Pharmaceutical Technology IV

Code:

MI074131

Acronym:

TFARM4

Keywords
Classification	Keyword
OFICIAL	Technological Sciences

Instance: 2011/2012 - 1S

Active?	Yes
Web Page:	http://moodle.up.pt/course/view.php?id=3641
Responsible unit:	Pharmaceutical Technology Laboratory
Course/CS Responsible:	MSc in Pharmaceutical Sciences

Cycles of Study/Courses

Acronym	No. of Students	Study Plan	Curricular Years	Credits UCN	Credits ECTS	Contact hours	Total Time
MICF	214	Official Curriculum	4	-	6	52	162

Teaching language

Portuguese

Program

1. Ophtalmic preparations.
1.1. Rules to prepare eye drops: precision of compounding; clearness; adjustment of tonus (physical and biological methods); pH; sterility.
1.2. Solvents used in the preparation of eye-drops: buffer solutions.
1.3. Excipients used in the preparation of eye-drops: to increase therapeutic activity, to prolong drug release, anti-oxidants and preservatives.
1.4. Preparation of aqueous eye-drops: dissolution; filtration; packaging (used material, shape, preparation and filling); sterilization.
1.5. Oily eye-drops.
1.6. Ophtalmic suspensions.
1.7. Quality control of ophtalmic preparations.
1.8. Labeling.
2. Nasal preparations.
2.1. Effect of drugs on the nasal epitelium.
2.2. Excipients: pH; isotonicity; preservatives (viscosity, sterility).
2.3. Packaging of nasal preparations.
2.4. Control of nasal preparations (inocuity and sterility).
3. Parenteral preparations.
3.1. Excipients for parenteral preparations.
3.2. Packaging of parenteral preparations.
3.2.1. Glass: composition; hydrolitic attack; types.
3.2.2. Plastics: types; plastics used in the packaging of medicinal products.
3.2.3. Washing, filling and closure of ampoules; silicone coating and sterilization; filling by vacuum, unit filling, asseptic preparation; methods of closure.
3.3. Preparation of parenterals.
3.3.1. Definitive parenterals; sterilization.
3.3.2. Extemporaneous parenterals: sterilization and packaging of powders (asseptic preparation); freeze-drying.
3.4. Stability of parenterals: contamination; active substances decomposition; incompatibilities; effect of packaging; isomerization; decomposition with release of toxic products.
3.5. Control of parenterals: description; physical and chemical control; identification and assay; sterility and apirogeny.
3.6. Selection and packaging of ampoules.
4. Modified release dosage forms.
4.1. Bioavailability of dosage forms. Therapeutic action: absorption, distribution, metabolism and elimination of drugs.
4.2. Modified release dosage forms; terminology; dosage forms and availability; preparation (immediate dose and maintainance dose); physiological, physico-chemical and galenic methods.
4.3. Efficacy evaluation: “in vivo” and “in vitro” methods.
4.4. New therapeutic systems.
4.4.1. Terminology.
4.4.2. Actual therapeutic systems: transdermic patches; release by diffusion or by permeation of membranes; drug targetting: lipossomes.
5. Stability of medicines.
5.1. Drug produts instability.
5.2. Rate, molecularity and order of chemical reactions; reactions kinetics.
5.3. Evaluation of the order of reactions.
5.4. Effect of temperature in the rate of reactions.
5.5. Evaluation of the decomposition rate.
5.6. Evaluation of shelf-life.
6. Industrial pharmacy.
6.1. Organization of a manufacturer of dosage forms: departments and/or sections; the evolution of Quality; Good Manufacturing Practices; materials flow.
6.2. New products: chemical development, pharmacological, toxicological and clinical action; marketing authorization; manufacturing authorization; Regulatory affairs - national and international authorities.
6.3. Other definitions: galenic developmente and pharmaceutical development; analytical validation; process validation; planning; application of Good Manufacturing Practices and Quality Assurance Systems.

Evaluation Type

Distributed evaluation with final exam

Assessment Components

Description	Type	Time (hours)	Weight (%)	End date
Attendance (estimated)	Participação presencial	52,00
	Total:	-	0,00