ANALISI DEI FARMACI E DEI PRODOTTI PER LA SALUTE 1 - ANALISI DEI FARMACI E DEI PRODOTTI PER LA SALUTE 2 A - L

Module ANALISI DEI FARMACI E DEI PRODOTTI PER LA SALUTE 1

Knowledge and Ability to Understand: The course provides the theoretical and practical tools for performing qualitative analysis and recognition of pharmaceutical elements and compounds of inorganic nature.

Ability to apply knowledge and understanding: the student acquires in the laboratory the skills necessary to perform manual and instrumental analyses.

Ability to learn: the student becomes capable of applying the tools of chemical analysis to recognize the identity of anions and cations.

Autonomy of judgment: the student develops critical ability in the analysis of unknown mixtures, where he or she tries his or her hand at interpreting the recognition reactions performed.

Insight into an exemplary case: the student applies instrumental analysis methods on unknown analytes and discusses the procedural aspects of the analysis performed.

Problem-solving skills: the results of instrumental analyses are interpreted by the student, who thus addresses problems that may arise and learns to critically evaluate possible solutions to the analytical problem proposed by the instructor.

The teaching will be delivered through face-to-face lectures (4.5 CFU, 31 hours) and single-place laboratory exercises (1.5 CFU, 23 hours). Should the teaching be delivered in a blended or distance mode, necessary variations from what has been stated above may be introduced in order to adhere to the planned syllabus stated in the Syllabus.

Information for students with disabilities and/or DSA
As a guarantee of equal opportunity and in compliance with current laws, interested students may request a personal interview so that any compensatory and/or dispensatory measures can be planned, based on educational objectives and specific needs.
The CInAP (Center for Active and Participatory Integration - Disability and/or DSA Services) contact teacher at DSFS, Prof. Santina Chiechio, can also be contacted.

Knowledge of general and inorganic chemistry. Main topics of general chemistry preparatory for analysis: Periodic system of elements - Chemical equilibrium (equilibrium constants, mass action law, equilibrium shift and Le Chatelier's principle) - Ionic equilibria in aqueous solution (electrolyte concept, electrolyte dissociation, acids and bases, strength of an acid and base and their measurement, ionization of water, ionic product of water, pH, pH calculation for weak and strong acids and bases, salt solutions and hydrolysis, buffer solutions, pH indicators) - Precipitation equilibria (solubility and solubility product Kps, effect of common ion, pH, temperature and concentration on solubility of poorly soluble salts) - Complex ions (structure and nomenclature of complexes, bonding in complexes, stability and instability constants, equilibria of complex ions). - Nomenclature and chemical reactions (oxidation numbers. oxidation and reduction).

Compulsory attendance according to the rules of the didactic regulations of the CdS in Pharmacy as stated in the link: https://www.dsf.unict.it/it/corsi/lm-13/regolamento-didattico
In addition, for attendance of practical exercises, it is strongly recommended not to make absences, except in unavoidable cases. 

In order to attend the course, it is MANDATORY to attend an information course on SAFETY IN EDUCATIONAL LABORATORIES, organized by University  before the start of the practical exercises.

The course aims to provide the student with theoretical knowledge and practical skills for the qualitative determination of inorganic substances of pharmaceutical interest found in medicinal and health products, either by their chemical behavior or by instrumental techniques. This knowledge will also be extended to some nutraceutical and natural substances. 

The course consists of lectures, single-place laboratory exercises. During the lectures, theoretical aspects related to the analysis of compounds, mainly of inorganic nature of pharmaceutical and health product interest, will be discussed. The laboratory exercises are scheduled so that within each exercise the student can practically implement the analytical approach covered in theoretical form during the lectures.

The course program (6 CFU total) is divided as follows:

MODULE 1 (2.5 CFU): GENERALITIES ON LABORATORY OPERATIONS AND TECHNIQUES.
Generalities on analytical methods. Classification, stages of an analysis, applications. Contents Italian Official Pharmacopoeia (F.U.) and European Pharmacopoeia (PhEur).
Basic techniques and operations in semimicro analysis. Materials and equipment in laboratories. Simple procedures of sample pretreatment: dissolution, precipitation, filtration, centrifugation, decantation, solid-liquid and liquid-liquid extraction, crystallization, sublimation, evaporation, pH measurement.
Safety and Good Laboratory Practices. Safety and behavior rules, hazard classes and symbols of harmful substances, safety data sheets, personal protective equipment, waste disposal, accident prevention, elements of first aid.
Non-instrumental chromatographic methods. Generalities, classification, mechanisms, separation and operating techniques. Application example: thin layer chromatography (TLC).

MODULE 2 (2 CFU): INORGANIC SUBSTANCES OF PHARMACEUTICAL AND TOXICOLOGICAL INTEREST ENROLLED IN F.U.
Chemical reactions. Reaction balancing, classification of chemical reactions.
Chemical-analytical and pharmaceutical properties of:
IONS THAT ARE DRY SEARCHED: carbonates, sulfites, acetates, borates, ammonium;
CATIONS THAT ARE SEARCHED BY WET WAY: silver, aluminum, iron, calcium, magnesium, sodium, lithium, potassium;
ANIONS THAT ARE SEARCHED BY WET: halides, oxalates, phosphates, sulfates, nitrates.
Identification reactions described in F.U. for the above ions - Limit assays
Case studies/SYSTEMATIC ANALYSIS.

LABORATORY EXERCISES (1.5 CFU)
Laboratory Safety. Simple sample pretreatment procedures: dissolution, precipitation, filtration, centrifugation, extraction, pH measurement, preparation of a buffer solution, analysis of simple mixtures by chromatographic methods: TLC.
Analysis of cationic and anionic species: dry analysis: flame assays, microtube assays: carbonates, acetates, borates, ammonium ion.
Wet analysis: single and mixture analysis of cations: Ag+ Al3+ Fe2+/ Fe3+ Ca2+ Mg2+
Wet analysis: single and mixture analysis of anions: Cl- Br- I- C2O42- PO43- SO42- NO3-
Analysis of cations and/or anions present in a mixture for pharmaceutical use.

Should the teaching be given in a blended or distance learning mode, necessary variations from what has been stated above may be introduced to comply with the planned syllabus stated in the syllabus.

1. Araneo A. Chimica analitica qualitativa. Metodo periodale. Ambrosiana Milano Ed 1993.
2. F. Savelli, O. Bruno: Analisi Chimico farmaceutica, Piccin
3. Cozzi. P. Protti, T. Ruaro: Analisi chimica strumentale, volume C
4. Cavrini V, Andrisano V. Principi di Analisi Farmaceutica. Esculapio ed. 2018
5. Farmacopea Ufficiale Italiana XII edizione.
6. European Pharmacopoeia 11th edizione e supplementi

The exam is written (as indicated by the lecturer in the classroom) and may be taken on the dates indicated in the calendar, only if the general chemistry exam is passed. In addition, an evaluation of the overall activity carried out during the practical exercises and any tests taken during the year will also contribute to the final grade.

Minimum knowledge essential for passing the examination: 
the student should be able to represent in writing and comment on the main reactions in which ions of pharmaceutical interest, covered in the lecture, are involved in a mixture containing two anions and two cations that are searched by dry and/or wet routes.
Knowledge that determines the value of the final exam grade: 
1) What are the procedures for determining the solubility of a solid sample and the methods of solid-liquid separation.
2) Theoretical principles of thin-layer chromatography.
3) Knowledge of traditional and IUPAC nomenclature of coordination compounds and the recognition reactions involving them, among those covered in lecture.
4) Pharmaceutical properties of calcium, magnesium and phosphate ions.