FABRIZIO MERCIAI | ANALYTICAL METHODS FOR PHARMACEUTICAL AND HERBAL DRUGS ANTICOUNTERFEITIN

cod. 0760400046

ANALYTICAL METHODS FOR PHARMACEUTICAL AND HERBAL DRUGS ANTICOUNTERFEITIN

	0760400046
	DIPARTIMENTO DI FARMACIA
	EQF7
	PHARMACEUTICAL CHEMISTRY AND TECHNOLOGY
	2024/2025

PERCORSO SHARED STUDY PATHWAY

	YEAR OF COURSE 5
	YEAR OF DIDACTIC SYSTEM 2023
	AUTUMN SEMESTER

TEACHING UNITS

	SSD	CFU	HOURS	ACTIVITY	TYPE OF ACTIVITY
1	METODI ANALITICI PER IL CONTRASTO ALLA CONTRAFFAZIONE DI FARMACI MODULO DI METODI ANALITICI PER IL CONTRASTO ALLA CONTRAFFAZIONE DI FARMACI E FITOTERAPICI
	CHIM/08	3	24	LESSONS	SUPPLEMENTARY COMPULSORY SUBJECTS
2	METODI ANALITICI PER IL CONTRASTO ALLA CONTRAFFAZIONE DI FITOTERAPICI MODULO DI METODI ANALITICI PER IL CONTRASTO ALLA CONTRAFFAZIONE DI FARMACI E FITOTERAPICI
	BIO/15	3	24	LESSONS	SUPPLEMENTARY COMPULSORY SUBJECTS

PROFESSORS

	LAURA DE MARTINO2 T Curriculum
	FABRIZIO MERCIAI1 Curriculum

	Objectives
	THE COURSE IS DESIGNED TO PROVIDE STUDENTS WITH THE KNOWLEDGE AND UNDERSTANDING NECESSARY FOR IDENTIFYING COUNTERFEIT MEDICINES AND HERBAL PRODUCTS BASED ON EUROPEAN AND NATIONAL SURVEILLANCE PROGRAMS. SPECIFICALLY, THE COURSE WILL COVER THE ISSUES INVOLVED IN DETECTING DRUGS THAT ARE COMMONLY USED FOR SLIMMING, ANABOLIC, AND SEXUAL ENHANCEMENT PURPOSES. THE COURSE WILL EXAMINE THE CHALLENGES IN IDENTIFYING COUNTERFEIT PHARMACEUTICALS AND PHYTOTHERAPY PRODUCTS THAT ARE FREQUENTLY PURCHASED FROM UNOFFICIAL SOURCES, SUCH AS ONLINE WEBSITES. THESE PRODUCTS POSE SIGNIFICANT HEALTH RISKS TO CONSUMERS WHO MAY BE UNAWARE OF THEIR TRUE COMPOSITION AND POTENTIAL SIDE EFFECTS. THE COURSE WILL ALSO ADDRESS THE FRAUDULENT USE OF SUBSTANCES WITH PHARMACOLOGICAL ACTIVITY IN FOOD SUPPLEMENTS AND BOTANICALS, AS WELL AS THE MISUSE OF MEDICAL DEVICES WITH FORMULATIONS AND INDICATIONS SIMILAR TO MEDICINES (BORDERLINE PRODUCTS) KNOWLEDGE AND UNDERSTANDING IN TERMS OF KNOWLEDGE AND UNDERSTANDING, THE COURSE WILL PROVIDE STUDENTS WITH AN IN-DEPTH UNDERSTANDING OF THE RISKS ASSOCIATED WITH COUNTERFEIT PHARMACEUTICALS, SUPPLEMENTS, AND PLANT-BASED PRODUCTS. ADDITIONALLY, STUDENTS WILL LEARN ABOUT THE TECHNIQUES USED TO IDENTIFY FRAUDULENT ADULTERATIONS IN THESE PRODUCTS. MAKING JUDGMENTS BY THE END OF THE COURSE, STUDENTS WILL BE ABLE TO APPLY THEIR KNOWLEDGE AND SKILLS TO IDENTIFY THE MOST COMMON FRAUDULENT MODIFICATIONS TO FORMULATIONS, PHARMACEUTICAL PREPARATIONS, AND PLANT-BASED PRODUCTS. THEY WILL ALSO BE ABLE TO VERIFY THE QUALITY AND SAFETY OF THESE PRODUCTS USING CHEMICAL-PHYSICAL TECHNIQUES.

