Pharmaceutical Technology III

Recommended Prerequisites

Applied Physics, Physical Chemistry, Organic Chemistry, Pharmaceutical Technology I, Pharmaceutical Technology II.  

Teaching Methods

The lectures last for sixty minutes and follow the model of scholarly lesson. The presentation of the syllabus of each class is always preceded by a brief introduction, linking the contents with the previous lesson, if there is continuity. At the end of each lesson the most relevant concepts are highlighted and support material and bibliography is provided, together with a detailed summary of subjects taught. The laboratory sessions last for two hours to enable the practical work described above.

Learning Outcomes

he main purpose of this course is to impart knowledge to students about technologies and dosage forms that were not covered in the courses of Pharmaceutical Technology I and II, which are considered essential for graduate training.

• To plan and conduct drug stability studies;

• To know and prepare new therapeutic systems for drug administration: pellets, hydrophylic matrices, nanoparticles;

• To justify the importance of pre-formulation studies in drug development;

• To know and prepare modified drug release systems;

• To plan and conduct drug dissolution studies and present a critical analysis of the obtained results;

• To plan and conduct validation studies of pharmaceutical processes.

Work Placement(s)

No

Syllabus

Plenary Lectures

1. Presentation

2. Pellets as drug dosage forms

3. Drug dissolution and stability studies

4. Dissolution kinetics

5. Pulmonary delivery systems

6. Polymer therapeutics

7. Quality by Design (QbD)

8. Process Analytical Technologies (PAT)

9. Continuos manufacture of medcines

10. Microencapsulation

11. Nanoencapsulation

12. Controlled release drug delivery systems (CRDDS)

13. Transdermal systems

14. Microneedling

15. Drug delivery systems to the mouth

Laboratory Program:

1. Stability testing

2. Production of pellets

3. Pellet quality control

4. Pellet coating

5. Drug dissolution of solid dosage forms

6. Preparation of hydrophilic matrices

7. Dissolution of hydrophilic matrices and validation studies

8. Nanoencapsulation

9. Modified-release dosage forms.

10. Solving problems on kinetics.

Head Lecturer(s)

António José Ribeiro

Assessment Methods

Avaliação final
Exam: 100.0%

Bibliography

ICH Topic Q 1 A Stability Testing of new Drug Substances and Products. EMEA, November, 2005;

Siewert et al, FIP/AAPS Guidelines to Dissolution/in Vitro Release Testing of Novel/Special Dosage Forms. --

AAPS PharmSciTech, (2003), 4, (81), 1 – 10;

Smart, J. D. “The basics and underlying mechanisms of mucoadhesion”. Advanced  Drug Delivery Reviews, (2005), 1556 – 1568;

Qui, Y. Rational Design of Oral Modified - release Drug Delivery Systems. Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Elsevier Inc, (2009);

Aulton, M. “Libertação pulmonar de fármacos” Delineamento de formas farmacêuticas. Ed. Artmed, (2009) pag. 478-493.

-Silva C, Ribeiro A, Ferreira D, Veiga F (2003) Administração oral de peptídeos e proteínas: II. Aplicação de métodos de microencapsulação. Revista Brasileira de Ciências Farmacêuticas 39: 1-20.

-Allen LV, Popovich NG, Ansel HC, Ansel's Pharmaceutical Dosage Forms and Drug Delivery Systems, 9th Ed. Wolters Kluwer Health/Lippincott Williams & W