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An oral thin film (OTF) is a very thin film composed of a mono or multi-layer polymeric matrix that is applied in the mouth.
OTFs are often water-based soluble polymers designed to rapidly deliver drugs systematically. Depending on the drug candidate and the targeted indication, OTF can be formulated either as:
- Orodispersible films working like conventional orodispersible tablets. In this case, OTF dissolves within seconds in the mouth and the drug substance is swallowed together with the saliva and takes the same route as a tablet
- A transmucosal film where the active substance directly enters the systemic circulation via the buccal mucosa, avoiding the hepatic first-pass effect
The active ingredient can be either dissolved or suspended in the polymeric matrix.
The OTF dosage form presents several advantages, among which:
- An easy drug intake therefore high acceptance by young and old patient thanks no swallowing difficulties and no beverages requirement for intake
- Flexible manufacturing with area proportional dosage (different doses from one base bulk)
- Potential avoidance of the first-pass effect and improved bioavailability.
- Innovative and appealing design offering more options for differentiating a product range
- A discreet and pain-free application