The technologies of the medical chewing gum MediChew offer several advantages to the patient: buccal absorption facilitates fast uptake of the API and reduces possible adverse side effects, such as stomach ache or vomiting, related to the intake of a tablet. Medication can be taken without any water, contributing to the discretion value and non-stigmatisation of the patient.
As one of the leading developers and manufacturers of medical chewing gum, Fertin Pharma A/S produces all of its products according to cGMP at its EU and FDA production and packing facilities in Vejle, Denmark. Fertin Pharma’s combined laboratory, production and packing facilities make up more than 20,000m² – representing a yearly capacity of more than 3,000 tonnes.
Fertin Pharma’s business platform includes contract development and manufacturing, and the outlicensing of product concepts, for example, those within the therapeutic areas of allergies and coughs and colds. Fertin Pharma controls two technologies:
- conventional chewing gum – coated rectangular tablets used for nicotine products sold worldwide to our business partners in the nicotine market
- compressed chewing gum – a variety of shapes and colours used in the production of most products with APIs different from nicotine. Fertin Pharma A/S holds a worldwide patent for the two- or multi-layered compressed gum tablet technology.
During development in the GMP laboratory facilities, focus is on the controlled release of the API, documentation of the release rate, development of optimal texture and flavour combinations and taste masking. Professional, qualified taste panels assess various sensory attributes to evaluate and compare various prototypes. Clinical testing and patent application submission are also within Fertin Pharma’s competencies.
Products are QC tested in the laboratories according to specifications; the release rate is tested in equipment described in The European Pharmacopeia and product stability is monitored, documented and reported.