PHARMACEUTICAL TECHNOLOGY AND LABORATORY

Single discipline educational activity

Course Sheet

Course code:

TFL010

Academic Year of enrolment:

2017

Year of supply:

2020/2021

Type of Course:

Characterising

Degree:

Course of Single Cycle Degree 5 years in PHARMACY

Disciplinary Sector:

Applied Technological Pharmaceutics

Language:

Italian

Location:

CHIETI

Divisions:

Cognomi A-G - Professor: CELIA Christian
Cognomi H-Z - Professor: DI MARZIO Luisa

Credits:

Programme Year:

Cycle:

First semester

Obligatory attendance:

Yes

Minimum hours of attendance:

Hours of classroom activity:

136

Individual study hours:

214

Prerequisites:

Chimica Farmaceutica e Tossicologica I

Objectives

The course offers an overview for the preparation, characterization and procedures of conventional and innovative pharmaceutical dosage forms. Students will acquire the basic knowledges for the production of galenic formulations and the relative information for managing the best practice in pharmacy.

Contents

SOLUTION AS PHARMACEUTICAL DOSAGE FORMS:
Fundamentals: Physical bases of dissolution process. Principles of dissolution. Dissolution process and analysis. Solubility measurements. Procedures to evaluate the solubility and concentration of solutions.
Water: Water for pharmaceutical use (deionized water, sterile water, water for injection, sterile water for injection). Procedures for water fabrication: filtration, ion-exchange, distillation, reverse and direct osmosis.
Solutions or colloidal suspensions: Fundamental and properties. Lyophilic and lyophobic colloids. Hydrophilic colloids or mucilage. Natural, semisynthetic and synthetic products forming hydrophilic colloids.
Gels: Fundamentals. Rheological properties. Physicochemical and pharmaceutical properties of gels.
Emulsions: Liquid-liquid systems. Surface-active agents. Classification of emulsions (W/O and O/W). Surfactants: properties, classification and choice of surfactants (Bancroft, HLB and its determination). Methods for preparation of the emulsions. Identification of emulsions. Physical factors affecting emulsion stability: creaming, flocculation and coalescence. Accelerated stability tests. Stokes' law and physical stability of emulsions. Application of emulsions. Micro-emulsions.
Suspensions: Physical and chemical characteristics of suspensions. Flocculated and deflocculated suspensions. Zeta potential and its role in the stability of suspensions. Preparation of suspensions and surfactant agents. Stability of suspensions. Fundamentals of pharmaceutical suspensions: oral, parenteral and topical application.
Syrups: Fundamentals and general properties. Syrups of F.U.I. Classification of syrups: regular, flavored and medicated. Modification of syrups for pharmaceutical use: sorbitol and saccharin. Procedures and equipment to make syrups: advantages and disadvantages of different methods. Storage and tests of syrups.

SEMISOLID PHARMACEUTICAL DOSAGE FORMS:
Epidermal and transdermal drug delivery: Anatomical and physiological features of the skin. Percutaneous absorption of drugs. Classifications: ointments, creams, pastes and gels. Physicochemical properties and fundamentals of hydrophilic and lipophilic excipients.

RECTAL AND VAGINAL DRUG DELIVERY:
Rectal and vaginal drug delivery: Introduction. Fundamentals. Physicochemical properties. Classification of excipients and related properties. Therapeutic use.
Suppositories and capsules for rectal delivery: Introduction. Fundamentals. Physicochemical properties. Lipophilic, water-dispersible and water-soluble excipients. Classification of excipients. Production and preparation methods of suppositories. Rectal adsorption of drugs.
Pessaries and vaginal tablets: Introduction. Fundamentals. Physicochemical properties. Classification of excipients. Vaginal adsorptions of drugs.
Urethral glow plugs: Introduction. Fundamentals. Physicochemical properties. Classification of excipients.

PARENTERAL DOSAGE FORMS:
Fundamentals. Classification of parenteral dosage forms according to F.U.I. PIntravenous administration: fundamentals, preparation, vehicles (water and natural oil), glass and plastic containers. Piggyback parenteral perfusion. Lyophilized powders for injection.

OPHTHALMIC DOSAGE FORMS:
Anatomy and physiology of the eye. Bioavailability and adsorption of drugs through the eye. Types of ophthalmic products: eye drops, ophthalmic solutions, ophthalmic suspensions, ophthalmic ointments, ocular insert, intraocular solution. Fundamentals, physicochemical properties and preparation methods. Osmolarity and relative determination.

NASAL DRUG DELIVERY:
Anatomy and physiology of the nose. Physicochemical factors influencing drug absorption in the nasal cavity. Strategy for improving drug availability in nasal administration. Nasal delivery systems and their formulations.
Aerosol: Fundamentals. Introduction. Adsorption of drugs through the nasal mucosa. Trans-mucosal adsorption. Mechanisms of adsorption through the nasal mucosa. Containers for the nasal drug delivery. Classification of the nasal dosage forms: liquid nasal dosage forms, squeeze-bottles nasal dosage forms, metered-dose pump systems, nasal powders.

