Devices for local and systemic delivery of active substance and methods of manufacturing thereof

Solid gel film compositions for local and systemic delivery of active substances through the skin or mucosal epithelial layer of a subject are provided. More particularly, delivery discs are provided containing a uniform mixture, wherein the uniform mixture contains a filmogenic polymer and a therapeutically effective dose of an active substance, wherein the delivery disc is a single uniform layer device which is non-tacky and which dissolves onto a skin tissue skin tissue with few drops of water or lotion or mucosal epithelial tissue of a subject when applied thereto. Methods for administering an active substance to a subject using a delivery disc of the present invention are provided. Methods for preparing the delivery discs of the present invention are also provided.

EXAMPLES The preferred embodiments of the present invention will now be further described through the following examples set forth here in below which are intended to be illustrative of the preferred embodiments of the present invention and are not intended to limit the scope of the invention as set forth in the appended claims. 
 Examples 1-5 Five example formulations for preferred delivery discs of the present invention are set forth in Table 1. 1 TABLE 1 Ex. 1 Ex. 2 (wt % (wt % Ex. 3 Ex. 4 Ex. 5 Ingredient dry) dry) (wt % dry) (wt % dry) (wt % dry) Polyvinyl 86.0 88.3 86.0 86.0 80.0 pyrrolidone Polyethylene 5.5 0.9 5.5 5.5 5.5 glycol-4000 Butylene glycol 3.0 Glycerin 3.0 Spheron L-1500 3.0 3.0 3.0 3.0 Silica Laponite XL 1.0 Sodium Magnesium Silicate Menthol 10.0 Salicylic acid 4.0 Ascorbic acid 4.0 Lactic acid 4.0 Avalure UR- 2.0 410 Polyurethane Nylon 66 4.8 Water QS QS QS QS QS 
 Example 1 The uniform mixture formulation identified in Table 1 as Example 1 was prepared as follows: (a) dissolving the polyvinyl pyrrolidone in a volume of alcohol; (b) slowly adding the polyethylene glycol into the product of (a); (c) dissolving the lactic acid into a volume of water; (d) adding the butylene glycol to the product of (c); (e) adding the product (d) to the product of (b); (f) removing air from the product of (e); (g) adding the silica to the product of (f) mix until uniform; (h) casting the product of (g) onto a release liner at 1 5mil thickness; and, (i) drying the product of (h) in an oven until uniform and non-tacky (about 10 minutes). 
 Example 2 The uniform mixture formulation identified in Table 1 as Example 2 was prepared as follows: (a) adding laponite XL into a volume of water under vigorous agitation until a clear gel with no entrained particles is formed; (b) adding polyvinyl pyrrolidone into a volume of alcohol with agitation; (c) adding the polyethylene glycol to the product of (b) and mixing until uniform (d) mixing the products of (a) and (c) (e) blending the avalure with the glycerin and a volume of water until uniform; (f) adding the product of (e) to the product of (d); (g) removing air from the product of (f); (h) adding the nylon 66 to the product of (g); (i) casting the product of (h) onto a release liner at 1 5-mil thickness; and, (j) drying the product of (i) in an oven until the film is uniform and not-tacky (about 10 minutes). 
 Example 3 The uniform mixture formulation identified in Table 1 as Example 3 was prepared as follows: (a) adding the polyvinyl pyrrolidone to a volume of alcohol; (b) adding the polyethylene glycol to the product of (a); (c) blending the salicylic acid, the butylene glycol and a volume of water and adding the blend to the product of (b); (d) removing air from the product of (c); (e) adding silica to the product of (d); (f) casting the product of (e) onto a release liner at 1 5-mil thickness; and (g) drying the product of (f) in an oven until the film is uniform and not tacky (about 10 minutes). 
 Example 4 The uniform mixture formulation identified in Table 1 as Example 4 was prepared as follows: (a) adding polyvinyl pyrrolidone to a volume of alcohol; (b) adding the polyethylene glycol to the product of (a); (c) dissolving ascorbic acid into a volume of water; (d) adding butylene glycol to the product of (c); (e) mixing the products of (b) and (d); (f) removing air from the product of (e); (g) adding silica to the product of (f); (h) casting the product of (g) onto a release liner at 1 5-mil thickness; and, (i) drying the product of (h) in an over until the film is uniform and non-tacky (about 10 minutes). 
 Example 5 The uniform mixture formulation identified in Table 1 as Example 5 was prepared as follows: (a) adding polyvinyl pyrrolidone to a volume of alcohol; (b) adding polyethylene glycol to the product of (a); (c) dissolving the menthol in the butylene glycol and a volume of water; (d) mixing the products of (b) and (c); (e) removing air from the product of (d); (f) adding silica to the product of (e); (g) casing the product of (f) on a release liner at 15-mil thickness; and, (h) drying the product of (g) in an over until the film is uniform and non-tacky (about 10 minutes). 
