67193 - Technology and Regulation of Health Products II

Learning outcomes

After completing the course, students acquire the knowledge training relatively to the formulation of health products with particular reference to the formulation, productive and regulatory. It also has knowledge of the techniques and methodologies for the quality control of health products intended as a safety evaluation, stability, presentable and effectiveness.

Course contents

(The attendance to lessons is strongly recommended)

Technology of solid dosage forms:

basic operations: grinding processes and machines, sieving processes and machinery, mixing processes and machinery, drying processes and machinery.

Powders: dimensional analysis, equipment and methods of dimensional control of dust, powder flow measurement and slip, granules, wet granulation processes and equipment, dry granulation processes and equipment, "melt granulation" processes and machinery.

Tablets, alternative tablet presses, rotary tablet presses, notes on physical of compression process, ingredients for the formulation of tablets, defectiveness of tablets, coated tablets, processes and equipment for coating tablets, ingredients for the coated tablets, coated tablets defects, sachets: processes and machinery, hard capsules, machinery and processes for preparation of hard capsules, excipients for hard capsule, "softgel" excipients and preparation processes of softgel, pellets and "pelletising" processes

Technological controls on solid dosage forms. Test of the Pharmacopoeia. Dissolution testing: methods and applications in control of pharmaceutical products.

Technology of liquid dosage forms:

basic operations: dissolution, filtration processes and machinery, notes on distillation, extraction, mixing of liquids. Solutions and their properties. Solubilization and methods of solubilization. Solvents, co-solvents, surface tension.. Water for pharmaceutical uses: types and methods of preparations.

Syrups: excipients, formulation, preparation methods, industrial and labo process, oral drops.

Ophthalmic and otological preparations.(fundamentals)

Technological controls on liquid dosage forms. Test of the Pharmacopoeia.

Technology of rectal, vaginal and urethral dosage forms: use in therapy of suppositories, vaginal pessaries and urethral preparations , rectal, vaginal and urethral absorption of active ingredients Formulation factors that influence rectal and vaginal absorption, rectal and vaginal administration: advantages and disadvantages, lipophilic excipients and their characteristics, hydrophilic excipients and their characteristics, formulation and choice of excipients, antioxidants and preservatives, thickeners, controls on excipients for suppositories , laboratory preparation of suppositories, "double melting", method, calculation of replacement factor, industrial production of suppositories: processes and machinery, defects, packaging: plastic and aluminum. Technological controls on suppositories and pessaries. Pharmacopoeial Test

Biopharmaceutical elements: concepts of bioavailability and bioequivalence, drug biopharmaceutical classification system (BCS) BCS system and role in the development of oral dosage forms, oral bioavailability: affecting factors, methods for evaluating bioavailability of a drug .

Formulation and industrial development of medicines: (fundamentals) strategic and practical approach to the development, role and functions of development pharmaceutics, regulations , ICH and EMA guidelines for development a medicinal product.

Formulation and development of herbal products, herbal remedies and dietary supplements: vegetable raw materials, herbal drugs: harvesting and transformation of vegetal products. Plant extracts, classification, herbal drugs and European Pharmacopoeia, vegetal extract preparation, machinery and processes: maceration, percolation, distillation, supercritical fluids extraction, " fast extractors ".

Technological and quality criteria for selection of raw materials for herbal products, herbal medicines and nutraceuticals. Galenic methods for herbals: definition, dosage forms. Formulation of herbal products and food supplements. Traditional herbal medicinal products: characteristics, regulation , EMA guidelines, development. Protocols stability for herbal formulations, herbal medicines, and nutraceutical products. Concept of 'Nutricosmetics". Design and quality of formulations and their functionality: practical examples. Production of herbal formulations, herbal medicines and nutraceuticals. Validation of production processes and "batch by batch." quality . Health claims, regulations and documentation for commercializing food supplements and herbal products.

module 2: Laboratory dott.ssa Roberta Zocchi

The teaching of laboratory module is carried out in 5 phases for all the pharmaceutical forms which are treated, in order to allow the student the acquisition of iter basic knowledge of proper development practices:

1. design (analysis of technical / regulatory feasibility)

2. formulation (theoretical)

3. technological production

4. technological compliance organoleptic control

5. review and / or validation of the formulation (and note to stability tests for nutraceuticals )

Development a dietary supplement in swallowable tablet

pratical activities related to Phase 3: wet granulation of the fiber constituents, adsorption of essential oils, mixing, sifting, tableting

pratical activities related to the phase 4: Visual Checks (appearance and color uniformity), uniformity of weight, hardness, friability, and the unbundling of the compressed time

Development a dietary supplement in chewable tablets

pratical activities related to Phase 3: adsorption of flavors, mixing, sifting, comprimitura

pratical activities related to the phase 4: Visual Checks (appearance and color uniformity), palatability, weight uniformity, hardness and friability of the tablet

Development of food supplements in liquid form

pratical activities related to the phase 3: preparation of the preservative solution, preparation of the final solution, any filtration

pratical activities related to the phase 4: Visual Checks (appearance, color change, formation of deposits, opalescence or outcrops), palatability of the possible, of any viscosity

Development of a medical device for vaginal use in hard capsules

pratical activities related to Phase 3: mixing, sifting, incapsulation

pratical activities related to the phase 4: Visual Checks (appearance, uniformity of capsule closure), weight uniformity, pH control and disaggregation time

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.
• 4) G. Proserpio, Chimica e Tecnica Cosmetica 2000 Vol I e II, Sinerga ed. Tecnico Scientifiche.
• 5) 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 fron the lectures

Teaching methods

lectures and laboratory work

Assessment methods

The evaluation of the student on teaching "Technology and Regulation of Health Product II" 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 Roberta Zocchi