THE COURSE IS DESIGNED TO PROVIDE STUDENTS WITH THE KNOWLEDGE AND UNDERSTANDING NECESSARY FOR IDENTIFYING COUNTERFEIT MEDICINES AND HERBAL PRODUCTS BASED ON EUROPEAN AND NATIONAL SURVEILLANCE PROGRAMS. SPECIFICALLY, THE COURSE WILL COVER THE ISSUES INVOLVED IN DETECTING DRUGS THAT ARE COMMONLY USED FOR SLIMMING, ANABOLIC, AND SEXUAL ENHANCEMENT PURPOSES. THE COURSE WILL EXAMINE THE CHALLENGES IN IDENTIFYING COUNTERFEIT PHARMACEUTICALS AND PHYTOTHERAPY PRODUCTS THAT ARE FREQUENTLY PURCHASED FROM UNOFFICIAL SOURCES, SUCH AS ONLINE WEBSITES. THESE PRODUCTS POSE SIGNIFICANT HEALTH RISKS TO CONSUMERS WHO MAY BE UNAWARE OF THEIR TRUE COMPOSITION AND POTENTIAL SIDE EFFECTS.
THE COURSE WILL ALSO ADDRESS THE FRAUDULENT USE OF SUBSTANCES WITH PHARMACOLOGICAL ACTIVITY IN FOOD SUPPLEMENTS AND BOTANICALS, AS WELL AS THE MISUSE OF MEDICAL DEVICES WITH FORMULATIONS AND INDICATIONS SIMILAR TO MEDICINES (BORDERLINE PRODUCTS)

KNOWLEDGE AND UNDERSTANDING
IN TERMS OF KNOWLEDGE AND UNDERSTANDING, THE COURSE WILL PROVIDE STUDENTS WITH AN IN-DEPTH UNDERSTANDING OF THE RISKS ASSOCIATED WITH COUNTERFEIT PHARMACEUTICALS, SUPPLEMENTS, AND PLANT-BASED PRODUCTS. ADDITIONALLY, STUDENTS WILL LEARN ABOUT THE TECHNIQUES USED TO IDENTIFY FRAUDULENT ADULTERATIONS IN THESE PRODUCTS.

MAKING JUDGMENTS
BY THE END OF THE COURSE, STUDENTS WILL BE ABLE TO APPLY THEIR KNOWLEDGE AND SKILLS TO IDENTIFY THE MOST COMMON FRAUDULENT MODIFICATIONS TO FORMULATIONS, PHARMACEUTICAL PREPARATIONS, AND PLANT-BASED PRODUCTS. THEY WILL ALSO BE ABLE TO VERIFY THE QUALITY AND SAFETY OF THESE PRODUCTS USING CHEMICAL-PHYSICAL TECHNIQUES.

	Prerequisites
	THE ACQUISITION OF THE OBJECTIVES RELATED TO THE FOLLOWING DISCIPLINES IS REQUIRED: PHARMACEUTICAL CHEMICAL ANALYSIS II, PHYTOCHEMISTRY AND PHARMACOGNOSY.

