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`PTO/SBI14 (06—07)
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`Approved for use through 06/302010. OMB 0651—0032
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`US. Patent and Trademark Office; US. 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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`Cl C. 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 06/302010. OMB 0651—0032
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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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`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING
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`US. Patent and Trademark Office; US. DEPARTMENT OF COMMERCE
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`Application Data Sheet 37 CFR 1.76
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`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING
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`not claimed. Providing this information in the application data sheet constitutes the claim for priority as required by 35 U.S.C. 119(b)
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`Organization Name Monosoin LLC
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`2007—07—10
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`US. Patent and Trademark Office; US. 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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`This collection of information is required by 37 CFR 1.76. The information is required to obtain or retain a benefit by the public which
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`is to file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14. This
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`collection is estimated to take 23 minutes to complete, including gathering, preparing, and submitting the completed application data
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`sheet form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount oftime you require to
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`complete this form and/or suggestions for reducing this burden, should be sent to the Chief Information Officer, US. Patent and
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`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM INCORPORATING TASTE-MASKING
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`The information provided by you in this form will be subject to the following routine uses:
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`whether the Freedom of Information Act requires disclosure of these records.
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`The Privacy Act of 1974 (PL. 93—579) requires that you be given certain information in connection with your submission of the attached form related to
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`of this information is 35 U.S.C. 2(b)(2); (2) furnishing of the information solicited is voluntary; and (3) the principal purpose for which the information is
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`furnish the requested information, the US. Patent and Trademark Office may not be able to process andlor examine your submission, which may
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`result in termination of proceedings or abandonment of the application or expiration of the patent.
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`EFS Web 2.2.0
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`A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a court, magistrate, or
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`A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a request involving an
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`A record in this system of records may be disclosed, as a routine use, to anotherfederal agency for purposes of National Security
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`review (35 U.S.C. 181) and for review pursuant to the Atomic Energy Act (42 U.S.C. 218(c)).
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`A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services, or hislher designee,
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`during an inspection of records conducted by GSA as part of that agency's responsibility to recommend improvements in records
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`management practices and programs, under authority of 44 U.S.C. 2904 and 2906. Such disclosure shall be made in accordance with the
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`to 35 U.S.C. 122(b) or issuance ofa patent pursuant to 35 U.S.C. 151. Further, a record may be disclosed, subject to the limitations of 37
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`1 199-4B CIP
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`UNIFORM FILMS FOR RAPID DISSOLVE DOSAGE FORM
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`INCORPORATING TASTE-MASKING COMPOSITIONS
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`controlled—release coated particles uniformly distributed throughout the film.
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`CROSS-REFERENCE TO RELATED APPLICATIONS
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`2001; this application is also a continuation—in-part of US. Application No. 10/856,176, filed
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`May 28, 2004, which claims priority to US. Provisional Application No. 60/473,902, filed May
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`28, 2003; US. Application No. 10/856,176 is also a continuation-in-part of US. Application No.
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`lO/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 invention relates to rapidly dissolving films and methods of their
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`preparation. The films contain a polymer component and active ingredients as taste-masked or
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`Page 8
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`1 199-4B CIP
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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 added to 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% of the 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 swallowing difficulties, this is not a suitable solution for
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`many tablet or 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, may also destroy the controlled release properties.
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`[0004]
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`As an 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 number of 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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`Films that incorporate a pharmaceutically active ingredient are disclosed in
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`expired US. Patent No. 4,136,145 to Fuchs, et a1. ("Fuchs"). These films may be formed into a
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`sheet, dried and then cut into individual doses. The Fuchs disclosure 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. These allegedly flexible films are disclosed as being useful
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`for oral, topical or enteral use. Examples of specific uses disclosed by Fuchs include application
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`[0006]
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`Examination of films made in accordance with the process disclosed in Fuchs,
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`however, reveals that such films suffer from the aggregation or conglomeration of particles, i.e.,
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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 not disclosed likely include the use of relatively long drying
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`of the films to mucosa] membrane areas of the body, including the mouth, rectal, vaginal, nasal
`and ear areas.
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`Page 9
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`1 1 99-4B CIP
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`times, thereby facilitating intermolecular attractive forces, convection forces, air flow and the
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`like to form such agglomeration.
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`respectively, to increase the viscosity of the film prior to drying in an effort to reduce
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`[0007]
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`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 change in the dimensions of the
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`film would lead to a large difference in the amount of active per film. If such films were to
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`include low dosages of active, it is possible that portions of the film may be substantially devoid
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`of any active. Since sheets of film are usually cut into unit doses, certain doses may therefore be
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`devoid of or contain an insufficient amount of active for the recommended treatment. Failure to
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`achieve a high degree of accuracy with respect to the amount of active ingredient in the cut film
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`can be harmful to the patient. For this reason, dosage forms formed by processes such as Fuchs,
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`would not likely meet the stringent standards of governmental or regulatory agencies, such as the
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`US. 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 amount of active present. When applied to dosage units based on films, this
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`virtually mandates that uniformity in the film be present.
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`[0008]
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`The problems of self-aggregation leading to non-uniformity of a film were
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`addressed in US. Patent No. 4,849,246 to Schmidt ("Schmidt"). Schmidt specifically pointed
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`out that the methods disclosed by Fuchs did 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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`above is especially important in the pharmaceutical area. Schmidt abandoned the idea that a
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`mono-layer film, such as described by Fuchs, may provide an accurate dosage form and instead
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`attempted to solve this problem by forming a multi—layered film. Moreover, his process is 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 US. Patents directly addressed the problems of palticle 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, US. Patent 5,629,003 to Horstmann et al. and US. Patent 5,948,430
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`to Zerbe et a1. incorporated additional ingredients, i.e. gel formers and polyhydric alcohols
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`Page 10
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`1199-4B CIP
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`aggregation of the components in the film. These methods have the disadvantage of requiring
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`additional components, which translates to additional cost and manufacturing steps.
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`Furthermore, both methods employ the 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 of drying time aids in promoting the aggregation of the
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`active and other adjuvant, notwithstanding the use of viscosity modifiers. Such processes also
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`run the risk of exposing the active, Le, a drug, or vitamin C, or other components to prolonged
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`exposure to moisture and elevated temperatures, which may render it 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 themselves are 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 morphology of the resultant film product. Uniformity is particularly
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`difficult to achieve via conventional drying methods where a 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 portions of the 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 amount of 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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`Conventional drying methods generally include the use of forced hot air using a
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`related to the rheological properties and the process of water evaporation in the film-forming
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`composition. When the surface of an aqueous polymer solution is contacted with a high
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`temperature air current, such as a film-forming composition passing through a hot air oven, the
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`surface water is immediately evaporated forming a polymer film or skin on the surface. This
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`seals the remainder of the aqueous film-forming composition beneath the surface, forming a
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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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`Page 11
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`11 99-43 CIP
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`barrier through which the remaining water must force itself as it is evaporated in order to achieve
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`a dried film. As the temperature ou