Objectives

Aim of this course is to provide the basic knowledge on pharmaceutical technology concerning formulation and classification of conventional drug delivery systems.
The students will acquire also the fundamentals on National and CEE pharmaceutical laws.
General aims

At the end of theoretical lessons:
- The students will acquire the fundamental aspects of pharmaceutical technology concerning the main conventional dosage forms for human and veterinary use.
- The students will acquire the basic rules concerning the selling of drugs according to the different kind of prescription. Furthermore, they will possess the basic knowledge of the regulatory affairs for pharmaceutical compounding.
- The students will acquire also the fundamentals on pharmaceutical laws particularly about the dispensing of the drug and the basic knowledge on pharmaceutical compounding of the most common solid, semi-solid and liquid dosage forms and their control, according to Official Pharmacopeia.
After individual pharmaceutical compounding practice:
- the student will be able to compound the most common solid, semi-solid and liquid dosage forms and control them, according to Official Pharmacopeia.
- The student will be able to verify and control the legaly requires of medical prescription.
Knowledge and understanding of:
- fundamentals of pharmaceutical technology concerning formulation, compounding and control of the main conventional dosage forms for human and veterinary use. National and international pharmaceutical laws concerning compounding and dispensing dosage forms for human and veterinary use
Applying knowledge and understanding:
- ability to understand the productive steps of pharmaceutical production;
- ability to understand problems related to pharmaceutical formulation processing with particular attention to regulatory and safety assessments;
- ability to verify the prescription and dispensing requirements of medicines;
- ability to correctly calculate in pharmaceutical compounding.


Making judgements:
Our theoretical and practical teaching will satisfy current needs in developing pharmacist profession:
- to evaluate technological and practical activities related to formulating and dispensing medicines;
- to identify and evaluate the impact of risks in formulating dosage forms;
- to evaluate if medical prescription meets legal requirements.
Communication skills:
A classroom environment relies heavily on the quality of communication taking place within it. As an instructor, taking steps towards improving the communication skills of our students will contribute positively towards your classroom climate. Furthermore class discussion will be fundamental to develop critical and highest level of competence to be well prepared when entering the professional ranks as a new pharmacist.
Learning skills
The course aims to provide a smooth transition between university and professional pharmacist life and to help students to become people with life-long learning ability and habit.
The course aims to help students to become able to dispense medications prescribed by doctors, to explain to their patients how to use these drugs correctly and to help patients in managing, illnesses and avoiding interactions between different active compounds.





-

Channels

A - L

MARIA CARAFA MARIA CARAFA   Teacher profile

Programme

Due to the high content peculiarity, in order to create optimal learning conditions for students, the use of a differentiated approach to the proposed syllabus is adopted. The framework of the syllabus might be subject to changes, due to the continuous law changes.

Regulatory and Law- General principles of national and Community law.
Community code relating to medicinal products for human use. Definition of medicines. medicines authorized for introduction on the market (AIC), Masterly and officinal formulas.
The Pharmacopoeias and their role in the technical regulatory framework for the quality of medicines. Good Manufacturing Practices and Standards of Good preparation in pharmaceutical compounding Production and control of medicines. General aspects. Quality Assurance System. Staff. Laboratory and equipment. Raw material. Preparation operations Quality control. Packaging and labeling. Stability of the preparation. Microbiological aspects of the preparations.
Position of paper masterly preparations by the SIFAP (Italian Society of Pharmacists).
The National Medicines Tariff.
Overview on REACH, CLP and PICS regulations.
Prescription medicines and non-prescription medicines, SP and OTC. Therapeutic equivalents. The dispensation of medicines : definition and classifications of medical prescription . Medical prescriptions for veterinary use. The electronic prescription . The classification in the supply of medicinal products for human and veterinary use subject to medical prescription medicines (Tables 3,4,5 FU) Prescription of masterly preparations. (Law No. 94, April 8, 1998).
The rules governing the production , purchase and dispensing of narcotics and psychotropic substances : the DPR 309 /90 and its updates. Statement of " poisons " and their dispensation.
Legislation relating to substances whose use is considered doping (the WADA list).
Legislation relating to the substances acting anorectic.

