Kursussøgning, efter- og videreuddannelse – Københavns Universitet

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Kursussøgning, efter- og videreuddannelse

Pharmaceutical Preformulation - Profiling Drug Substances for the Biomedical Sciences

Practical information
Study year 2016/2017
Time
Block 2
Programme level Full Degree Master
Full Degree Master choice
ECTS See exam description
Course responsible
  • Susan Weng Larsen (12-7678766471316f64757668714376787167316e7831676e)
  • Department of Pharmacy
Course number: SFKKA9081U

Course content

The course focuses on preformulation activities in drug discovery and in the drug development phase with emphasis on a practical approach. Experimental methods and data related to physical chemical characterization and stability studies of drug substances are presented and discussed. The following subjects are covered:

1. Solid state properties and characterization

◦ polymorphism, amorphous/crystalline forms, solvates

◦ experimental methods such as X-ray diffraction, DSC and TGA

2. Aqueous solubility

◦ pH-solubility profiles, salt selection, intrinsic dissolution rate

◦ solubility enhancing methods

◦ experimental measurements

◦ prediction

3. pKa

◦ experimental methods

◦ prediction

4. Partitioning

◦ pH-distribution profiles, extra thermodynamic relationships,

◦ experimental and calculation methods

5. Kinetics and chemical reactivity

◦ types of chemical reactions

◦ simple and complicated rate equations

◦ pH-rate profiles

◦ prodrugs

6. Stability testing

◦ planning stability tests

◦ temperature accelerated degradation

◦ solid state stability including drug-excipient compatibility

◦ experimental methods

 

Case studies and project work are used as the basis for discussing the application of the knowledge of physicochemical and stability properties of substances for selecting drug candidates and designing dosage forms . Further, the course is designed with emphasis on providing practical skills related to prediction and calculation of basic preformulation parameters.

Learning outcome

The objectives of the course are to give students:

  • insight into the methods used for physicochemical characterization of drug substances and instability studies as well as interpretation and assessment of experimental data.
  • understanding of the importance of pharmaceutical profiling of drug substances in relation to selecting formulation strategies and drug administration route.
     

At the end of the course students should be able to:

Knowledge

  • define concepts and terms related to preformulation.
  • identify and discuss the importance of basic physicochemical and stability properties of drug substances in drug development.
  • account for the advantages and limitations of methods used in pharmaceutical profiling of drug substances.

 

Skills

  • calculate/predict basic prefomulation parameters.
  • assess experimental data obtained in preformulation studies.
  • discuss the selection of drug candidates and design of dosage forms on the basis of their stability and measured physicochemical properties.
  • present and discuss preformulation issues in the form of a poster.

 

Competencies:

  • design experiments related to physicochemical characterization and stability studies of drug substances.
  • obtain further and specialized knowledge and skills related to preformulation.

Recommended prerequisites

Course teaching is based on the assumption that students have basic skills in organic, analytical and physical chemistry.

Sign up

For enrolment at the course the student has to fill in an application. If the student is accepted in the course he/she will automatically be enrolled in STADS

Education

MSc in Pharmaceutical Sciences - elective, MSc in Medicinal Chemistry - elective, Cand.Scient.Pharm. - elective, Cand.Pharm. - elective

Studyboard

Study Board of Pharmaceutical Sciences

Duration

1 block

Schedulegroup

B
---- SKEMA LINK ----

Teaching and learning methods

•Lectures: 26 hours
•Student activities (project work, poster preparation, theoretical exercises, case studies, discussion of scientific articles, oral presentations): 18 hours
•Excursion: 3 hours

Capacity

30 studerende.

Language

English

Literature

Selected scientific articles, chapters from relevant books and supplementary notes.

Workload

Category Hours
Lectures 26
Preparation 156
Practical exercises 18
Excursions 3
Exam 3
English 206

Exam 1 (SFKKA9081U - reports and project work)

Type of assessment

Continuous assessment
Course certificate
Three written reports with acceptable answers to assignments and satisfactory participation in project work in groups of 2-3 students

Aid

All aids allowed

Marking scale

passed/not passed

Criteria for exam assessment

To pass the course the students should be able to:

Knowledge

  • define concepts and terms related to preformulation.
  • identify and discuss the importance of basic physicochemical and stability properties of drug substances in drug development.
  • account for the advantages and limitations of methods used in pharmaceutical profiling of drug substances.

 

Skills

  • calculate/predict basic prefomulation parameters.
  • assess experimental data obtained in preformulation studies.
  • discuss the selection of drug candidates and design of dosage forms on the basis of their stability and measured physicochemical properties.
  • present and discuss preformulation issues in the form of a poster.

 

Competencies:

  • design experiments related to physicochemical characterization and stability studies of drug substances.
  • obtain further and specialized knowledge and skills related to preformulation.

Censorship form

No external censorship

Exam 2 (SFKKA9081U - oral examination)

Type of assessment

Oral examination, 15-20 min
Individual oral examination based on the project work. A short presentation (7 min) followed by questioning and discussion with course teacher(s).

Aid

All aids allowed

Marking scale

passed/not passed

Criteria for exam assessment

To pass the course the students should be able to:

Knowledge

  • define concepts and terms related to preformulation.
  • identify and discuss the importance of basic physicochemical and stability properties of drug substances in drug development.
  • account for the advantages and limitations of methods used in pharmaceutical profiling of drug substances.

 

Skills

  • calculate/predict basic prefomulation parameters.
  • assess experimental data obtained in preformulation studies.
  • discuss the selection of drug candidates and design of dosage forms on the basis of their stability and measured physicochemical properties.
  • present and discuss preformulation issues in the form of a poster.

 

Competencies:

  • design experiments related to physicochemical characterization and stability studies of drug substances.
  • obtain further and specialized knowledge and skills related to preformulation.

Censorship form

No external censorship
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