`US 20020045184Al
`(19) United States
`
`(12) Patent Application Publication
`(10) Pub. No.: US 2002/0045184 A1
`
`(43) Pub. Date: Apr. 18, 2002
`
`Chen
`
`(54) PACKAGING SYSTEM
`
`
`
`Related U.S. Application Data
`
`(76) Inventor:
`
`
`Chih-Ming Chen, Davie, FL (US)
`
`
`
`
`(63) Non provisional of provisional application No.
`
`60/237,220, filed on Oct. 2, 2000.
`
`DAVIDSON & KAPPEL, LLC
`
`Correspondence Address:
`
`DAVIDSON,
`485 SEVENTH AVENUE, 14TH FLOOR
`NEW YORK, NY 10018 (US)
`
`
`
`Publication Classification
`
`(51) Int. Cl? ....................................................... C12Q l/68
`
`(52) U.S. Cl. ............................... 435/6;
`
`
`206/532; 206/534
`
`09/970,049
`(21) Appl. No.:
`
`Oct. 2, 2001
`(22) Filed:
`
`In certain embodiments, the invention is directed to a
`
`
`
`
`
`
`
`package for dispensing a combination of a proton pump
`
`
`
`inhibitor and a non steroidal anti inflammatory drug.
`
`(57)
`
`ABSTRACT
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`US 2002/0045184 A1
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`Apr. 18, 2002
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`PACKAGING SYSTEM
`
`BACKGROUND OF THE INVENTION
`
`piece comprises one or more blister layers and a rupturable
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`substrate, wherein the rupturable substrate and the one or
`[0001] This application
`
`claims priority from U.S. Provi
`
`
`
`
`more blister layers are on opposed sides of the blister card;
`
`
`sional Application No. 60/237,220, filed Oct. 2, 2000,
`
`
`
`
`and wherein each blister layer comprises therein one or more
`
`hereby incorporated by reference.
`
`
`unit dosage forms of a nonsteroidal anti inflammatory drug,
`one or more unit dosage forms of a proton pump inhibiting
`drug, or a combination thereof.
`[0002] Nonsteroidal
`anti inflammatory drugs (NSAIDS)
`
`[0009] The invention
`also provides a kit compnsmg a
`
`
`
`
`are widely administered for the treatment of a variety of
`
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`container comprising therein a plurality of blister cards of
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`
`conditions including rheumatoid arthritis, osteoarthritis,
`the invention.
`
`
`
`
`
`juvenile arthritis, ankylosing spondylitis, tendinitis, bursitis,
`
`
`
`
`and gout. Despite the considerable therapeutic success that
`[0010] In other embodiments,
`the invention is directed to
`
`
`
`
`
`has been realized with these drugs, their use is limited due
`
`
`a drug packaging system as disclosed herein comprising
`
`
`to gastrointestinal toxicity. For example, many NSAIDS
`
`
`
`
`
`packaging material comprising therein combined prescrip
`
`
`have been found to cause gastrointestinal bleeding, ulcer
`
`
`tion drug therapy comprising one or more unit dosage forms
`
`
`ation or perforation upon repeated administration.
`of a first drug and one or more unit dosage forms of a second
`[0003] Proton pump inhibitors
`
`drug. Preferably, the first and second drug are independently
`are a class of antisecretory
`
`
`
`selected from the group consisting of non steroidal anti
`
`
`
`
`compounds that suppresses gastric acid secretion by inhibi
`
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`
`
`inflammatory drugs, proton pump inhibitors, calcium chan
`
`tion of the H+ /K+ ATPase enzyme system at the secretory
`
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`
`nel blockers, angiotensin converting enzyme (ACE) inhibi
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`
`surface of gastric parietal cells. This enzyme system is the
`
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`tors, anti depressants, selective serotonin reuptake
`
`
`
`
`acid (proton) pump within the gastric mucosa. Thus, proton
`
`
`
`
`inhibitors, antihistamines, decongestants, biguanides, sulfo
`
`pump inhibitors can be used to block the final step of acid
`
`
`
`nylureas, 3 hydroxy 3 methylglutaryl coenzyme A (HMG
`
`
`
`
`
`production in the gastrointestinal tract, thereby reducing the
`
`CoA) reductase inhibitors, anti epileptic, and anti diabetics.
`
`
`
`gastrointestinal toxicity associated with NSAID administra
`
`It is meant that the two drugs can be the same drug, e.g., the
`
`
`it may be beneficial to administer one or
`
`
`same strength or different strengths.
