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

Learning outcomes

The aim of this course is providing students with the knowledge regarding innovative pharmaceutical formulations, nanoparticulate systems and modified drug release. Moreover the course will provide knowledge about the main aspects drug of bioavailability correlated with the characteristics of the excipients in the pharmaceutical formulation. Laboratory activity will also be provided to support the learning activity.

Course contents

1st  Module   Prof.ssa I. Orienti

Pharmacokinetic models for  the drug distribution in the body
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. 
 
Conventional drug delivery systems Formulative and preparative aspects correlable with the administration route and the release characteristics of the pharmaceutical formulation. Dissolution. Partition. Methods to modify the drug dissolution and partition from the conventional pharmaceutical formulations.

Modified release 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.
 
Innovative pharmaceutical formulations. Micro and nanoparticulate systems. Macromolecular systems. Liposomes. Micelles. Formulative, preparative physico-chemical and functional characteristics correlable to their utilization in the conventional, controlled, modified release or in passive and active drug targeting.

 

2nd module  Dott.ssa  Cristina Cavallari

The pharmaceutical technologist. Development of a pharmaceutical form. Good practices for pharmaceutical development. Laboratory of Pharmaceutical development.
pre-formulative Developments. Chemical stability. compatibility and interactions.
Nature of the physical state of drugs and excipients
The polymorph state. The amorphous state. The glass transition temperature. Stabilizing the amorphous state.
Analysis of the solid state: Thermal analysis: DSC, TGA, and HSM. X-ray diffraction
Routes of administration of drugs. Pharmaceutical forms for oral use: pellets (production methods and technologies), capsules and effervescent tablets. . Preparations for parenteral use.
Pharmaceutical forms can be administered by transmucosal: prepared for nasal administration, pulmonary, ocular, buccal and vaginal
Gastro-resistant pharmaceutical forms: Examples and materials used
Release oral pharmaceutical forms: colon-specific systems
Route of administration of ophthalmic drugs.
The inhalation of dust and aerosols.
The orodispersible formulations.
The vaginal preparations
Polymers of pharmaceutical interest: Polyvinylpirrolidone (PVP), Polyethylenglicols (PEG), poloxamers; acrylic polymers (Carbopol and EUDRAGIT).
Polysaccharide polymers: cellulose, derivatives (HPMC) and chitosan.
Taste masking of oral pharmaceutical forms.
Freeze drying: process description, formulation and development.

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

- SWARBRICK, BOYLAN, Encyclopedia of Pharmaceutical Technology, Dekker, 1999-2005.

- P. Colombo, P. Castellani, A. Gazzaniga, E. Menegatti, E. Vidale, Principles of Pharmaceutical Technology, Casa Editrice Ambrosiana, Milan, 2004.
- A. T. Florence, D. Attwood, chemical and physical bases of Pharmaceutical Technology, EdiSES Srl, Naples, 2006.
- Handbook of pharmaceutical excipients, 6th ed. Edited by Raymond C. Rowe, Paul J. Sheskey, Sian C. Owen, Pharmaceutical Press and American Pharmacists Association, Chicago, 2009

Teaching methods

Lesson and  laboratory practice / 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 or 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 a written test lasting 2 hours without the aid of notes or books, followed by a oral examination in character (optional).
The final exam test is intended to verify the achievement of the following objectives:
Basic principles necessary to the formulation, production of oral pharmaceutical forms, pellets, capsules and effervescent tablets. for nasal, buccal, ophthalmic, vaginal and targeted to the colon as well as a deeper understanding of some excipients commonly used in pharmaceutical technology.

The written test, preparatory to the oral one, consists of 3 open-ended questions

Teaching tools

power point

Office hours

See the website of Isabella Orienti

See the website of Cristina Cavallari

See the website of Cristina Cavallari