call of the academic year, thus, the note of practice or theory will save in the case of having passed practice or theoric exam in another call the same academic year. In any case such ratings of practice or theory for subsequent academic years will be saved.