Patent ID: 11904049
Assignee: KLARIA PHARMA HOLDING AB
Field: Pharmaceuticals (Chemistry)
Classification: CPC A | IPC A

Claim 13:
14. A method of manufacturing a film according to claim 1, said method comprising:
(A) either:
(a) optionally, mixing one or more preservatives in water;
(b) either: (i) mixing the API and, optionally, at least one buffering component in water, or in the solution obtained in (a), and subsequently adjusting the pH of the resultant solution to the desired level by addition of an appropriate acid or base, typically a diluted aqueous acid or alkali; or
(ii) adjusting the pH of water, or the solution obtained in (a), to the desired level by addition of an appropriate acid or base, typically a diluted aqueous acid or alkali, and subsequently mixing the API and, optionally, at least one buffering component in the pH-adjusted solution;

(c) optionally, adding further water and/or one or more plasticizers under further mixing; and
(d) adding the alginate salt of monovalent cation under suitable conditions to result in the formation of a viscous cast;
or alternatively:

(i) mixing one or more excipients and one or more preservatives in an acidic aqueous solution;
(ii) separately, dissolving the API in water;
(iii) mixing the solution obtained in (i) with the alginate salt of monovalent cation;
(iv) adding the solution obtained in (ii) to the solution obtained in (iii) under suitable conditions to result in the formation of a viscous cast; and
(v) optionally, adding a chelating agent to the cast;

(B) optionally, leaving the cast to de-aerate;
(C) pouring the cast onto a surface and spreading the cast out to the desired thickness;
(D) drying the cast layer, typically at a temperature of from 40 to 70° C. until the residual water content of the film is from 5 to 15% by weight and a solid film is formed; and
(E) optionally, cutting the solid film into pieces of the desired size, further optionally placing these pieces into pouches, sealing the pouches and further optionally, labelling them.