ANALISI DEI FARMACI E DEI PRODOTTI PER LA SALUTE 1 - ANALISI DEI FARMACI E DEI PRODOTTI PER LA SALUTE 2 M - Z

Module ANALISI DEI FARMACI E DEI PRODOTTI PER LA SALUTE 1

1. Knowledge and Understanding

Upon successful completion of the course, students will be able to:

• describe the fundamental principles of qualitative pharmaceutical analysis;
• illustrate the main laboratory operations employed in sample pretreatment;
• identify the chemical and analytical properties of the principal ionic species of pharmaceutical interest;
• recognize the identification procedures reported in the Italian Pharmacopoeia and the European Pharmacopoeia.

2. Applying Knowledge and Understanding

Students will be able to:

• apply qualitative analytical procedures for the identification of cations and anions;
• correctly use the main laboratory techniques;
• perform separation, identification, and characterization of inorganic chemical species of pharmaceutical interest;
• solve simple analytical problems through systematic identification schemes.

3. Making Judgements

Students will be able to:

• critically analyze experimental results;
• evaluate the reliability of analytical procedures;
• interpret qualitative data obtained from laboratory activities;
• identify possible sources of experimental error.

4. Communication Skills

Students will be able to:

• discuss the principles of qualitative analysis using appropriate scientific terminology;
• describe the strategies adopted for the identification of chemical species;
• accurately report observations and experimental results.

5. Learning Skills

Students will be able to:

• independently deepen the topics covered during the course;
• retrieve information from updated bibliographic and regulatory sources;
• develop autonomous study skills useful for subsequent courses in pharmaceutical analysis.

The course consists of lectures (4.5 ECTS credits; 31 hours) and individual laboratory practical sessions (1.5 ECTS credits; 23 hours).

The course may be adapted to blended or distance-learning formats when necessary, while ensuring full coverage of the syllabus.

Students are expected to have a sound knowledge of General and Inorganic Chemistry, including: periodic table of the elements; chemical equilibrium (equilibrium constants, law of mass action, Le Châtelier's principle); ionic equilibria in aqueous solutions; acids and bases; pH calculations; buffer solutions and indicators; precipitation equilibria and solubility product; complex ions and coordination chemistry; chemical nomenclature; oxidation-reduction reactions.

These prerequisites are considered essential for a full understanding of the course contents.

Attendance is mandatory according to the regulations of the Pharmacy Degree Programme. Students may not exceed absences corresponding to 30% of the total teaching hours. Attendance at practical laboratory sessions is strongly recommended.

Before participating in laboratory activities, students are required to attend a Laboratory Safety Training Course organized by the University.

MODULE 1 (2.5 ECTS): GENERAL INFORMATION ON LABORATORY OPERATIONS AND TECHNIQUES

General information on analytical methods. Classification, stages of an analysis, applications. Italian Official Pharmacopoeia Content (F.U.I).

Basic techniques and operations in semimicro analysis. Material and equipment in laboratories. Simple sample pretreatment procedures: dissolution, precipitation, filtration, centrifugation, decantation, extraction, pH measurement.

Safety and good practice in the laboratory. Safety and behaviour rules, hazard classes, symbols of harmful substances, safety data sheets, protective individual devices, waste disposal, accident prevention, first aid items.

Introduction to chromatographic methods. General information, classification, mechanisms, separation techniques and operating techniques. Application example: thin layer chromatography (TLC) and dry-column flash chromatography.

MODULE 2 (2.0 ECTS): INORGANIC SUBSTANCES OF PHARMACEUTICAL AND TOXICOLOGICAL INTEREST ENTERED IN F.U.I.

Chemical reactions. Type and classification;

Chemical-analytical and pharmaceutical properties of: 

carbonates, sulphites, acetates, borates, ammonium;

silver, aluminium, iron, calcium, magnesium, sodium, lithium, potassium;

halogens, oxalates, phosphates, sulphates, nitrates.