	Contents
	THE COURSE IS DIVIDED IN TWO MODULES, NAMED: ANALYTICAL METHODS FOR COUNTERFEIT AND ILLICIT DRUG DETECTION AND ANALYTICAL METHODS AGAINST THE COUNTERFEITING OF HERBAL DRUGS MODULE 1: ANALYTICAL METHODS FOR COUNTERFEIT AND ILLICIT DRUGS DETECTION (24H – 3 CFU) INTRODUCTION TO DRUG COUNTERFEITING: DEFINITION OF DRUG COUNTEFEITING, OVERVIEW OF GUIDELINES FOR COMBATING COUNTERFEITING, ANALYSIS OF RISKS ASSOCIATED WITH PURCHASE AND USE. (2H – 0.25 CFU) ANALYTICAL ITER OF A COUNTERFEIT DRUG AND SAMPLE PREPARATION METHODS: PARAMETERS INFLUENCING THE CHOICE OF ANALYTICAL METHODS, THE ROLE OF PACKAGING, SAMPLE PRETREATMENT AND MAIN EXTRACTION TECHNIQUES. (4H – 0,5 CFU) ANALYTICAL METHODS FOR IDENTIFICATION OF COUNTERFEIT DRUGS: OPTICAL SCREENING METHODS (UV/VIS SPECTROSCOPY, IR SPECTROSCOPY, ELECTRON MICROSCOPY AND SEM), COLORIMETRIC METHODS, DIFFRACTOMETRIC METHODS. (4H – 0,5 CFU) SEPRATION METHODS FOR CHARACTERIZATION OF COUNTERFEIT DRUGS: INTRODUCTION TO CHROMATOGRAPHY, HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC, UHPLC), GAS CHROMATOGRAPHY, THIN LAYER CHROMATOGRAPHY (TLC), CHROMATOGRAPHY COUPLED TO MASS SPECTROMETRY. (8H – 1 CFU) COUNTERFEITING OF MAJOR CATEGORIES OF DRUGS: ANABOLIC STEROIDS, WEIGHT LOSS DRUGS, ERECTILE DYSFUNCTION DRUGS. (4H – 0,5 CFU) TECHNOLOGICAL INNOVATIONS IN THE FIGHT AGAINST DRUG COUNTERFEITING. (2H – 0,25 CFU) MODULE 2: ANALYTICAL METHODS AGAINST THE COUNTERFEITING OF HERBAL DRUGS (24H – 3 CFU) COURSE INTRODUCTION (2 HOURS) INTRODUCTION TO PHYTOTHERAPEUTICS: DRUG, ACTIVE PRINCIPLE, AND PHYTOCOMPLEX (2 HOURS - 0.25 CFU) VARIABILITY OF MEDICINAL PLANTS: FACTORS DEPENDENT ON THE PLANT, FACTORS DEPENDENT ON THE DRUG PREPARATION PROCESS, FACTORS DEPENDENT ON THE DRUG PROCESSING (2 HOURS - 0.25 CFU) DEFINITION OF PHYTOTHERAPEUTICS, CLASSIFICATION, AND THERAPEUTIC IMPORTANCE (2 HOURS) REGULATORY FRAMEWORK FOR PLANT-BASED PRODUCTS AND THEIR DERIVATIVES: FOOD PRODUCTS, COSMETICS, MEDICINES, MEDICAL DEVICES (2 HOURS - 0.25 CFU) HISTORY AND SCIENTIFIC BASIS OF PHYTOTHERAPEUTIC USE (2 HOURS - 0.25 CFU) EXTRACTION, PREPARATION, AND STANDARDIZATION OF PHYTOTHERAPEUTICS (4 HOURS - 0.50 CFU) IDENTIFICATION AND CHARACTERIZATION OF THE MAIN CLASSES OF ACTIVE PRINCIPLES PRESENT IN PHYTOTHERAPEUTICS (2 HOURS - 0.25 CFU) QUALITY CONTROL OF PHYTOTHERAPEUTICS: FROM CAUSES OF ALTERED QUALITY OF A PRODUCT TO THE DETERMINATION OF CHARACTERISTIC CHEMICAL CONSTITUENTS (4 HOURS - 0.50 CFU) MAIN ANALYTICAL TECHNIQUES TO IDENTIFY THE PRESENCE OF ADULTERANTS AND CONTAMINANTS IN PHYTOTHERAPEUTICS (2 HOURS - 0.25 CFU)

Contents

THE COURSE IS DIVIDED IN TWO MODULES, NAMED: ANALYTICAL METHODS FOR COUNTERFEIT AND ILLICIT DRUG DETECTION AND ANALYTICAL METHODS AGAINST THE COUNTERFEITING OF HERBAL DRUGS
MODULE 1: ANALYTICAL METHODS FOR COUNTERFEIT AND ILLICIT DRUGS DETECTION (24H – 3 CFU)
INTRODUCTION TO DRUG COUNTERFEITING: DEFINITION OF DRUG COUNTEFEITING, OVERVIEW OF GUIDELINES FOR COMBATING COUNTERFEITING, ANALYSIS OF RISKS ASSOCIATED WITH PURCHASE AND USE. (2H – 0.25 CFU)
ANALYTICAL ITER OF A COUNTERFEIT DRUG AND SAMPLE PREPARATION METHODS: PARAMETERS INFLUENCING THE CHOICE OF ANALYTICAL METHODS, THE ROLE OF PACKAGING, SAMPLE PRETREATMENT AND MAIN EXTRACTION TECHNIQUES. (4H – 0,5 CFU)
ANALYTICAL METHODS FOR IDENTIFICATION OF COUNTERFEIT DRUGS: OPTICAL SCREENING METHODS (UV/VIS SPECTROSCOPY, IR SPECTROSCOPY, ELECTRON MICROSCOPY AND SEM), COLORIMETRIC METHODS, DIFFRACTOMETRIC METHODS. (4H – 0,5 CFU)
SEPRATION METHODS FOR CHARACTERIZATION OF COUNTERFEIT DRUGS: INTRODUCTION TO CHROMATOGRAPHY, HIGH-PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC, UHPLC), GAS CHROMATOGRAPHY, THIN LAYER CHROMATOGRAPHY (TLC), CHROMATOGRAPHY COUPLED TO MASS SPECTROMETRY. (8H – 1 CFU)
COUNTERFEITING OF MAJOR CATEGORIES OF DRUGS: ANABOLIC STEROIDS, WEIGHT LOSS DRUGS, ERECTILE DYSFUNCTION DRUGS. (4H – 0,5 CFU)
TECHNOLOGICAL INNOVATIONS IN THE FIGHT AGAINST DRUG COUNTERFEITING. (2H – 0,25 CFU)