Design of pharmaceutical forms. Routes of drug administration.
Pharmaceutical forms: classification.
Powders for pharmaceutical use: powder mixing. Forces and mixing mechanisms. Demixing or segregation. Solid mixing equipment. Mixing small quantities of powders in the pharmacy.
Powders for pharmaceutical use: particle size and dimensional distribution. Average statistical diameter.
Tablets definition F.U. XII ed. Preparation of the tablets. Alternate table and Rotary tablet presses. Production of multilayer tablets. Excipients for the tablets. Direct compression. Properties of tablets and controls. Appearance: shape, size and color. Uniformity of weight and uniformity of content. Resistance to breakage and friability. Porosity. Disaggregation time. Dissolution rate. Stability and control of microbial load.
Pelleting. Film coating. Types of film coatings. Excipients used for film coating. Coating film formation mechanisms. Coating equipment. Pharmaceuticals Fluid Bed Equipment. Main variables of the filming process. Problems in the filming process. Alternative coating techniques.
Coating for double compression.
Granulates definition F.U. XII ed..Characteristic features of granulates Granulation process. Wet and dry granulation. Fluid bed granulator.
Capsules definition F.U. XII ed. Hard capsules. Industrial production of capsules (empty capsules). Industrial filling. Filling of hard capsules in pharmacies. Soft capsules. Production and filling. Modified-release capsules Gastro-resistant capsules Controls FU XII ed.
Liquid preparations. Solutions. Solute concentration. Properties of solutions. Solutions such as pharmaceutical forms. Liquid preparations for oral use. Hydroalcoholic preparations. Dilution of alcohol. Isotonia and isoosmia. Isotonization methods. Water for pharmaceutical use. Water quality and water classification for pharmaceutical use. Water characteristics for pharmaceutical use and production technologies. Purified water, highly purified water and water for injectable use. Water treatments and conditioning. Dechlorination, softening, demineralization, ion exchange resins, reverse osmosis, distillation (single and multiple effect distillation).
Dispersed systems. Colloidal systems. Electrical properties of interfaces. Stability of colloids. Suspensions. Particle wettability. Contact angle. Interactions between solid particles and liquid vehicle. Electric double layer theory and factors that influence stability of didpersed systems. DLVO theory. Instability: sedimentation. Free surface energy. Enlargement of the particles. Flocculation and deflocculation. Ostwald ripening phenomenon.
Suspension formulation. Suspension stability. Bioavailability of suspended drugs. Controls FU XII ed. on suspensions.
Emulsions. Types of emulsions. Emulsion stability. Surface tension. Definition of HLB. Micelle formation. Preparation of emulsions. HLB concept required. Controls on emulsions. Evaluation of the stability of emulsions.
Sterile and apyrogenic pharmaceutical forms. Cellular inactivation kinetics (D value and Z value). Sterilization and depyrogenation methods. Filtration sterilization Environments for the production of sterile pharmaceutical forms. Classification of sterile rooms. Air sterilization. Cleaning and sterilization of the sterile block. Checking the contaminations of the sterile block.
Drying processes: lyophilization. Definition and properties of freeze-dried products. Stages of the freeze-drying process. Freezing. Criticality of the freezing process. Effect of speed on the quality of the liophyle. Freeze drying. Stages of the lyophilization process: primary and secondary drying. Use of cryo-protectors. Control of the lyophilization process.
Semi-solid preparations for cutaneous application. Principles of rheology. Fluid flow. Newtonian and non-Newtonian fluids. Types of non-Newtonian behavior. Time-dependent behavior: thixotropy. Viscometers and rheometers. Viscoelasticity. Application of rheology to pharmaceutical formulations.
Essays and technological procedures envisaged by the F.U. for the most common pharmaceutical forms.
Packaging of medicinal products. Primary and secondary packaging. Packaging materials. Glass. Plastics. Tires and elastomers. Metals. Laminates.

Adopted texts

Farmacopea Italiana XII Ed.
Farmacopea Europea (edizione in vigore e supplementi)

A.T. Florence –D. Attwood: Physicochemical Principles of Pharmacy - Pharmaceutical Pr
M. E. Aulton, K. M. Taylor - Aulton's Pharmaceutics The Design and Manufacture of Medicines - Churchill Livingstone
M. Amorosa – Principi di Tecnica Farmaceutica – Ed. Tinarelli – Bologna
P. Colombo, F. Alhaique, C. Caramella, B. Conti, A. Gazzaniga, E. Vidale -Principi di Tecnologia Farmaceutica (II edizione) - Ed. CEA Casa Editrice Ambrosiana.

