PhD defence J.C. Visser

“Orodispersible films as pharmacy preparation. Let’s get flexible”.

Specific patient groups, such as children and elderly, may receive medicines that are not designed to their special needs. A drug formulation or dosage strength is not commercially available and the dose of available products often has to be adapted. The differences in pharmacokinetic and pharmacodynamics parameters are thereby neglected. If commercial products are unsuitable or unavailable, pharmacy preparations are a good alternative. Pharmacy preparations include extemporaneous preparations (e.g. prepared from raw materials) made for an individual patient which are supplied and used immediately after preparation. In view of this definition and the clinical need for a suitable oral dosage form, orodispersible films (ODFs) may fill up the niche and gain place in the therapeutic arsenal.An ODF is placed on the tongue where it sticks immediately and disintegrates within a few seconds. Most of the content is swallowed with the saliva. An ideal ODF is thin, flexible and easy to administer. ODFs can be cut into separate smaller pieces which creates ample dose flexibility combined with dose accuracy. For the preparation of the ODFs the solvent casting method is usually applied. This method is relatively easily performed on a small scale and there is no need for sophisticated equipment.

In her thesis Caroline Visser has explored the possibility to develop a standard formulation for a casting solution that can serve as a starting point for developing ODFs for various active pharmaceutical ingredients and herbal extracts. Besides, a review is given on problem solving in the pharmaceutical development of ODFs.

Dissertation

Promotor: Prof.dr. H.W. Frijlink