Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The Design Flexibility in Monographs for Excipients

Dr. René Leubert (Abschlußjahr: 2011)

Language: English

Excipients are all substances in a dosage form that are not intended as active pharmaceutical ingredient. Such substances contribute to the drug delivery function and shape of the dosage form, help to identify the dosage form by color and are important in the whole life cycle of a drug including manufacturing, storage and using: it becomes clear that excipients potentially can have many functions in a drug and it is important to control and to define their quality.

One well known possibility to control and to define the quality of an excipient is the use of monographs. Such documents traditionally describe the quality of a single substance with corresponding test methods and limits in a text book as kind of public specification issued by pharmacopoeias. An upcoming problematic is that more and more excipients used in pharmaceutical dosage forms are not covered by a suitable monograph. The reasons of this are diverse but a main reason is that the thorough elaboration of a monograph is complex, time consuming and includes many different stakeholders with different interests. In addition the requirements of modern dosage forms are increasing which stimulates also the requirements of excipients. Therefore the market of excipients is evolving fast to respect those requirements and the resulting needs of users accompanied by a growing count of different kind of excipients like co-processed versions. This is in contrast to the goal of pharmacopoeias to monograph all excipients used in approved drugs and broaden the gap between monographed and non-monographed excipients.

However there are concepts of adaptations in monographs to improve the situation. The use of such flexibilities likely contributes to cover more excipients by a monograph. Such adaptations are provided by already used concepts like Family Monographs, Functionality Related Testing, Attributes of Different Articles or upcoming ideas like Flexible- and Performance-Based Monographs. A case study elaborates the feasibility of a merge of two different commercial products under the roof of one existing monograph by using some of the mentioned concepts.

The use of the concepts supports the goal of pharmacopoeias to cover all substances used in approved drugs in monographs. This helps to establish and to keep a high quality standard for excipients and consequently to provide high quality and safe drugs to the public.

Pages: 47, annexes: 3 pages