What is oral dissoluble films, ODF
Chinese Pharmacopoeia: A film-like preparation made by processing medicines and suitable film-forming materials for oral or mucosal use.
European Pharmacopoeia: Single-layer or multi-layer film-like preparations, which can be quickly dispersed in the mouth.
Foreign literature: a drug-containing water-soluble polymer material (natural, synthetic) film, which is the size of a postage stamp, is placed on the tongue, and can be dissolved or melted immediately.
Since 2009, the National Engineering Research Center for Pharmaceutical Preparations has restarted the ODF platform, starting from packaging, researching new film agents, imitating them and making them innovative, and fully considering the industrialization of film agents.
Advantages and disadvantages of ODF
Easy to use and carry, no water is needed for delivery, especially suitable for children, elderly patients and bedridden
Patients with dysphagia; less energy consumption, less dust, less auxiliary materials, low production cost, and high production efficiency;
A coating production line can be applied to large, medium and small batch production, and the packaging line can be as needed
Split metering packaging is conducive to automated production: it can replace a part of orally disintegrating tablets and freeze-dried tablets;
Can play a highly effective and quick-acting role: some medicinal films have good stability.
Disadvantages:
A new production line must be set up: taste masking is a challenge for membranes; it is not suitable for large doses of drugs.
Preparation of coating liquid
Solvent: water, organic solvent (used to dissolve drugs and shorten the drying time) or water-organic solvent mixture
After the excipients are added, they are homogenized to form a viscous liquid. Drug addition: can be pre-dissolved or pre-dispersed in the solution and added
The solid particles in the coating liquid cannot be> 250um, otherwise it will accumulate during the coating or cause scratches on the film surface
The defoaming of the coating liquid adopts the vacuum stirring method
