010TEC - PHARMACEUTICAL TECHNOLOGY AND LEGISLATION WITH LABORATORY

courses

ID:

010TEC

Duration (hours):

88

CFU:

SSD:

FARMACEUTICO TECNOLOGICO APPLICATIVO

Located in:

CHIETI

Url:

Course Details:

MEDICINAL CHEMISTRY AND PHARMACEUTICAL TECHNOLOGY /CORSO GENERICO Year: 4

Year:

2025

Course Catalogue:

https://unich.coursecatalogue.cineca.it/af/2025?co...

Date/time interval

Primo Semestre (01/10/2025 - 31/01/2026)

Course Objectives

The expected learning outcomes are in relation to the necessary skills in the pharmaceutical technology sector pertaining to the design and development of pharmaceutical dosage forms, and the knowledge of the legislative regulations of the pharmaceutical sector and to the knowledge of the industrial organization relating to the production of drugs.

Course Prerequisites

Chimica Farmaceutica e Tossicologica 1

Teaching Methods

The course consists of 60 hours of frontal teaching lessons, 40 hours of galenic laboratory exercises and at least two seminars with topics to be agreed held by experts from the Pharmaceutical Industry

Assessment Methods

The evaluation will be carried out through a written technological-legislative test and an oral interview.

Texts

-A. Martin. Physical Pharmacy, fourth ed.. Williams & Wilkins.
-M. E. Aulton. The Science of Dosage Form. Churchill Livingstone.
-A. T. Florence, D. Attwood. Le basi chimico-fisiche della tecnologia farmaceutica EdiSES.
-R. E. Notari, Biopharmaceutics and Clinical Pharmacokinetics-an Introduction. Marcel Dekker, inc..
-J. L. Bootman, R. J. Townsend. W. F. McGhan. Introduzione alla Farmacoeconomia. OEMF.
- F.U.I. XII ed. e successive integrazioni/correzioni

Pharmaceutical technology: definition
- Biopharmaceutics and Pharmacokinetics: Bioavailability and therapeutic effect. Chemical and biological equivalence. Factors that affect the bioavailability. Kinetics of the processes of absorption, distribution, metabolism and elimination in relation to routes of drug administration. Curves of blood levels and pharmacokinetic parameters: biological half-life , absorption and elimination constants , apparent volume of distribution. Evaluation of clearance of a drug. Non- compartmental and compartmental models .
Techniques of preparation, routinely control tests and biopharmaceutical evaluations of solid dosage forms: powders, granules, tablets, capsules.
-Continuous Manufacturing Processes
-Ethyl alcohol: definition and determination of the alcohol content.
- Natural extracts for the pharmaceutical industry .
The aqueous and non – aqueous solutions.
-Water for pharmaceutical use.
-Isotonic solutions.
-Sterilization Methods.
-Preparations for ophthalmic use .
-Preparations for parenteral use .
-Syrups and elixirs.
-Interfacial phenomena: surface tension and surfactants. Disperse systems : wettability , flocculation , sedimentation.
- Colloidal dispersions.
- Emulsions and suspensions.
-Rheology: Newtonian and non-Newtonian fluids. Thixotropy. Viscosity
determination methods. Creep test. Measures in oscillatory.
-The semi-solid dosage forms. Percutaneous absorption: theoretical principles
-Preparations for dermatological use: chemical-physical features, and classification of the excipients used.
-Transdermal patches
-Rectal and vaginal drug delivery
-Pulmonary drug delivery
- Stability and stabilization of drugs
- Homeopathy and homeopathic preparations: formulation and legislative aspects .

Laboratory classes
Powders and Capsules, Dermal semisolid preparations, emulsions, suspensions, syrups, suppositories.

PHARMACEUTICAL LEGISLATION
-Italian Pharmacopoeia.
-European Pharmacopoeia .
-The Pharmaceutical Service
-Hospital pharmacies.
-The prescription: definition and classification, the obligations of the pharmacist
- Medicinal products for veterinary use
-Narcotic drugs and psychotropic substances:
-Good Manufacture Practices.
-Generics: current regulations on production and marketing.
-Biosililars
-Off-label use for pharmaceutical drugs
-Procedures for authorizing the production of the active ingredients and medicinal products for human and veterinary use.
- Cosmetics legislation
- Classification of medical devices
-Botanicals : pharmaceutical and legislation overwiev
- Labeling , packaging and advertising of medicines