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 selected from the group consisting of antimicrobial agents, non-steroidal anti-inflammatory drugs, anti-tussives, decongestants, antihistamines, expectorants, anti-diarrheals, H2 antagonists, proton pump inhibitors, general non-selective CNS depressants, general non-selective CNS stimulants, selective CNS functional modifiers, anti-parkinsonism drugs, narcotics, analgesics, neuromuscular drugs, erectile dysfunction therapeutic actives, PDES inhibitors, anti-pyretics, psychopharmacological drugs and combinations thereof; and
c. at least one plasticizer, wherein the film product has a partial immersion dissolution value in the range of about 1 to about 60 seconds.
2 . The film product according to claim 1 , wherein the film product has a partial immersion dissolution value in the range of about 2 to about 30 seconds.
3 . The film product according to claim 1 , wherein the film product has a partial immersion dissolution value in the range about 2 to about 10 seconds.
4 . The film product according to claim 1 , wherein the at least one linear polysaccharide is a polysaccharide with an alpha 1,4 glycosidic linkage or an 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, tragacanth 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 the film product has a tensile strength of about 0.8 N/mm or greater.
11 . The film product according to claim 1 , wherein the film product has a tensile strength of about 1 N/mm or greater.
12 . 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
iv) 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 the total polymer content.
13 . 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.
14 . 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.
15 . The film product of claim 1 , further comprising a buffer.
16 . The film product of claim 1 , further comprising a component selected from the group consisting of flavors, sweeteners, coloring agents, pigments, fillers, viscosity modifiers, solubility enhancers, excipients, lubricants, buffering agents, stabilizers, blowing agents, pigments, bulking agents, fragrances, release modifiers, adjuvants, flow accelerators, mold release agents, granulating agents, diluents, binders, buffers, absorbents, glidants, adhesives, anti-adherents, acidulants, softeners, resins, demulcents, solvents, surfactants, emulsifiers, and combinations thereof.
17 . The film product of claim 1 , wherein the active component is in a controlled release form.
18 . The film product of claim 1 , wherein at least two active components are present.
19 . The film product of claim 1 formed from two or more film layers.
20 . The film product of claim 19 , wherein each layer comprises at least one active component and the active component in each film layer may be the same or different from the active component in any other film layer.
21 . The film product of claim 20 , comprising two film layers, wherein a different active component is present in each of the two film layers.
22 . The film product of claim 1 , wherein the active component is about 40% or greater by weight based on the dry weight of the film product.
23 . The film product of claim 1 , wherein the active component is about 50% or greater by weight based on the dry weight of the film product.
24 . The film product of claim 1 , wherein the active component is about 55% or greater by weight based on the dry weight of the film product.
25 . A film product comprising:
a. at least one linear polysaccharide;
b. a therapeutically effective amount of a drug selected from the group consisting of sildenafil, tadalafil, and combinations thereof; and
c. a plasticizer,
wherein the film product has a partial immersion dissolution value in the range of about 1 to about 60 seconds.
26 . A film product comprising:
a. at least one linear polysaccharide;
b. a therapeutically effective amount of at least one active component selected from the group consisting of general non-selective CNS stimulants, general non-selective CNS depressants, and combinations thereof; and
c. a plasticizer,
wherein the film product has a partial immersion dissolution value in the range of about 1 to about 60 seconds.
27 . A film product comprising:
a. at least one linear polysaccharide;
b. a therapeutically effective amount of one or more neuromuscular drugs; and
c. a plasticizer,
wherein the film product has a partial immersion dissolution value in the range of about 1 to about 60 seconds.