P. Minghetti – Legislazione Farmaceutica (edizione corrente) – CEA Casa Editrice Ambrosiana - Milano
E. Ragazzi - Galenica pratica - Ed. Cortina, Padova

Dizionario della lingua italiana
P. Mastrocola - La passione ribelle, Laterza

Bibliography

British Pharmacopeia US Pharmacopeia https://www.ijpc.com/ (International Journal of Pharmaceutical Compounding) https://www.sifap.org/ (SIFAP Società Italiana Farmacisti Preparatori) http://www.agenziafarmaco.gov.it/ (AIFA) http://www.salute.gov.it/portale/home.html (Ministero della Salute) https://www.iss.it/ (Istituto Supriore di Sanità) http://www.ema.europa.eu/ema/ (EMA) https://www.wada-ama.org/ (World Anti-doping Agency) http://www.reach.gov.it/ (Regolamento REACH) https://echa.europa.eu/it/regulations/clp/understanding-clp (Regolamento CLP) http://www.fofi.it/ (Federazione Ordini Farmacisti Italiani)

Prerequisites

The student must have: a) Good command of specific technical expression. b) Mastery of elementary algebra (properties of logarithms, operations with numbers in scientific notation, fractions and percentages) of elementary geometry and trigonometry c) In order to understand the contents of the lessons and to achieve the learning objectives, it is necessary that the student know the key competences related to General and Inorganic Chemistry, Organic Chemistry and Physics courses (unit of concentration, conversion operations of the main measurement units, definition and measurement units of the main physical quantities, physical state and phase transition processes, thermodynamics, colligative properties, pH effect and ionization, buffer systems, formulas and structures of organic substances, general aspects of organic reactions) At the beginning of the course a test is proposed to students, which has no test value and is not evaluated, to put the accent on the basic knowledge necessary to understand the contents of the lessons and to achieve the learning objectives.

Study modes

The course provides lectures aimed to provide the main scientific and technological knowledge necessary for the design, development and control of dosage forms as well as knowledge of national and supranational pharmaceutical regulation. During the lessons the teacher stimulates active participation of the student: at the end of each lesson the teacher asks questions to the students in order to have a feedback to verify the correct learning in order to modify the teaching activities in a more effective way, stimulating the self-directed learning. The active participation of the students in the lesson is completed by practical exercises: in fact, numerical exercises and exercises aimed to apply the theoretical bases of pharmaceutical law for the evaluation and dispensing of dosage forms for human and veterinary use are proposed, in order to promote flipped-classroom teaching. Pharmaceutical compounding practices are also supplied; the attendance is mandatory. During compounding, the student learns the methods of preparation of the main conventional dosage forms and the main professional responsibilities of the pharmacist related to the preparation, control and dispensation only if a valid prescription is presented. The introduction of a differentiated approach into the educational process helps to individualize the learning process of students, contributes to a more lasting and deeper acquiring of knowledge, the formation of positive motivation to learning, creation of a comfortable learning environment, building students’ self-esteem and making them more autonomous.

Exam modes

The exam consists of two parts: a written test and an oral test.
Oral test can only be taken if the written test has been successful (minimum mark: 18/30)
During the written test the Pharmacopoeia, the Medicinal Table, the WADA list, the National Medicines Tariff can be used; it is instead forbidden to use books, notes, reports on practical activities carried out in the laboratory, PC, smartphone and any device that allows access to the internet.
The test time is 2 hours.

Oral exam
The student have to demonstrate abilities in classifying conventional dosage forms, in evaluating the features of excipients, in the knowledge of the basic rules concerning the selling of drugs according to the different kind of prescription. Furthermore, the student will possess the basic knowledge of the regulatory affairs for pharmaceutical compounding.

To obtain a final grade of 18/30 (minimum mark) student must demonstrate to possess basic knowledge and skills related to compounding, control and prescription of conventional dosage forms.
The student must also demonstrate to have basic ability in verifying and control of the legal requires of medical prescription

To obtain a final grade of 30/30 cum laude, student must demonstrate to possess an excellent knowledge of the overall addressed arguments, with the ability to think critically in a logic and coherent way. The student must also demonstrate to have understood the key and characterizing elements to be able to spend the professional abilities of pharmacist in different working environments.

