Ateneo - UPO

Preparation of pharmaceutical forms, according to the concepts of biopharmaceuticals and bioavailability, and the Good Pharmaceutical Preparation Practices.

Farmacopea Ufficiale XII edizione. Medicamenta.

The course is worth 2 CFU for a total of 20 hours. The aim of the course is to provide the student with the knowledge of the preparation methods and the excipients of the pharmaceutical forms and to understand how to produce a qualitatively valid product. For this purpose it is essential to know the main operations of pharmaceutical technique, the Good Preparation Standards, the routes of administration and understand the concepts of active ingredient, excipient, bioavailability, incompatibility, stability, quality control, pharmaceutical calculations, compilation of the label , laboratory equipment, work environments, packaging materials, legislative aspects, and what is meant by error of therapy and how it could occur during the preparation phase. Following the reading of a formula the student must be able to set up a pharmaceutical form by manipulating the ingredients contained in the formula, correctly applying the pharmaceutical operations, choosing the correct laboratory instruments to be used and then finally packaging and labeling the finished product

The student must be in possession of the basic notions of Chemistry, Biochemistry and General Pharmacology.

The course includes lectures and laboratory practice.The excipients used in the pharmaceutical preparations, their chemical-physical characteristics, the pharmaceutical operations, the laboratory instruments and the preparation technique will be described. Some formulas will be presented and will be taught how to integrate the individual components, according to their characteristics, to produce a finished product that is qualitatively valid. A 5-hour guided tour of a pharmaceutical plant will be carried out to review the methods of industrial preparation of the tablets and to understand the concept of quality in the production of medicines.

Students with disabilities, Specific Learning Disabilities (SLD), or Special Educational Needs (SEN) can request specific services and tools by visiting the dedicated page on the University website: https://uniupo.it/it/servizi/servizi-studentesse-e-studenti-condizione-di-fragilità-disabilità-dsa-bes. Students with disabilities, SLD, or SSEN, after contacting the University staff, can contact the professor in charge of the course regarding the specific exam modalities and educational aspects.

Students will have to take an oral test on topics concerning pharmaceutical preparations. They will have to demonstrate that they have assimilated the basic notions of the Pharmaceutical Technique and how to prepare a qualitatively valid preparation. To this end a formula will be submitted and the student will have to comment on it, proving to know the excipients, their main chemical and physical characteristics and incompatibility and will have to describe which pharmaceutical operations apply to produce a finished galenic product, in possession of the necessary qualitative requirements and properly packaged and labeled.

Pharmaceutical operations.
Grinding, mixing, solubilization, aseptic technique, sterilization, filtration. Labeling and packaging. Good Preparation Standards and quality in the production of medicines. Classification of pharmaceutical forms according to the route of administration.
Oral way.
Syrups, emulsions, suspensions, tablets, capsules, powders and granules, sachets. Bioavailability of oral forms.
Rectal way. Suppositories.
Penetration of the active substance through the mucosa, excipients, preparation.
Dermal route. Ointments.
Penetration of the active substance through the skin, excipients, preparation.
Ocular way. Eye drops.
Requirements required for an ocular formulation, preparation.
Parenteral route.
Properties of injectable preparations, formulations, preparation, aseptic packaging, sterile environments, vertical and horizontal laminar flow hoods.
Preparation of bags for total parenteral nutrition, anticancer drugs.

The Dublin descriptors will be the terms of assessment: D1 - KNOWLEDGE AND UNDERSTANDING: The student will know and understand the basic concepts of general pharmacology and the pharmacotoxicological characteristics of substances of abuse and various drug classes. D2 - ABILITY TO APPLY KNOWLEDGE AND UNDERSTANDING: The student will acquire the ability to use the theoretical knowledge taught in class to reason critically, demonstrating the ability to make connections between different topics and to apply the acquired knowledge in the context of clinical analyses of various drugs or toxic substances. D3 - JUDGMENT ABILITY: The student will acquire the ability to critically examine the theoretical concepts acquired and to be able to independently argue the problems arising from their practical application. D4-COMMUNICATIVE SKILLS: Students will acquire the ability to communicate their acquired knowledge using specific and appropriate vocabulary in order to communicate professionally and competently in both academic and professional settings. D5-LEARNING SKILLS: Students will acquire learning skills useful for ongoing training in the procedures required in a clinical analysis laboratory. Students will be able to prepare a galenic medicine using the correct technique, using the appropriate equipment, selecting the most appropriate excipients, and completing the label completely.