67194 - Technology and Regulation of Health Products I

Learning outcomes

At the end of the course the student has a good knowledge in the formulation and technological preparation of various types of health products with particular emphasis on functional aspects and applications and the different routes of administration, under the regulations.

Course contents

(The attendance to lessons is strongly recommended)

Module 1 : Dott. Leonardo Marchitto- 24 hours

Pharmaceutical technology and health products: the role and purposes. Pharmacopoeias: features and monographs. Pharm Eur, BP, USP, JP.

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.

Disperse systems technology: properties and characteristics, interfacial phenomena, colloidal systems, characteristics, zeta potential. DVLO theory.

Emulsions: emulsions, excipients theory used in emulsions, surfactants, uses and characteristics of surfactants, HLB, HLB calculation examples of a surfactant. Formulation of emulsions. Emulsion stability: coalescence, flocculation, creaming, emulsion “breaking”. Methods for emulsions preparation industrial and labo methods.

technological controls on emulsions. Test of the Pharmacopoeia

Microemulsions: characteristics, uses, formulation and development.

Suspension: characteristics, classification, excipients and wetting agents, wettability of the particles in suspension, the suspension formulation, stability: flocculation, sedimentation. Methods for the industrial preparation of the suspensions and of laboratory. technological controls. Test Pharmacopoeia.

Technology of semi-solid dosage forms for skin: the skin, hydrating the skin, percutaneous absorption and absorption pathways of active ingredients, techniques to increase percutaneous absorption, use of topical dosage forms, creams, ointments, pastes, gels, features , excipients and formulation: thickeners and suspending agents and their characteristics, criteria for the preservation of the formulations, antimicrobial and antioxidant choice and efficacy tests for antimicrobial excipients, industrial production of creams, ointments, gels and pastes: processes and equipment , products defects. Technological controls on semi-solid dosage forms for cutaneous use. Test of the Pharmacopoeia.

Rheology: viscosity and rheology, rheology of liquid and semi-solid systems, "normal stress", "shear stress", "shear rate" and deformations, rheograms, materials "like Liquid," "Solid-like" and viscoelastic systems, viscosity "Newtonian fluids" stickiness "non-Newtonian fluids", viscosity and temperature, fluid plastic, pseudo-plastic fluids, dilatant fluids, thixotropic, capillary viscometers, viscometers ball "falling ball", rotational viscometers. Rotational rheometer: use for monitoring and research, Brookfield viscometer: use to control viscosity.

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

Module 2: Dr. A. Mazzucco - "Cosmetics products" - 24 hours

Types of cosmetic products

Formulation and cosmetic ingredients

Test and control on cosmetic products

Preparation of cosmetics and cosmetic legislation

Module 3 Laboratoires

Preparation of powders, granules, tablets and capsules. Dimensional analysis of powders and granulates. Preparation of solutions, emulsions, hydrogels, lipogels pastes and ointments. Preparation of suppositories. Control assays according Pharmacopoeia.

Prior to start exercises of the workshop, the teacher in charge of the module will take an introductory lesson on the purpose and the general characteristics of the formulations to be prepared during the course as well as safety behavior in a pharmaceutical laboratory.

Readings/Bibliography

•P. Colombo et al., “Principi e Tecnologia Farmaceutica” casa Editrice Ambrosiana, Milano, II Ed. 2015

•E. Aulton “Tecnologie Farmaceutiche” ediz. Italiana ” EDRA editore 2015

•F. Bettiol, Manuale delle preparazioni galeniche, Tecniche Nuove.

• G. Proserpio, Chimica e Tecnica Cosmetica 2000 Vol I e II, Sinerga ed. Tecnico Scientifiche.

• J. KNOWLTON, Handbook of Cosmetic Science and Technology, Elsevier, 1993.

•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.

•Principi di Tecnica Farmaceutica – M. Amorosa – Libreria Universitaria Tinarelli – Bologna.

•notes from lectures

Teaching methods

lectures and laboratory work

Assessment methods

The evaluation of the student on teaching "Technology and Legislation of Health Product I" consists of a practical test and an oral exam.

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 score will be inclusive of the ascertained fitness to practice test. The assessment of the preparation of the candidate may also have other questions to specify aspects of the main questions.

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.

During the test it is not allowed the use of support material such textbooks, notes, computer media.

The goal of the practical test, performed using practical work, it is to verify the proper learning or the proper ability of preparation of pharmaceutical products , cosmetics and herbal with related technological controls. The test is passed when the candidate is given an approval certificate. This assessment has not expired validity. A “non approval certificate” for a student need e new test by the candidate. The duration of the practical test is two hours.

Teaching tools

Computer: power point presentations, workshop, video projector

Office hours

See the website of Leonardo Marchitto

See the website of Antonio Mazzucco

See the website of Luisa Stella Dolci