Kaisa Naelapää
Adjunkt
E-mail: kn(at)farma.ku.dk
Telefon: 35 33 61 55
Rum 13 – 710

Solid state transformations during dissolution - in-line monitoring with Raman spectroscopy
During dissolution solid state transformations from one form to another can appear. This is especially the case when several polymorphic forms of the drug exist. In-line monitoring with Raman spectrometer can be used in order to identify differences and the actual extent of conversion. Previous work on this project has included theophylline as the model drug; furthermore the influence of different biorelevant media has been studied. In the next phase of the project influence of excipients on the solid state transformations needs to be investigated.
Supervisor: Kaisa Naelapää

Multiple drug delivery - Taste masking coatings
Specific formulations and drug administration devices for special patient groups are needed. Special formulations for example paediatric and geriatric patient groups may involve the administration of a liquid or a semi-solid formulation as these are easiest for them to swallow. However, several challenges have to be overcome. First, the drug is in direct contact with the vehicle and it will be dissolved and therefore also tasted. Secondly, the stability of the solution is always an issue, as well as the polypharmacy that magnifies the problem. A possible solution is the encapsulation in order to mask the bad/ bitter taste of drugs as this can prevent potential physicochemical interactions between these. You will be continuing the work done by previous Master students who have worked on encapsulating drugs and on formulating a vehicle for administration of the encapsulated particles.
Supervisor: Kaisa Naelapää in collaboration with associate professor Daniel Bar-Shalom

Solid state characterisation of Polymer-in-Drug formulations
This work is aiming to increase the current understanding of the formulation of high dose solid dispersions. Specifically, the formulation of high dose water soluble drug in combination with a polymer will be investigated in order to obtain prolonged release of the drug. A deeper insight into the solid state transformations is needed as well as the stability of the formulations needs to be studied.
Supervisor: Kaisa Naelapää in collaboration with associate professor Daniel Bar-Shalom and professor Jukka Rantanen

Risk analysis and risk management for increasing coating process understanding
ICH Q9 guideline was launched with the aim of guiding the industry. The desired state of the industry is that the quality should be assured through mechanistic understanding of how raw materials, formulation and critical process parameters affect the product performance. Risk analysis, i.e. systematic identification of critical process variables; design of experiments (DoE) and multivariate data analysis (MVDA) in combination with process analytical technologies (PAT) are a part of a successful application of the QbD approach. Coating, like all pharmaceutical manufacturing processes is a complex multi-factorial unit operation where the interaction of several variables like equipment design, formulation, and critical process parameters (CPPs) are determining the quality of the applied coating and the final product performance is directly related to the process.
Supervisor: Kaisa Naelapää