`
`
`more proton pump inhibiting agents in combination with
`
`
`NSAID therapy, in order to minimize the unwanted gas
`[0011] In other embodiments,
`the invention is directed to
`
`
`
`
`
`trointestinal side effects associated with the NSAID therapy.
`
`
`
`a drug packaging system comprising packaging material
`[0004] Unfortunately, therapies
`
`that require the adminis
`
`
`
`
`comprising therein combined prescription drug therapy
`
`
`
`
`
`tration of multiple therapeutic agents, in differing amounts,
`
`comprising one or more unit dosage forms of a first drug and
`
`
`
`
`over extended periods of time, pose particular problems for
`
`one or more unit dosage forms of a second drug, wherein at
`
`
`
`
`packagers of medicine, for patients, and for medical per
`
`least one of said first or second drug are selected from the
`
`
`
`sonnel who administer medicines to patients. Such combi
`
`
`
`group consisting of non steroidal anti inflammatory drugs,
`
`
`
`nation therapies often cause confusion regarding when or
`
`
`
`
`
`calcium channel blockers, angiotensin converting enzyme
`
`
`whether a given dosage has been administered. Thus, one
`
`
`
`(ACE) inhibitors, anti depressants, selective serotonin
`
`
`can easily administer too many or too few doses in a given
`
`
`
`
`reuptake inhibitors, antihistamines, decongestants, bigu
`
`
`
`period of time, thereby reducing the efficacy of the medi
`
`
`
`anides, sulfonylureas, 3 hydroxy 3 methylglutaryl coen
`
`
`cation or causing bodily damage.
`
`
`
`zyme A (HMG CoA) reductase inhibitors, anti epileptic, and
`anti diabetics.
`[0005] To increase
`
`
`compliance and convenience and to
`
`
`reduce the confusion that is associated with a combination
`[0012] In other embodiments,
`the invention is directed to
`
`
`
`
`
`therapy that provides for the administration of both an
`
`
`
`a drug packaging system comprising packaging material
`
`NSAID and a proton pump inhibitor, it would be beneficial
`
`
`
`
`comprising therein combined prescription drug therapy
`
`
`
`to have a single packaging system that would provide each
`
`comprising one or more unit dosage forms of a first drug and
`
`
`agent for easy distribution and administration. There is
`one or more unit dosage forms of a second drug, wherein
`
`
`currently a need for such a packaging system.
`
`said first and second drug are independently selected from
`
`
`
`the group consisting of antibiotics and anti ulcer agents
`SUMMARY OF THE INVENTION
`
`
`
`selected from the group consisting of H2 antagonists, ant
`[0006] Applicant
`has discovered that many of the pack
`
`
`
`
`
`
`acids, bismuth compounds, prostaglandins, carbenoxolone
`
`
`aging and dosing problems associated with a combination
`
`and anticholinergic agents.
`
`
`
`therapy that provides for the administration of both an
`[0013] The drugs disclosed
`above and throughout the
`
`
`
`NSAID and a proton pump inhibitor can be remedied using
`
`
`application include the base drug and pharmaceutically
`
`
`a drug packaging system that provides one or more unit
`
`acceptable salts thereof.
`
`
`dosage forms of a non steroidal anti inflammatory drug and
`one or more unit dosage forms of a proton pump inhibiting
`
`
`
`drug in a single packaging material.
`
`tion. As a result,
`
`BRIEF DESCRIPTION OF THE FIGURES
`
`[0007] Accordingly,
`the invention provides a drug pack
`
`
`[0014] FIG. 1 illustrates
`
`
`
`
`
`
`aging system comprising packaging material comprising
`
`
`
`the present invention (front view).
`
`therein one or more unit dosage forms of a nonsteroidal
`[0015] FIG. 2 illustrates
`
`
`
`
`anti inflammatory drug and one or more unit dosage forms
`
`
`the present invention (rear view).
`
`of a proton pump inhibiting drug.
`
`a preferred packaging material of
`
`a preferred packaging material of
`
`[0008] The invention
`[0016] FIG. 3 illustrates
`also provides a blister card compris
`
`
`
`
`
`
`
`
`
`ing a plurality of perforated pieces, wherein each perforated
`
`
`
`the present invention (front view).
`
`a preferred packaging material of
`
`
`
`US 2002/0045184 A1
`
`2
`
`Apr. 18, 2002
`
`[0037] FIG. 24 illustrates
`[0017] FIG. 4 illustrates
`
`
`a preferred packaging material of
`
`a preferred blister card of the
`
`
`
`the present invention
`
`present invention
`card
`
`includes perforations.
