PHARMACEUTICAL TECHNOLOGIES II
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- Versione italiana
- Academic year
- 2022/2023
- Teacher
- GAIA COLOMBO
- Credits
- 9
- Didactic period
- Primo Semestre
- SSD
- CHIM/09
Training objectives
- The present is the second course of Pharmaceutical Technology and continues the learning process started with “Pharmaceutical Technology 1” by focusing on the medicinal drug product as a whole, whose deep knowledge must be completed by the pharmacist to come.
The general learning outcome of the course is to provide the students with theory concepts and critical mind to express such knowledge of the medicinal product as a whole, i.e., in its being a product (either of industrial or galenic origin) composed of:
• FORMULATION: composition of chemicals with different functions (drug active and excipients) and in different amounts, accurately selected depending on their function and the product’s administration route
• CONTAINER CLOSURE SYSTEM (or DEVICE, if appropriate) and any accessory, as a function of the administration route
• SECONDARY PACKAGE
• PATIENT INFORMATION LEAFLET and LABEL.
The main acquired knowledge will be, with respect to the medicinal product:
• how it is presented (composition, dosage form, container/device)
• how it is manufactured (both in industry and pharmacy) and how to assess its quality according to the Pharmacopoeia
• how to use it (e.g. container handling, extemporaneous operations, dose calculation and measurement, etc.)
• how to store it
• how it works (limitedly to biopharmaceutical features of drug release, i.e., not considering the pharmacological action).
The basic acquired abilities (that are the capacity of applying the acquired knowledge) will be:
• to manage the industrial medicinal product in the pharmacy (from supply thru storage and disposal, if necessary)
• to assess the appropriateness of a prescription
• to assist and train/educate the patient at proper management of the medicinal product (instructions for use and storage at home)
• to counsel the patient in choosing the most appropriate product (e.g. when the market offers different brand products containing the same active ingredient at the same dosage)
• to prepare the medication in the pharmacy (limitedly to the theoretical aspects)
• to make pharmaceutical calculations as those faced in the galenic activity (preparation or extemporaneous manipulation of medications) as well as in managing the therapy at home (e.g. dose measurement for a multidose oral liquid) or in a hospital (e.g. dose adjustments, injections and infusions). Prerequisites
- It is mandatory to have acquired and possess the knowledge given by the following courses:
• “MATHEMATICS”: algebra, proportions, equivalencies of units of measures of the decimal metric system for length, mass and volume), basic mathematical functions (linear, exponential, logarithmic), basic statistics (mean, standard deviation), graph plotting from data sets, graph interpretation;
• “INORGANIC AND ANALYTICAL CHEMISTRY”: concepts of atom, molecule, ion, acid, base, salt, basic inorganic reactions, acid-base dissociation equilibriums, pH, pKa, physical state of the matter and phase transitions, density, solubility, concentrations and measure units thereof;
• “ORGANIC CHEMISTRY” and “BIOCHEMISTRY”: functional groups, basic organic reactions (e.g. esterification, hydrogenation, etc.), natural and synthetic polymers;
• “GENERAL PHARMACOLOGY”: concept of dose, plasma concentration curves, pharmacokinetics.
The contents of the “PHARMACEUTICAL TECHNOLOGY 1” course are also capital pre-requisites as liquid (solutions, suspensions, emulsions) and semisolid formulations are used for administration routes other than oral and cutaneous.
The student is required to possess a sufficient level in scientific English enabling him/her to read and understand reference bibliographic material (European Pharmacopoeia, American Pharmacopoeia, suggested books in the university library).
To take the final examination (learning assessment), students must have passed the propaedeutic exam “Pharmaceutical Technology I”. Course programme
- The course develops over 72 hours of face-to-face class teaching, 70% of which on theory and 30% dedicated to the analysis of marketed medicinal products and pharmaceutical calculation practice. PLEASE NOTE: the hours dedicated to each topic are provisional and possible subjected to variations in consequence of specific course’s needs.
0) COURSE INTRODUCTION (4h)
Presentation of Learning outcomes, course content, pre-requisites, examination method – Revision of general concept in pharmaceutical technology: definition of medicinal product, requirements, formulation, containers, patient leaflet.
1) POWDERS (14h)
Definition, fundamental and derived properties and methods for measuring them – Manufacturing by milling and mixing in industry and pharmacy – Galenic sachets – Powders as medicinal products: advantage, administration routes, controls – Analysis of marketed products for use by oral, cutaneous and injection routes with case studies.
2) PHARMACOPEIAL TESTS TO ASSESS DRUG CONTENT IN SINGLE-DOSE PREPARATIONS (2h)
Uniformity of Mass, Uniformity of Content, Uniformity of Dosage Units.
3) GRANULES (6h)
Definition and rationale – Granulation methods and equipment – Controls – Pellets - Analysis of marketed products: effervescent, enteric and modified release granules.
4) CAPSULES (8h)
Definition – Hard capsules: design, capacity, shell composition, gelatin – Hard shell industrial manufacturing - Industrial filling – Solid and liquid formulations – Softgel Capsules: advantage, composition, industrial manufacturing, bioavailability – Controls – Hard capsule filling in pharmacy - Analysis of marketed products (hard capsules and softgels).
5) TABLETS (9h)
Definition – Manufacturing and tableting machines – Physics of compression – Excipients – Controls. Analysis of marketed products (for each tablet type) – Solid oromucosal preparations – Medicated chewing-gums.
6) COATING OF ORAL SOLIDS (4h)
Rationale – Sugar coating – Film coating.
