PHARMACEUTICAL TECHNOLOGIES II

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Versione italiana
Academic year
2019/2020
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 the tools to possess such knowledge of the medication as a whole, i.e., in its being a product (either of industrial or galenic origin) composed of:
• FORMULATION: pool 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 required and considered capital 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 examination is divided in two parts, a written and an oral exam. Normally, they take place within 2 days and up to 1 week apart one from the other. The time between the two parts depends on the number of students taking the exam (excluding withdrawn and absent students) and is required to check the written exam. The two parts are:
- WRITTEN EXAM (3 questions of which the first is an open question, the second a focused question on a concept or definition and the third is a pharmaceutical calculation to solve) on all topics treated. This part aims to assess the study and comprehension of the topics and is selective (the student showing insufficient knowledge of the topics is not admitted to the next part). It is mandatory to solve correctly the calculation in order to pass this first part. The evaluation is given by a judgment and a grade between 18 and 30/30. The time available to answer is 1 hour and a half. Books, PCs, smart phones are not allowed, whereas calculators can be used.
- ORAL EXAM in which the assessment will focus not on the ability to “repeat” some topic treated in class, but to make links and transversal comparisons with a critical approach. In particular, this ability will be assessed by providing the student with a commercial product, including box and leaflet, to be analyzed as done in class and limitedly to formulation, packaging, labeling, use and storage characteristics. A minimum of 18 points over 30 is required to pass the oral.
The final grade is normally established keeping into account the grades of both parts, however the first grade is not binding for the final grade and may or may not be considered to define it.
The exam is passed with a minimum final grade of 18/30. If the second part was below the minimum, it may be necessary to repeat both parts.

Reference texts

All topics treated must be studied in deeper detail with the following books ordered for relevance to the course. They are all available in the university library except for #4 (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. HC. Ansel, SJ Stockton, Principi di calcolo farmaceutico. A cura di: G. Colombo et al. EDRA, 2017.
4. Ansel H.C., Pharmaceutical Calculations 14th Edition, Wolster Kluwer, 2012.
5. <1160> Pharmaceutical Calculations in Pharmacy Practice, USP 38
6. Aulton M.E., Kevin M.G.T., Tecnologie Farmaceutica. EDRA, 2015.
7. M. Amorosa, Principi di Tecnica Farmaceutica. Libreria Universitaria L. Tinarelli, Bologna.
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.