United States Patent [19]
`United States Patent [19]
`United States Patent [19]
`Schmidt
`Schmidt
`Schmidt
`
`[54] PROCESS FOR PRODUCING AN
`[54] PROCESS FOR PRODUCING AN
`[54] PROCESS FOR PRODUCING AN
`ADMINISTRATION OR DOSAGE FORM
`ADMINISTRATION OR DOSAGE FORM
`ADMINISTRATION OR DOSAGE FORM
`FOR DRUGS, REAGENTS OR OTHER
`FOR DRUGS, REAGENTS OR OTHER
`FOR DRUGS, REAGENTS OR OTHER
`ACTIVE INGREDIENTS
`ACTIVE INGREDIENTS
`ACTIVE INGREDIENTS
`[76] Inventor: Wolfgang Schmidt, Reembroden 44,
`[76] Inventor: Wolfgang Schmidt, Reembroden 44,
`[76] Inventor: Wolfgang Schmidt, Reembroden 44,
`D-2000 Hamburg 63, Fed. Rep. of
`D-2000 Hamburg 63, Fed. Rep. of
`D-2000 Hamburg 63, Fed. Rep. of
`Germany
`Germany
`Germany
`60,689
`60,689
`60,689
`Oct. 7, 1986
`Oct. 7, 1986
`Oct. 7, 1986
`
`[21] Appl. No.:
`[21] Appl. No.:
`[21] Appl. No.: (cid:9)
`[22] PCT Filed:
`[22] PCT Filed:
`[22] PCT Filed: (cid:9)
`
`(cid:9) (cid:9)
`(cid:9) (cid:9)
`
`PCI/EP86/ 00571
`PCT/EP86/00571
`PCT/EP86/00571
`[86] PCT No.: (cid:9)
`[86] PCT No.:
`[86] PCT No.:
`Jun. 9, 1987
`Jun. 9, 1987
`§ 371 Date:
`Jun. 9, 1987
`§ 371 Date: (cid:9)
`§ 371 Date:
`Jun. 9, 1987
`Jun. 9, 1987
`§ 102(e) Date:
`§ 102(e) Date:
`Jun. 9, 1987
`§ 102(e) Date: (cid:9)
`[87] PCT Pub. No.: W087/02241
`[87] PCT Pub. No.: WO87/02241
`[87] PCT Pub. No.: W087/022.41
`PCT Pub. Date: Apr. 23, 1987
`PCT Pub. Date: Apr. 23, 1987
`PCT Pub. Date: Apr. 23, 1987
`Foreign Application Priority Data
`[30]
`Foreign Application Priority Data
`[30] (cid:9)
`Foreign Application Priority Data
`[30] (cid:9)
` 3536024
`Oct. 9, 1985 [DE] Fed. Rep. of Germany (cid:9)
` 3536024
`Oct. 9, 1985 [DE] Fed. Rep. of Germany (cid:9)
`Oct. 9, 1985 [DE] Fed. Rep. of Germany ..... .. 3536024
`
` AO1W 1/02; A61K 9/00;
`AO1W 1/02; A61K 9/00;
`[51] Int. CM
`[51] Int. C1.4
`[51] Int. 01.4 ...... .Q .............. .. A01W 1/02; A61K 9/00;
`A61K 15/00; A61K 21/00
`A61K 15/00; A61K 21/00
`A61K 15/00; A61K 21/00
` 427/2; 424/478;
` 427/2; 424/478;
`[52] U.S. Cl. (cid:9)
`[52] U.S. Cl. (cid:9)
`[52] US. Cl. ...................................... .. 427/2; 424/478;
`424/479;427/3
`424/479; 427/3
`424/479; 427/3
`[58] Field of Search (cid:9)
` 427/2, 3; 424/478, 479
`[58] Field of Search (cid:9)
` 427/2, 3; 424/478, 479
`[58] Field of Search .............. .. 427/2, 3; 424/478, 479
`
`[11] Patent Number: (cid:9)
`[11] Patent Number: (cid:9)
`[11] Patent Number:
`[45] Date of Patent: (cid:9)
`[45] Date of Patent: (cid:9)
`[45] Date of Patent:
`
`4,849,246
`4,849,246
`4,849,246
`Jul. 18, 1989
`Jul. 18, 1989
`Jul. 18, 1989
`
`[56]
`[561 (cid:9)
`[56]
`
`References Cited
`References Cited
`References Cited
`U.S. PATENT DOCUMENTS
`U.S. PATENT DOCUMENTS
`U.S. PATENT DOCUMENTS
`RiNgell (cid:9)
` 128/260
` 128/260
`3,444,858 5/1969 Rmscrll (cid:9)
`3,444,858 5/1969 Russell .............................. .. 128/260
`3,444,858 5/1969
`FOREIGN PATENT DOCUMENTS
`FOREIGN PATENT DOCUMENTS
`FOREIGN PATENT DOCUMENTS
`2746414 4/1979 Fed. Rep. of Germany .