Identification reactions described in F.U.I. for the aforementioned ions - Limit essays

Case study / SISTEMATIC ANALYSIS

LABORATORY EXERCISES (1.5 ECTS)

Safety in the laboratory. Simple sample pretreatment procedures: dissolution, precipitation, filtration, centrifugation, extraction, pH measurement, analysis of simple mixtures by chromatographic methods: TLC. Purification of crude products by dry-column flash chromatography .

Analysis of cationic and anionic species:

carbonates, acetates, borates, ammonium ion.

cation analysis: Ag⁺, Al⁺⁺⁺, Fe⁺⁺, Fe⁺⁺⁺, Ca⁺⁺, Mg⁺⁺

anion analysis: Cl^-, Br^-, I^-, C₂O₄^2-, PO₄^3-, SO₄^2-, NO^3-

analysis of cations and / or anions present in a mixture of pharmaceutical use.

Should teaching be carried out in mixed mode or remotely, it may be necessary to introduce changes with respect to previous statements, in line with the programme planned and outlined in the syllabus.

• Teaching material available on Studium for the current academic year
• ARANEO – Chimica Analitica Qualitativa - Casa Editrice Ambrosiana Milano
• F.U.I. XII°  and European Pharmacopoeia 10°
• “Agenti Chimici – Lavorare In Sicurezza” a cura di Associazione Ambiente e Lavoro (edizione aggiornata)
• F. Savelli, O. Bruno: Analisi Chimico farmaceutica, Piccin
• G. Caliendo: Manuale di Analisi Qualitativa, EdiSES
• Cozzi. P. Protti, T. Ruaro: Analisi chimica strumentale, volume C
• Hogness, Johnson, Armstrong: Analisi Qualitativa & Equilibrio Chimico, PICCIN
• Web-page suggested by the teacher

Learning outcomes will be assessed through a written examination (approximately 120 minutes) including theoretical and application-oriented questions. An intermediate assessment is planned for the integrated course.

The assessment will evaluate:

• theoretical knowledge of inorganic qualitative analysis;
• ability to apply analytical protocols;
• competence in planning qualitative analytical strategies;
• appropriate use of scientific language and chemical notation;
• ability to independently integrate acquired knowledge.

Performance during laboratory practical activities will also contribute to the final grade. The final mark will be calculated as the arithmetic mean of the grades obtained in Pharmaceutical and Health Product Analysis I and Pharmaceutical and Health Product Analysis II.

GRADING SCALE

Fail

The student does not demonstrate the minimum required knowledge and is unable to appropriately apply acquired concepts.

18-21/30

Basic knowledge of the main topics with limited analytical skills and simple but substantially correct scientific language.

22-25/30

Fair knowledge of the subject with the ability to establish simple connections and correctly apply basic analytical procedures.

26-28/30

Good preparation, appropriate interpretation of experimental results, and proper use of technical terminology.

29-30/30 cum laude

Excellent and comprehensive knowledge, critical thinking skills, independent judgment, mastery of technical language, and ability to solve complex analytical problems.

Information for Students with Disabilities and/or Specific Learning Disorders (SLD)

To ensure equal opportunities and compliance with current legislation, students may request an individual meeting to discuss and arrange appropriate compensatory and/or dispensatory measures, in accordance with the learning objectives of the course and their specific needs. Students may contact Prof. Santina Chiechio (santina.chiechio@unict.it), the Departmental CInAP Representative (Center for Active and Participatory Inclusion - Services for Students with Disabilities and/or Specific Learning Disorders) at the Department of Drug and Health Sciences.

• What are MSDS/SDS and what role do they play in laboratory safety?
• Describe the principal solid-liquid and liquid-liquid separation methods.
• Explain the centrifugation process.
• Discuss the biological aspects, pharmaceutical applications, and pharmacopoeial preparations of calcium ion.
• Complete the pharmacopoeial identification test for sulfate ion, including the relevant chemical reactions.
• Write the dissolution, separation, and identification reactions required for the systematic analysis of a mixture containing silver acetate and aluminium phosphate. Subsequently, write the appropriate identification reactions for the corresponding anions.