Pharmaceutical substances and excipients
There are a few groups of medical devices, which have pharmaceutical substances in their composition. For example, filers with hyaluronic acid or stents with immunosuppressors. (details by link) However, medical devices can contain not only pharmaceutical substances but excipients.
According to Federal Law 61 “On circulation of Medicinal Products” excipients are substances of inorganic or organic origin used in the process of production, manufacture of medicinal preparations for providing them with necessary physical and chemical properties.
Thus, the structure of stents may include not only active pharmaceutical substances, but also polymers, which are fillers. They provide a gradual release of the medicinal substance. However, these substances do not have pharmacological effect.
Excipients include the following groups:
- Fillers providing a certain mass
- Binding substances required for particle adhesion
- Disintegrant that ensure the penetration of liquids
- Anti-friction substances providing the necessary flow of granulates in the equipment
- Lubricating substances, which are mainly used in the production of tablets and facilitate the popping of tablets from the matrix
- Flavors of taste, color and smell
In case of registration of medicinal products in the dossier it is necessary to provide the following information concerning excipients:
- Specification and its justification
- Information on the use of new excipients, excipients of human or animal origin
- Analytical methods used in the implementation of quality control excipients
It should be noted that for medical products, which include medicinal substances and excipients, there is no clearly definition of excipients in the normative acts and the list of documents required for the registration dossier. It is to be hoped that someday this issue will be resolved, as it has happened with medicines in the composition of medical devices. (Read more by the link )
 Order dated July 12, 2017 N 409n On approval of the procedure for the formation of the registration dossier on the drug and the requirements for documents in its composition, requirements for the amount of information provided in the registration dossier for certain types of medicinal preparations for medical application and the order of submission of documents from which the registration dossier on the medicinal product for medical use for the purpose of its state registration is formed.