3 ECTS credits
90 h study time
Offer 1 with catalog number 4023448ENR for all students in the 2nd semester at a (E) Master - advanced level.
In this course, students will learn how to reach, guard and preserve the sterility of medicines and other pharmaceutical preparations. Students will also learn about the very specific sterility criteria of biopharmaceutical products, ophthalmica, implantations and infusions. Furthermore, the students will get insight in the production process of solid dosage forms. Special attention is paid to the excipients, the quality, the production techniques and parameters as well as the release, biological availability and stability of the active substances in solid dosage forms.
The course covers the following topics:
- Sterility in the pharmacy and general sterilization processes (heat sterilization & filtration)
- Pyrogens and endotoxins
- Microbicide and microbistatic agents
- Preservation of medicines and cosmetics
- Parenteralia and biofarmaceuticals
- Biofarmaceuticals in the pharmacy including the preservation of biopharmaceuticals that routinely are delivered to patients in the pharmacy including recombinant proteins, vaccins and monoclonal antibodies.
- Ophthalmica, contact lenses and contact lens solutions
- Nose and ear preparations
- Implantations and infusions
- Agglomeration and (coated) tablets
- Controlled release from solid dosage forms
The topics about sterility of medicines and their sterilization processes are covered by Prof. J. De Kock.
The topics about solid dosage forms are covered by Prof. C. Vervaet.
The student:
- knows what is understood by ‘sterility’ and how this needs to be applied for the preparation of sterile medicines in the pharmacy
- can explain to a third person which sterilisation methods are being used in the pharmacy and how they work
- can identify and correct the consequences of bad sterilisation practices
- understands and is able to explain how disinfection solutions work, knows which factors influence their disinfection efficacy and how they can cause resistance
- understands the concept of ‘self-sterilisation’ in the context of preservatives and is able to explain it to a third person
- knows the legislation concerning the enforced or prohibited use of preservatives in sterile preparations
- knows the sterility criteria of parenteral medicines and biopharmaceuticals and knows how these criteria (sterility, pH, osmolarity) are influenced by the route of application
- can critically explain the difference between the quality criteria of parenterally applied chemical substances and biopharmaceuticals in the context of the latter’s biological origin
- knows how to preserve parenteral medicines and biopharmaceuticals that are routinely delivered to patients by the pharmacy including vaccines, recombinant proteins and monoclonal antibodies
- knows the quality criteria of ophthalmica, contact lenses and contact lens solutions, can correctly apply these criteria and is able to perform correct calculations in the context of the osmolarity of the dissolved particles, choose the right preservative(s), and take into account the sensitivity to oxidation and pH
- has sufficient knowledge about the industrial fabrication as well as the galenic preparation of nose and ear preparations
- knows the most abundant home applications of infusions and implantations and knows how total parenteral nutritions (TPNs) are sterile prepared, and which criteria they need to fulfil
- knows the functions of the excipients in solid dosage forms
- knows the techniques used to manufacture solid dosage forms
- can assess the impact of the composition and the production parameters on the drug release rate of solid dosage forms
- has knowledge about the factors that determine the release, bioavailability and stability of the drug in a solid dosage form
- has knowledge about the interaction between the composition, production and quality of solid dosage forms
The final grade is composed based on the following categories:
Written Exam determines 100% of the final mark.
Within the Written Exam category, the following assignments need to be completed:
Written exam. Final score on /20.
This offer is part of the following study plans:
Master of Pharmaceutical Care: Standaard traject NIEUW (only offered in Dutch)