Objectives

Aim of the course is to provide the basic knowledge on pharmaceutical technology and italian regulations on pharmaceutics, allowing to perform the activity of herbalist and pharmaceutical representative.

This final aim is achieved through the achievement of specific objectives concerning:
• the knowledge of the national regulatory bases of medicinal, cosmetic and health products;
• the knowledge of the main techniques of formulation and production of medicinal, cosmetic and health products of natural and synthetic origin;
• awareness of the role in the various professional areas of relevance, on the basis of legislation and professional preparation;
• the ability to systematically apply the knowledge acquired in the course, to the various operating contexts characterizing the professional context;
• the ability to communicate the results of their own elaborations to the stakeholders;
• to be able to find the information necessary for self-updating.

These specific objectives will be achieved through the provision of lectures, the execution of group work and the preparation of written reports.

Channels

NESSUNA CANALIZZAZIONE

STEFANIA PETRALITO STEFANIA PETRALITO   Teacher profile

Programme

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.
Regulatory landscape of dietary supplements and herbal medicines
medical devices
cosmetics
Prescription medicines and non-prescription medicines, SP and OTC. Therapeutic equivalents.

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.
suppositories
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. Controls on emulsions. Evaluation of the stability of emulsions.
Sterile and apyrogenic pharmaceutical forms. Cellular inactivation kinetics (D value and Z value).
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.

Adopted texts

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

M. Amorosa – Principi di Tecnica Farmaceutica – Ed. Piccin
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

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)

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.

Frequency modes

non- mandatory

Exam modes

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 conventional dosage forms and legal aspects.

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 in different working environments.

Exam reservation date start Exam reservation date end Exam date
09/01/2022 13/01/2022 14/01/2022
17/01/2022 10/02/2022 14/02/2022
28/02/2022 25/03/2022 28/03/2022
22/04/2022 28/04/2022 29/04/2022
10/04/2022 05/05/2022 09/05/2022
19/05/2022 01/06/2022 06/06/2022
16/06/2022 30/06/2022 04/07/2022
25/08/2022 14/09/2022 19/09/2022
01/10/2022 29/10/2022 04/11/2022
14/11/2022 30/11/2022 05/12/2022
05/12/2022 20/01/2023 24/01/2023
Course sheet
  • Academic year: 2021/2022
  • Curriculum: INFORMAZIONE SCIENTIFICA SUL FARMACO
  • Year: Third year
  • Semester: Second semester
  • SSD: CHIM/09
  • CFU: 6
Activities
  • Attività formative caratterizzanti
  • Ambito disciplinare: Discipline Farmaceutiche e Tecnologiche
  • Lecture (Hours): 48
  • CFU: 6.00
  • SSD: CHIM/09