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US 2022/0088201 A1Published application
Linear polysaccharide based film products
AssigneeAquestive Therapeutics, Inc.
InventorsGarry L. Myers, Michael Li, Beuford Arlie Bogue, Eric Dadey
Life of this patent
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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.
Claims21
-31. (canceled)
A cast film product comprising:
- a film composition comprising a matrix capable of delivering an active and from which self-supporting high dose, fast disintegrating unit doses can be formed comprising:
- a. at least one linear polysaccharide polymer comprising pullulan;
- b. a plasticizer composition comprising a first plasticizer and a second plasticizer;
- and
- c. a resin complex comprising a resin and an active;
- wherein the first plasticizer is a sugar alcohol;
- wherein the second plasticizer is selected from the group consisting of polyethylene glycol, polyalkylene oxide, glycerin, glycerol monoacetate, glycerol diacetate, glycerol triacetate, triacetin, polysorbate, cetyl alcohol, propylene glycol, sorbitol, erythritol, citric acid and any combination thereof;
- wherein the plasticizer composition is 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;
- wherein unit doses of the film composition having a size of 20 mm×22 mm, having a substantially uniform thickness, and having a weight of about 18 mg to about 97 mg exhibit a disintegration value in the range of about 0.5 to about 20 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;
- and;
- wherein the unit dose film delivers an active in amounts of about 0.01% to about 65% by weight of the unit dose.
8 more elements
Dependencies are inferred from the claim text.