Thin film with non-self-aggregating uniform heterogeneity and drug delivery systems made therefrom
First Claim
Patent Images
1. A film product formed by the steps of:
- (a) combining a polymer and a polar solvent to form a material with a non-self-aggregating uniform heterogeneity;
(b) forming said material into a film; and
(c) drying said film in a controlled manner to maintain said non-self-aggregating uniform heterogeneity.
14 Assignments
0 Petitions
Accused Products
Abstract
The invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. Desirably the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film.
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Citations
61 Claims
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1. A film product formed by the steps of:
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(a) combining a polymer and a polar solvent to form a material with a non-self-aggregating uniform heterogeneity;
(b) forming said material into a film; and
(c) drying said film in a controlled manner to maintain said non-self-aggregating uniform heterogeneity. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. A process for making a film having a substantially uniform distribution of components comprising:
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(a) combining a polymer component and polar solvent to form a matrix with a uniform distribution of said components;
(b) forming a film from said matrix;
(c) providing a surface having top and bottom sides;
(d) feeding said film onto said top side of said surface; and
(e) drying said film by applying heat to said bottom side of said surface. - View Dependent Claims (24, 25, 26, 27, 28, 29, 30, 31)
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32. A method of orally administering an active comprising the steps of:
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(a) preparing a film by the steps of;
(i) combining a polymer, an active component, and water to form a material with a non-self-aggregating uniform heterogeneity;
(ii) forming said material into a film; and
(iii) drying said film in a controlled manner to maintain said non-self-aggregating uniform heterogeneity; and
(b) introducing said film to the oral cavity of a mammal.
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33. A method of introducing an active component to liquid comprising the steps of:
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(a) preparing a film by the steps of;
(i) combining a polymer, an active component, and a polar solvent to form a material with a non-self-aggregating uniform heterogeneity;
(ii) forming said material into a film; and
(iii) drying said film in a controlled manner to maintain said non-self-aggregating uniform heterogeneity; and
(b) placing said film into a liquid; and
(c) allowing said film to dissolve. - View Dependent Claims (34, 35, 36)
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37. A dosage form for the administration of an active comprising:
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(a) a first layer comprising a film formed by the steps of;
(i) combining a polymer, an active component, and a polar solvent to form a material with a non-self-aggregating uniform heterogeneity;
(ii) forming said material into a film; and
(iii) drying said film in a controlled manner to maintain said non-self-aggregating uniform heterogeneity; and
(b) a substantially non-water soluble second layer. - View Dependent Claims (38, 39, 40, 41, 42, 43)
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44. A method of preparing a dosage form for the administration of an active comprising the steps of:
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a. combining a polymer, an active component, and a polar solvent to form a material with a non-self-aggregating uniform heterogeneity;
b. forming said material into a film;
c. applying said film to a substantially non-water soluble support; and
d. drying said film in a controlled manner to maintain said non-self-aggregating uniform heterogeneity.
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45. A method of administering an active comprising the steps of:
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(a) preparing dosage form by the steps of;
(i) combining a polymer, an active component, and a polar solvent to form a material with a non-self-aggregating uniform heterogeneity;
(ii) forming said material into a film;
(iii) applying said film to a substantially non-water soluble support; and
(iv) drying said film in a controlled manner to maintain said non-self-aggregating uniform heterogeneity;
(b) removing said film from said support; and
(c) applying said film to the oral cavity of a mammal. - View Dependent Claims (46)
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47. A film product formed by the steps of:
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(a) combining a water soluble polymer and water to form a material with a non-self-aggregating uniform heterogeneity;
(b) forming said material into a film; and
(c) drying said film in a controlled manner to maintain said non-self-aggregating uniform heterogeneity.
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48. A film product formed by the steps of:
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(a) combining a polymer and a polar solvent to form a material with a non-self-aggregating uniform heterogeneity, said polymer selected to provide a viscosity sufficient to maintain said non-self aggregating heterogeneity;
(b) forming said material into a film; and
(c) drying said film.
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49. A film product formed by the steps of:
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(a) combining a polymer and a polar solvent to form a material with a non-self-aggregating uniform heterogeneity;
(b) forming said material into a film by reverse roll coating; and
(c) drying said film in a controlled manner to maintain said non-self-aggregating uniform heterogeneity.
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50. A film product formed by the steps of:
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(a) combining a polymer and a polar solvent to form a material with a non-self-aggregating uniform heterogeneity, said polymer selected to provide a viscosity sufficient to maintain said non-self aggregating heterogeneity;
(b) forming said material into a film by reverse roll coating; and
(C) drying said film in a controlled manner to maintain said non-self-aggregating uniform heterogeneity.
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51. A process for making a film having a substantially uniform distribution of components comprising:
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(a) combining a polymer component, and polar solvent to form a matrix with a uniform distribution of said components, said polymer selected to provide a viscosity sufficient to maintain said uniform distribution;
(b) forming a film from said matrix;
(c) providing a surface having top and bottom sides;
(d) feeding said film onto said top side of said surface; and
(e) drying said film by applying heat to said bottom side of said surface.
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52. A process for making a film having a substantially uniform distribution of components comprising:
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(a) combining a polymer component, and polar solvent to form a matrix with a uniform distribution of said components;
(b) forming a film from said matrix by reverse roll coating;
(c) providing a surface having top and bottom sides;
(d) feeding said film onto said top side of said surface; and
(e) drying said film by applying heat to said bottom side of said surface.
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53. A process for making a film having a substantially uniform distribution of components comprising:
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(a) combining a polymer component, and polar solvent to form a matrix with a uniform distribution of said components, said polymer selected to provide a viscosity sufficient to maintain said uniform distribution;
(b) forming a film from said matrix by reverse roll coating;
(c) providing a surface having top and bottom sides;
(d) feeding said film onto said top side of said surface; and
(e) drying said film by applying heat to said bottom side of said surface.
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54. A process for making a film having a substantially uniform distribution of components comprising:
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(a) combining a polymer component and polar solvent to form a matrix with a uniform distribution of said components;
(b) forming a film from said matrix; and
(c) drying said film by feeding said film onto a surface having top and bottom sides;
said bottom side being in substantially uniform contact with a water bath at a temperature sufficient to dry said film. - View Dependent Claims (55)
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56. A pharmaceutical and/or cosmetic dosage form comprising a film having a uniformly dispersed composition comprising a polymer, a pharmaceutical and/or cosmetic active and a solvent, said film being formed by depositing a wet film of said composition onto a substrate surface and controllably drying the wet film from the side contacting the substrate to prevent self-aggregation and achieve compositional uniformity.
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57. A pharmaceutical and/or cosmetic dosage form comprising a polymeric film having no more than a 10% variance of a pharmaceutical and/or cosmetic active per unit area.
- 58. A pharmaceutical composition in the form of a film for enteral or topical administration, comprising a composition having a uniformly distributed combination of a polymer, a polar solvent, and a pharmaceutical active, said composition in its dried film form maintaining the uniform distribution of components through the application of controlled bottom drying of the film.
Specification