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`PTO/SB/14 (06-07)
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`Approved for use through 06/30/2010. OMB 0651-0032
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
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`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
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`1199-4B CIP
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`Application Data Sheet 37 CFR 1.76
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`Title of Invention UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING
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`Req uest Not to Publish. | hereby request that the attached application not be published under 35 U.S.
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`[| ©. 122(b) and certify that the invention disclosed in the attached application has not and will not be the subject of
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`Approved for use through 06/30/2010. OMB 0651-0032
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
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`Application Data Sheet 37 CFR 1.76
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`Organization Name MonoSolRx LLC
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`Date (YYYY-MM-DD)}
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`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
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`Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it contains a valid OMB control number.
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`Application Data Sheet 37 CFR 1.76
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`Title of Invention
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`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING
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`COMPOSITIONS
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`complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S. Patent and
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`Privacy Act Statement
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`to 35 U.S.C. 122(b) or issuance of a patent pursuant to 35 U.S.C. 151. Further, a record may be disclosed, subjectto the limitations of 37
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`1199-4B CIP
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`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM
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`INCORPORATING TASTE-MASKING COMPOSITIONS
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`CROSS-REFERENCE TO RELATED APPLICATIONS
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`This application is a continuation-in-part of U.S. Application No. 10/768,809,
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`2001; this application is also a continuation-in-part of U.S. Application No. 10/856,176,filed
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`May 28, 2004, which claimspriority to U.S. Provisional Application No. 60/473,902, filed May
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`28, 2003; U.S. Application No. 10/856,176 is also a continuation-in-part of U.S. Application No.
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`10/768,809; the contents all of which are incorporated herein by reference.
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`FIELD OF THE INVENTION
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`[0002]
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`The present inventionrelates to rapidly dissolving films and methodsoftheir
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`preparation. The films contain a polymer component and active ingredients as taste-masked or
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`controlled-release coated particles uniformly distributed throughoutthe film.
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`BACKGROUND OF THE RELATED TECHNOLOGY
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`[0003]
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`Active ingredients, such as drugs or pharmaceuticals, may be prepared in a tablet
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`form to allow for accurate and consistent dosing. However,this form of preparing and
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`dispensing medications has many disadvantages including that a large proportion of adjuvants
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`that must be addedto obtain a size able to be handled, that a larger medication form requires
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`additional storage space, and that dispensing includes counting the tablets which has a tendency
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`for inaccuracy. In addition, many persons, estimated to be as much as 28% ofthe population,
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`have difficulty swallowing tablets. While tablets may be broken into smaller pieces or even
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`crushed as a means of overcoming swallowingdifficulties, this is not a suitable solution for
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`manytabletor pill forms. For example, crushing or destroying the tablet or pill form to facilitate
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`ingestion, alone or in admixture with food, mayalso destroy the controlled release properties.
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`[0004]
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`Asan alternative to tablets and pills, films may be used to carry active ingredients
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`such as drugs, pharmaceuticals, and the like. However, historically films and the process of
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`making drug delivery systems therefrom have suffered from a numberof unfavorable
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`characteristics that have not allowed them to be used in practice.
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`[0005]
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`Filmsthat incorporate a pharmaceutically active ingredient are disclosed in
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`expired U.S. Patent No. 4,136,145 to Fuchs, et al. ("Fuchs"). These films may be formedinto a
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`sheet, dried and then cut into individual doses. The Fuchsdisclosure alleges the fabrication of a
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`uniform film, which includes the combination of water-soluble polymers, surfactants, flavors,
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`sweeteners, plasticizers and drugs. Theseallegedly flexible films are disclosed as being useful
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`for oral, topical or enteral use. Examples of specific uses disclosed by Fuchsinclude application
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`of the films to mucosal membraneareasof the body, including the mouth,rectal, vaginal, nasal
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`and ear areas.
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`[0006]
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`however,reveals that such films suffer from the aggregation or conglomeration ofparticles,i.c.,
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`Examination of films made in accordance with the process disclosed in Fuchs,
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`self-aggregation, making them inherently non-uniform. This result can be attributed to Fuchs’
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`process parameters, which although notdisclosedlikely include the useof relatively long drying
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`Page 9
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`1199-4B CIP
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`times, therebyfacilitating intermolecular attractive forces, convection forces, air flow and the
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`like to form such agglomeration.
