Process for making a film having a substantially uniform distribution of components
DC CAFCFirst Claim
1. A process for making a film having a substantially uniform distribution of components, comprising the steps of:
- (a) forming a flowable polymer matrix comprising an edible polymer, a solvent and a desired amount of at least one active, said matrix having a substantially uniform distribution of said at least one active;
(b) casting said flowable polymer matrix;
(c) rapidly evaporating at least a portion of said solvent upon initiation of drying to form a visco-elastic film within about the first 4.0 minutes to maintain said substantially uniform distribution of said at least one active by locking-in or substantially preventing migration of said at least one active within said visco-elastic film;
(d) further drying said visco-elastic film to form a self-supporting edible film having a substantially uniform distribution of said at least one active component; and
wherein said substantially uniform distribution of said at least one active component is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active.
7 Assignments
Litigations
1 Petition
Accused Products
Abstract
The invention relates to the film products and methods of their preparation that demonstrate a non-self-aggregating uniform heterogeneity. 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. The films contain a polymer component, which includes polyethylene oxide optionally blended with hydrophilic cellulosic polymers. Desirably, the films also contain a pharmaceutical and/or cosmetic active agent with no more than a 10% variance of the active agent pharmaceutical and/or cosmetic active agent per unit area of the film.
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Citations
30 Claims
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1. A process for making a film having a substantially uniform distribution of components, comprising the steps of:
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(a) forming a flowable polymer matrix comprising an edible polymer, a solvent and a desired amount of at least one active, said matrix having a substantially uniform distribution of said at least one active; (b) casting said flowable polymer matrix; (c) rapidly evaporating at least a portion of said solvent upon initiation of drying to form a visco-elastic film within about the first 4.0 minutes to maintain said substantially uniform distribution of said at least one active by locking-in or substantially preventing migration of said at least one active within said visco-elastic film; (d) further drying said visco-elastic film to form a self-supporting edible film having a substantially uniform distribution of said at least one active component; and
wherein said substantially uniform distribution of said at least one active component is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)
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26. A process for making a film having a substantially uniform distribution of components, comprising the steps of:
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(a) forming a flowable polymer matrix comprising an edible polymer, a solvent and a desired amount of at least one active, said matrix having a substantially uniform distribution of said at least one active; (b) casting said flowable polymer matrix; (c) rapidly evaporating at least a portion of said solvent upon initiation of drying to form a visco-elastic film within about the first 4.0 minutes to maintain said substantially uniform distribution of said at least one active by locking-in or substantially preventing migration of said at least one active within said visco-elastic film; (d) further drying said visco-elastic film to form a self-supporting edible film having a substantially uniform distribution of said at least one active component and having a water content of about 10% or less; and
wherein said substantially uniform distribution of said at least one active component is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active.
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27. A process for making a film having a substantially uniform distribution of components, comprising the steps of:
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(a) forming a flowable polymer matrix comprising a cellulosic polymer, a solvent and a desired amount of at least one active, said matrix having a substantially uniform distribution of said at least one active; (b) casting said flowable polymer matrix; (c) rapidly evaporating at least a portion of said solvent upon initiation of drying to form a visco-elastic film within about the first 4.0 minutes to maintain said substantially uniform distribution of said at least one active by locking-in or substantially preventing migration of said at least one active within said visco-elastic film; (d) further drying said visco-elastic film to form a self-supporting edible film having a substantially uniform distribution of said at least one active component and having a water content of about 10% or less; and
wherein said substantially uniform distribution of said at least one active component is measured by substantially equally sized individual unit doses which do not vary by more than 10% of said desired amount of said at least one active. - View Dependent Claims (28, 29)
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30. A process for manufacturing a resulting film suitable for commercialization and regulatory approval, said regulatory approval including analytical chemical testing which meets the standards of the U.S. Food and Drug Administration relating to variation of an active in individual dosage units, said film having a substantially uniform distribution of components comprising a substantially uniform distribution of said active in individual dosage units of said resulting film, comprising the steps of:
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(a) forming a flowable polymer matrix comprising a water-soluble polymer, a solvent and said active, said active selected from the group consisting of bioactive actives, pharmaceutical actives and combinations thereof, said matrix having a substantially uniform distribution of said active; (b) casting said flowable polymer matrix, said flowable polymer matrix having a viscosity from about 400 to about 100,000 cps; (c) controlling drying through a process comprising conveying said flowable polymer matrix through a drying apparatus to evaporate at least a portion of said solvent to form a visco-elastic film, having said active substantially uniformly distributed throughout, within about the first 4 minutes by rapidly increasing the viscosity of said flowable polymer matrix upon initiation of drying to maintain said substantially uniform distribution of said active by locking-in or substantially preventing migration of said active within said visco-elastic film, such that uniformity of content in the amount of said active in substantially equal sized individual dosage units, sampled from different locations of said visco-elastic film, varies by no more than 10%, and wherein during said drying said flowable polymer matrix temperature is 100°
C. or less;(d) forming said resulting film from said visco-elastic film by further controlling drying through a process comprising drying at a temperature differential ranging from 5°
C. to 30°
C. between polymer matrix inside temperature and outside exposure temperature to minimize degradation wherein water content of said resulting film is 10% or less and wherein said substantially uniform distribution of active by said locking-in or substantially preventing migration of said active is maintained, such that uniformity of content in the amount of said active in substantially equal sized individual dosage units, sampled from different locations of said resulting film, varies by no more than 10%; and(e) performing analytical chemical tests for uniformity of content of said active in substantially equal sized individual dosage units of said sampled resulting film, said tests indicating that uniformity of content in the amount of said active varies by no more than 10% and said resulting film is suitable for commercial and regulatory approval, wherein said regulatory approval is provided by the U.S. Food and Drug Administration.
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Specification