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1. WO2020115497 - FILMS BUCCAUX MINCES

Note: Texte fondé sur des processus automatiques de reconnaissance optique de caractères. Seule la version PDF a une valeur juridique

[ EN ]

CLAIMS:

1. An orally dissolvable film including at least one layer comprising:

a first pharmaceutically active ingredient;

a resinate comprising an ion exchange resin and a second pharmaceutically active ingredient; and

a matrix and/or binder.

2. The film according to any preceding claim, wherein the first pharmaceutically active ingredient and/or the resinate is incorporated in the at least one layer of the film.

3 The film according to any preceding claim, wherein the first pharmaceutically active ingredient is provided in the at least one layer in an amount of about 0.1-50 wt.%.

4. The film according to any preceding claim, wherein the resinate is provided in the at least one layer in an amount of about 1-50 wt.%.

5. The film according to any preceding claim, wherein the weight ratio of the second pharmaceutically active ingredient to the resin in the resinate is about 2:1 to 1 :5

6. The film according to any preceding claim, wherein the first pharmaceutically active ingredient dispersed in the at least one layer is associated with a first release rate.

7. The film according to claim 6, wherein the first release rate is at least 30%, optionally at least 50%, after 5 minutes, when measured at pH 6.8.

8. The film according to claim 6, wherein the first release rate is at least 50%, optionally at least 60%, after 5 minutes, when measured at pH 1.2.

9. The film according to any preceding claim, wherein the second pharmaceutically active ingredient comprised in the resinate is associated with a second release rate.

10. The film according to claim 9, wherein the second release rate is about 5-80%, optionally about 10-60%, after 1 hour, when measured at pH 6.8.

11. The film according to claim 9, wherein the second release rate is about 10-80%, optionally about 20-60%, after 1 hour, when measured at pH 1.2.

12. The film according to any preceding claim, wherein the ion exchange resin is provided in the form of beads having an associated particle size and/or or associated mesh size, the mesh size and/or particle size of the ion exchange resin or mixture ion exchange resins being selected to provide a desired rate of release of the active ingredient or drug.

13. The film according to claim 12, wherein the resin has a mesh size in the region of 50-100 mesh size and/or has a particle size in the region of 150-300 pm.

14. The film according to claim 12, wherein the resin has a mesh size in the region of 100-200 mesh size and/or has a particle size in the region of 74-150 pm.

15. The film according to claim 12, wherein the resin has a mesh size in the region of 200-400 mesh size and/or has a particle size in the region of 37-74 pm.

16. The film according to any preceding claim, wherein the ion-change resin and/or resinate is provided in the form of particles coated and/or encapsulated within a processing material selected so as to withstand degradation or dissolution within one or more areas of the digestive system, and degrade or dissolve in one or more other areas of the digestive system.

17. The film according to any preceding claim, wherein the at least one layer further comprises a free or unloaded ion exchange resin.

18. An orally dissolvable film including at least one layer comprising:

a first resinate comprising a first ion exchange resin and a first pharmaceutically active ingredient;

a second resinate comprising a second ion exchange resin and a second pharmaceutically active ingredient; and

a matrix and/or binder.

19. The film of claim 1 or the film of claim 18, wherein the first pharmaceutically active ingredient and the second pharmaceutically active ingredient are the same.

20. The film of claim 1 or the film of claim 18, wherein the first pharmaceutically active ingredient and the second pharmaceutically active ingredient are different.

21. A method of delivering one or more pharmaceutically active ingredients to a subject, the method comprising administering orally an orally dissolvable film including at least one layer comprising:

a first pharmaceutically active ingredient;

a resinate comprising an ion exchange resin and a second pharmaceutically active ingredient; and

a matrix and/or binder.

22. A method of delivering one or more pharmaceutically active ingredients to a subject, the method comprising administering orally an orally dissolvable film including at least one layer comprising:

a first resinate comprising a first ion exchange resin and a first pharmaceutically active ingredient;

a second resinate comprising a second ion exchange resin and a second pharmaceutically active ingredient; and

a matrix and/or binder.

23. Use of an orally dissolvable film according to any of claims 1 to 20, in a method of treating one or more conditions or diseases selected from pain, migraine, headache, inflammation, metabolic bone disease, hypophosphataemia, nausea, vomiting, gastroesophageal reflux disease, anxiety, dyspnoea, sleep disorders, erectile dysfunction, and/or movement disorders e.g. Parkinson’s.

24. A method of preparing an orally dissolvable film, the method comprising casting on a support a formulation comprising a first pharmaceutically active ingredient; a resinate comprising an ion exchange resin and a second pharmaceutically active ingredient; and a binder.

25. A method of preparing an orally dissolvable film, the method comprising casting on a support a formulation comprising a first resinate comprising a first ion exchange resin and a first pharmaceutically active ingredient; a second resinate comprising a second ion exchange resin and a second pharmaceutically active ingredient; and a binder.