WHATIS CLAIMEDIS:
`
`-47-
`
`A storage-stable omeprazole system,
`
`the system comprising a therapeutically effective
`
`amount of omeprazole, or a pharmaceutically acceptable salt thereof, wherein the system
`
`contains a percentage of moisture of no more than about 2.5%, and wherein the system
`
`contains no sodium from a sodium-containing buffering agent or the system contains sodium
`
`and potassium at a ratio of from about 1:2.6 to about 1:3.4 by weight, and further wherein the
`
`storage-stable omeprazole system is constituted with water prior to administration.
`
`The storage-stable omeprazole system of claim 1, wherein the sodium and potassium are
`
`presentat a ratio of about 1:3.2 by weight.
`
`The storage-stable omeprazole system of claim 1 or 2, wherein the system has a moisture
`
`content of about 0.5% to about 1.5%.
`
`The storage-stable omeprazole system of any of the preceding claims, further comprising a
`
`pharmaceutically acceptable desiccant.
`
`The storage-stable omeprazole system of claim 4, wherein the pharmaceutically acceptable
`
`desiccant is sodium alginate.
`
`The storage stable omeprazole system of claim 5, wherein the sodium alginate is dry.
`
`The storage-stable omeprazole system of claim 6, wherein the dry sodium alginate has a
`
`moisture content of about 0.5% to about 1.5%.
`
`The storage-stable omeprazole system of any one of claims 5-7, wherein the sodium alginate
`
`is low viscosity grade sodium alginate.
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`- 48 -
`
`The storage-stable omeprazole system of any of the preceding claims, wherein the system
`
`comprises one or more buffering agents each independently selected from the group
`
`consisting of alkali metal or alkaline earth metal carbonates, bicarbonates, phosphates,
`
`citrates, borates, acetates, phthalates, tartrates, and succinates.
`
`10.
`
`The storage-stable omeprazole system of any one of claims 1 and 3-9, wherein the system
`
`comprises one buffering agent which is potassium bicarbonate.
`
`11.
`
`The storage-stable omeprazole system of claim 9, wherein the system comprises two or more
`
`buffering agents selected from sodium and potassium carbonates, bicarbonates, phosphates,
`
`citrates, borates, acetates, phthalates, tartrates, and succinates.
`
`12.
`
`The storage-stable omeprazole system of claim 9 or 11, comprising sodium bicarbonate and
`
`potassium bicarbonate.
`
`13.
`
`The storage-stable omeprazole system of claim 12, wherein the sodium bicarbonate and
`
`potassium bicarbonate are presentat a ratio of about 1:2.7 by weight.
`
`14.
`
`The storage-stable omeprazole system of any one of preceding claims, wherein the system is
`
`in a form of a powder, a pellet, a granule, a seed, a bead, a spheroid, a microsphere, or a
`
`mixture thereof.
`
`15.
`
`A storage-stable omeprazole system, the system comprising(i) a first mixture comprising (a)
`
`a therapeutically effective amount of omeprazole, or a pharmaceutically acceptable salt
`
`thereof, wherein the first mixture contains a percentage of moisture of no more than about
`
`2.5%; and (ii) a second mixture comprising a second buffering agent, wherein the second
`
`mixture contains a percentage of moisture of no more than about 2.5%, wherein the first
`
`mixture and the second mixture are stored separately from each other and are mixed together
`
`on or just before constitution with water, and wherein the system contains no sodium from a
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`sodium-containing buffering agent or the system contains sodium and potassium ata ratio of
`
`from about 1:2.6 to about 1:3.4 by weight.
`
`- 49 -
`
`16.
`
`The storage-stable omeprazole system of claim 15, wherein the sodium and potassium are
`
`presentat a ratio of about 1:3.2 by weight.
`
`17.
`
`The storage-stable omeprazole system of claims 15 or 16, wherein the first mixture and/or
`
`the second mixture has a moisture content of about 0.5% to about 1.5%.
`
`18.
`
`The storage-stable omeprazole system of any one of claims 15-17, wherein the first mixture
`
`further comprises (b) a first desiccant and/or the second mixture further comprises a second
`
`desiccant.
`
`19.
`
`The storage-stable omeprazole system of any one of claims 15-18, wherein the first desiccant
`
`and the second desiccant are sodium alginate.
`
`20.
`
`The storage-stable omeprazole system of any one of claims 15-19, wherein the first mixture
`
`further comprises(c) a first buffering agent.
`
`21.
`
`The storage-stable omeprazole system of any one of claims 15-20, wherein the first mixture
`
`and the second mixture are each independently in a form of a powder, a pellet, a granule, a
`
`seed, a bead, a spheroid, a microsphere, or a mixture thereof.
`
`22.
`
`The storage-stable omeprazole system of any one of claims 1-21, wherein the omeprazole or
`
`the pharmaceutically acceptable salt thereof is micronized.
`
`23.
`
`The storage-stable omeprazole system of any one of claims 1-21, wherein the omeprazole or
`
`the pharmaceutically acceptable salt thereof is a mixture of micronized and non-micronized
`
`omeprazole or the pharmaceutically acceptable salt thereof.
