Ateneo - UPO

The teaching is aimed to illustrate principles, strategies and technologies used for the development and production of solid and liquid dosage forms employed in the therapeutic field, with a particular focus on the industrial medicines. The structure and the characteristics of the different pharmaceutical forms, the properties of the ingredients and their impact on the product performance, the processes employed by both pharmacists and industrial companies for their production and control will be described.

Colombo P et al. Principi di tecnologie farmaceutiche. 2° Ed, 2015, Ed. Ambrosiana.
Aulton ME, Taylor K.M.G. Tecnologie farmaceutiche, 2015 EDRA LSWR.
Ansel, HC et al. Principi di calcolo farmaceutico. Quindicesima edizione. 2017 Ed. Edra.
Minghetti P, Marchetti M. Legislazione farmaceutica. Ed. Ambrosiana.
Farmacopea Ufficiale Italiana edizione vigente.
Farmacopea Europea edizione vigente.
Lachman L, Lieberman H, Kanig J. The theory and practice of industrial pharmacy. Ed. Lea & Febiger, USA.
Fabris L, Rigamonti S. La fabbricazione industriale dei medicinali. Ed. Esculapio, Bologna.
Manuali Tecnici A.F.I., Ed. OEMF, Milano.

The course objective is to provide students with knowledge about the characteristics and functions of conventional drug dosage forms and the ability to understand which tools and methodologies are used for their development and manufacturing

There are no prerequisites, but it is strongly recommended to attend the training only after having passed the examinations of the courses of the first two years

The course will be provided in form of lectures (in classroom or as audiolessons). Occasionally, the students will be asked to answer questions about the treated subjects and to recover supplementary material from AIFA, EMA and FDA websites.

Students with physical disabilities, Learning Disabilities or Special Education Needs can request specific services and tools via the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti, consulting the University webpage: https://www.uniupo.it/en/services/services-students-physical-or-learning-disabilities

Students with disabilities, learning disabilities or special education needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects.

The examination will be carried out in oral form. To achieve the final vote, the student must demonstrate that he has understood, and he is able to use the fundamental concepts of each topic. The evaluation will be based on the following criteria:
1. knowledge and theoretical understanding and application of the studied subjects;
2. independence of judgment and ability to link the studied arguments;
3. communication skills and appropriateness in the use of technical language;
4. learning ability.

• Pharmaceutical dosage forms (PDF): definition of dosage form; principles of biopharmaceutics (drug delivery, absorption, distribution, metabolization and elimination; concept of bioavailability); route of drug administration (oral sublingual, buccal, rectal, transdermal, nasal, pulmonary, parenteral, topical, ophtalmic, vaginal route); concept of preformulation.
• Pharmaceutical powders: definition; powder properties: particle shape, particle size, particle size analysis methods (sieve methods, microscope methods, Coulter Counter, sedimentation methods, laser light scattering methods) and particle size distribution, surface area and methods for the determination of the surface area; volume; density; porosity; flowability properties.
• Materials employed in pharmaceutical field. Measure, control and regulation of temperature, pressure and flow. Ventilated, controlled climate and clean rooms.
• Processes for solid dosage forms: milling, seiving, granulation, desiccation.
• Granules: formulation of granules; introduction to granulation, granulation methods (wet granulation and dry granulation) and granulation mechanisms; effervescent granules, coated granules, modified release granules, gastroresistant granules; specific technological assays.
• Tablets: definition; characteristics; classification (uncoated tablets, multiplayer tablets, coated tablets, effervescent tablets, chewable tablets, soluble and dispersible tablets, oral disisntegrating tablets, sublingual tablets, gastro-resistant tablets, modified release tablets); excipients for tablets (fillers, binders, lubricants, antiadherents, glidants, disintegrants, colourants, flavours, modified release agents); examples of tablet formulations; specific technological tests; coating of tablets (sugar coating, film coating, press coating).
• Capsules: definition; hard gelatin capsules: excipients, shell manufacturing procedure and capsule filling; soft gelatin capsules; specific technological tests.
• Manufacturing processes of pharmaceutical dosage forms: powders, tablets, coated tablets, capsules.
• Solutions: properties of solutions; surfactants, interfacial tension, HLB; pharmaceutical solutions and excipients; aqueous and non-aqueous solutions; syrups; quality assurance tests; extractive preparations: hydrolates, essences, alcoholates, exctracts, infusions, tinctures, decoctions.
• Parenteral dosage forms: classification; requirements; vehicles; packaging; insulin formulations; small volume preparations (SVP) and large volume preparations (LVP); parenteral nutrition; powders for parenteral administration. Sterilization: definition, physical and chemical methods; sterility assurance level.
• Ophthalmic dosage forms: definition; eye anatomy and physiology; requirements and specific characteristics of ophthalmic preparations; eye drops; semisolid ophthalmic preparations; ophthalmic inserts; eye-baths; specific technological tests.
• Manufacturing processes of liquid not parenteral and parenteral forms. Extemporaneous liquid pharmaceutical forms. Freeze-drying: principles, equipment, control and regulation tools.
• Transfer of solids, liquids and gases in the pharmaceutical plant

The student must demonstrate how to apply the acquired knowledge for identifying and describing the technological and biopharmaceutical properties of pharmaceutical forms, how to use the specific language of this discipline, how to identify the role played by the components of the pharmaceutical vehicle and to evaluate how they affect the properties of the medicament and the activity of the active ingredient.