PULMONARY DRUG DELIVERY:
Lung anatomy and physiology.
Biopharmaceutics of inhaled drug delivery: Size. Density. Shape. Influence of environmental humidity on particle size. Particle deposition in the airways.
Classification of pulmonary drug delivery: Fundamentals. Introduction. Excipients for inhaled drug delivery. Physicochemical properties. Classification and synthesis of inhaled drug delivery.
Nebulized drug delivery: Nebulizers, jet nebulizers, ultrasonic nebulizers, dry powder inhaler, formulating nebulizer fluids.
Metered dose inhaler: containers, propellants, metering valve, formulating metered-dose inhaler, filling metered-dose inhaler canisters, spacers and breath-actuated metered dose-dose inhalers.

PHARMACEUTICAL DOSAGE FORMS FOR ALTERNATIVE THERAPY:
Homeopathy: Fundamentals. Introduction. Physicochemical and technological properties. Management and law governing the production and distribution of homeopathy drug.
Plant and phytochemical drugs: Fundamentals. Introduction. Physicochemical and technological properties. Management and law governing the production and distribution of plant and phytochemical drugs.
Medical devices and latexes: Fundamentals. Introduction. Physicochemical and technological properties. Management and law governing the production and distribution of medical devices and latexes.
Veterinary drugs: Fundamentals. Introduction. Physicochemical and technological properties. Management and law governing the production and distribution of veterinary drugs.

BIOPHARMACEUTICS:
Release Adsorption Distribution Metabolism and Elimination (LADME): Fundamentals. Introduction. Drug adsorption. Drug delivery across the biological barriers. Administration routes and physiological factors that affect the drug absorption. Release of drug from delivery systems. Bioavailability: Fundamentals. Introduction. Plasmatic and urinary curve analysis. Multiple dose studies. Bioequivalence. Experimental protocols. Pre-formulation studies for innovative drug delivery.

DRUG DELIVERY SYSTEMS:
Fundamentals: Differences between drug delivery systems and conventional drug dosage form. Transport equations. Diffusion or transport of the substance: flow and Fick's first law, Fick's second law, diffusion in different media. Solubility and partition coefficient. Classification of drug delivery systems and relative mechanisms. Application of drug delivery systems.
Polymers: silicones; polyvinylchloride; polyethylene vinyl acetate; polyesters; polyamides; cellulose; polyurethanes; polyacrylates; polyethylene glycol. Analytical methods used for the characterization of polymers. Hydrogels. Therapeutic applications of drug delivery systems.
Dermal and transdermal patches: Fundamental. Introduction. Physicochemical and technological properties. Classifications. Mechanisms of drug delivery systems. Physicochemical properties of drug delivery systems. Pharmaceutical applications. Samples of transdermal patches: Nitroderm® and Transcop®.
Subcutaneous implants: Fundamentals. Introduction. Physicochemical and technological properties. Classifications. Mechanisms of drug delivery systems. Physicochemical properties of drug delivery systems. Pharmaceutical applications. Samples of intrauterine drug delivery systems: spirals, implants, intrauterine systems.
Osmotic drug delivery systems: Fundamentals. Introduction. Mechanisms regulating the release of drugs. Physicochemical and technological properties of osmotic drug delivery systems. Classification: osmotic systems with single compartment (elementary osmotic systems and controlled osmotic systems); multicompartiment osmotic systems (push-pull). Therapeutic applications of osmotic systems.

LIPID AND POLYMERIC BASED NANOPARTICLES:
Polymeric nanoparticles for oral administration: Fundamentals. Introduction. Physicochemical and technological properties. Physicochemical properties of payloads. Formulations based polymeric nanoparticles for oral administration.
Polymeric nanoparticles for trans-mucosal administration: Fundamentals. Introduction. Physicochemical and technological properties. Physicochemical properties of payloads. Formulations based polymeric nanoparticles for trans-mucosal administration.
Micro- and nano- particles: polymeric micro- and nano- particles, solid lipid nanoparticles, nanostructured lipid carrier systems. Synthesis and physicochemical characterization. Preparation procedures. Stability. Mechanisms of interaction with biological models. Route of administration. Therapeutic applications.
Vesicular nanocarriers: Fundamentals. Introduction. Classification of vesicular nanocarriers based on composition, size, shape and physical properties. Excipients used to make vesicular nanocarriers. Synthesis and physicochemical characterization. Preparation procedures. Stability. Mechanisms of interaction with biological models. Route of administration. Passive and active targeting strategies. Therapeutic applications of vesicular nanocarriers: liposomes, niosomes, transfersomes, ethosomes.

