Unit PHARMACEUTICAL TECHNOLOGY AND GALENIC LABORATORY

Course
Pharmacy
Study-unit Code
A000528
Location
PERUGIA
Curriculum
In all curricula
Teacher
Cinzia Pagano
Teachers
  • Cinzia Pagano
Hours
  • 184 ore - Cinzia Pagano
CFU
10
Course Regulation
Coorte 2019
Offered
2022/23
Learning activities
Caratterizzante
Area
Discipline chimiche, farmaceutiche e tecnologiche
Academic discipline
CHIM/09
Type of study-unit
Obbligatorio (Required)
Type of learning activities
Attività formativa monodisciplinare
Language of instruction
Italian
Contents
Pharmaceutical technology: conventional dosage forms for drugs administration. Preparation methods both for industrial and galenic medicines. Regulatory aspects for the magistral and officinal prescriptions.
Laboratory: preparation of galenic formulations for both oral and topical use.
Reference texts
P. Colombo et al., Principi di Tecnologie Farmaceutiche Casa Editrice Ambrosiana, 2015;

M.E. Aulton, K.M.G. Taylor, Tecnologie farmaceutiche, Progettazione e allestimento dei medicinali, eds Aulton, Edra LSWR, 2015

F. Bettiol. Manuale delle preparazioni galeniche. IV Edizione. Tecniche Nuove. Milano

Paola Minghetti, Legislazione farmaceutica, 10th Ed., Casa Editrice Ambrosiana. Zanichelli. 2021
Educational objectives
The main aim of this teaching is to provide students the bases for the design and realization of conventional dosage forms both industrial and galenic.
Main knowledge acquired will be:
- methods and instruments for conventional formulation preparation: powders, granules, tablets, capsules, syrups, suspensions and emulsions for oral use, semi-solid preparations for cutaneous application, formulations for rectal use, ophthalmic formulations and injectable preparations;
- distinction between magistral and officinal galenic preparations;
- regulatory aspects for magistral and officinal galenic products preparation and dispensing;
- techniques and methods used in pharmacy for the preparation of: powders, capsules, liquid dosage forms for oral administration (solutions, suspensions, emulsions), semisolid preparations for cutaneous use (oinments, pastes, creams, gels, cream-gel);
- regulatory aspects of magistral prescriptions.
Prerequisites
In order to follow the course “Tecnologia Farmaceutica e Laboratorio Galenico” and to take the exam it is required that the student has already passed the exams of:
- Chimica Organica
-Fisiologia Generale
Teaching methods
The course is organized as follows:
- Lectures on all subjects of the course (7 CFU);
- Laboratory exercises (3 CFU) at the didactic laboratory of pharmaceutical technology. The students will be involved in the preparation of the main products prepared in pharmacy as: powders, capsules, liquid formulations for oral use, oinments, pastes, creams, gels, emulgels.
Learning verification modality
A Practical test will be performed at the end of laboratory practices (lasting 2 hours). It consists in the preparation and simulation of the dispensing of a magistral or officinal preparation. The student must identify the type of prescription and indicate its formalism, correctly describe the preparation of the prescribed formula and quality controls which must be performed, indicate all aspects inherent the Good Manufacturing Practice Guidelines for the pharmacist. This test allows to evaluate the acquisition of theoretical and practical knowledge regarding the dispensing of medicines in the pharmacy. This allows to verify both the ability to apply the acquired knowledge and skills for the right preparation and dispensing of magistral and officinal products.
An oral exam will consist in an interview 30 minutes long (but it depends on the performance of the test itself) aiming to verify the knowledge level and the understanding capability acquired by the student on theoretical and methodological contents as indicated on the program. The exam has the aim to evaluate the student communication skills and his autonomy in the organization and exposure of the topics of the course.
Extended program
Farmacopea Ufficiale Italiana (F.U.): general chapters, monographs. Tables: 1-8. Good Practice Galenic Preparation integrals and simplified. General rules and safety in pharmacy and in the galenic laboratory.
Medicines produced in pharmacy: magistral, officinal and hospital galenic products. Regulatory aspects for the dispensing of magistral prescriptions of substances listed in Tab. 4 and 5 (except for narcotic and psychotropic substances) of the Farmacopea Ufficiale Italiana (F.U.). Medicines National Tariff. Label for magistral and officinal galenic products.
Main rules of biopharmaceutics. LADME, factors responsible for the bioavailability of the active ingredient in a dosage from, Noyes-Whitney law, Fick law.
Excipients: definition and classification. Medicines and drugs: definitions and main regulatory aspects.
Powders. Classification according to F.U. and uses. Powder properties. Hygroscopicity, deliquescence, efflorescence, eutectic. Methods for powders production: crystallization, precipitation, sublimation, crushing, grinding, micronization. Grinding methods and instruments (mills and micronizers). Properties of materials that influence the grinding process. Factors responsible for powders mixing efficiency (density, shape, humidity, flow, components ratio). Mixers: rotating and fix body. Spray drying.
Granules. Definition, classification, excipients, properties. Dry and wet granulation. fluid bed granulator.
Pellets. Formation and preparation techniques.
Tablets. Definition and classification according F.U. Preparation. Excipients for tablets. Compression phases, rotary tablet machines, alternative tablet machine. Coated tablets. Coating types, methods and equipments. Sugar-coating.
Capsules: hard and soft. Definitions, properties and uses. Excipients for hard and soft capsules production. Production methods.
Liquid formulations. Water solutions. Solubility and factors influencing it (solvents, co-solvents, temperature, pH, ionic strength, surfactants, complexing agents). Colligative properties of solutions.
Suspensions. Properties of liquid surfaces: interfacial energy and interfacial tension, surface energy and tension, solid surfaces wettability (contact angle). Measurement of surface and interfacial tension. Colloidal dispersions. Lyophilic and lyophobic colloids, association colloids (micelles, CMC). Physical stability of colloid dispersions. Pharmaceutical uses of colloidal dispersions. Suspensions stability: Stokes law. Zeta Potential, DLVO theory, deflocculation, coagulation (cake, flocculation, flocculation degree). Suspensions preparation. Stability.
Emulsions. Types and uses, emulsifiers (types, mechanism of action), Bancroft rule, HLB. Surfactants: classification, properties, uses and mechanism of action. Stability/instability of emulsions, creaming, coalescence, breaking, phase inversion, Ostwald ripening. Preparation methods.
Semisolid formulations for cutaneous application. Skin physiology. Percutaneous absorption of active ingredients. Excipients and preparation methods for: oinments, creams W/O and O/W, gels, pastes, emulgels, cataplasms and medicated poultice.
Rectal formulations: FU definition and uses. Excipients and preparation methods.
Injectable preparations. Freeze-drying. Water for injection properties and controls: visual inspection, pyrogen test.
Ophthalmic formulations. Eye physiology. Absorption pathways. Properties of formulations for ophtalmic use (eyewash, powders, semisolid formulations).
Galenic laboratory (single seat). Multidose and single-dose powders. Hard capsules. Solutions, suspensions and emulsions for oral use. Oinments, pastes, creams, gels, cream-gel.
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