Source: http://www.google.com/patents/US7824588?dq=7800613
Timestamp: 2014-03-13 10:33:48
Document Index: 517071302

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60']

Patent US7824588 - Method of making self-supporting therapeutic active-containing film - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsThe 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...http://www.google.com/patents/US7824588?utm_source=gb-gplus-sharePatent US7824588 - Method of making self-supporting therapeutic active-containing filmAdvanced Patent SearchPublication numberUS7824588 B2Publication typeGrantApplication numberUS 12/102,071Publication dateNov 2, 2010Filing dateApr 14, 2008Priority dateOct 12, 2001Also published asUS7357891, US7910031, US20040258896, US20080260805, US20090182062, US20110182969, US20120128848, US20130337148, US20140008830Publication number102071, 12102071, US 7824588 B2, US 7824588B2, US-B2-7824588, US7824588 B2, US7824588B2InventorsRobert K. Yang, Richard C. Fuisz, Garry L. Myers, Joseph M. FuiszOriginal AssigneeMonosol Rx, LlcExport CitationBiBTeX, EndNote, RefManPatent Citations (99), Non-Patent Citations (4), Classifications (21), Legal Events (4) External Links: USPTO, USPTO Assignment, EspacenetMethod of making self-supporting therapeutic active-containing filmUS 7824588 B2Abstract 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.
CROSS-REFERENCE TO RELATED APPLICATIONS The present application is a divisional of U.S. application Ser. No. 10/768,809, filed Jan. 30, 2004, now U.S. Pat. No. 7,357,891, which claims benefit to U.S. Provisional Application No. 60/443,741 filed Jan. 30, 2003, and which is a continuation-in-part of PCT/US02/32575 filed Oct. 11, 2002, which claims priority to U.S. application Ser. No. 10/074,272, filed Feb. 14, 2002, now U.S. Pat. No. 7,425,292, which claims priority to U.S. Provisional Application No. 60/328,868, filed Oct. 12, 2001, and U.S. Provisional Application No. 60/386,937, filed Jun. 7, 2002; U.S. application Ser. No. 10/768,809 is also a continuation-in-part of PCT/US02/32594, filed Oct. 11, 2002, which claims priority to U.S. Provisional Application No. 60/414,276, filed Sep. 27, 2002, U.S. application Ser. No. 10/074,272, filed Feb. 14, 2002, now U.S. Pat. No. 7,425,292, which claims priority to U.S. Provisional Application No. 60/328,868, filed Oct. 12, 2001 and U.S. Provisional Application No. 60/386,937, filed Jun. 7, 2002; and U.S. application Ser. No. 10/768,809 is also a continuation-in-part of PCT/US02/325442, filed Oct. 11, 2002, which claims priority to U.S. Provisional Application No. 60/371,940, filed Apr. 11, 2002, U.S. application Ser. No. 10/074,272, fled Feb. 14, 2002, which claims priority to U.S. Provisional Application No. 60/328,868, filed Oct. 12, 2001 and U.S. Provisional Application No. 60/386,937, filed Jun. 7, 2002, the contents all of which are incorporated herein by reference.
SUMMARY OF THE INVENTION In one aspect of the present invention there is provided 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 the premix to at least one mixer; (c) adding a pharmaceutical or biological active component to the at least one mixer; (d) mixing the pharmaceutical or biological active component and the predetermined amount of the premix to form a material having a substantially uniform distribution of components; (e) forming the material into a film; (f) providing a conveyor surface having top and bottom sides; (g) feeding the film onto the top side of the surface; and (h) drying the film by applying heat to the bottom side of the conveyor surface at a temperature above a degradation temperature of the pharmaceutical or biological active component, wherein the degradation temperature is 70� C. or higher, wherein the drying step further comprises rapidly forming a visco-elastic film within about the first 4.0 minutes by applying heat to the bottom side of the surface in the absence of hot air currents on the top side of the surface; and drying the visco-elastic film to form a self-supporting ingestible film, wherein the pharmaceutical or biological active component is maintained at the desired level, and wherein the water is present in the dried film at about 10% by weight of the film or less. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 shows a side view of a package containing a unit dosage film of the present invention.
Examples CC-CI Example CG Thin film compositions of the present invention were prepared using the amounts described in Table 15.
Example CH A composition including the ingredients of Example CH was combined and formed into films, as in Example CG. The films were dried by the process of the present invention, under the same time and temperature conditions as in Example CC. In particular the films were dried in an 80� C. air oven for 9 minutes on trays lined with furnace filters. The films were dried to about 1.89 percent moisture. The resulting films had no streaks, and were homogenous. Due to uniform heat diffusion throughout the film, no particle aggregations developed, as depicted in FIG. 17.
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