Biopharmacy and Pharmacokinetic

Code:

MI074256

Acronym:

BIOFFC

Keywords
Classification	Keyword
OFICIAL	Technological Sciences

Instance: 2019/2020 - 2S

Active?	Yes
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	186	Official Curriculum	3	-	3	52	81

Teaching language

Portuguese

Objectives

The student must get the theoretical knowledges in order to understand therapeutic inequivalence resulting from biological or technological causes.
The student should also get the pharmacokinetics knowledge that enables him to establish and change posological plans.

Learning outcomes and competences

To justify the inequivalence between drug products.
To establish posological plans.

Working method

Presencial

Pre-requirements (prior knowledge) and co-requirements (common knowledge)

The student should knowl the subjects that are teached in Tecnologia Farmacêutica I and Tecnologia Farmacêutica II.

Program

1. Concept of Bioavailability, Biopharmacotechnics and Pharmacokinetics
1.01. History
1.02. Importance of biopharmacotechnics
2. Physiological factors
2.01. Drug products to be applied on the skin
2.02. Drug products to be applied on mucous tissues
2.03. Drug products for oral use
2.04. Drug products for parenteral use
3. Physico-chemical factors
3.01. Drug substance: weak acids and bases; salts, complexes, esthers; isomers and polymers
3.02. Decomposition of the drug substance: hydrolisis and oxido-reduction
3.03. Physical state of the drug substance: particle dimension, intrinsic and modified solubility, crystalline state and polymorphism
4. Pharmacotechnical factors
4.01. Importance of the excipients: primary and secondary excipients.
4.02. Importance of the container: glass and plastic; protective varnish.
4.03. Importance of the dosage form: coated solids, emulsions, suspensions and release; immediate release and modified release.
4.04. Importance of the manufacturing process on bioavailability.
5. Drug product control
5.01. Control of solid dosage forms
5.02. Control of semissolid dosage forms
5.03. Control of liquid dosage forms
6. Pharmacokinetics
6.01. Zero order and order one kinetics: rate costants.
6.02. Distribution pharmacokinetics parameters: apparent volume.
6.03. Elimination pharmacokinetic parameters: rate constant, half-life, clearance (renal, metabolic, hepatic and total), extraction (first-pass effect)
6.04. Compartment: one compartment and two compartment models
6.05. Bioavailability: absolute bioavailability and relative bioavailability
6.06. Bolus administration. Application and determination of the main parameters
6.07. Intravenous perfusion: determination of the main parameters
6.08. Single-dose extravascular administration: absorption rate
6.09. Two compartment models: determination of the main parameters
6.10. Multiple dose administration. Posology and cumulatiuve effect.
6.11. Pharmacokinetic altered poarametrs: weght, blood flow, gastric emptying, temperature, protein binding
6.12. Change of posologic plans: renal and hepatic disturbances
6.13. Bioavailability and bioinequivalence. Bioequivalence experimental evaluation. Methods.

Mandatory literature

Prista L. Nogueira; Tecnologia farmacêutica. ISBN: 978-972-31-0975-7 (vol. 1)
Prista L. Nogueira; Tecnologia farmacêutica. ISBN: 972-31-0682-5 (Vol. 2)

Teaching methods and learning activities

Theoretical and practical lectures

Software

Não aplicável

keywords

Technological sciences > Technology > Pharmaceutical technology
Health sciences > Pharmacological sciences > Pharmacy

Evaluation Type

Evaluation with final exam

Assessment Components

designation	Weight (%)
Exame	100,00
Total:	100,00

Amount of time allocated to each course unit

designation	Time (hours)
Estudo autónomo	45,00
Frequência das aulas	36,00
Total:	81,00

Eligibility for exams

Number of theoretical lectures (prevision) = 24
Number of practical lectures (prevision) = 12
Limit of absences to the practical lectures = 3

Calculation formula of final grade

Final classification: 50% for the subjects teached in the theoretical lectures and 50 % for the subjects teached in the practical lectures.

Examinations or Special Assignments

Not applicable.

Internship work/project

Not applicable.

Special assessment (TE, DA, ...)

According to the Normas de Avaliação that are in force in the FFUP for the MICF.

Classification improvement

According to the Normas de Avaliação that are in force in the FFUP for the MICF.