Transdermal therapeutic system with crystallization-inhibiting protective film (release liner)

1. Solid transdermal therapeutic system with at least one active-ingredient containing matrix layer which comprises a polymer matrix supersaturated with gestodene or a gestodene ester, and optionally comprising ethinylestradiol, and a removable protective film directly adjacent to the matrix which is a silicone- or fluoropolymer-coated polyester removable film,

Wherein the fraction of gestodene or gestodene ester in the form of amorphous or crystalline particles at the interface between the removable protective film and the active-ingredient-containing matrix or in the active-ingredient-containing matrix is on less than 2% of the area of the system, and

wherein the matrix is free from solubility promoters, crystallization inhibitors and dispersants.

2. Solid transdermal therapeutic system of claim 1 , wherein the limited amount of amorphous or crystalline particles which are present have an average diameter of not more than 200 μm.

3. Solid transdermal therapeutic system according to claim 1 , wherein the fraction of gestodene or gestodene ester in the form of amorphous or crystalline particles at the interface between the removable protective film and the active-ingredient-containing matrix or in the active-ingredient containing matrix is on less than 1% of the area of the system.

4. Solid transdermal therapeutic system of claim 3 , wherein the limited amount of amorphous or crystalline particles which are present have an average diameter of not more than 100 μm.

5. Solid transdermal therapeutic system according to claim 1 , wherein the system comprises, in order: a backing layer, an adhesive layer, a separation layer, the at least one active-ingredient-containing matrix layer and the removable protective film.

6. Solid transdermal therapeutic system according to claim 5 , wherein the adhesive layer comprises a UV absorber.

7. Solid transdermal therapeutic system according to claim 6 , wherein the UV absorber is 2,4-bis-([4-(2′-ethylhexylxy-2-hydroxy]phenyl)-6-(4-methoxypheyl)-(1,3,5)-triazine.

8. Solid transdermal therapeutic system according to claim 1 , wherein the system has gestodene present in an amount of 2.1 mg and ethinylestradiol present in an amount of 0.55 mg.

9. Solid transdermal therapeutic system according to claim 8 which has an area of 11 cm 2 .

10. Solid transdermal therapeutic system (TTS) according to claim 1 , wherein the TTS is in the form of a patch.

11. Solid transdermal therapeutic system according to claim 10 which is suitable for continuous application the skin of a patient over a period of 7 days.

12. Kit comprising 1 to 52, 1 to 26, or 1 to 13 patches as defined in claim 10 for continuous application over a period of 52, 26 or 13 weeks, respectively, in each case plus 7 days without patch.

13. Solid transdermal therapeutic system (TTS) according to claim 1 , wherein the removable protective film is a silicone-coated polyester removable film.

14. Solid transdermal therapeutic system (TTS) according to claim 1 , wherein the removable protective film is a fluoropolymer-coated polyester removable film.

15. Solid transdermal therapeutic system (TTS) according to claim 1 , wherein the polymer matrix comprises a polymer selected from the group consisting of polyisobutylene, polybutene, polyacrylate, polydimethylsiloxane, styrene-isoprene block polymer or polyisoprene.

16. Solid transdermal therapeutic system (TTS) according to claim 1 , wherein the polymer matrix comprises a polymer selected from the group consisting of polyisobutylene, polybutene, polydimethylsiloxane, styrene-isoprene block polymer or polyisoprene.

17. Solid transdermal therapeutic system (TTS) according to claim 1 , wherein the polymer matrix comprises polyisobutylene.

18. Solid transdermal therapeutic system (TTS) according to claim 1 , wherein the polymer matrix excludes a polymer comprising polyacrylate.