`2746414 4/1979 Fed. Rep. of Germany .
`2746414 4/ 1979 Fed. Rep. of Germany .
`51-54917 6/1976 Japan .
`51-54917 6/1976 Japan .
`51-54917 6/1976 Japan .
`139077 2/1920 United Kingdom .
`139077 2/1920 United Kingdom .
`139077 2/1920 United Kingdom .
`1061557 3/1967 United Kingdom .
`1061557 3/1967 United Kingdom .
`1061557 3/1967 United Kingdom .
`OTHER PUBLICATIONS
`OTHER PUBLICATIONS
`OTHER PUBLICATIONS
`Chemical Abstracts, vol. 85, 1976, p. 364.
`Chemical Abstracts, vol. 85, 1976, p. 364.
`Chemical Abstracts, vol. 85, 1976, p. 364.
`Primary Examiner——Michael Lusignan
`Primary Examiner—Michael Lusignan
`Primary Examiner—Michael Lusignan
`Attorney, Agent, or Firm-Cushman, Darby & Cushman
`Attorney, Agent, or Firm—Cushman, Darby & Cushman
`Attorney, Agent, or Firm—Cushman, Darby & Cushman
`ABSTRACI‘
`[57]
`[57]
`ABSTRACT
`ABSTRACT
`[57] (cid:9)
`A process for producing an administration or dosage
`A process for producing an administration or dosage
`A process for producing an administration or dosage
`form of drugs, reagents or other active ingredients. A
`form of drugs, reagents or other active ingredients. A
`form of drugs, reagents or other active ingredients. A
`watersoluble foil composed of starch, gelatin, glycerin
`watersoluble foil composed of starch, gelatin, glycerin
`watersoluble foil composed of starch, gelatin, glycerin
`and/or sorbit and if necessary other additives is coated
`and/or sorbit and if necessary other additives is coated
`and/or sorbit and if necessary other additives is coated
`by a roll coating process with a layer containing the
`by a roll coating process with a layer containing the
`by a roll coating process with a layer containing the
`active ingredients and composed of the samebasic ingre
`active ingredients and composed of the samebasic ingre-
`active ingredients and composed of the samebasic ingre-
`dients. After a corresponding prefragmentation, the
`dients. After a corresponding prefragmentation, the
`dients. After a corresponding prefragmentation, the
`administration form thus produced is particularly useful
`administration form thus produced is particularly useful
`administration form thus produced is particularly useful
`as an oral administration drug.
`as an oral administration drug.
`as an oral administration drug.
`
`15 Claims, No Drawings
`15 Claims, No Drawings
`15 Claims, No Drawings
`
`Par Pharm., Inc., et al.
