16198 - Technology, Socio-Economics and Pharmaceutical Legislation II (GR.B)

Course contents

1st Module  Prof. I. Orienti
Bioavailability and bioequivalence.
Pharmaceutical dosage forms and pharmaceutical systems. Factors influencing drug absorption and drug availability. Pharmacokinetics. Plasma concentration –time curves. Absolute bioavailability. Relative bioavailability. Bioequivalence. Dose size and frequency of administration. 
 Physico-chemical processes that control drug release and drug absorption.
Fick's First and Second Lows. Passive diffusion through a membrane. Partition coefficient. Dissolution. Solubility. Thermodynamic parameters. Enhanced solubility. Micellisation. Salification. Complexation.
 Conventional drug delivery systems. Formulative and preparative aspects correlable with the administration route and the release characteristics. Powders, Granules, Tablets, Capsules, Solutions, Suspensions, Emulsions, Ointments, Hydrogels, Lipogels, Pastes.
 Controlled drug delivery systems. Physico-chemical properties of the excipients correlable with the release characteristics.
Diffusion controlled devices. Monolithic devices. Reservoir devices. Solvent controlled devices. Osmotically controlled devices. Swelling controlled devices. Chemically controlled devices.
 Drug targeting. Passive targeting. Active targeting. Preparation of drug containing microparticulates. Liposomes. Microspheres. Microcapsules. Cells. In vivo barriers to microparticulate distribution. Macromolecular systems. Selected examples of drug delivery with microparticulate and macromolecular systems.    
2nd Module  D.ssa G. Zuccari
General overview of the European Union pharmaceutical legislation concerning medicinal products for human use (Good Manufacturing Practice, procedures for Marketing authorisation, the Common Technical Document). Controls on the final drug product (medicine): Solid dosage forms (granules, tablets, capsules): uniformity of mass, uniformity of content, resistance to crushing of tablets, friability of tablets, disintegration test, dissolution tests. Liquid dosage forms (solutions, emulsions, suspensions): uniformity of mass, uniformity of content, dose and uniformity of dose, deliverable mass or volume, organoleptic characteristics, pH. Semi-solid dosage forms for cutaneous application (ointments, creams, gels and pastes): uniformity of mass, uniformity of content, deliverable mass or volume, organoleptic characteristics, consistency, viscosity, release tests. Suppositories and pessaries: uniformity of mass, uniformity of content, softening time determination, resistance to rupture, disintegration test, dissolution tests. Parental preparations : extractable volume, particulate contamination, pH. Preparation for inhalation: uniformity of delivered dose, number of deliveries, aerodynamic assessment of fine particles. Stability studies Stability of a drug product, ICH/CPMP guidelines for stability tests (long-term, accelerated and stress studies).

3th Module     Laboratories

1: Preparing a mucilage base

    Preparation of a wet granulate; using granulator

    Preparing oleogel and hydrogel

    Uniformity of weight of tablets

 

2: Dimensional analysis using sieves, vibrating screen

     Measuring angle of repose of a granular material

     Prepare a paste and demonstration of the Refiner

     Preparing emulgel

 

3: Measurement of the density of a powder with a hydrometer

     Monsanto hardness tester

     Friabilometer

     De-aggregator

     Preparation of an emulsion and analysis using Microscope

     Suppositories with the method of the double fusion

    

4: Manual Capsule filling machine (and uniformity of mass on the capsules)

     Demonstration and explanation of the operation of the tabletting machine

     Measurement of the content of a tablet using spectrophotometer

Readings/Bibliography

1) SWARBRICK, BOYLAN, Encyclopedia of Pharmaceutical Technology, Dekker, 1999-2005. 2) Italian and European Pharmacopeia

Teaching methods

lessons and lab exercises

Assessment methods

1st Module

The Assessment of the first module occurs only with the final exam, which ensures the acquisition of knowledge and skills expected by conducting a written test lasting 1 hour. 
The final exam test is intended to verify the achievement of the following objectives:

Knowledge of the  main functional differences among the different pharmaceutical formulations in relation to the physico-chemical characteristics of the excipients and the preparative methods. Correlations between drug release and administration environment. Evaluation methods for drug release. Correlations between release kinetics and bioavailability. Methods to improve bioavailability. Preparative methods for micro/nano particulate drug delivery systems and their functional evaluation.

The written test will consist of 16 questions with multiple choice answer. It will last 1 hour and the final evaluation will be done by assigning +2 to each correct answer,  - 1 to each wrong answer, -0.5 to each unanswered question.

 

2nd  Module
The Assessment of the second module occurs only with the final exam, which ensures the acquisition of knowledge and skills expected by conducting an oral examination.
The final exam test is intended to verify the achievement of the following objectives:
Knowledge of the main technological controls on pharmaceutical formulations aimed at meeting regulatory standards for safety, effectiveness and stability. 

This program provides training in pharmaceutical analysis, product formulation, quality assurance/control and manufacturing, microbiology and toxicology. The practical training provides students with hands on experience necessary to perform drug assays. Relevant GMP and regulatory requirements are included.

Teaching tools

power point

Office hours

See the website of Isabella Orienti

See the website of Guendalina Zuccari

See the website of Marcello Di Sabatino