7) MODIFIED DRUG RELEASE (4h)
Definition, rationale, scope and technologies – Reservoir systems – Matrix systems.
8) TRASNDERMAL AND OPTHALMIC THERAPEUTIC SYSTEMS (4h)
Rationale and advantage of transdermal administration – Reservoir-typ and matrix-type transdermal patches with marketed examples – Absorption enhancement across skin – Ophthalmic inserts and implants.
9) PRESSURIZED PREPARATIONS (4h)
Uses and advantage – Propellants and containers with their components – Filling and controls – Medicated foams – Examples of marketed products.
10) RESPIRATORY DRUG DELIVERY: NASAL AND PULMONARY ADMINISTRATION (10h)
General concepts on aerosolization and deposition – Aerodynamic diameter – NASAL ADMINISTRATION: Liquid and solid preparations (formulation, devices, controls) – PULMONARY ADMINISTARTION: deposition mechanisms, safety, biopharmaceutics – Liquid preparations for nebulization (formulation and nebulizers) – Pressurize Metered Dose Inhalers (pMDIs) – Dy Powder Inhalers (DPIs) – Pharmacopoeial tests: emitted dose uniformity and fine particle dose - Analysis of marketed products.
11) RECTAL AND VAGINAL PREPARATIONS (3h)
Features of these administration routes and types of products – Suppositories: bases (lipophilic and hydrophilic), formulation – Suppository manufacturing in pharmacy and industry – Controls – Other vaginal preparations (tablets, inserts). Analysis of marketed products. Didactic methods
- The course develops as follows:
lectures on all topics above listed;
video-watching on galenic preparation of powder sachet and capsules;
video-watching on industrial equipment/process described in the lectures (granulators, capsule filling and tableting machines, blister machines, etc.);
exercises on pharmaceutical calculations with direct student involvement;
seminars by pharmacists;
seminars by industrial or academic lecturers, also from abroad. Learning assessment procedures
- The aim of the examination is to assess the level of knowledge of the student with respect to the learning outcomes previously stated.
The exam is divided into 2 parts, a written and an oral part. They usually take place on the same day or 1-2 days apart. The time between the two depends on the number of students in the exam’s list and the position on the list of the individual student. The temporal distance between the two tests is in proportion to the number and duration of the oral tests of the previous students, net of absent, withdrawn and students who did not pass the written test.
The two parts are:
Part 1: a pharmaceutical calculation exercise carried out on paper autonomously (available time: 20 minutes). This test aims to evaluate the ability to solve real-case exercises related to the preparation of medicines in pharmacy (including hospital pharmacy), industrial manufacturing and quality control, and administration to the patient in conditions of efficacy and safety. THE STUDENT WHO DOES NOT CORRECTLY RESOLVE THE EXERCISE IN THE TIME AVAILABLE IS NOT ADMITTED TO THE NEXT TEST.
The test outcome is expressed through a judgment ("Approved" or "Not approved"). It is not allowed to consult texts or use PCs, nor smart phones. Calculator is allowed.
Part 2: oral exam which includes:
- open question
- analysis of a medicinal product form the market.
The oral exam does not assess the ability to "repeat aloud" the contents of the course. Conversely, it evaluates the ability to connect the contents logically and make connections, exploiting the elements learned in the course and those coming from the previous cultural background (pre-requisites and preparatory subjects). Furthermore, the ability to deepen the concepts exposed, explain and illustrate them, will be assessed as well taking into account the type of interlocutor (e.g. professor vs. patient in a pharmacy). In order to evaluate this ability, the student will be provided with a commercial medicinal product, with box and package leaflet, to be analyzed according to the methods used during the course and limited to the aspects of composition and formulation, packaging, label, methods of use and storage.
To pass the exam it is necessary to acquire a minimum score of 18 out of 30. If the oral exam is insufficient, it will not be necessary to repeat the first test (calculation). Reference texts
- All topics treated must be studied in deeper detail with the following books, listed per relevance to the course. They are all available in the university library except for #6 (free download online):
1. P. Colombo, F. Alhaique, C. Caramella, B. Conti, A. Gazzaniga, E. Vidale, Principi di Tecnologia Farmaceutica. Casa Editrice Ambrosiana, Milano, 2015.
2. Farmacopea Ufficiale Italiana (FUI), European Pharmacopoeia (EP), United States Pharmacopoeia (USP): current editions.
3. M. Amorosa, Principi di tecnica farmaceutica. Piccin, 2021.
4. HC. Ansel, SJ Stockton, Principi di calcolo farmaceutico. A cura di: G. Colombo et al. EDRA, 2017.
5. Ansel H.C., Pharmaceutical Calculations 14th Edition, Wolster Kluwer, 2012.
6. <1160> Pharmaceutical Calculations in Pharmacy Practice, USP 38
7. Aulton M.E., Kevin M.G.T., Tecnologie Farmaceutica. EDRA, 2015.
8. A. Martins, Physical pharmacy and pharmaceutical sciences: physical chemical and biopharmaceutical principles in the pharmaceutical sciences, 5th ed. Editor: Patrick J. Sinko, Lippincott Williams & Wilkins, Philadelphia, 2006.
9. Handbook of pharmaceutical excipients, 7th ed. Edited by Raymond C. Rowe, Paul J. Sheskey, Sian C. Owen, Pharmaceutical Press and American Pharmacists Association, Chicago, 2012.
10. Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems, Lippincott Raven, 2014.