`[0018] FIG. 5 illustrates
`
`
`
`a preferred packaging material of
`[0038] FIG. 25 illustrates
`
`the present invention
`the period of
`a preferred blister card of the
`
`
`
`administration is four weeks.
`
`present invention
`card
`
`includes a backing.
`[0019] FIG. 6 illustrates
`
`
`
`a preferred packaging material of
`[0039] FIGS. 26 52 illustrate
`
`the present invention
`the period of
`
`
`
`administration is four weeks.
`
`the present invention.
`
`(rear view) wherein the blister
`(side view) wherein the blister
`
`preferred embodiments of
`
`[0020] FIG. 7 illustrates
`[0040] FIG. 53 illustrates
`a preferred packaging material of
`
`
`
`
`
`
`the present invention
`the period of
`invention.
`
`administration is two weeks.
`
`a blister pack rack of the present
`
`DETAILED DESCRIPTION OF THE
`
`INVENTION
`
`[0021] FIG. 8 illustrates
`a preferred packaging material of
`
`
`
`
`the present invention
`the period of
`
`administration is two weeks.
`[0041] Specific
`and preferred packaging materials, drug
`
`
`
`
`
`
`packaging systems, blister cards, kits, proton pump inhibi
`[0022] FIG. 9 illustrates
`a preferred blister card of the
`
`
`
`
`
`tors, nonsteroidal anti inflammatory drugs, and unit dosages
`
`present invention
`
`the blister card is
`
`
`
`described herein below are for illustration only; they do not
`round.
`
`
`
`exclude other packaging materials, proton pump inhibitors,
`[0023] FIG. 10 illustrates
`a preferred blister card of the
`
`
`
`
`
`nonsteroidal anti inflammatory drugs, or unit dosages.
`
`present invention
`
`the blister card is
`round.
`
`[0042] As used herein,
`
`the term "unit dosage form" means
`
`
`
`an administrable pharmaceutical composition comprising a
`[0024] FIG. 11 illustrates
`a preferred blister card of the
`
`
`
`
`
`discrete or measurable amount of an active agent in com
`
`present invention
`
`the blister card is
`
`
`
`
`bination with a pharmaceutical carrier. For example, the
`round.
`
`term unit dosage form can include hard or soft gelatin
`
`
`
`
`capsules, cachets, or tablets, each containing a predeter
`[0025] FIG. 12 illustrates
`a preferred blister card of the
`
`
`
`mined amount of an active agent as a powder or as granules.
`
`present invention
`
`the blister card is
`
`
`The term unit dosage form can also include lozenges com
`round.
`
`
`prising a predetermined amount of an active agent in a
`[0026] FIG. 13 illustrates
`a preferred blister card of the
`
`
`
`
`
`
`flavored base, such as sucrose and acacia or tragacanth. Unit
`
`present invention
`
`the blister card is
`
`
`
`
`dosage forms can be adapted to provide sustained release of
`
`
`round and the period of administration is one month.
`
`
`
`an active ingredient, e.g., by combination thereof with
`
`
`
`
`
`certain hydrophilic polymer matrices, e.g., comprising natu
`[0027] FIG. 14 illustrates
`a preferred blister card of the
`
`
`
`
`
`
`ral gels, synthetic polymer gels or mixtures thereof, or using
`
`present invention
`
`the blister card is
`
`
`
`other sustained release technologies known in the art.
`
`
`round and the period of administration is one month.
`
`(rear view).
`(front view), wherein
`(rear view), wherein
`(front view), wherein
`(rear view), wherein
`(front view) wherein
`(rear view) wherein
`(front view) wherein
`(rear view) wherein
`(front view) wherein
`(rear view) wherein
`(front view) wherein
`(rear view) wherein
`(front view).
`(rear view).
`(front view).
`[0045] As used herein,
`(rear view).
`
`(e.g. blister cards) of the
`(front view) wherein the blister
`(rear view) wherein the blister
`(front view) wherein the blister
`
`[0043] As used herein
`
`the term "indicia" includes marks,
`
`
`[0028] FIG. 15 illustrates
`a preferred blister card of the
`
`
`
`
`
`colors, symbols, letters, numbers, and the like, that provide
`
`
`present invention
`
`the blister card is
`
`
`
`information to aid with removal of medicaments from a
`
`
`round and the period of administration is one month.