`Exhibit 1020
`Page 001
`
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`PROCESS FOR PRODUCING AN
`PROCESS FOR PRODUCING AN
`PROCESS FOR PRODUCING AN
`ADMINISTRATION OR DOSAGE FORM FOR
`ADMINISTRATION OR DOSAGE FORM FOR
`ADMINISTRATION OR DOSAGE FORM FOR
`DRUGS, REAGENTS OR OTHER ACTIVE
`DRUGS, REAGENTS OR OTHER ACTIVE
`DRUGS, REAGENTS OR OTHER ACTIVE
`INGREDIENTS
`INGREDIENTS (cid:9)
`INGREDIENTS
`
`5
`5
`
`55
`55
`55
`
`1
`1
`1
`
`4,849,246
`4,849,246
`4,849,246
`2
`2
`2
`exist for solid drugs with respect to other parameters,
`exist for solid drugs with respect to other parameters,
`exist for solid drugs with respect to other parameters,
`such as the disintegration time and dissolving rate.
`such as the disintegration time and dissolving rate.
`such as the disintegration time and dissolving rate.
`The aforementioned prior art proposals lead to prod
`The aforementioned prior art proposals lead to prod-
`The aforementioned prior art proposals lead to prod-
`ucts with an inadequate acceptance by the patient (e.g.
`ucts with an inadequate acceptance by the patient (e.g.
`ucts with an inadequate acceptance by the patient (e.g.
`it is dif?cult to ingest paper portions) and do not permit
`it is difficult to ingest paper portions) and do not permit
`it is difficult to ingest paper portions) and do not permit
`an accurate dosing per surface unit, as is an absolute
`an accurate dosing per surface unit, as is an absolute
`an accurate dosing per surface unit, as is an absolute
`requirement. When incorporating the active ingredient
`requirement. When incorporating the active ingredient
`requirement. When incorporating the active ingredient
`into a ?lm, dif?culties are caused not only by the precise
`into a film, difficulties are caused not only by the precise
`into a film, difficulties are caused not only by the precise
`dosing, but also it is necessary to produce a separate ?lm
`dosing, but also it is necessary to produce a separate film
`dosing, but also it is necessary to produce a separate film
`for each active ingredient, so that the production pro
`for each active ingredient, so that the production pro-
`for each active ingredient, so that the production pro-
`cess is not economic.
`cess is not economic.
`cess is not economic.
`The problem of the present invention is to provide a
`The problem of the present invention is to provide a
`The problem of the present invention is to provide a
`“two-dimensional” administration and dosage form,
`"two-dimensional" administration and dosage form,
`"two-dimensional" administration and dosage form,
`which does not suffer from the aforementioned disad
`which does not suffer from the aforementioned disad-
`which does not suffer from the aforementioned disad-
`vantages, which can be easily produced and can be very
`vantages, which can be easily produced and can be very
`vantages, which can be easily produced and can be very
`?exibly adapted to the requirements of the market and
`flexibly adapted to the requirements of the market and
`flexibly adapted to the requirements of the market and
`different active ingredients.
`different active ingredients.
`different active ingredients.
`The invention therefore relates to a process for the
`The invention therefore relates to a process for the
`The invention therefore relates to a process for the
`production of an administration and dosage form for
`production of an administration and dosage form for
`production of an administration and dosage form for
`drug active ingredients, reagents or other active ingre
`drug active ingredients, reagents or other active ingre-
`drug active ingredients, reagents or other active ingre-
`dients in the form of a ?lm with an active ingredient
`dients in the form of a film with an active ingredient-
`dients in the form of a film with an active ingredient-
`containing coating, which is characterized in that.
`containing coating, which is characterized in that.
`containing coating, which is characterized in that.
