Successful completion of the TRIO project „Development of a new dosage form for oral vaccine administration”

AUMED, a.s. successfully completed a multi-year project of the research and development support program of the Ministry of Industry and Trade called TRIO. AUMED, a.s. implemented a three-year project in this program entitled “Development of a new dosage form for oral vaccine administration” (Project no.: FV 40365).

The aim of the project was a microbial vaccine in the form of a lyophilized tablet which intended for administration into the oral cavity. A newly innovated pertussis vaccine has been chosen as a model vaccine which was developed by the company AUMED, a.s. in recent years. AUMED, a.s. cooperates on this project with the Charles University, Faculty of Pharmacy in Hradec Králové (Department of Pharmaceutical Technology, Head of Department: doc. PharmDr. Zdeňka Šklubalová, Ph.D.).

The goals of the project have been achieved. Two types of lyophilized tablets were prepared. The prepared tablets were used for an accelerated and long-term stability study. Lyophilized tablets of both types remained stable throughout the accelerated study. Even after 12 months in the long-term stability study, the tablets remain stable.

The project met two main results – Z (tech) proven technology – Preparation of a human vaccine in the form of a lyophilized tablet as a new carrier and Z (semi-pilot) pilot plant – Design and construction of equipment for production.

AUMED, a.s. plans to implement the achieved results into practice. The product must first be subjected to preclinical testing and then to clinical evaluation. The lyophilized tablet can also be used as a carrier for other types of bacterial vaccines.