84924 - Pharmaceutical Technology and Galenical Preparations Laboratory (GR.A)

Academic Year 2021/2022

  • Moduli: Federica Bigucci (Modulo 1) Federica Bigucci (Modulo 2)
  • Teaching Mode: Traditional lectures (Modulo 1) Traditional lectures (Modulo 2)
  • Campus: Rimini
  • Corso: Single cycle degree programme (LMCU) in Pharmacy (cod. 9223)

    Also valid for Single cycle degree programme (LMCU) in Pharmacy (cod. 9223)

Learning outcomes

The purpore of this course is to introduce pharmacy students to the principles, practices and technologies applied in the preparation of pharmaceutical dosage forms: powders, granules, tablets, capsules, solutions, eye drops, ointments, creams, emulsions, suspensions, gels, suppositories.

Course contents

Pharmaceutical technology (part I)

Drug, excipient and drug dosage form. Classification of dosage forms. Introduction to biopharmaceutics.

Solid dosage forms. Particle properties. Primary particle properties (particle size and particle size distribution, shape, surface area). Secondary particle properties (packing, density, porosity, flow). Powder technology. Introduction to particle size reduction. Influence of material properties on size reduction. Size reduction methods. Introduction to size separation. Size separation methods. Mixing principles. Mechanisms of mixing and demixing. Mixing methods. Drying. Drying of wet solids. Drying methods. Drying of solutions and suspensions: spray-drying, freeze-drying.

Powders, granules and granulation. Introduction to powder and granules. Powdered and granulated products as dosage forms. Granules used as an intermediate in tablet manufacture. The technology of granule production. Granulation mechanisms. Pharmaceutical granulation equipment and processes. Tablets and compaction. Quality attributes of tablets. Tablet types. Tablet manufacturing. Tablet excipients. Fundamental aspects of the compression powders. Relationships between material properties and tablet strength. Coating of tablets and multiparticulates. Sugar coating. Film coating. Compression coating. Coating of tablets. Coating of multiparticulates. Hard capsules and soft gelatine capsule dosage form. Rationale for the selection of capsule as a dosage form. Description of the hard capsules and soft capsules. Raw materials. Manufacture. Formulation. Suppositories and pessaries. Absorption of drugs from the rectum and from the vagina. Formulation considerations for suppositories and pessaries. Manufacture.

Liquid dosage forms. Solutions. Advantages and disadvantages of pharmaceutical solutions. The solvent system and the excipients. Solution stability. Syrups. Suspensions. Solid particle-liquid vehicle interactions. Particle movement in suspensions. Dispersibility issues-surface wetting. Suspension formulation. Stability consideration for suspensions. Manufacturing considerations. Emulsions. Emulsions in pharmacy. Formulations of emulsions. Emulsifying agents. Manufacture and processing of emulsions. Emulsion properties. Emulsion stability. Parenteral preparations. Routes of parenteral administration. Pharmacopoeial requirements. Absorption from injection sites. Excipients. Enhancement of drug solubility. Sterile dosage forms and principles of sterilization.

Semisolid dosage forms. Creams, ointments, gels and pastes. Skin structure and function. Transport to the skin. Transdermal and topical preparations. Principles of rheology. Raw materials. Formulation principles andoptions.

Plant-based products. Plant-based products. Production methods used to obtain plant-derived active constituents. Formulation and manufacture of plant-based medicines.

Pharmacy Practice Laboratory (part II)

Preparation, packaging and labelling of galenic formulations: capsules, syrups, suspensions, emulsions, creams, ointments, pastes, suppositories and pessaries.

Readings/Bibliography

M.E. Aulton, K.M.G. Taylor, Aulton's Pharmaceutics, Elsevier, Amsterdam (2015).

A.T. Florence, D. Attwood, Physicochemical principles of pharmacy in manufacture, formulation and clinical use, Pharmaceutical Press, London (2015).

Teaching methods

The course is divided into two parts, 56 hours (7 ECTS Credits) of lessons and 60 hours (4 ECTS Credits) of laboratory practice. Laboratory practical is carried out individually, with a final test. Attendance is mandatory.

As concerns the teaching methods of this course unit, all students must attend Module 1, 2 [https://www.unibo.it/en/services-and-opportunities/health-and-assistance/health-and-safety/online-course-on-health-and-safety-in-study-and-internship-areas] online, 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.

Assessment methods

The examination is divided into two parts: a practical examination concerning the preparation of a galenic formulation, calculation of price, packaging and labelling and an oral examination consisting of 3-5 open questions on the arguments of the program.

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 chemical reagents, instrumentations and texts.

Office hours

See the website of Federica Bigucci

SDGs

Good health and well-being

This teaching activity contributes to the achievement of the Sustainable Development Goals of the UN 2030 Agenda.