`(a) a water—soluble support ?lm is produced from an
`(a) a water-soluble support film is produced from an
`(a) a water-soluble support film is produced from an
`aqueous composition based on starches, gelatins, glyc
`aqueous composition based on starches, gelatins, glyc-
`aqueous composition based on starches, gelatins, glyc-
`erol and/or sorbitol, as well as optionally natural and
`erol and/or sorbitol, as well as optionally natural and-
`erol and/or sorbitol, as well as optionally natural and-
`/or synthetic resins and/or gums,
`/ or synthetic resins and/ or gums,
`/or synthetic resins and/or gums,
`(b) an aqueous coating material is prepared from the
`(b) an aqueous coating material is prepared from the
`(b) an aqueous coating material is prepared from the
`active ingredient, as well as starches, gelatins, glycerol
`active ingredient, as well as starches, gelatins, glycerol
`active ingredient, as well as starches, gelatins, glycerol
`and/or sorbitol, as well as optionally natural and/or
`and/or sorbitol, as well as optionally natural and/or
`and/or sorbitol, as well as optionally natural and/or
`synthetic resins and/ or gums, and
`synthetic resins and/or gums, and
`synthetic resins and/or gums, and
`(c) the coating material is continuously applied by
`(c) the coating material is continuously applied by
`(c) the coating material is continuously applied by
`means of a roll coating process and in a precisely prede
`means of a roll coating process and in a precisely prede-
`means of a roll coating process and in a precisely prede-
`termined quantity (coating thickness) to at least one side
`termined quantity (coating thickness) to at least one side
`termined quantity (coating thickness) to at least one side
`of the support ?lm.
`of the support film.
`of the support film.
`The inventively produced administration form has a
`The inventively produced administration form has a
`The inventively produced administration form has a
`large number of important advantages:
`large number of important advantages:
`large number of important advantages:
`One support film can be used for the most varied
`One support film can be used for the most varied
`One support ?lm can be used for the most varied
`active ingredients and can therefore be economically
`active ingredients and can therefore be economically
`active ingredients and can therefore be economically
`produced in larger numbers.
`produced in larger numbers.
`produced in larger numbers.
`The active ingredient-containing coating can be very
`The active ingredient-containing coating can be very
`The active ingredient-containing coating can be very
`thin in the case of very ef?caceous drugs, because the
`thin in the case of very efficaceous drugs, because the
`thin in the case of very efficaceous drugs, because the
`support material ensures an adequate mechanical
`support material ensures an adequate mechanical
`support material ensures an adequate mechanical
`strength.
`strength.
`strength.
`With the aid of modern roll application processes the
`With the aid of modern roll application processes the
`With the aid of modern roll application processes the
`active ingredient-containing coating can be applied
`active ingredient-containing coating can be applied
`active ingredient-containing coating can be applied
`with a constant thickness, so that the necessary toler-
`with a constant thickness, so that the necessary toler-
`with a constant thickness, so that the necessary toler
`ances can be respected.
`ances can be respected.
`ances can be respected.
`If sterilization is necessary, this can be achieved with-
`If sterilization is necessary, this can be achieved with
`If sterilization is necessary, this can be achieved with-
`out dif?culty by radiation treatment due to the limited
`out difficulty by radiation treatment due to the limited
`out difficulty by radiation treatment due to the limited
`coating thickness.
`coating thickness.
`coating thickness.
`The support can be printed with different information
`The support can be printed with different information
`The support can be printed with different information
`on the front and in particular rear surface using physio
`on the front and in particular rear surface using physio-
`on the front and in particular rear surface using physio-
`logically acceptable printing inks.
`logically acceptable printing inks.
`logically acceptable printing inks.
`As a result of the relatively large surface area of e.g.
`As a result of the relatively large surface area of e.g.
`As a result of the relatively large surface area of e.g.
`4 to 10 cm2, detailed information for the user can be
`4 to 10 cm2, detailed information for the user can be
`4 to 10 cm2, detailed information for the user can be
`printed on the uncoated support material, or even subse-
`printed on the uncoated support material, or even subse-
`printed on the uncoated support material, or even subse
`quently.
`quently.
`quently.