SUPRAMOLECULAR CARRIERS:
Pro-drugs: Fundamentals. Introduction. Physicochemical and technological properties to improve the delivery of payloads. Mechanisms of release.
Cyclodextrins: Fundamentals. Introduction. Physicochemical and technological properties of cyclodextrins. Classification of cyclodextrins (α, β, γ). Natural and synthetic cyclodextrins. Classification of preparation procedures to make the complex between drug and cyclodextrins. Physicochemical characterization of cyclodextrins: solid and liquid state procedures (differential scanning calorimetry, X-ray diffraction, circular dichroism, UV-Vis spectroscopy, nuclear magnetic resonance). Dissolution tests on cyclodextrin. Solubility studies of cyclodextrins. Active targeting of cyclodextrins.

ETHIC, SOCIO-ECONOMIC AND LEGAL IMPLICATIONS IN THE PRESCRIPTION AND DELIVERY OF MEDICINES:
Health system pharmacy. Professional activity in pharmacy. Delivery of medicines. Classifications of medical prescriptions. Management and delivery of toxic drugs. Mandatory records and equipment in pharmacy. Pharmaceutical care. Public and private pharmacy. Classification of pharmacies: urban, rural, rural with assistance, branch pharmacies, pharmaceutical dispensary, temporary pharmacy management. Ownership and management of private pharmacies. Organic plant and ordinary and extraordinary competition for pharmaceutical locations. Regulations relating to the management and delivery of drugs (D.P.R. 309/90) and relative amendments. Consolidated text of the laws on the subject of the regulation of narcotic drugs and psychotropic substances: purchase, possession, dispatch and possible destruction. Medicinal legislation. Classification of medicines: medicinal specialties, magisterial and industrial drugs, OTC, SOP, generics and specialty copy. Anti-doping legislation. Presentation of medicines: label and leaflet. Italian Official Pharmacopoeia (F.U.I.). European Pharmacopoeia. Deontological code.

Extended Syllabus

Recommended Bibliography

Farmacopea Ufficiale Italiana (F.U.I.) XII Edizione. Farmacopea Europea. Preparati galenici per uso umano, Ultima edizione. - AMOROSA M., Principi di tecnica farmaceutica, Libreria Universitaria Tinarelli, Bologna, Ultima edizione. - RAGAZZI E., Principi di Tecnica Farmaceutica, Libreria Cortina, Padova, Ultima edizione. - REMINGTON'S PHARMACEUTICAL SCIENCE, Ultima edizione. - MEDICAMENTA, Cooperativa Farmaceutica, Milano, Ultima edizione. - MARCHETTI M., MINGHETTI P., Legislazione Farmaceutica, Casa Ed. Ambrosiana, Ultima Edizione. - COLOMBO P., CATELLANI P.L., GAZZANIGA A., MENEGATTI E., VIDALE E., Principi di tecnologie farmaceutiche, Ambrosiana, Milano, Ultima edizione, - AULTON Tecnologie Farmaceutiche, Progettazione e allestimento dei medicinali, Caviglioli G., Coviello T., De Rosa G., Modena T., Ultima edizione; A.T. FLORENCE, D. ATTWOOD Le basi chimico-fisiche della tecnologia farmaceutica. Edises Ultima edizione.

Methods of Provision

Conventional

Teaching Methods

The course includes frontal lessons: interactive lesson (at least 2 hours) to be held in the classroom with the students; laboratory work (at least 4 hours) individual activity to make and calculate the cost of galenic medicines, that are part of program; class work (at least 2 hours) in the classroom the students will discuss topic developed in class during the activity and exercises by the teaching program. The educational activities are supplemented by a tutor activity provided to the students. The tutor is selected among the most eligible students of the Department of Pharmacy through a competitive call published by the University and evaluated by an appropriate commission selected by the Department of Pharmacy.

Evaluation methods

Verification of learning:

The exam consists of working laboratory test concerning of preparation and evaluation of cost of galenic formulation. The test required maximum 4 hours maximum and give the opportunity to attend a class working that has not any effect on the final score. All students, who successfully pass the working laboratory, will have the access to the written test which consists of 3 exercises (5 points each) and the description and cost analysis of galenic formulation (15 points). The test is passed if a minimum score of 18 points is obtained. The written test does not affect the final score of the student, but it is mandatory to get access to the oral exam. The oral exam consists of at least 5 questions covering all topics of program. The exam is considered passed if the minimum score of 18/30 is reached during the oral exam. The written test must be repeated by students who not pass the written test. The laboratory working exam will be made during the February and June calendar of the exams, except possible extensions provided by the Teacher, and it shell be valid for the full Academic Year. A supplementary laboratory exam shall be carried out during the summer season in the September.

Contacts/More Information

Individual laboratories activity.
Individual meetings after scheduled appointments and interactive discussion during teaching activities

Università degli Studi
"G. d'Annunzio"

Chieti - Pescara

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