`
`
`
`packaging system of the invention, or that provide dosing
`[0029] FIG. 16 illustrates
`a preferred blister card of the
`
`
`
`
`
`information or instructions for a patient. For example,
`
`present invention
`
`the blister card is
`
`
`
`
`indicia can be included on unit dosage forms, blister layers,
`
`
`round and the period of administration is one month.
`
`
`
`
`rupturable substrates, or backing layers, or on other pack
`
`
`
`
`aging materials. Indicia can be printed, stamped, embossed,
`[0030] FIG. 17 illustrates
`a preferred packaging material
`
`
`
`
`
`or embedded on the materials using techniques that are
`
`
`of the present invention
`
`
`known in the packaging and printing field.
`[0031] FIG. 18 illustrates
`a preferred packaging material
`
`
`
`
`of the present invention
`
`[0044] As used herein,
`
`the term "medicament" includes a
`
`
`
`unit dosage form of one or more proton pump inhibitors, a
`[0032] FIG. 19 illustrates
`a preferred packaging material
`
`
`unit dosage form of one or more nonsteroidal anti inflam
`
`
`of the present invention
`
`
`matory drugs, or a combination thereof.
`[0033] FIG. 20 illustrates
`a preferred packaging material
`
`
`
`
`of the present invention
`
`the term container can include any
`
`
`
`
`
`
`structure that can enclose a plurality of packaging systems
`[0034] FIG. 21 illustrates
`a preferred blister card of the
`
`
`
`
`invention. Such containers typi
`
`present invention
`card
`
`
`
`
`cally facilitate the storage, transport, distribution or sale of
`
`includes perforations.
`
`
`
`
`the packaging systems of the invention. For example, suit
`
`
`
`
`
`able containers include cardboard or plastic boxes, as well as
`[0035] FIG. 22 illustrates
`a preferred blister card of the
`
`
`
`
`paper or plastic wrapping materials.
`
`present invention
`card
`[0046] Packaging
`
`includes perforations.
`Materials
`
`[0047] Any suitable packaging material can be employed
`
`
`
`[0036] FIG. 23 illustrates
`a preferred blister card of the
`
`
`
`present invention
`card
`
`
`
`
`in the packaging system of the invention, provided the unit
`
`includes perforations.
`
`dosage forms of the proton pump inhibitor and the nonste
`
`
`
`US 2002/0045184 A1
`
`3
`
`Apr. 18, 2002
`
`
`
`(i.e., third)
`
`2, one unit dosage form of an NSAID can be contained
`roidal anti inflammatory drug can be contained within the
`
`
`
`layer 2, and a second unit dosage form
`
`
`
`packaging material and are available for co administration.
`
`
`within another blister
`
`
`
`
`
`Suitable packaging materials may include bottles, vials,
`
`of an NSAID can be contained within another
`layer 2. Assuming
`
`boxes, foil wraps, and dispensing packs, such as those
`blister
`the three unit dosage forms are to
`
`
`
`disclosed in U.S. Pat. Nos. 4,553,670; 5,954,204; 4,574,954;
`
`
`be taken daily and assuming the course of administration is
`2 on the blister
`
`one month, the number of blister layers
`
`
`
`
`4,850,489; 5,927,500; 4,158,411; 4,429,792; 3,211,503;
`1 can conveniently
`package
`be about 90 or about 96.
`
`
`
`3,283,885; 3,311,229; 3,324,996; 3,380,578; 3,397,671;
`
`
`
`3,494,322; 3,630,346; 3,759,371; 3,856,144; 4,211,326;
`
`[0054] The rupturable 3 can be manufactured
`substrate
`
`
`
`3,054,503; 3,503,493; 3,933,245; 4,371,080; 6,024,222;
`
`
`
`
`from any suitable material. Suitable exemplary materials
`
`
`
`
`2,012,405; 2,317,860; 3,324,995; 3,780,856; 3,835,995;
`
`
`
`
`
`include tempered metal foil, paperboard, polyvinyl chloride,
`
`
`
`
`3,899,080; 2,012,405; 2,317,860; 3,324,995; 3,397,671;
`
`
`
`a polyolefin, polystyrene, a polyester, a fiuoropolymer resin,
`
`
`
`
`3,494,322; 3,780,856; 3,835,995; 3,899,080; and 6,024,222;
`3 may be
`
`
`
`and combinations thereof. The rupturable substrate
`
`in U.S. Design Pat. No. 237 864; and references cited
`2 or to the
`
`
`
`sealed to each of the one or more blister layers
`therein.