`The dosage units can be rendered flexible by a corre-
`The dosage units can be rendered flexible by a corre-
`The dosage units can be rendered ?exible by a corre
`sponding pre-separation, e.g. by perforation, so that it is
`sponding pre-separation, e.g. by perforation, so that it is
`sponding pre-separation, e.g. by perforation, so that it is
`only necessary to produce one product for different
`only necessary to produce one product for different
`only necessary to produce one product for different
`dosages (e.g. for adults and children); whereby the pre
`dosages (e.g. for adults and children); whereby the pre-
`dosages (e.g. for adults and children); whereby the pre-
`separation can optionally be carried out in the pharma
`separation can optionally be carried out in the pharma-
`separation can optionally be carried out in the pharma-
`cists or hospital in accordance with details provided by
`cists or hospital in accordance with details provided by
`cists or hospital in accordance with details provided by
`the doctor.
`the doctor.
`the doctor.
`The inventive administration form shares the com-
`The inventive administration form shares the com
`The inventive administration form shares the com-
`mon advantage of the known ?lm-form administration
`mon advantage of the known film-form administration
`mon advantage of the known film-form administration
`forms of extremely small space requirements. Thus, in
`forms of extremely small space requirements. Thus, in
`forms of extremely small space requirements. Thus, in
`place of folding boxes, it is e.g. possible to use pouches
`place of folding boxes, it is e.g. possible to use pouches
`place of folding boxes, it is e.g. possible to use pouches
`
`Drugs or pharmaceuticals can be orally administered
`Drugs or pharmaceuticals can be orally administered
`Drugs or pharmaceuticals can be orally administered
`in the form of powders, dropping solutions or juices. As
`in the form of powders, dropping solutions or juices. As
`in the form of powders, dropping solutions or juices. As
`precise dosing is dif?cult with such administration
`precise dosing is difficult with such administration
`precise dosing is difficult with such administration
`forms, preference is generally given to manufacturer
`forms, preference is generally given to manufacturer- 10
`forms, preference is generally given to manufacturer- 10
`dosed administration forms such as tablets, dragees or
`dosed administration forms such as tablets, dragees or
`dosed administration forms such as tablets, dragees or
`capsules. Reagents and other active ingredients, e.g.
`capsules. Reagents and other active ingredients, e.g.
`capsules. Reagents and other active ingredients, e.g.
`sweeteners or ?avouring agents are frequently also
`sweeteners or flavouring agents are frequently also
`sweeteners or flavouring agents are frequently also
`tableted for a precisely dosed administration. The pro
`tableted for a precisely dosed administration. The pro-
`tableted for a precisely dosed administration. The pro-
`duction procedure for tablets, dragees, capsules, etc. has
`duction procedure for tablets, dragees, capsules, etc. has 15
`duction procedure for tablets, dragees, capsules, etc. has 15
`15
`largely been completely developed, but it is not possible
`largely been completely developed, but it is not possible
`largely been completely developed, but it is not possible
`to overlook a number of system-related disadvantages.
`to overlook a number of system-related disadvantages.
`to overlook a number of system-related disadvantages.
`For low-dosed active ingredients, a large proportion
`For low-dosed active ingredients, a large proportion
`For low-dosed active ingredients, a large proportion
`of adjuvants must be added in order to obtain a handla
`of adjuvants must be added in order to obtain a handla-
`of adjuvants must be added in order to obtain a handla-
`ble size of the individual dose. It is also substantially
`ble size of the individual dose. It is also substantially 20
`ble size of the individual dose. It is also substantially 20
`impossible to precisely mark individual tablets or
`impossible to precisely mark individual tablets or
`impossible to precisely mark individual tablets or
`dragees. Therefore blister packs have been adopted,
`dragees. Therefore blister packs have been adopted,
`dragees. Therefore blister packs have been adopted,
`which contain a large number of tablets, dragees and
`which contain a large number of tablets, dragees and
`which contain a large number of tablets, dragees and
`also capsules and which are printed with the necessary
`also capsules and which are printed with the necessary
`also capsules and which are printed with the necessary
`information and in particular the product name. The
`information and in particular the product name. The 25
`information and in particular the product name. The 25
