Ateneo - UPO

The teaching is aimed to illustrate principles, strategies and technologies used for the development and production of liquid and solid dosage forms containing biotechnological products and employed in the therapeutic field. 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 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.
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.
Daan J. A. Crommelin, Robert D. Sindelar, Bernd Meibohm. Pharmaceutical biotechnology. Ed. Springer Nature; 5° edizione
M. Luisa Calabrò. Compendio di biotecnologie farmaceutiche. Ed. Edises.

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

There are no prerequisites

The course will be delivered mainly in form of lectures (in classroom or as audio lessons). Some seminars are planned, carried out by experienced people from pharmaceutical industry, which will illustrate the practical application of the exposed theoretical concepts. Occasionally, students will be invited to respond jointly to questions on topics already treated and to recover supplementary educational material on AIFA, EMA and FDA web sites

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.

• Medicinal products: definitions and background. Marketing Authorization.
• 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. Powders as drug dosage forms
• 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.
• Tablets: definition; characteristics; classification; 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; production and specific technological tests on hard and soft capsules.
• Multiunit drug delivery systems: micro- and nano-systems. Development, manufacturing and quality control.
• Solutions: properties of solutions; surfactants, interfacial tension, HLB; pharmaceutical solutions and excipients; aqueous and non-aqueous solutions. Water for pharmaceutical and biotechnological uses: production, storage and distribution.
• Parenteral dosage forms: classification; requirements; vehicles; packaging. Small volume preparations (SVP) and large volume preparations (LVP); parenteral nutrition. Manufacturing of parenteral medicines. Powders for parenteral administration: Freeze Drying. Sterilization: definition, physical and chemical methods; sterility assurance level.
• Biological/biotechnological drugs: routes of administration of peptide drugs, biopharmaceutical and pharmacokinetic considerations. Antigenicity and immunogenicity. Preformulation studies, formulation and stability aspects of biotechnological products. The PEGylation of peptides and proteins. Stages in the manufacturing process and quality testing of biological/biotechnological medicinal products. Pharmaceutical aspects for the production of vaccines.
• Advanced Therapy Medicinal Products (ATMP): Introductory concepts related to Advanced Therapy Products and Regenerative Medicine. Regulatory framework. Large-scale and hospital-based production of medicinal products for gene therapy, somatic cell therapy and advanced combination therapies.

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