B029431 - INNOVATIVE PHARMACEUTICAL FORMS AND MEDICAL DEVICES

Italian

To introduce the principles underlying the design, preparation / production and control of the main unconventional pharmaceutical forms, with particular reference to the innovative ones for the different routes of administration. The course aims to provide advanced knowledge on the most recent aspects of biopharmaceuticals applied to the delivery of active ingredients and medical devices, capable of optimizing therapy in humans.

Colombo et al.“Principi di tecnologie farmaceutiche”Ambrosiana Ed.
Aulton M.E. “Pharmaceutics”Churchill Livingstone Ed.
FlorenceA.T. Attwood D. “Physicochemical Principles of Pharmacy”Macmillan Press Ed.
Amorosa M. “Principi di Tecnica Farmaceutica”
European Pharmacopoeia 8° ed.
Vincieri, Cirinei e Cervini “La gestione normativa dei medicinali” Il pensiero Scientifico Ed.

The objective of the course is to provide in-depth knowledge on innovative formulations (both those on the market and those currently under development) and medical devices and general knowledge on how they are designed, developed and produced. A further objective is to provide students with the tools for a correct processing of knowledge and for their integration with what has been acquired in previous years and to be able to compare the formulations and innovative strategies for administering drugs (subject of the course) with traditional formulations and routes of administration. Also provide knowledge for each type of formulation / medical device / route of administration or release mechanism, the potential, any limitations, the impact on patient therapy and any critical issues. The aspects of pharmacokinetics, release, absorption, distribution, metabolization and elimination of drugs, administered dose and bioavailable dose, and bioequivalence will be addressed. Formulative and preparative characteristics in relation to the route of administration and therapeutic purposes. Physico-chemical and functional characteristics of excipients. Correlation between the main formulation and preparation parameters and the release characteristics. Passive and active management. Microparticulate systems, nanoparticulate vesicles, self-assembling macromolecular and polymeric systems. Formulation of biological drugs and blood products, radiopharmaceuticals. The concepts of stability and storage of medicines in general will also be introduced and notions on homeopathic preparations and orphan drugs will be provided. Finally, issues related to the chemical and technological notions necessary to solve problems of development and production of biomaterials and medical devices will be addressed and examples based on risk classes.

Students are required to have an excellent knowledge of traditional pharmaceutical technology, which is the basis of innovative pharmaceutical forms.
Lezioni con ausilio di presentazioni sul computer

Lessons using ppt presentation

Oral examination. The evaluation parameters will focus on the ability to organize knowledge discursively, the ability of critical reasoning on the study carried out, the quality of the exposure and competence in the use of specialized vocabulary

Biopharmaceutical aspects of conventional and advanced pharmaceutical forms. Bioavailability and bioequivalence: definitions, BCS definition, guidelines for the study of bioavailability and bioequivalence, equivalent medicines. Innovative technological strategies. Classification of modified release pharmaceutical forms. Active and passive directing, the controlled release of drugs. Modified release and targeted release site pharmaceutical forms. Modified release and targeted release site pharmaceutical forms: definition (sustained, delayed, repeated release, mucoadhesive, colonic), routes of administration (parenteral, oral, ophthalmic and intrauterine systems, implants, transdermal patches). FU realization, applications and assays. Inhalation preparations: definition, liquid and powder preparations, implementation, applications and FU assays. Medicated foams: definition, realization, applications and FU assays. Transdermal implants and patches. Micro- and nanoparticulate vectors. Polymers used in the preparation of modified release pharmaceutical forms: classification and properties. Systems controlled by drug diffusion: reservoir systems. Membrane systems: polymers used, preparation, advantages, limits, characteristics, applications. Vesicles: lipids, preparation, classification, advantages and limitations, applications. Solid lipid nanoparticles: lipids used, preparation, advantages, limits, characteristics, applications. Characteristic polymeric micelles and dendrimers, formulation properties, modifications and applications; Ion exchange resins preparation, characterization, advantages, limitations, application. Solvent controlled release systems: osmotic pumps. Bioadhesive systems and mucoadhesive systems; mucus adhesion. Installations. Reserve systems. Matrix systems. Solvent activated systems. Biodegradable systems. Main methodologies for modifying the release kinetics of drugs from such systems. Formulation of biotechnological drugs preparation, advantages, limits, characteristics, applications. Stability and storage of medicines. Radiopharmaceuticals: strategies, problems and controls. Preparations present in FU. Stability, stabilization and storage of drugs: stability acceptability criteria, causes of drug degradation, kinetics of decomposition reactions, stability tests. Herbal medicines: definitions, regulatory aspects, differentiation of phytotherapics from food supplements of plant origin and other botanical derivatives. Homeopathic preparations: definition, implementation, FU controls, regulatory aspects. Orphan drugs: definition of orphan drug, rare and neglected diseases. Classification of medical and diagnostic devices, in particular risk classes, CE compliance and specific regulations of the different classes of devices and hints on the device market various examples of medical and diagnostic devices.