`25
`manufacture of such packs naturally involves an addi
`manufacture of such packs naturally involves an addi-
`manufacture of such packs naturally involves an addi-
`tional operation and pack transfers in the form of fold
`tional operation and pack transfers in the form of fold-
`tional operation and pack transfers in the form of fold-
`ing boxes are required, which have a considerable
`ing boxes are required, which have a considerable
`ing boxes are required, which have a considerable
`empty volume and therefore take up additional storage
`empty volume and therefore take up additional storage
`empty volume and therefore take up additional storage
`space. Another serious disadvantage of dragees and
`space. Another serious disadvantage of dragees and 30
`space. Another serious disadvantage of dragees and 30
`capsules is that splitting up is not possible, so that the
`capsules is that splitting up is not possible, so that the
`capsules is that splitting up is not possible, so that the
`minimum dose is predetermined. An accurate breaking
`minimum dose is predetermined. An accurate breaking
`minimum dose is predetermined. An accurate breaking
`up is also difficult in the case of tablets and only larger
`up is also difficult in the case of tablets and only larger
`up is also difficult in the case of tablets and only larger
`tablets provided with a notch as a predetermined break
`tablets provided with a notch as a predetermined break-
`tablets provided with a notch as a predetermined break-
`ing point can be split, but frequently fragments of un
`ing point can be split, but frequently fragments of un- 35
`ing point can be split, but frequently fragments of un- 35
`35
`equal size are obtained.
`equal size are obtained.
`equal size are obtained.
`Attempts have already been made to find a new ad-
`Attempts have already been made to ?nd a new ad
`Attempts have already been made to find a new ad-
`ministration form for the oral administration of drugs in
`ministration form for the oral administration of drugs in
`ministration form for the oral administration of drugs in
`the form of active ingredient-containing films or foils.
`the form of active ingredient-containing films or foils.
`the form of active ingredient-containing films or foils.
`Belgian Pat. No. 637,363 discloses a paper-like support
`Belgian Pat. No. 637,363 discloses a paper-like support 40
`Belgian Pat. No. 637,363 discloses a paper-like support 40
`40
`material of insoluble cellulose ?bres impregnated with
`material of insoluble cellulose fibres impregnated with
`material of insoluble cellulose fibres impregnated with
`an active ingredient solution or coated by application or
`an active ingredient solution or coated by application or
`an active ingredient solution or coated by application or
`sprinkling, dosing being achieved by perforating the
`sprinkling, dosing being achieved by perforating the
`sprinkling, dosing being achieved by perforating the
`support ?lm in the manner of a sheet of postage stamps.
`support film in the manner of a sheet of postage stamps.
`support film in the manner of a sheet of postage stamps.
`The closing of the active ingredient is necessarily ex
`The dosing of the active ingredient is necessarily ex- 45
`The dosing of the active ingredient is necessarily ex- 45
`45
`tremely imprecise. DE-OS No. 24 32 925 and DE-OS
`tremely imprecise. DE-OS No. 24 32 925 and DE-OS
`tremely imprecise. DE-OS No. 24 32 925 and DE-OS
`No. 24 49 865 disclose the incorporation of drug active
`No. 24 49 865 disclose the incorporation of drug active
`No. 24 49 865 disclose the incorporation of drug active
`ingredients into ?lm forming agents, which are prefera
`ingredients into film forming agents, which are prefera-
`ingredients into film forming agents, which are prefera-
`bly in the form of water-soluble compounds, such as
`bly in the form of water-soluble compounds, such as
`bly in the form of water-soluble compounds, such as
`methyl and ethyl cellulose, but in particular hydroxy
`methyl and ethyl cellulose, but in particular hydroxy- 50
`methyl and ethyl cellulose, but in particular hydroxy- 50
`propyl cellulose, hydroxyethyl cellulose or methylhy
`propyl cellulose, hydroxyethyl cellulose or methylhy-
`propyl cellulose, hydroxyethyl cellulose or methylhy-
`droxypropyl cellulose. The ?lms can also contain ?llers
`droxypropyl cellulose. The films can also contain fillers
`droxypropyl cellulose. The films can also contain fillers
`and parting agents. The thus obtained active ingredient
`and parting agents. The thus obtained active ingredient-
`and parting agents. The thus obtained active ingredient-
`containing films can also be subdivided into individual
`containing films can also be subdivided into individual
`containing films can also be subdivided into individual
`portions by perforation for dosing purposes.
