B2940 - Pharmaceutical Technology and Galenic Pharmacy (Gr.A)

Learning outcomes

The course provides a comprehensive understanding of the process of converting an active pharmaceutical ingredient into a medicinal product that can be safely and effectively administered to patients. On completion of the course, the student will have an in-depth knowledge of: - the correlation between physico-chemical properties of the active pharmaceutical ingredient, dosage form, route of administration and therapeutic outcome; - the formulation of solid, semi-solid and liquid dosage forms; - the role and application of excipients in the development of dosage forms; - the principles that govern stability improvement and quality assessment of dosage forms; - the technologies and equipment used in manufacturing processes. The course also provides practical skills related to pharmaceutical compounding.

Course contents

Module 1 (Pharmaceutical technology)

Introduction. Definitions of drug, excipient and dosage form. Classification of dosage forms according to physical state, route of administration and drug release.

Biopharmaceutical factors affecting drug bioavailability. Introduction to biopharmaceutics. Bioavailability. Gastrointestinal tract and absorption. Factors affecting drug release and absorption.

Pharmaceutical excipients. Rule of excipients in dosage forms. Solvents. Enhancement of drug solubility: pH adjustment, cosolvents, complexation with cyclodextrins, surfactants and micelles. Antimicrobial preservatives. Antioxidants. Buffers and pH-adjusting agents. Colors, flavors, sweeteners, and scents. Surfactants. Viscosity-inducing agents.

Particle science and powder technology. Particle size and particle size analysis. Particle size reduction and size separation. Mixing. Powder flow. Drying.

Solid dosage forms. Powders and granules. Powdered and granulated products as dosage forms. Granules as intermediate in tablet manufacture. Pharmaceutical technology of granule production. Granulation mechanisms. Pharmaceutical granulation equipment and processes. Tablets. Quality attributes of tablets. Tablet types. Tablet manufacturing. Tablet excipients. Fundamental aspects of the compression of powders. Fundamental aspects of the compaction of powders. Relationships between material properties and tablet strength. Coated oral dosage forms. Reasons for coating dosage forms. Starting material. Sugar coating. Film coating. Compression coating. Capsules. Hard capsules. Soft capsules. Raw materials and manufacturing processes. Rectal and vaginal suppositories. Anatomy and physiology of the rectum and vagina. Absorption of drugs from the rectum and vagina. Requirements of suppositories. Suppository bases. Formulation principles and manufacturing processes.

Semi-solid dosage forms. Skin structure and function. Transport through the skin. Classification of semi-solid preparations for cutaneous application: ointments, creams, gels and pastes. Requirements of preparations with semi-solid properties. Formulation principles and manufacturing technology. 

Liquid dosage forms. Solutions. Pharmaceutical solutions. Formulation and manufacturing processes. Solution stability. Syrups. Emulsions. Emulsion types. Formulation of pharmaceutical emulsions. Instability phenomena and stabilizing principles. Emulsifying agents. Preparation technology. Suspensions. Definition. Solid particle-liquid vehicle interactions. Particle movement in suspensions. Dispersibility issues and surface wetting. Stability. Formulation and manufacturing technology. Parenteral formulations. General introduction. Routes of parenteral administration. Pharmacopoeial requirements. Excipients. Preparation of solutions and suspensions for injection. Parenteral depot drug formulations. Pharmaceutical sterilization. Ophthalmic preparations. Anatomy and physiology of the eye. Biopharmaceutical aspects. Eye drops.

Module 2 (Galenic pharmacy)

Introduction. European Pharmacopoeia and Official Pharmacopoeia of the Italian Republic. Ministerial Decree 18 November 2003. “Norme di buona preparazione dei medicinali in farmacia-NBP”. Organization and management of the galenic laboratory.  Medicinal products prepared in a pharmacy: magistral and official formulas. Packaging, price calculation and labelling of magistral and official formulas. 

Galenic laboratory. Small-scale manufacturing (compounding), packaging and labelling of powders, capsules, solutions, suspensions, liquid emulsions, creams, ointments, gels, pastes and suppositories.

 

 

Readings/Bibliography

A. Fahr, G.L. Scherphof, Voigt's Pharmaceutical Technology, Wiley, New York (Twelfth Edition, 2018).

M.E. Aulton, K.M.G. Taylor, Aulton's Pharmaceutics - The Design and Manufacture of Medicines, Elsevier, Amsterdam (Sixth Edition, 2022).

Teaching methods

The course is divided into two parts, 64 hours (8 ECTS Credits) of lessons and 60 hours (4 ECTS Credits) of laboratory practice. Laboratory practical is carried out individually.

The obligation to attend the didactic activities is considered to be fulfilled attending at least 80% of the laboratory activities and 70% of lessons.

Prerequisite: Medicinal and toxicological chemistry I and Physics, Elements of mathematics (I.C.).

As concerns the teaching methods of this course unit, all students (including all the international incoming exchange students, i.e. ERASMUS) must attend Module 1, 2 online [https://www.unibo.it/it/servizi-e-opportunita/salute-e-assistenza/salute-e-sicurezza/sicurezza-e-salute-nei-luoghi-di-studio-e-tirocinio], while Module 3 on health and safety is to be attended in class. Information about Module 3 attendance schedule is available on the website of your degree programme ("studiare"--"formazione obbligatoria su sicurezza e salute").

Assessment methods

The assessment method consists into a practical test at the end of the laboratory and an oral test, to be taken on the exam dates indicated on Almaesami.
The practical test consists in the preparation, calculation of price, packaging and labeling of a galenic preparation and in the drafting of a report describing the preparation procedure. During the practical test, the student can use the texts made available by the teacher, as well as the laboratory manual. Passing the practical test is subject to the preparation of a dosage form of acceptable pharmaceutical quality, correctly labelled and priced. Failure to pass the practical test precludes access to the oral exam.
The oral test initially includes the discussion of the practical test (module 2) and continues with 3 open-ended questions relating to the topics covered during the lectures (module 1). In particular, the student is required to describe the general aspects that characterize a dosage form, its composition and production methods.

The final grade is defined taking into account the outcome of the practical test and the outcome of the oral test.

Registration for the oral exam must take place via Almaesami (https://almaesami.unibo.it/almaesami/welcome.htm).

 

Teaching tools

The theoretical lessons will be held by using common audio-visual means.

Practical activities will be carried out in laboratories equipped with all necessary chemicals, equipment and texts (European Pharmacopoeia and Official Pharmacopoeia of the Italian Republic).

The material used for lectures (power-point presentations, laboratory manual) will be made available to students on the Virtuale website.

Office hours

See the website of Federica Bigucci