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US 12,622,971 B2Granted
Linear polysaccharide based film products
AssigneeAquestive Therapeutics, Inc.
InventorsGarry L. Myers, Michael Li, Beuford Arlie Bogue, Eric Dadey
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Abstract
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.
Claims16
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.
5 more elements
Dependencies are inferred from the claim text.