Abstract
There are two main goals in the development of steroid containing drug delivery systems (DDS); firstly, to enhance the therapeutic value of the resulting systems versus standard dosage forms such as peroral tablets or injections. And secondly to manage the life cycle of drug substances which are going off patents. An example of an important development is patient friendly transdermal delivery systems (TDS) for oestrogen replacement therapy, which requires application intervals of once-a-week only, despite the fact that the biological half-life of the delivered oestradiol is ~ 20 min. Even more impressive are the achievements in the classes of intrauterine systems (IUS) and implants where the application intervals can be up to 5 years, throughout which low dosages of levonorgestrel are constantly released with high precision and reproducibility. Novel system developments also include steroid loaded vaginal rings for fertility control. On the basis of the technologies already available in the aforementioned areas of TDS, IUS, implants and vaginal rings, many efforts currently concentrate on expanding the therapeutic value of these system types via integrated technological and clinical development activities. Main targets are fertility control, hormone replacement therapy, treatment of gynaecological conditions (e.g. menorrhagia) and andropause (male hormone replacement therapy).