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3PC-030 Different substrates for orodispersible films: you have the choice!
  1. S Sauer,
  2. AN Weber,
  3. T Hoppe-Tichy
  1. University Hospital Heidelberg, Pharmacy Department, Heidelberg, Germany


Background and importance Orodispersible films (ODF) are thin layers of a polymer that can be loaded with an active ingredient (API). This could be realised during the film-forming process or afterwards. Different polymers produce different film properties (eg, dissolution behaviour). So, you have the choice!

Aim and objectives Films of different compositions and heights were produced and investigated. The aim was to estimate whether the resulting films are appropriate candidates for further processing.

Material and methods Four formulations were chosen based on: (1) polyvinyl alcohol (PVA), (2) hydroxypropylmethylcellulose (HPMC), (3) HPMC with microcrystalline cellulose (MCC) and (4) starch.

The ODF based on starch was a commercial product, an ‘edible paper’. ODF were produced with solvent casting and different heights. After drying, pieces were investigated for appearance, residual moisture and dissolution time.

Results The dried films differed in resulting thickness. Edible paper was the thickest followed by the mixture of HPMC and MCC, then PVA and finally HPMC. The very thin films of HPMC were difficult to handle.

All the films look different: PVA is white and very flexible. HPMC is colourless and flexible also. It becomes sticky when it comes into contact with water. When MCC is mixed with HPMC the films are white and too brittle to handle. Edible paper is green (colourant added) and also brittle, but is easy to handle.

Residual moisture depends especially on the formulation. PVA has ~1%–2%, HPMC MCC ~5%, starch ~7% and HPMC ~7%–10%.

Dissolution time depends on both the formulation and the height of the films. Starch takes more than 15 min and HPMC up to 3 min. Both formulations become sticky when they come into contact with water. The others predominantly show times under 1 min.

Conclusion and relevance Investigations revealed the different characteristics of the resulting films. The stickiness and prolonged dissolution time could be useful for mucoadhesial formulations. Mixture with MCC shortens the dissolution time but increases the brittleness. This formulation could be optimised. PVA and starch exhibit the easiest handling.

Incorporation of API should be possible for all formulations that were casted when API is dissolved. If the API is to be loaded after film production (eg, via inkjet printing) PVA and starch are promising candidates.

Conflict of interest No conflict of interest

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