Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Regulatory Implications Using API Cocrystals for Generic Medicinal Products within the EU and US ***

Dr. Sam Ringle (Abschlußjahr: 2018)

Summary
Language: English
The characterization of an active pharmaceutical ingredient (API) is one of the most important stages in the development of a medicinal product. Unfortunately, not all APIs posses ideal properties for their use in a pharmaceutical. For instance, many newly discovered active substances exhibit poor solubility. However, methods have been developed to alter and enhance various properties of an API. A strategy that is frequently applied to improve the solubility of an active substance is by generating salt derivatives. However, this approach has its limitations as not every API possesses the characteristics to be converted into a salt.
In recent years, a new engineering approach has been developed to generate new API forms with desirable properties. Pharmaceutical cocrystals are a results of these developmental efforts and enable medicinal product manufactures to modify already existing APIs or to generate new ones with tailored characteristics. Beside the scientific challenges that are associated with the development of a pharmaceutical, manufacturer are also confronted with regulatory requirements that have to be fulfilled in order to obtain an approval and enter the market. Since pharmaceutical cocrystals are a relative new API-form, not much regulatory guidance concerning cocrystals has been formulated for two of the biggest pharmaceutical markets, namely the United States of America (USA) and the European Union (EU).
This thesis shall analyze which regulatory requirements have to be fulfilled in order to use pharmaceutical cocrystals within generic pharmaceuticals that are intended for the USA and EU. This thesis will only discuss the requirements for immediate release and oral dosage forms containing an API cocrystal. Regulatory guidance documents published by the European Medicines Agency and the Food and Drug Administration will be consulted and discussed to see if pharmaceutical cocrystal are eligible for generic applications in both the USA and EU and if the outlined characteristics of this API form fit into the current legislation of both territories. Finally, this thesis will also discuss which data should be presented within the common technical document to justify the usage of cocrystal in a generic medicinal product.
Pages: 35