Development of product range for testosterone treatments

Abstract

Testosterone is a sexual hormone that can be synthesized in different pharmaceutical product presentation for medical purposes. In the present project, a pair of treatments have been selected for which to develop a range of products. The first one being testosterone replacement therapy, in the specific case for male hypogonadism, that affects the pituitary system and makes it not segregate enough testosterone; and the second one transgender hormonal therapy. Several presentations for medical testosterone have been contemplated, but just two have been selected. In the first case, gels have been selected as the presentation of testosterone for hypogonadism’s hormone replacement therapy. The conceptualization of the product has been defined, as well as the establishment of its quality factors, the most important ones being the gels rheological properties, like viscosity, and its sensorial factors, like how smooth it feels on the skin. For this, a selection of ingredients has been made, having in mind their different properties and the microstructure necessities. Another point in this project has been designing a process for manufacturing and picking the required equipment. In the processing of the gel, agitated vessels have been selected for dissolutions, several heat exchangers are to heat or cool the compounds to conditionate them, crushers are used to reduce the API’s particle size, and a pressure homogenizer is in charge of preparing the emulsion. In the end, it has been decided that testosterone gels would be packed in sachets, so a last equipment for the filling is required. On the other hand, the selected product presentation for transgender hormonal therapy has been tablets, which are not used nowadays. The same procedure has been made as with the gel. In this case, the most important quality factors are the chemical ones, and the particle size is important when manufacturing. The selected ingredients for the tablet match the products properties and have been selected to optimize the API’s penetration in the system. The design process for the solid product consists of crushers and granulators that regulate the particle size, as well as blenders that mix the different ingredients. The final steps consist of tableting the product by compression and coating it, to comply with the desired sizes and sensorial factors.