32046 - Pharmaceutical Technology and Law II

Learning outcomes

After completing the course the student knows the chemical and
physical characteristics of pharmaceutical excipients and methods
of preparation and functional assessment of pharmaceutical
formulations for controlled release and bio-distribution of drugs.
The student will be able to apply their knowledge to the
implementation and evaluation of innovative and conventional
pharmaceutical forms.

Course contents

Module 1 Prof.ssa I. Orienti
Pharmacokinetic model of the drug disposition in the body related
to therapeutic system.
Therapeutic systems. Release, absorption, distribution, metabolism
and elimination of drugs. Dose and dose bioavailable. AUC. Absolute
bioavailability and relative bioavailability. Bioequivalence:
chemically equivalent and bioequivalent alternative products.
Dosing regimens and blood levels. Loading doses and maintenance
doses. Dosing regimens ideal. Control of plasma by formulation
variables. Biopharmaceutical aspects in pharmaceutical systems for
immediate release or modified release.

Pharmaceutical forms and nano-particulate drug
targeting
Passive targeting passive, active and physical. Polymeric
nanoparticles, solid lipid nanoparticles, dendrimers, liposomes,
macromolecular systems and self-assembling. polymers. Systems for
the gene-delivery. Chemical and physical characteristics of the
drug-carrier systems, preparative technologies and functional
characteristics.

MODULE 2 “FORMULATION AND PHARMACEUTICAL
DEVELOPMENT” - dr. L. Marchitto
(The attendance is strongly recommended : compulsory attendance of at least 60% of lessons and 80% of the laboratory exercises: article 4 of the regulation of the course)
General quality criteria and technical legislation for drug development: basic definitions, the European Medicines Agency (EMA), European and Italian legislation for a medicinal product. Marketing Authorisation procedures, procedures for registration for a medicinal product, Italian Drug Agency (AIFA), authorization for production, Common Technical Document (CTD / Dossier): content, activities for development a medicinal product, the quality of the raw materials used, EDMF (European Drug Master File), quality of excipients.
Formulation and development of pharmaceutical forms liquid / semi-solid:
Industrial development and validation of oral liquid and semi-solid dosage forms. Transdermal Systems, Aerosol inhalers(fundamentals), muco-adhesive formulations: oro-mucosal, ophthalmic, nasal, vaginal.( fundamentals)
Formulation and development of solid oral dosage forms: Industrial development and validation of solid dosage forms, pellets and pellet production; Oro-dispersible granules and tablets, oro-dispersible film-strip, "Taste Masking" technologies, solid dosage forms and modified release: gastro-protection, sustained release, dissolution test in drug development.( fundamentals)
Formulation and pharmaceutical development of medicines for paediatric  use: guideline
Cosmetics: core technologies, ingredients, formulation and preparation
Pharmaceutical packaging technology:characteristics and used materials , primary packaging, role in the formulation and stability of a medicinal product, "extractable and leachable", secondary packaging, purpose and role of communication to users

Stability studies on medicines.
 
The pharmaceutical preformulation: preformulation as part of the development of a medicinal product, objectives of studies, characterization of the active substance: fundamental properties and derived properties, organoleptic characteristics: color, odor, flavor, properties of drugs and excipients in solid form: crystal habit, analysis of the solid state, polymorphism and bioavailability of drugs, partition coefficient oil / water solubility and intrinsic solubility, degree of ionization of an active and salting. Drug /excipients compatibility studies.
Regulations and ICH guidelines and EMA for the development of a medicinal product(fundamentals)

3th Module Laboratory

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) P. Colombo et al., Principles and Pharmaceutical Technologies, Editrice Ambrosiana, Milan, I Ed. 2004
2) Swarbrick, BOYLAN, Encyclopedia of Pharmaceutical Technology, Dekker, 1999-2005.
3) 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.
4) Principles of Pharmaceutical Technology - M. Amorosa - Libreria Universitaria Tinarelli - Bologna.
5) Class notes

 

Teaching methods

theoretical lessons and Laboratory exercises

Assessment methods

The student evaluation of "Technology and Pharmaceutical
Legislation II (Formulation and Pharmaceutical Development)" course
consists of an oral test. The teacher will communicate during the
course if it also provided a written test. </p>


The oral test is intended to check the acquisition of knowledge
required as detailed in the objectives of the course and will be
deemed superseded by the correct response to certain questions
relating to the main topics covered during the course. The
assessment of the preparation of the candidate may also have other
questions to specify aspects of the main questions. The score will
be inclusive of the overcoming of any written test.</p>

In the evaluation of the responses of the candidate, the commission
will pay particular attention when assessing the acquisition of a
logical-deductive method of contents.</p>

During the oral and written evidence of the possible is not allowed
the use of support material such as textbooks, notes, computer
media.


Note: The final vote on the course "Pharmaceutical Technology and
Law II" will be made from the average of the grade obtained by the
student in the theoretical module 1 (Prof. I. Orienti) and the
theoretical module 2 "Formulation and Drug Development" ( dr. L.
Marchitto) as well by passing the laboratory practice test (Dr. A.
Mazzucco)

Teaching tools

Computer: power point presentations, video projector

Office hours

See the website of Isabella Orienti

See the website of Leonardo Marchitto

See the website of Antonio Mazzucco