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 the dosage forms according to the 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 an intermediate in tablet manufacture. Pharmaceutical technology for granule production. Granulation mechanisms. Pharmaceutical granulation equipment and processes. Tablets. Quality attributes of the tablets. Tablet types. Tablet manufacturing. Tablet excipients. Fundamental aspects of the compression of the powders. Fundamental aspects of the compaction of powders. Relationships between the material properties and tablet strength. Coated oral dosage forms. Reasons for coating the 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 the 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 for 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).

The teaching material provided by the teacher is published on the Virtual platform (https://virtuale.unibo.it).

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.

In order to take the examination, the student must have attended at least 80% of the laboratory exercises and 70% of the lectures. Students are reminded to check the prerequisites listed in the course structure diagram (prerequisites: 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 of a practical test to be taken on the last day of the laboratory and an oral test on the exam dates indicated on Almaesami.

The practical test consists of the preparation, calculation of price, packaging and labeling of a galenic preparation and drafting of a report describing the preparation procedure and the label of the finished product, including the price calculation. Passing the practical test is subject to the preparation of a dosage form of acceptable pharmaceutical quality, correctly labelled and priced. Passing the practical test does not result in a grade, but rather the acquisition of a qualification to take the oral test. During the practical test, the student can use the texts made available by the teacher, as well as the laboratory manual.

The oral exam consists of 3 open-ended questions related to the topics covered during the lectures (module 1). Specifically, the student is expected to describe the general aspects that characterize a specific dosage form, its composition and manufacturing methods.

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

 

Students with learning disorders and\or temporary or permanent disabilities: please, contact the office responsible (https://site.unibo.it/studenti-con-disabilita-e-dsa/en/for-students) as soon as possible so that they can propose acceptable adjustments. The request for adaptation must be submitted in advance (15 days before the exam date) to the lecturer, who will assess the appropriateness of the adjustments, taking into account the teaching objectives.

Teaching tools

The lectures include the use of PowerPoint presentations and take place in classrooms equipped with a teacher PC connected to the network, a fixed video projector, a sound system and WI-FI access.

The practical exercises take place in specially equipped teaching laboratories where students have their workstation and the instruments, materials and texts necessary for the preparation of the galenic preparations. During the exercises, the support of tutors with advanced experience in laboratory practice is used.

The slides projected during the lectures and the laboratory handout are available on the Virtual platform (https://virtuale.unibo.it).

Office hours

See the website of Federica Bigucci