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 cast film product comprising:
a self-supporting film composition comprising a matrix from which self-supporting unit doses can be formed, said matrix comprising:
(a) at least one linear polysaccharide film-forming polymer comprising pullulan in amounts of about 10% to about 35% by weight of the film composition;
(b) an active present in amounts of about 6% to about 65% by weight of the film composition;
and
(c) a plasticizer composition present in an amount of about 10% to about 45% by weight based on the combined weight of the plasticizer composition and a total polymer content in the film product;
said plasticizer composition comprising xylitol and glycerin, wherein the glycerin is present in an amount that is equal to or less than the amount of the xylitol by weight;
and said matrix further comprising a resin;
wherein substantially uniformly sized unit doses of the film composition exhibit a disintegration value in the range of about 1 second to about 60 seconds as measured by suspending the unit dose film such that half of the unit dose film is submerged in water at 37° C. and determining the time for the submerged half of the unit dose film to separate from the suspended half.
2 . The cast film product of claim 1 , wherein the plasticizer composition further comprises a plasticizer selected from the group consisting of propylene glycol, triacetin and sorbitol.
3 . The cast film product of claim 1 , further comprising a sugar alcohol selected from the group consisting of sorbitol and maltitol.
4 . The cast film product of claim 1 , wherein the amount of the glycerin is equal to the amount of xylitol by weight.
5 . The cast film product of claim 1 , wherein the xylitol is present in an amount of about 10% to about 45% by weight based on the combined weight of the xylitol and the total polymer content.
6 . The cast film product of claim 1 , wherein the plasticizer composition is present in an amount of about 15% to about 22.5% by weight based on the combined weight of the plasticizer composition and the total polymer content.
7 . The cast film product of claim 1 , wherein the plasticizer composition is present in an amount of about 18% to about 21% by weight based on the combined weight of the plasticizer composition and the total polymer content.
8 . The cast film product of claim 1 , wherein the unit dose film has a thickness of from about 3 μm to about 500 μm.
9 . The cast film product of claim 1 , wherein the active is a neuromuscular drug.
10 . The cast film product of claim 1 , further comprising an additional polymer.
11 . The cast film product of claim 10 , wherein the additional 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.
12 . The cast film product of claim 1 , further comprising an acid.
13 . The cast film product of claim 12 , wherein the acid is 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.
14 . The cast film product of claim 1 , wherein the unit doses exhibit a disintegration value in the range of about 2 to about 10 seconds as measured by suspending the unit dose film such that half of the unit dose film is submerged in water at 37° C. and determining the time for the submerged half of the unit dose film to separate from the suspended half.
15 . The cast film product of claim 1 , wherein the film product has a tensile strength of about 0.8 N/mm 2 .
16 . The cast film product of claim 1 , wherein the film product has a tensile strength of about 1 N/mm 2 .