PRODUCTION PROCESS FOR ORAL CAPSULES CONTAINING MESOTHIC STEM CELL SECRETIONS AND CAPSULES OBTAINED FROM THIS PRODUCT

Abstract

The invention relates to a process for producing hard capsules containing secretions from mesenchymal stem cells (MSCs) and the capsules obtained from this process. The process includes the following steps: mixing MSCs with sodium alginate, sucrose, and a phosphate buffer; forming microcapsules by alginate-Ca2+ ion gelation via a dropper and peristaltic pump system; freeze-drying the microcapsules under controlled temperature and humidity conditions; encapsulating with acid-resistant or slow-release HPMC capsule shells; and storing the finished product at cold temperatures. The resulting microcapsules are capable of protecting the proteins and extracellular secretions (EVs) of MSCs from denaturation during the manufacturing process and in the acidic gastric environment. The finished capsules are highly stable, have a uniform protein content, and are suitable for oral administration.

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