In case of failure, both the written and the oral test need to be repeated.

Exam reservation date start Exam reservation date end Exam date
18/12/2020 14/01/2021 18/01/2021
15/01/2021 10/02/2021 15/02/2021
28/02/2021 25/03/2021 29/03/2021
10/04/2021 07/05/2021 10/05/2021
07/05/2021 30/05/2021 07/06/2021
05/06/2021 28/06/2021 05/07/2021
20/08/2021 15/09/2021 20/09/2021
02/10/2021 28/10/2021 02/11/2021
01/11/2021 27/11/2021 03/12/2021
17/12/2021 17/01/2022 24/01/2022

M - Z

STEFANIA PETRALITO STEFANIA PETRALITO   Teacher profile

Programme

Due to the high content peculiarity, in order to create optimal learning conditions for students, the use of a differentiated approach to the proposed syllabus is adopted. The framework of the syllabus might be subject to changes, due to the continuous law changes.

Regulatory and Law- General principles of national and Community law.
Community code relating to medicinal products for human use. Definition of medicines. medicines authorized for introduction on the market (AIC), Masterly and officinal formulas.
The Pharmacopoeias and their role in the technical regulatory framework for the quality of medicines. Good Manufacturing Practices and Standards of Good preparation in pharmaceutical compounding Production and control of medicines. General aspects. Quality Assurance System. Staff. Laboratory and equipment. Raw material. Preparation operations Quality control. Packaging and labeling. Stability of the preparation. Microbiological aspects of the preparations.
Position of paper masterly preparations by the SIFAP (Italian Society of Pharmacists).
The National Medicines Tariff.
Overview on REACH and CLP regulations.
Prescription medicines and non-prescription medicines, SP and OTC. Therapeutic equivalents. The dispensation of medicines : definition and classifications of medical prescription . Medical prescriptions for veterinary use. The electronic prescription . The classification in the supply of medicinal products for human and veterinary use subject to medical prescription medicines (Tables 3,4,5 FU) Prescription of masterly preparations. (Law No. 94, April 8, 1998).
The rules governing the production , purchase and dispensing of narcotics and psychotropic substances : the DPR 309 /90 and its updates. Statement of " poisons " and their dispensation.
Legislation relating to substances whose use is considered doping (the WADA list).
Legislation relating to the substances acting anorectic.