MODULE 2: ANALYTICAL METHODS AGAINST THE COUNTERFEITING OF HERBAL DRUGS (24H – 3 CFU)
COURSE INTRODUCTION (2 HOURS)
INTRODUCTION TO PHYTOTHERAPEUTICS: DRUG, ACTIVE PRINCIPLE, AND PHYTOCOMPLEX (2 HOURS - 0.25 CFU)
VARIABILITY OF MEDICINAL PLANTS: FACTORS DEPENDENT ON THE PLANT, FACTORS DEPENDENT ON THE DRUG PREPARATION PROCESS, FACTORS DEPENDENT ON THE DRUG PROCESSING (2 HOURS - 0.25 CFU)
DEFINITION OF PHYTOTHERAPEUTICS, CLASSIFICATION, AND THERAPEUTIC IMPORTANCE (2 HOURS)
REGULATORY FRAMEWORK FOR PLANT-BASED PRODUCTS AND THEIR DERIVATIVES: FOOD PRODUCTS, COSMETICS, MEDICINES, MEDICAL DEVICES (2 HOURS - 0.25 CFU)
HISTORY AND SCIENTIFIC BASIS OF PHYTOTHERAPEUTIC USE (2 HOURS - 0.25 CFU)
EXTRACTION, PREPARATION, AND STANDARDIZATION OF PHYTOTHERAPEUTICS (4 HOURS - 0.50 CFU)
IDENTIFICATION AND CHARACTERIZATION OF THE MAIN CLASSES OF ACTIVE PRINCIPLES PRESENT IN PHYTOTHERAPEUTICS (2 HOURS - 0.25 CFU)
QUALITY CONTROL OF PHYTOTHERAPEUTICS: FROM CAUSES OF ALTERED QUALITY OF A PRODUCT TO THE DETERMINATION OF CHARACTERISTIC CHEMICAL CONSTITUENTS (4 HOURS - 0.50 CFU)
MAIN ANALYTICAL TECHNIQUES TO IDENTIFY THE PRESENCE OF ADULTERANTS AND CONTAMINANTS IN PHYTOTHERAPEUTICS (2 HOURS - 0.25 CFU)

	Teaching Methods
	THE TEACHING CONSISTS OF 48 HOURS OF LESSONS (6 CFU).

	Verification of learning
	MODULE 1: ANALYTICAL METHODS FOR COUNTERFEIT AND ILLICIT DRUG DETECTION THE ACHIEVEMENT OF KNOWLEDGE AND UNDERSTANDING IS ASSESSED THOUGH AN ORAL EXAM CONSISTING OF A DISCUSSION OF APPROXIMATELY 20 MINUTES. DURING THIS DISCUSSION, THE STUDENT WILL BE ASKED QUESTIONS AND ENGAGE IN DISCUSSIONS RELATED TO THE CONTENTS OF THE TEACHING PROGRAM IN ORDER TO EVALUATE THE LEVEL OF KNOWLEDGE AND UNDERSTANDING. ADDITIONALLY, THEIR ABILITY TO ARTICULATER CONCEPTS CLEARLY AND ACCURATELY, USING APPROPRIATE TERMINOLOGY, WILL BE EVALUATED. THE EXAM WILL BE CONSIDERED PASSED WITH A MINIMUM SCORE OF 18 OUT OF 30. MODULE 2: ANALYTICAL METHODS AGAINST THE COUNTERFEITING OF HERBAL DRUGS THE EXAMINATION CONSISTS OF A 30-MINUTE ORAL TEST AIMED AT ASSESSING THE LEVEL OF KNOWLEDGE ACQUISITION, CORRECT TERMINOLOGY USAGE, AND ANALYTICAL SKILLS. THE FINAL EVALUATION, EXPRESSED IN THIRTIETHS, TAKES INTO CONSIDERATION: THE LEVEL OF ACQUIRED KNOWLEDGE, SYNTHESIS AND PRESENTATION SKILLS, LANGUAGE APPROPRIATENESS, AND ANALYTICAL ABILITIES. THE FINAL SCORE WILL BE GIVEN BY THE AVERAGE OF THE SCORES OBTAINED IN THE INDIVIDUAL MODULES.

