A new Chinese Drug Master File filing regulation concerning the review and approval of active pharmaceutical ingredients (APIs), pharmaceutical excipients and pharmaceutical packaging materials is in force since 1st January 2018. The previous pre-market approval policy was repealed. It is no longer possible to register respective materials independently of a pharmaceutical product application.
API, pharmaceutical excipient and packaging material manufacturers are required to register their products and submit a dossier to the CFDA (China Food and Drugs Administration) in order to be able to export their products to China. After submission, the dossier undergoes a review by the NMPA together with the drug application dossier.
In order to continue to serve the Chinese market Jungbunzlauer has registered CITROFOL® AI Pharma as excipient in China. We are pleased to announce that we have successfully submitted our excipient DMF within the NMPA.
In pharmaceutical applications, CITROFOL® AI Pharma (triethyl citrate) is used as excipient in tablet coatings.
Film coating is a common process in the pharmaceutical industry in which a thin film is applied on the surface of the tablets. The purpose of this method is to mask unpleasant taste and odour, protect active ingredients, modify the drug release characteristics or improve the ingestion and appearance.
Polymer-based coating dispersions mainly consist of water, a polymer, a plasticiser and further additives. Plasticisers play an important role in film coatings as they influence their mechanical properties. They can act as lubricants reducing the cohesive intermolecular forces along the polymer chains. This leads to a reduced stiffness and improved processability of the polymer. Additionally, plasticisers decrease the internal stress in the film resulting in a decreased elastic modulus and glass transition temperature of the film coating. Common plasticisers are polyols like glycerol or esters like triacetin and triethyl citrate (CITROFOL® AI Pharma).
CITROFOL® AI Pharma, triethyl citrate, is a citrate ester produced by the esterification of citric acid and ethanol both derived from fermentation. It is a clear, viscous and colourless oily liquid which is slightly soluble in water. CITROFOL® AI Pharma is produced according to the standards of the European Pharmacopeia (Ph. Eur.) as well as the United States Pharmacopeia (USP) and is therefore perfectly suitable as pharmaceutical excipient.
In film coatings, CITROFOL® AI Pharma shows multiple advantages. It reduces the glass transition temperature, making film coatings more flexible. It can also reduce the minimum film forming temperature and therefore facilitate the processability of the film coating. Among other things, also the controlling of the permeability of the film as well as the drug release is possible.
Further information about our pharma portfolio: jungbunzlauer.com/en/products/pharma