`portions by perforation for dosing purposes. (cid:9)
`portions by perforation for dosing purposes. (cid:9)
`However, these proposals have not led to practical
`However, these proposals have not led to practical
`However, these proposals have not led to practical
`adoption and in the latest text book “Arzneiformen
`adoption and in the latest text book "Arzneiformen-
`adoption and in the latest text book "Arzneiformen-
`lehre” by RH. List, fourth edition, Stuttgart 1985, no
`lehre" by P.H. List, fourth edition, Stuttgart 1985, no
`lehre" by P.H. List, fourth edition, Stuttgart 1985, no
`mention is made thereof. This is clearly based on the
`mention is made thereof. This is clearly based on the
`mention is made thereof. This is clearly based on the
`fact that the hitherto known proposals do not make it
`fact that the hitherto known proposals do not make it 60
`fact that the hitherto known proposals do not make it 60
`possible to obtain the requisite constant weight and
`possible to obtain the requisite constant weight and
`possible to obtain the requisite constant weight and
`uniform active ingredient distribution, such as are
`uniform active ingredient distribution, such as are
`uniform active ingredient distribution, such as are
`nowadays required. The Pharmakopoea Europae e.g.
`nowadays required. The Pharmakopoea Europae e.g.
`nowadays required. The Pharmakopoea Europae e.g.
`sets criteria for the uniformity of the weight of individu
`sets criteria for the uniformity of the weight of individu-
`sets criteria for the uniformity of the weight of individu-
`ally dosed drugs, which are graded according to the
`ally dosed drugs, which are graded according to the 65
`ally dosed drugs, which are graded according to the 65
`65
`maximum permitted variations in per cent correspond
`maximum permitted variations in per cent correspond-
`maximum permitted variations in per cent correspond-
`ing to the particular average weight. This requirement
`ing to the particular average weight. This requirement
`ing to the particular average weight. This requirement
`is generally-i5 to max. 10%. Corresponding values
`is generally ±-5 to max. 10%. Corresponding values
`is generally ±-5 to max. 10%. Corresponding values
`
`Par Pharm., Inc., et al.
`Exhibit 1020
`Page 002
`
`(cid:9)
`(cid:9)
`(cid:9)
`

`

`4,849,246
`4,849,246
`4,849,246
`4
`4
`4
`3
`3
`3
`e.g. preservatives, such as p-hydroxybenzoates, inert
`e.g. preservatives, such as p-hydroxybenzoates, inert
`e.g. preservatives, such as p-hydroxybenzoates, inert
`or bags made from plastic film or plastic-coated paper,
`or bags made from plastic film or plastic-coated paper,
`or bags made from plastic ?lm or plastic-coated paper,
`soluble or insoluble fillers, sugar or other sweeteners,
`soluble or insoluble fillers, sugar or other sweeteners,
`soluble or insoluble ?llers, sugar or other sweeteners,
`into which the product is sealed, in much the same way
`into which the product is sealed, in much the same way
`into which the product is sealed, in much the same way
`other polyols, waxes or dyes.
`other polyols, waxes or dyes.
`other polyols, waxes or dyes.
`as moist refreshing cloths.
`as moist refreshing cloths.
`as moist refreshing cloths.