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`[0007]
`The formation of agglomerates randomly distributes the film components and any
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`active present as well. When large dosages are involved, a small changein the dimensionsof the
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`film wouldlead to a large difference in the amountofactive per film. If such films were to
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`include low dosagesofactive, it is possible that portions ofthe film may besubstantially devoid
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`of any active. Since sheets offilm are usually cut into unit doses, certain doses may therefore be
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`devoid of or contain an insufficient amount ofactive for the recommendedtreatment. Failure to
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`achieve a high degree of accuracy with respectto the amountofactive ingredient in the cutfilm
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`can be harmfulto the patient. For this reason, dosage forms formed by processes such as Fuchs,
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`would notlikely meet the stringent standards of governmental or regulatory agencies, such as the
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`U.S. Federal Drug Administration (“FDA”), relating to the variation of active in dosage forms.
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`Currently, as required by various world regulatory authorities, dosage forms may not vary more
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`than 10% in the amountof active present. When applied to dosage units based onfilms, this
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`virtually mandates that uniformity in the film be present.
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`[0008]
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`The problemsofself-aggregation leading to non-uniformity of a film were
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`addressed in U.S. Patent No. 4,849,246 to Schmidt ("Schmidt"). Schmidt specifically pointed
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`out that the methods disclosed by Fuchsdid not provide a uniform film and recognized that that
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`the creation of a non-uniform film necessarily prevents accurate dosing, which as discussed
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`aboveis especially important in the pharmaceutical area. Schmidt abandonedthe idea that a
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`mono-layer film, such as described by Fuchs, may provide an accurate dosage form andinstead
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`attempted to solve this problem by forming a multi-layered film. Moreover, his processis a
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`multi-step process that adds expense and complexity and is not practical for commercial use.
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`[0009]
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`Other U.S. Patents directly addressed the problemsof particle self-aggregation
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`and non-uniformity inherent in conventional film forming techniques. In one attempt to
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`overcome non-uniformity, U.S. Patent 5,629,003 to Horstmannet al. and U.S. Patent 5,948,430
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`to Zerbe et al. incorporated additional ingredients, i.e. gel formers and polyhydric alcohols
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`respectively, to increase the viscosity of the film prior to drying in an effort to reduce
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`harmful.
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`aggregation of the components in the film. These methods have the disadvantage ofrequiring
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`additional components, which translates to additional cost and manufacturingsteps.
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`Furthermore, both methods employthe use the conventional time-consuming drying methods
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`such as a high-temperature air-bath using a drying oven, drying tunnel, vacuum drier, or other
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`such drying equipment. The long length ofdrying time aids in promoting the aggregation ofthe
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`active and other adjuvant, notwithstandingthe use ofviscosity modifiers. Such processes also
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`run the risk of exposing the active,i.e., a drug, or vitamin C, or other components to prolonged
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`exposure to moisture and elevated temperatures, which may renderit ineffective or even
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`[0010]
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`In addition to the concerns associated with degradation of an active during
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`extended exposure to moisture, the conventional drying methods themselvesare unable to
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`provide uniform films. The length of heat exposure during conventional processing, often
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`referred to as the “heat history”, and the manner in which such heat is applied, have a direct
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`effect on the formation and morphologyofthe resultant film product. Uniformity is particularly
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`difficult to achieve via conventional drying methods wherea relatively thicker film, which is
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`well-suited for the incorporation of a drug active, is desired. Thicker uniform films are more
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`difficult to achieve because the surfaces of the film and the inner portionsofthe film do not
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`experience the same external conditions simultaneously during drying. Thus, observation of
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`relatively thick films made from such conventional processing shows a non-uniform structure
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`caused by convection and intermolecular forces and requires greater than 10% moisture to
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`remain flexible. The amountof free moisture can often interfere over time with the drug leading
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`to potency issues and therefore inconsistency in the final product.
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`[0011]
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`drying oven, drying tunnel, and the like. The difficulty in achieving a uniform film is directly
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`Conventional drying methods generally include the use of forced hotair using a
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`related to the rheological properties and the process of water evaporationin the film-forming
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`composition. Whenthe surface of an aqueous polymersolution is contacted with a high
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`temperature air current, such as a film-forming composition passing through a hotair oven,the
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`surface water is immediately evaporated forming a polymerfilm or skin on the surface. This
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`seals the remainder of the aqueousfilm-forming composition beneath the surface, forming a
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`1199-4B CIP
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`barrier through which the remaining water mustforceitself as it is evaporated in o