LINEAR POLYSACCHARIDE BASED FILM PRODUCTS
Film products, especially suitable for oral delivery, which can be formed during manufacture in the form of large and/or heavy film strips or sheets and subsequently cut into uniform dosage units, each dosage unit being uniform in content and having distributed therein a linear polysaccharide, such as pullulan, a plasticizer, and an active component.
1 . A film product comprising:
a. at least one linear polysaccharide;
b. a therapeutically effective amount of at least one active component; and
c. at least one plasticizer.
2 . The film product according to claim 1 , wherein the at least one active component is selected from the group consisting of antimicrobial agents, non-steroidal anti-inflammatory drugs, anti-tussives, decongestants, antihistamines, expectorants, anti-diarrheals, H 2 antagonists, proton pump inhibitors, general non-selective CNS depressants, general non-selective CNS stimulants, selective CNS functional modifiers, anti-parkinsonism drugs, narcotics, analgesics, erectile dysfunction therapeutic actives, PDE5 inhibitors, anti-pyretics, psychopharmacological drugs and combinations thereof.
3 . The film product according to claim 1 , wherein the at least one active component is an erectile dysfunction therapeutic active.
4 . The film product according to claim 1 , wherein the at least one linear polysaccharide is a polysaccharide with an alpha 1,4 or and alpha 1,6 glycosidic linkage.
5 . The film product according to claim 1 , wherein the at least one linear polysaccharide is selected from the group consisting of pullulan, elsinan, and combinations thereof.
6 . The film product of claim 1 , further comprising an additional film-forming polymer.
7 . The film product of claim 6 , wherein the additional film-forming polymer is selected from the group consisting of hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, ethyl cellulose, hydroxypropyl ethyl cellulose, cellulose acetate phthalate, hydroxypropyl methyl cellulose phthalate, sodium alginate, polyethylene glycol, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, starch, gelatin, and combinations thereof.
8 . The film product according to claim 1 , wherein the plasticizer is xylitol, glycerin, or a combination thereof.
9 . The film product according to claim 1 , wherein i) the film product has a total polymer content; ii) the plasticizer is xylitol, and iii) the xylitol is present in an amount of about 10% to about 40% by weight based on the combined weight of the xylitol and the total polymer content.
10 . The film product according to claim 1 , wherein i) the film product has a total polymer content; ii) the plasticizer is a combination of xylitol and glycerin; and iii) the amount of glycerin is about equal to or less than the amount of xylitol by weight; and iii) the combination of glycerin and xylitol is present in an amount of about 40% or less by weight based on the combined weight of the xylitol, glycerin, and total polymer content.
11 . The film product according to claim 1 , wherein i) the film product has a total polymer content; ii) the plasticizer is glycerin, and iii) the glycerin is present in an amount of about 15% to about 22.5% by weight based on the combined weight of the xylitol and the total polymer content.
12 . The film product according to claim 1 , wherein i) the film product has a total polymer content; ii) the plasticizer is glycerin, and iii) the glycerin is present in an amount of about 18% to about 21% by weight based on the combined weight of the xylitol and the total polymer content.
13 . The film product according to claim 1 , further comprising an acid.
14 . The film product according to claim 1 , further comprising an acid selected from the group consisting of citric acid, formic acid, acetic acid, propionic acid, ascorbic acid, lactic acid, malic acid, tartaric acid, and combinations thereof.
15 . The film product according to claim 1 , further comprising citric acid, wherein i) the film product has a total polymer content; ii) the plasticizer is xylitol, iii) the amount of citric acid is about equal to or less than the amount of xylitol by weight; and iv) the xylitol is present in an amount of about 10% to about 40% by weight based on the combined weight of the xylitol and the total polymer content.
16 . The film product according to claim 1 , further comprising citric acid, wherein i) the film product has a total polymer content; ii) the plasticizer is a combination of xylitol and glycerin; and iii) the combination of glycerin, xylitol, and citric acid is present in an amount of about 45% or less by weight based on the combined weight of the xylitol, glycerin, and total polymer content.
17 . The film product according to claim 1 , wherein the film product comprises less than about 5% water by weight based on the total weight of the film product.
18 . The film product according to claim 1 , wherein the film product comprises less than about 2% water by weight based on the total weight of the film product.
19 . The film product according to claim 1 , wherein the amount of active component is about 40% or greater by weight based on the dry weight of the film product.
20 . The film product according to claim 1 , wherein the amount of active component is about 50% or greater by weight based on the dry weight of the film product.
21 . The film product according to claim 1 , wherein the amount of active component is about 55% or greater by weight based on the dry weight of the film product.
22 . The film product according to claim 1 , wherein the amount of active component is about 60% or greater by weight based on the dry weight of the film product.
23 . The film product according to claim 1 , wherein the film product has a partial immersion dissolution time of about 1 to about 60 seconds.
24 . The film product according to claim 1 , wherein the film product has a partial immersion dissolution time of about 2 to about 30 seconds.
25 . The film product according to claim 1 , wherein the film product has a partial immersion dissolution time of about 2 to about 10 seconds.
26 . The film product according to claim 1 , wherein the film product has a partial immersion dissolution time of about 10 to about 30 seconds.
27 . The film product according to claim 1 , wherein the film product has a tensile strength of about 0.8 N/mm or greater.
28 . The film product according to claim 1 , wherein the film product has a tensile strength of about 1 N/mm or greater.
29 . A film product comprising:
a. pullulan;
b. a therapeutically effective amount of sildenafil or a pharmaceutically acceptable salt thereof; and
c. at least one plasticizer.
30 . A film product comprising:
a. at least one linear polysaccharide;
b. a therapeutically effective amount of a pregabalin; and
c. at least one plasticizer.
31 . A film product comprising:
a. pullulan;
b. a therapeutically effective amount of tadalafil; and
c. at least one plasticizer.