`The possibility of printing the front and back of the
`The possibility of printing the front and back of the
`The possibility of printing the front and back of the
`The support film is manufactured in per se known
`The support film is manufactured in per se known
`The support ?lm is manufactured in per se known
`support film is a particular advantage of the inventive
`support film is a particular advantage of the inventive
`support ?lm is a particular advantage of the inventive
`manner using a continuously operating roll-based film 5
`manner using a continuously operating roll-based film 5
`manner using a continuously operating roll-based ?lm
`administration form. For example, it is possible to print
`administration form. For example, it is possible to print
`administration form. For example, it is possible to print
`machine. The coating process for producing the sup-
`machine. The coating process for producing the sup-
`machine. The coating process for producing the sup
`on the marking, details on the constituents, together
`on the marking, details on the constituents, together
`on the marking, details on the constituents, together
`port film is based on the roller principle, i.e. the aqueous
`port film is based on the roller principle, i.e. the aqueous
`port ?lm is based on the roller principle, i.e. the aqueous
`with dosage details. It is optionally even possible to
`with dosage details. It is optionally even possible to
`with dosage details. It is optionally even possible to
`composition for the support film is applied by means of
`composition for the support film is applied by means of
`composition for the support ?lm is applied by means of
`print on the back the entire content of a pack-in label,
`print on the back the entire content of a pack-in label,
`rolls and doctor blades and spread out to form thin
`rolls and doctor blades and spread out to form thin
`print on the back the entire content of a pack-in label,
`rolls and doctor blades and spread out to form thin
`thereby rendering superfluous the need for such a sepa-
`thereby rendering superfluous the need for such a sepa-
`thereby rendering super?uous the need for such a sepa
`webs, predried on the rolls and then in the main drying 10
`webs, predried on the rolls and then in the main drying 10
`webs, predried on the rolls and then in the main drying
`rate label, which is frequently lost. In the case of drugs
`rate label, which is frequently lost. In the case of drugs
`rate label, which is frequently lost. In the case of drugs
`process subsequently dried to the desired final moisture
`process subsequently dried to the desired final moisture
`process subsequently dried to the desired ?nal moisture
`or pharmaceuticals which are regularly taken, e.g. in
`or pharmaceuticals which are regularly taken, e.g. in
`or pharmaceuticals which are regularly taken, eg in
`content. The end product obtained is so strong and
`content. The end product obtained is so strong and
`content. The end product obtained is so strong and
`the case of hormonal contraceptives, the complete ad-
`the case of hormonal contraceptives, the complete ad-
`the case of hormonal contraceptives, the complete ad
`elastic that it can be wound onto reels and stored, if the
`elastic that it can be wound onto reels and stored, if the
`elastic that it can be wound onto reels and stored, if the
`ministration program can be given in such a way that it
`ministration program can be given in such a way that it
`ministration program can be given in such a way that it
`residual moisture content is not too high (risk of mould
`residual moisture content is not too high (risk of mould
`residual moisture content is not too high (risk of mould
`is possible to simply check the taking thereof. For print
`is possible to simply check the taking thereof. For print-
`is possible to simply check the taking thereof. For print-
`15
`15
`formation). (cid:9)
`formation). (cid:9)
`formation).
`15
`ing purposes it is necessary to use physiologically ac-
`ing purposes it is necessary to use physiologically ac-
`ing purposes it is necessary to use physiologically ac
`The width of the film can be of a random nature and
`The width of the film can be of a random nature and
`The width of the ?lm can be of a random nature and
`ceptable inks (food colours), because the support film
`ceptable inks (food colours), because the support film
`ceptable inks (food colours), because the support ?lm
`is advantageously adapted to the coating machine
`is advantageously adapted to the coating machine
`is advantageously adapted to the coating machine
`forms part of the orally administered administration
`forms part of the orally administered administration
`forms part of the orally administered administration
`width. It is obvious to adapt the two widths to one
`width. It is obvious to adapt the two widths to one
`width. It is obvious to adapt the two widths to one
`form.
`form.
`form.
`another at the time of manufacture. It is technically also
`another at the time of manufacture. It is technically also
`another at the time of manufacture. It is technically also
`The active ingredient-containing coating material is
`The active ingredient-containing coating material is
`The active ingredient-containing coating material is
`possible to carry out film production and coating in 20
`possible to carry out film production and coating in 20
`possible to carry out ?lm production and coating in
`an aqueous composition, which is physiologically inert
`an aqueous comp