US 12,115,247 B2
Structured orodispersible films
Denise Steiner, Braunschweig (DE); and Arno Kwade, Wendeburg (DE)
Assigned to LTS LOHMANN THERAPIE-SYSTEME AG, Andernach (DE)
Appl. No. 16/486,447
Filed by LTS LOHMANN THERAPIE-SYSTEME AG, Andernach (DE)
PCT Filed Feb. 16, 2018, PCT No. PCT/EP2018/053920
§ 371(c)(1), (2) Date Aug. 15, 2019,
PCT Pub. No. WO2018/149983, PCT Pub. Date Aug. 23, 2018.
Claims priority of application No. 102017103346.7 (DE), filed on Feb. 17, 2017.
Prior Publication US 2020/0108011 A1, Apr. 9, 2020
Int. Cl. A61K 9/00 (2006.01); A61K 9/70 (2006.01); A61K 47/32 (2006.01); A61K 47/38 (2006.01)
CPC A61K 9/0056 (2013.01) [A61K 9/70 (2013.01); A61K 47/32 (2013.01); A61K 47/38 (2013.01)] 19 Claims
 
1. A method for producing an orodispersible film, comprising the following steps:
i) forming a suspension of a pharmaceutically acceptable solvent, a pharmaceutically acceptable matrix material, and a pharmaceutically acceptable binder, said solvent being selected such that the solubility of the pharmaceutically acceptable matrix in the solvent is not more than 1 g/L, whereas the pharmaceutically acceptable binder is dissolved in the solvent, wherein the proportion of pharmaceutically acceptable binder in the total quantity of pharmaceutically acceptable matrix material and binder lies in the range of from 0.2 to 0.5, and wherein the solvent has a water content of maximum 20 vol. %, in relation to the total quantity of solvent,
ii) casting the suspension onto a neutral support, thereby forming a wet film,
iii) drying the wet film and obtaining a porous dry film, and iii)
iv) applying a suspension or solution of a pharmaceutically active ingredient in a pharmaceutically acceptable solvent to the porous dry film and drying the film, an orodispersible dry film being obtained, the pores of which are filled at least partially with the pharmaceutically active ingredient.