Design of pharmaceutical forms. Routes of drug administration.
Biopharmaceutical aspects of pharmaceutical forms design. Therapeutic considerations in the design of pharmaceutical forms .
Pharmaceutical development: preformulation Physical and chemical properties of the active pharmaceutical substance. Solubility. Dissolution. Partition coefficient. Dissociation constant
Pharmaceutical forms: classification.
Powders for pharmaceutical use: powder mixing. Forces and mixing mechanisms. Demixing or segregation. Solid mixing equipment. Mixing small quantities of powders in the pharmacy.
Powders for pharmaceutical use: particle size and dimensional distribution. Average statistical diameter.
Tablets definition F.U. XII ed. Preparation of the tablets. Alternate table and Rotary tablet presses. Production of multilayer tablets. Excipients for the tablets. Direct compression. Properties of tablets and controls. Appearance: shape, size and color. Uniformity of weight and uniformity of content. Resistance to breakage and friability. Porosity. Disaggregation time. Dissolution rate. Stability and control of microbial load.
Pelleting. Film coating. Types of film coatings. Excipients used for film coating. Coating film formation mechanisms. Coating equipment. Pharmaceuticals Fluid Bed Equipment. Main variables of the filming process. Problems in the filming process. Alternative coating techniques.
Coating for double compression.
Granulates definition F.U. XII ed..Characteristic features of granulates Granulation process. Wet and dry granulation. Fluid bed granulator.
Capsules definition F.U. XII ed. Hard capsules. Industrial production of capsules (empty capsules). Industrial filling. Filling of hard capsules in pharmacies. Soft capsules. Production and filling. Modified-release capsules Gastro-resistant capsules Controls FU XII ed.
Liquid preparations. Solutions. Solute concentration. Properties of solutions. Solutions such as pharmaceutical forms. Liquid preparations for oral use. Hydroalcoholic preparations. Dilution of alcohol. Isotonia and isoosmia. Isotonization methods. Water for pharmaceutical use. Water quality and water classification for pharmaceutical use. Water characteristics for pharmaceutical use and production technologies. Purified water, highly purified water and water for injectable use. Water treatments and conditioning. Dechlorination, softening, demineralization, ion exchange resins, reverse osmosis, distillation (single and multiple effect distillation).
Dispersed systems. Colloidal systems. Electrical properties of interfaces. Stability of colloids. Suspensions. Particle wettability. Contact angle. Interactions between solid particles and liquid vehicle. Electric double layer theory and factors that influence stability of didpersed systems. DLVO theory. Instability: sedimentation. Free surface energy. Enlargement of the particles. Flocculation and deflocculation. Ostwald ripening phenomenon.
Suspension formulation. Suspension stability. Bioavailability of suspended drugs. Controls FU XII ed. on suspensions.
Emulsions. Types of emulsions. Emulsion stability. Surface tension. Definition of HLB. Micelle formation. Preparation of emulsions. HLB concept required. Controls on emulsions. Evaluation of the stability of emulsions.
Sterile and apyrogenic pharmaceutical forms. Cellular inactivation kinetics (D value and Z value). Sterilization and depyrogenation methods. Filtration sterilization Environments for the production of sterile pharmaceutical forms. Classification of sterile rooms. Air sterilization. Cleaning and sterilization of the sterile block. Checking the contaminations of the sterile block.
Drying processes: lyophilization. Definition and properties of freeze-dried products. Stages of the freeze-drying process. Freezing. Criticality of the freezing process. Effect of speed on the quality of the liophyle. Freeze drying. Stages of the lyophilization process: primary and secondary drying. Use of cryo-protectors. Control of the lyophilization process.
Semi-solid preparations for cutaneous application. Principles of rheology. Fluid flow. Newtonian and non-Newtonian fluids. Types of non-Newtonian behavior. Time-dependent behavior: thixotropy. Viscometers and rheometers. Viscoelasticity. Application of rheology to pharmaceutical formulations.
Essays and technological procedures envisaged by the F.U. for the most common pharmaceutical forms.
Packaging of medicinal products. Primary and secondary packaging. Packaging materials. Glass. Plastics. Tires and elastomers. Metals. Laminates.

Adopted texts

.Farmacopea Italiana XII Ed.
Farmacopea Europea (edizione in vigore e supplementi)

M. Amorosa – Principi di Tecnica Farmaceutica – Ed. Tinarelli – Bologna
A.T. Florence –D. Attwood: Le basi chimico-fisiche della Tecnologia Farmaceutica - EdiSES S.r.l (Napoli)
P. Colombo, F. Alhaique, C. Caramella, B. Conti, A. Gazzaniga, E. Vidale -Principi di Tecnologia Farmaceutica (II edizione) - Ed. CEA Casa Editrice Ambrosiana.
M. E. Aulton, K. M. Taylor - Aulton. Tecnologie farmaceutiche. Progettazione e allestimento dei medicinali – Edra – Milano
M.Marchetti, P. Minghetti – Legislazione Farmaceutica (edizione corrente) – CEA Casa Editrice Ambrosiana - Milano
E. Ragazzi - Galenica pratica - Ed. Cortina, Padova

Bibliography

British Pharmacopeia US Pharmacopeia https://www.ijpc.com/ (International Journal of Pharmaceutical Compounding) https://www.sifap.org/ (SIFAP Società Italiana Farmacisti Preparatori) http://www.agenziafarmaco.gov.it/ (AIFA) http://www.salute.gov.it/portale/home.html (Ministero della Salute) https://www.iss.it/ (Istituto Supriore di Sanità) http://www.ema.europa.eu/ema/ (EMA) https://www.wada-ama.org/ (World Anti-doping Agency) http://www.reach.gov.it/ (Regolamento REACH) https://echa.europa.eu/it/regulations/clp/understanding-clp (Regolamento CLP) http://www.fofi.it/ (Federazione Ordini Farmacisti Italiani)