`4 through
`
`
`
`backing the application of heat and pressure as is
`
`
`
`typically done in the art through conventional thermal
`[0048] Numerous
`
`
`
`packaging materials are illustrated in
`3 may also be
`
`
`
`forming methods. The rupturable substrate
`to FIGS. 1 25, the
`
`
`the Figures. For example, referring
`
`
`
`
`composed of a plurality of laminated layers of different
`
`
`
`packaging material can be a blister package
`material
`
`U.S. Pat. No. 6,024,222), as long
`1 includes
`package
`one or more blister
`
`
`
`as the basic operation is not affected. The rupturable sub
`
`2, a rupturable 3 that is located
`layers
`substrate
`
`opposite to
`3 can optionally
`strate
`
`
`be replaced by a removable backing
`
`2, and a medicament 6 in the
`
`the one or more blister layers
`
`that can be peeled off to provide access to the medicament
`
`
`
`
`form of a tablet or pill can be contained between each of the
`6.
`
`2 and the rupturable 3.
`
`one or more blister layers
`substrate
`1 can also optionally
`
`The blister package
`
`includes backing
`[0055] The rupturable substrate 3 can be a continuous
`
`4 that is interposed
`2
`
`
`between the one or more blister layers
`2, or
`
`
`
`surface that can essentially cover all the blister layers
`3.
`
`and the rupturable substrate
`
`
`
`can be a plurality of surfaces each covering one or more
`
`layer 2. When the backing 4 is present,
`blister
`the rupturable
`[0049] Each of the one or more blister layers
`
`
`2 can be
`3 can essentially cover
`substrate
`
`
`the entire surface of the
`
`
`
`
`manufactured from any suitable material. Suitable exem
`4 or can cover
`backing
`
`
`a portion or portions of the backing
`
`
`
`
`plary materials include polyvinyl chloride, a thermoplastic
`4, wherein
`4 corresponds
`
`each portion of the backing
`to a
`
`
`
`material, a polyolefin, and combinations thereof.
`
`layer 2. When the rupturable 3 essentially
`blister
`substrate
`[0050] Each of the
`2 can have
`one or more blister layers
`
`4, the portion
`
`
`
`covers the entire surface of the backing
`or
`
`
`
`any suitable shape, provided each of the one or more blister
`3 that are located
`
`
`
`portions of the rupturable substrate
`oppo
`layers 2 can contain
`6. Suitable
`
`therein the medicament
`2 will rupture
`
`site to the one or more blister layers
`upon
`
`shapes include, e.g., circles
`6. When the rupturable
`
`dispensing the medicament
`substrate
`and rectangles
`3 covers a portion
`4, the portion
`
`or portions of the backing
`
`
`
`
`or portions will typically rupture upon dispensing the medi
`
`[0051] In one embodiment, package 1 can
`the blister
`cament 6.
`layer 2, as shown in FIGS. 17 18. In such
`
`include one blister
`layer 2 contains
`
`an embodiment, the blister
`
`therein, one or
`
`[0056] The blister 1 can preferably
`package
`
`include a
`
`more unit dosage forms of a proton pump inhibitor and one
`4 can
`backing
`the backing
`
`or more unit dosage forms of an NSAID. In another embodi
`3
`
`
`
`
`have any suitable shape, provided the rupturable substrate
`1 can include
`
`ment, the blister package
`two or more blister
`2 can be contained
`
`and each of the one or more blister layers
`layers 2, as shown in FIGS. 1 16 and 19 24. In such
`
`4. In one embodiment, 4 can
`on the backing
`the backing
`1 can preferably
`
`
`embodiment, the blister package
`include
`
`
`
`
`have a rectangular shape. In another embodiment, the back
`
`2 to about 120 blister 2, or
`
`about two blister layers
`layers
`ing 4 can have a circular shape.
`
`2 to about 31 blister 2. In such
`
`about 7 blister layers
`layers
`
`
`[0057] The blister 1 can include 8
`package
`perforations
`2 can
`
`
`an embodiment, each of the two or more blister layers
`2 can exist on a single
`
`such that one or two blister layers
`
`
`contain therein, one or more unit dosage forms of a proton
`
`piece 16 of blister 1, as shown in FIGS. 1 8. In one
`package
`
`pump inhibitor and/or one or more unit dosage forms of an
`1 can include
`8 such
`
`embodiment, the package
`perforations
`NSAID.