Verification of learning

MODULE 1: ANALYTICAL METHODS FOR COUNTERFEIT AND ILLICIT DRUG DETECTION
THE ACHIEVEMENT OF KNOWLEDGE AND UNDERSTANDING IS ASSESSED THOUGH AN ORAL EXAM CONSISTING OF A DISCUSSION OF APPROXIMATELY 20 MINUTES. DURING THIS DISCUSSION, THE STUDENT WILL BE ASKED QUESTIONS AND ENGAGE IN DISCUSSIONS RELATED TO THE CONTENTS OF THE TEACHING PROGRAM IN ORDER TO EVALUATE THE LEVEL OF KNOWLEDGE AND UNDERSTANDING. ADDITIONALLY, THEIR ABILITY TO ARTICULATER CONCEPTS CLEARLY AND ACCURATELY, USING APPROPRIATE TERMINOLOGY, WILL BE EVALUATED. THE EXAM WILL BE CONSIDERED PASSED WITH A MINIMUM SCORE OF 18 OUT OF 30.

MODULE 2: ANALYTICAL METHODS AGAINST THE COUNTERFEITING OF HERBAL DRUGS
THE EXAMINATION CONSISTS OF A 30-MINUTE ORAL TEST AIMED AT ASSESSING THE LEVEL OF KNOWLEDGE ACQUISITION, CORRECT TERMINOLOGY USAGE, AND ANALYTICAL SKILLS. THE FINAL EVALUATION, EXPRESSED IN THIRTIETHS, TAKES INTO CONSIDERATION: THE LEVEL OF ACQUIRED KNOWLEDGE, SYNTHESIS AND PRESENTATION SKILLS, LANGUAGE APPROPRIATENESS, AND ANALYTICAL ABILITIES.

THE FINAL SCORE WILL BE GIVEN BY THE AVERAGE OF THE SCORES OBTAINED IN THE INDIVIDUAL MODULES.

	Texts
	MODULE1 : ANALYTICAL METHODS FOR COUNTERFEIT AND ILLICIT DRUG DETECTION SKOOG DA., HOLLER FJ., CROUCH SR. CHIMICA ANALITICA STRUMENTALE. EDISES EDUCATIONAL MATERIAL PROVIDED DURING THE COURSE MODULE 2: ANALYTICAL METHODS AGAINST THE COUNTERFEITING OF HERBAL DRUGS MAZZANTI G., DELL’AGLI M., IZZO A.A. FARMACOGNOSIA E FITOTERAPIA: BASI FARMACOLOGICHE E ASPETTI APPLICATIVI. PICCIN, PADOVA. CAVRINI V., ANDRISANO V. PRINCIPI DI ANALISI FARMACEUTICA. SOCIETA’ EDITRICE ESCULAPIO, MILANO. EDUCATIONAL MATERIAL PROVIDED DURING THE COURSE

Texts

MODULE1 : ANALYTICAL METHODS FOR COUNTERFEIT AND ILLICIT DRUG DETECTION
SKOOG DA., HOLLER FJ., CROUCH SR. CHIMICA ANALITICA STRUMENTALE. EDISES
EDUCATIONAL MATERIAL PROVIDED DURING THE COURSE

MODULE 2: ANALYTICAL METHODS AGAINST THE COUNTERFEITING OF HERBAL DRUGS
MAZZANTI G., DELL’AGLI M., IZZO A.A. FARMACOGNOSIA E FITOTERAPIA: BASI FARMACOLOGICHE E ASPETTI APPLICATIVI. PICCIN, PADOVA.
CAVRINI V., ANDRISANO V. PRINCIPI DI ANALISI FARMACEUTICA. SOCIETA’ EDITRICE ESCULAPIO, MILANO.
EDUCATIONAL MATERIAL PROVIDED DURING THE COURSE

	More Information
	ANALYTICAL METHODS FOR COUNTERFEIT AND ILLICIT DRUGS DETECTION: PROF. FABRIZIO MERCIAI ANALYTICAL METHODS FOR COUNTERING HERBAL PRODUCT COUNTERFEITING: PROF. LAURA DE MARTINO LANGUAGE OF TEACHING: ITALIAN; LOCATION OF THE LECTURES: DEPARTMENT OF PHARMACY. FOR FURTHER INFORMATION CONTACT THE TEACHERS: LDEMARTINO@UNISA.IT, FMERCIAI@UNISA.IT

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FABRIZIO MERCIAI | ANALYTICAL METHODS FOR PHARMACEUTICAL AND HERBAL DRUGS ANTICOUNTERFEITIN