 Examples 6-8 (Cleansing Solid Gels) The example formulations for preferred cleansing gel delivery discs of the present invention are set forth in Table 2. 2 TABLE 2 Ex. 6 Ex. 7 Ex. 8 Ingredient (wt % dry) (wt % dry) (wt % dry) Polyvinyl pyrrolidone 78.0 81.3 80.0 (K-90) Polyethylene glycol 4000 5.5 0.9 5.5 Butylene glycol 1.5 1.5 Glycerin 3.0 Spheron L-1500 Silica 3.0 3.0 Laponite XL (Sodium 1.0 Magnesium Silicate) Salicylic acid 4.0 Lactic acid 2.0 Avalure UR-410 2.0 polyurethane Nylon 66 4.8 Surfadone LP (Lauryl 1.0 Pyrrolidone Betaine 2.0 Alkyl (C12, C10, C16) 3.0 Glucoside Magnesium Laureth 5.0 Sulfate Sodium Lauryl sulfate 7.0 5.0 Water QS QS QS 
 Example 6 The uniform mixture formulation identified in Table 2 as Example 6 was prepared as follows: (a) adding the polyvinyl pyrrolidone to ethyl alcohol blending well; (b) adding the polyethylene glycol to the product of (a); (c) adding the lactic acid and the butylene glycol to the product of (b); (d) adding the alkyl glucoside and sodium lauryl sulfate to the product of (c); (e) removing air from the product of (d); (f) adding silica to the product of (e); (g) casting the product of (f) onto a release liner at 1 5-mil thickness; and, (h) drying the product of (g) in an oven to produce a uniform non-tacky film. 
 Example 7 The uniform mixture formulation identified in Table 2 as Example 7 was prepared as follows: (a) adding the polyvinyl pyrrolidone to ethyl alcohol, then adding to this mixture the Laponite XL (which is dispersed into a volume of water under vigorous agitation); (b) adding the magnesium laureth sulfate to the product of (a); (c) adding the polyethylene glycol to the product of (b); (d) blending avalure and glycerin until uniform; (e) mixing the products of (c) and (d); (f) adding betaine to the product of (e); (g) removing air from the product of (f); (h) adding nylon 66 to the product of (g); (i) casting the product of (h) onto a release liner at 1 5-mil thickness; and, (j) drying the product of (i) until the film is uniform and non-tacky (about 10 minutes). 
 Example 8 The uniform mixture formulation identified in Table 2 as Example 7 was prepared as follows: (a) mixing the polyvinyl pyrrolidone into ethanol; (b) adding the polyethylene glycol and sodium laureth sulfate to the product of (a); (c) dissolving the salicylic acid in the butylene glycol; (d) mixing the products of (b) and (c); (e) removing air from the product of (d); (f) adding silica to the product of (e); (g) adding surfadone to the product of (f); (h) casting the product of (g) onto a release liner at 15-mil thickness; and, (i) drying the product of (h) in an oven until the film is uniform and non-tacky (about 10 minutes). 
 Examples 9-14 (Devices for Local/Systemic Delivery of Active Substances) The example formulations for preferred cleansing gel delivery discs of the present invention are set forth in Table 3. 3 TABLE 3 Ex. 9 Ex. 10 Ex. 11 Ex. 12 Ex. 13 Ex. 14 (wt % (wt % (wt % (wt % (wt % (wt % Ingredient dry) dry) dry) dry) dry) dry) Hormone 6.20 6.20 6.20 Linoleic acid 1 6.00 Lipocol-12 2 8.00 Isopropyl myristate 3.70 3.70 Cosmetic agent 2.50 2.50 2.50 Eutanol ZG16S 3 2.50 2.50 L-Menthol 4 5.00 5.00 Montane 80 VGA 5 1.5 Gliadin mixture 6 93.30 Polyvinly pyrrolidone 7 42.40 41.50 41.70 42.90 91.00 Polyethylene glycol - 400 8 45.40 44.30 44.60 45.90 4.00 1 Linoleic acid is a fatty acid commercially available from Croda Chemicals Ltd. 2 Lipocol-12 is 12 mole polyethylene glycol ether of lauryl alcohol commercially available from LIPO Chemicals Inc. 3 Eutanol G 16S is hexyldecyl stearate commercially available from Henkel KgaA. 4 L-Menthol is commercially available from Sigma Chemical Co. 5 Montane 80 VGA is polysorbate monooleate commercially available from Seppic. 6 Gliadin mixture is commercially available from Inocosm Lab. 7 Polyvinyl pyrrolidone is commercially available from BASF Aktiengesellschaft under the trademark “Kollidon 90 F”. 8 Polyethylene glycol 400 is commercially available from ICI Surfactants. The present invention having been disclosed in connection with the foregoing embodiments, additional embodiments will now be apparent to persons skilled in the art. The present invention is not intended to be limited to the embodiments specifically mentioned, and accordingly reference should be made to the appended claims rather than the foregoing discussion, to assess the spirit and scope of the present invention in which exclusive rights are claimed.