THIN FILM WITH NON-SELF-AGGREGATING UNIFORM HETEROGENEITY AND DRUG DELIVERY SYSTEMS MADE THEREFROM
The invention relates to film products containing desired levels of active components and methods of their preparation. Desirably, the films disintegrate in water and may be formed by a controlled drying process, or other process that maintains the required uniformity of the film. Desirably, the films may be exposed to temperatures above that at which the active components typically degrade without concern for loss of the desired activity.
1 . An ingestible film product containing a desired level of a pharmaceutical or biological active component formed by the steps of:
(a) combining a water-soluble polymer, water and a pharmaceutical or biological active component to form a material having a substantially uniform distribution of components;
(b) forming said material into a film;
(f) providing a conveyor surface having top and bottom sides;
(g) feeding said film onto said top side of said surface; and
(h) drying said film within about 10 minutes or fewer by applying heat to said bottom side of said conveyor surface with substantially no hot air currents on the top side of said surface at a temperature above a degradation temperature of said pharmaceutical or biological active component, wherein said degradation temperature is 70° C. or higher,
wherein said pharmaceutical or biological active component is maintained at said desired level, and
wherein said water is present in said dried film at about 10% by weight of said film or less.
2 . The film product of claim 1 , wherein said water added in step (a) has a weight percent of at least about 30%.
3 . The film product of claim 1 , wherein said drying of said film reduces the weight percent of said water to about 8% or less.
4 . The film product of claim 1 , wherein said drying of said film reduces the weight percent of said water to about 6% or less.
5 . The film product of claim 1 , wherein said polymer is a cellulose derivative.
6 . The film product of claim 1 , wherein said polymer is a member selected from the group consisting of hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, polyvinylpyrrolidone, carboxymethyl cellulose, polyvinyl alcohol, sodium aginate, polyethylene glycol, xanthan gum, tragancanth gum, guar gum, acacia gum, arabic gum, polyacrylic acid, methylmethacrylate copolymer, carboxyvinyl copolymers, starch and combinations thereof.
7 . The film product of claim 1 , wherein said film product has a thickness of greater than about 0.1 mils.
8 . The film product of claim 1 , wherein said film product has a thickness of about 10 mils or fewer.
9 . The film product of claim 1 , wherein said film product has a substantially uniform thickness.
10 . The film product of claim 1 , wherein said film product is divided into dosage forms of substantially equal dimensions.
11 . The film product of claim 10 , wherein said dosage forms contain an amount of said pharmaceutical or biological active that varies about 10% or less among said dosage forms.
12 . The film product of claim 1 , wherein said pharmaceutical or biological active component is a protein.
13 . The film product of claim 1 , wherein said pharmaceutical or biological active component is taste-mask coated.
14 . An ingestible film product containing a desired level of a pharmaceutical or biological active component formed by the steps of:
(a) forming a master-batch premix of a water-soluble polymer and water;
(b) feeding a predetermined amount of said premix to at least one mixer;
(c) adding a pharmaceutical or biological active component to said at least one mixer;
(d) mixing said pharmaceutical or biological active component and said predetermined amount of said premix to form a material having a substantially uniform distribution of components;
(e) forming said material into a film;
(f) providing a conveyor surface having top and bottom sides;
(g) feeding said film onto said top side of said surface; and
(h) drying said film by applying heat to said bottom side of said conveyor surface at a temperature above a degradation temperature of said pharmaceutical or biological active component, wherein said degradation temperature is 70° C. or higher,
wherein said drying step further comprises rapidly forming a visco-elastic film within about the first 4.0 minutes by applying heat to said bottom side of said surface in the absence of hot air currents on the top side of said surface; and
drying said visco-elastic film to form a self-supporting ingestible film,
wherein said pharmaceutical or biological active component is maintained at said desired level, and
wherein said water is present in said dried film at about 10% by weight of said film or less.
15 . The film product of claim 14 , wherein said film product is divided into dosage forms of substantially equal dimensions.
16 . The film product of claim 15 , wherein said dosage forms contain an amount of said pharmaceutical or biological active that varies about 10% or less among said dosage forms.
17 . The film product of claim 14 , wherein said pharmaceutical or biological active component is a protein.
18 . The film product of claim 14 , wherein said pharmaceutical or biological active component is taste-mask coated.