`
`layer 2 can exist on a single piece 16 of
`that one blister
`[0052] Typically,
`2 present
`1, as shown in FIGS. 1 2, 5 6, and 23 24. In
`
`
`the number of blister layers on
`
`blister package
`package 1 will be determined
`2 can include
`a blister
`by the specific
`
`
`
`such an embodiment, each of the blister layers
`6 employed,
`medicament
`as well as the course of adminis
`
`both the one or more proton pump inhibitors and the one or
`6. For example,
`package 1 can
`
`tration for the medicament
`
`one proton pump
`
`more NSAIDS. Alternatively, the blister
`layer 2 and one
`
`8 such that two blister 2 can exist
`
`
`inhibitor can be contained within a blister
`
`include perforations
`layers
`layer 2. Each
`
`16 of blister 1, as shown in FIGS.
`
`
`
`
`NSA/D can be contained within another blister
`
`on a single piece package
`3 4, 7 8, and 21 22. In such an embodiment,
`
`
`of the proton pump inhibitor and the NSAID can be in the
`each of the
`2 can include
`
`
`form of a daily dosage. Assuming the period of administra
`
`blister layers
`
`either the unit dosage form of the
`
`
`tion for such a combination therapy is one month, the
`
`
`
`proton pump inhibitor or the unit dosage form of the
`
`layers 2 on the blister package 1 can
`8 allow a patient
`number of blister
`
`
`NSAID. The perforations to easily remove
`6.
`
`conveniently be about 60 or about 62.
`a discrete
`
`card). The blister
`
`1 (e.g., a blister
`
`(see for example
`
`(see, e.g., FIGS. 9 16), ovals,
`(see, e.g., FIGS. 1 15 and 17 24).
`
`4 (see, e.g., FIG. 25). If present,
`
`[0053] In another
`
`[0058] The blister 1 can optionally
`embodiment, one unit dosage form of a
`
`package
`
`include indicia
`10 printed
`3 indicating
`
`
`
`
`
`proton pump inhibitor can be contained within a blister layer
`
`on the rupturable substrate
`the
`
`dosage (e.g., daily dosage) of medicament
`
`
`
`US 2002/0045184 A1
`
`4
`
`Apr. 18, 2002
`
`ulcer is 40 mg once daily (orally), for four to eight weeks.
`sequence of removal of the proton pump inhibitor and the
`
`
`
`
`
`non steroidal anti inflammatory drug from each of the of the
`
`
`The recommended adult dosage of omeprazole for symp
`2 (see, e.g., FIGS. 5, 7, 13, and 15). In one
`(GERD) with no
`
`blister layers
`
`
`tomatic gastroesophageal reflux disease
`10 is printed
`
`embodiment, the indicia
`on the rupturable
`
`
`
`esophageal lesions is 20 mg daily for up to 4 weeks. The
`3. In another
`10 is printed
`
`
`substrate embodiment, the indicia
`
`
`recommended adult oral dose for the treatment of patients
`
`4. In such an embodiment, 10 is
`on the backing
`the indicia
`
`
`
`
`with erosive esophagitis and accompanying symptoms due
`(e.g., proximally
`
`
`printed on a relevant location
`close to the
`to GERD is 20 mg daily for 4 to 8 weeks. The recommended
`layer 2) to aid the patient
`blister
`
`in dispensing the medica
`
`
`adult dosage of omeprazole for maintenance of healing of
`
`
`ment 6. Specifically, 10 can illustrate the day 12
`is 20 mg once daily (orally). The rec
`the indicia
`
`erosive esophagitis
`
`and/or the week 14 when the medicament 6 in a specific
`
`ommended adult dosage of omeprazole for pathological
`layer 2 is to be administered.
`blister
`
`
`
`
`hypersecretory conditions varies with the individual patient.
`
`
`
`For example, the recommended adult oral starting dose is 60
`[0059] The medicament 6 is a unit dosage form of one or
`
`
`
`mg omeprazole once a day. Doses up to 120 mg t.i.d. have
`
`more proton pump inhibitors, a unit dosage form of one or
`
`
`
`
`been administered. Typically daily dosages of greater than
`
`
`
`more nonsteroidal anti inflammatory drugs, or a combina
`
`
`80 mg should be administered in divided doses.
`tion thereof.
`
`[0061] Proton Pump Inhibitor
`
`Ed.), Merck & Co., Inc. (Rahway, N.J.), 1989.
`
`[0067] The recommended
`adult dosage of lansoprazole for
`
`[0060] As illustrated in FIG. 53, the invention
`
`also pro
`
`
`
`the short term