Prerequisites

Requirements: The student must have: a) Good command of specific technical expression. b) Mastery of elementary algebra (properties of logarithms, operations with numbers in scientific notation, fractions and percentages) of elementary geometry and trigonometry c) In order to understand the contents of the lessons and to achieve the learning objectives, it is necessary that the student know the key competences related to General and Inorganic Chemistry, Organic Chemistry and Physics courses (unit of concentration, conversion operations of the main measurement units, definition and measurement units of the main physical quantities, physical state and phase transition processes, thermodynamics, colligative properties, pH effect and ionization, buffer systems, formulas and structures of organic substances, general aspects of organic reactions) At the beginning of the course a test is proposed to students, which has no test value and is not evaluated, to put the accent on the basic knowledge necessary to understand the contents of the lessons and to achieve the learning objectives.

Study modes

The course provides lectures aimed to provide the main scientific and technological knowledge necessary for the design, development and control of dosage forms as well as knowledge of national and supranational pharmaceutical regulation. During the lessons the teacher stimulates active participation of the student: at the end of each lesson the teacher asks questions to the students in order to have a feedback to verify the correct learning in order to modify the teaching activities in a more effective way, stimulating the self-directed learning. The active participation of the students in the lesson is completed by practical exercises: in fact, numerical exercises and exercises aimed to apply the theoretical bases of pharmaceutical law for the evaluation and dispensing of dosage forms for human and veterinary use are proposed, in order to promote flipped-classroom teaching. Pharmaceutical compounding practices are also supplied; the attendance is mandatory. During compounding, the student learns the methods of preparation of the main conventional dosage forms and the main professional responsibilities of the pharmacist related to the preparation, control and dispensation only if a valid prescription is presented. The introduction of a differentiated approach into the educational process helps to individualize the learning process of students, contributes to a more lasting and deeper acquiring of knowledge, the formation of positive motivation to learning, creation of a comfortable learning environment, building students’ self-esteem and making them more autonomous.

Exam modes

The exam consists of two parts: a written test and an oral test.
Oral test can only be taken if the written test has been successful (minimum mark: 18/30)
During the written test the Pharmacopoeia, the Medicinal Table, the WADA list, the National Medicines Tariff can be used; it is instead forbidden to use books, notes, reports on practical activities carried out in the laboratory, PC, smartphone and any device that allows access to the internet.
The test time is 1.5 hours.

Oral exam
The student have to demonstrate abilities in classifying conventional dosage forms, in evaluating the features of excipients, in the knowledge of the basic rules concerning the selling of drugs according to the different kind of prescription. Furthermore, the student will possess the basic knowledge of the regulatory affairs for pharmaceutical compounding.

To obtain a final grade of 18/30 (minimum mark) student must demonstrate to possess basic knowledge and skills related to compounding, control and prescription of conventional dosage forms.
The student must also demonstrate to have basic ability in verifying and control of the legal requires of medical prescription

To obtain a final grade of 30/30 cum laude, student must demonstrate to possess an excellent knowledge of the overall addressed arguments, with the ability to think critically in a logic and coherent way. The student must also demonstrate to have understood the key and characterizing elements to be able to spend the professional abilities of pharmacist in different working environments.

In case of failure, both the written and the oral test need to be repeated.

Exam reservation date start Exam reservation date end Exam date
15/12/2020 14/01/2021 18/01/2021
01/02/2021 10/02/2021 15/02/2021
11/03/2021 26/03/2021 29/03/2021
16/04/2021 07/05/2021 10/05/2021
13/05/2021 30/05/2021 07/06/2021
17/06/2021 30/06/2021 05/07/2021
27/08/2021 19/09/2021 20/09/2021
17/10/2021 29/10/2021 02/11/2021
17/11/2021 26/11/2021 01/12/2021
Course sheet
  • Academic year: 2020/2021
  • Curriculum: Curriculum unico
  • Year: Fourth year
  • Semester: First semester
  • SSD: CHIM/09
  • CFU: 12
Activities
  • Attività formative caratterizzanti
  • Ambito disciplinare: Discipline Chimiche, Farmaceutiche e Tecnologiche
  • Exercise (Hours): 12
  • Lecture (Hours): 72
  • Lab (Hours): 40
  • CFU: 12.00
  • SSD: CHIM/09