Farmacotecnia Industrial II - Fful

Objectives

Concerning the dispersed systems (emulsions, suspensions and aerosols) and different dosage forms (ointments, suppositories and pessaries) the students shall: • Have a broad overview of the possibilities that the offer regarding the delivery of drugs, as well as their therapeutic benefits from its use • Explain the nature, sequence and organization of unit processes involved in the production and quality control to conform to the specifications of the manufactured product •Know industrial equipment for production •Recognize the existence of the regulatory universe and the configuration, utilities, support systems and flows of industrial pharmaceutical units

Syllabus

EMULSIONS, SUSPENSIONS, AEROSSOLES, OITMENTS, CREAMS, GELS, PASTES, SUPPOSITORIES and PESARIES: Physical aspects Basic properties and characteristics. Excipients. Formulation. Preparation and Production. Equipment. Quality Control. Preservation. CYCLODEXTRINS: Application, advantages of their use and examples of formulations. PHARMACEUTICAL INDUSTRY: Facts and figures; Regulatory universe: CGMP's Eudralex, ISPE guides, GAMP® 5, ISO, ICH; Configuration of industrial pharmaceutical units; Utilities and support systems; Architecture and design of facilities; Process, equipment, people and waste flows; Zone concept. PRACTICAL CLASSES: Numerical application exercises on emulsions and suspensions. Proposal for formulation, production (flowchart and equipment), and quality control (analytical certificate): of emulsions and oral suspensions; of ointments, creams, gels and pastes; and of suppositories and ovules. Reading and presentation of a scientific article on cyclodextrins.

Prerequisites

Any student that has been admitted to the following 2nd Cycle programmes are elligible to take this course: MEFARM, MEQ, MEBIOL, MEBIOM or MEAMBI.

Cross Competence Component

This unit provides the skills necessary to be able to read, navigate and understand international GMP and Quality Systems legislation, across multiple regulatory regions, as a function of quality culture differences and its relation to patient safety, assurance in terms therapeutic efficacy and their relation to product quality.

Laboratorial Component

Lab sessions to execute the galenic program and equipment familiarization.

Programming And Computing Component

Not applicable in the context of Programming and Computing. The course unit requires skills in Internet research, information searching, and the ability to understand what Project Functional Requirements and Specifications of different commercial software platforms (URS; FRS; FDS) available for the Pharmaceutical Industry are.

Ethical Principles

All members of a group are responsible for the group’s work In any assessment every student shall honestly disclose any help received and sources used. In an oral assessment, every student shall be alble to present and answer questions about the entire assignment and solution.