GALENIC PREPARATION AND THEIR MANUFACTURE

 

Course code: GYTKKA224

 

Hrs/week:

- therory: --

- practice /lab work/: 3

 

Lecturer: Dr. Peter Sipos

 

Form of exam: TERM MARK (5)

 

Credit: 3

 

Course requirement: Pharm. Techn. I.

 

ANNOTATION:

 

Module aims:

 

The main goal of the course is to show basic points of pharmaceutical technology methods used in industrial scale.

Students will learn how to use devices and equipments during preparation. The dosage form tests will be performed as well, according to the currently used European Pharmacopoea.

Important document types of quality assurance will be completed in parallel with the preparations.

 

Module Subject:

 

The goal of the course is the introduction into the preparation of liquid and semisolid dosage forms in semi-industrial scale and the connected fabrication methods and Pharmacopoea dosage form tests.

Methods: hydrodymanic methods, separation methods of dispersed dosage forms, material transfer methods, desintegration methods, dispensing and homogenizing methods.

Preparation and characterization of liquid and semisolid dosage forms:

Real and colloidal solutions, emulsions (macro, micro, multiple), suspensions (general, flocculated), ointment bases and ointments, creams, pastes, gels and hydrogels, suppository bases and suppositories, liposomes.

 

Recommended books:

 

European Pharmacopoea

United States Pharmacopoea

Aulton's Pharmaceutics - Michael E. Aulton: The Design And Manufacture of Medicines /Churchill Livingstone/

 

Classroom-based datum expressed in hours:

Seminars and labs (42h)

 

Evaluation:

Mid-term short written tests during the semester and comprehensive Final written test after topic completion, evalutaion of lab work (production sheets).

 

Learning outcomes:

- Knowledge and Understanding:

Understanding and application of the basic preparation methods of Pharmaceutical Technology (to understand, plan, use and control). Students will learn how to prepare and characterise liquid and semisolid dosage forms in industrial scale. Different dosage form preparation methods and related pharmaceutical calculations will be studied according to the current European Pharmacopoea. Successful completion of previous basic courses, like physical and colloidal chemistry is needed for best learning outcomes.

 

- Skills and Attributes:

Students will learn the basics of planning liquid and semisolid dosage forms, with the aid of different methods and devices. Documentation of quality management will be used and differences the definitions of changes and deviations will be used properly. Using the Pharmacopoea, students will be able to determine the quality of the dosage forms and decide weather or not to free the charge for application.

  

The term mark is 1.0 (failed) if

- the average of mid-term short tests does not reach 2.0

- the Final test does not reach 2.0 and the Final test repeated does not reach 2.0.