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`-50-
`
`24.
`
`The storage-stable omeprazole system of claim 23, wherein the omeprazole, or
`
`the
`
`pharmaceutically acceptable salt thereof, comprises about 30 to about 70 % micronized
`
`omeprazole, or the pharmaceutically acceptable salt thereof, and the rest of the omeprazole,
`
`or the pharmaceutically acceptable salt thereof, is non-micronized.
`
`25.
`
`The storage-stable omeprazole system of claim 24, wherein the omeprazole, or
`
`the
`
`pharmaceutically acceptable salt thereof, is a 1:1 mixture, by weight, of micronized and non-
`
`micronized omeprazole or the pharmaceutically acceptable salt thereof.
`
`26.
`
`The storage-stable omeprazole system of any one of claims 15-25, wherein thefirst buffering
`
`agent and the second buffering agent are present in an amount sufficient to increase gastric
`
`fluid pH to a pH that prevents degradation of at least some of the omeprazole in the gastric
`
`fluid.
`
`27.
`
`The storage-stable omeprazole system of any one of claims 20-26, wherein thefirst buffering
`
`agent and the second buffering agent together provide a buffering capacity of about 2
`
`mEq/ml dose of constituted powder with water.
`
`28.
`
`The storage-stable omeprazole system of any one of claims 15-27, wherein thefirst buffering
`
`agent and the second buffering agent are each independently selected from the group
`
`consisting of alkali metal or alkaline earth metal carbonates, bicarbonates, phosphates,
`
`citrates, borates, acetates, phthalates, tartrates, succinates, and mixturesthereof.
`
`29.
`
`The storage-stable omeprazole system of any one of claims 14-28, wherein thefirst buffering
`
`agent and the second buffering agent are each independently selected from the group
`
`consisting of sodium bicarbonate, potassium bicarbonate, and a mixture thereof.
`
`30.
`
`The storage-stable omeprazole system of any one of claims 20-29, wherein thefirst buffering
`
`agent is sodium bicarbonate.
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`31.
`
`The storage-stable omeprazole system of any one of claims 15-29, wherein the second
`
`buffering agent is a mixture of sodium bicarbonate and potassium bicarbonate.
`
`-5]-
`
`32.
`
`The storage-stable omeprazole system of claim 31, wherein the second buffering agent
`
`comprises about 11% sodium bicarbonate and about 89% potassium bicarbonate, by weight.
`
`33.
`
`The storage-stable omeprazole system of any one of claims 15-31, wherein the first mixture
`
`and the second mixture together comprise sodium bicarbonate and potassium bicarbonate at a
`
`ratio of about 1:2.7 by weight.
`
`34.
`
`The storage-stable omeprazole system of any one of claims 15-29, wherein thefirst buffering
`
`agent and the second buffering agent are potassium bicarbonate.
`
`35.
`
`The storage-stable omeprazole system of any one of claims 15-32 and 34, wherein the second
`
`mixture further comprises a sweetener and a preservative.
`
`36.
`
`The storage-stable omeprazole system of any of the preceding claims, wherein the storage-
`
`stable omeprazole system is provided in a drug delivery device suitable for multi-dose
`
`administration of omeprazole, or the pharmaceutically acceptable salt thereof.
`
`37.
`
`The storage-stable omeprazole system of claim 36, wherein the drug delivery device
`
`comprises two chambers.
`
`38.
`
`The storage-stable omeprazole system of claim 37, wherein the drug delivery device further
`
`comprises a means for releasing the contents of the first chamber into the second chamber
`
`without removing the cap from the drug delivery device.
`
`39.
`
`The storage-stable omeprazole system of any one of claims 15-38, wherein the storage-stable
`
`omeprazole system is provided in a container body comprising a cap, wherein (i) the
`
`container body contains the second mixture and has a container opening formed in an upper
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`-52-
`
`end thereof; (11) the cap comprises a cylindrical accommodation portion comprising the first
`
`mixture and a cap portion sealing an upper end of the accommodation portion, and wherein
`
`(iii) the cap is mounted in the container opening of the container body, wherein when the cap
`
`is twisted, the first mixture is released into the container body.
`
`AO.
`
`The storage-stable omeprazole system of claim 39, wherein the container body is an amber
`
`polyethylene terephthalate bottle and the cap is a polypropylene tamper evident cap.
`
`41.
`
`The storage-stable omeprazole system of any one of the preceding claims, wherein the
`
`powdersystem remainsstable at 25°C / 60% relative humidity for at least 2 years.
`
`42.
`
`A storage-stable omeprazole system formulated in a drug delivery device suitable for multi-
`
`dose administration of omeprazole, or the pharmaceutically acceptable salt thereof,
`
`the
`
`system comprising a therapeutically effective amount of omeprazole, or a pharmaceutically
`
`acceptable salt thereof, wherein the system contains a percentage of moisture of no more than
`
`about 2.5%, and wherein the system contains no sodium from a sodium-containing buffering
`
`agent or the system contains sodium and potassium at a ratio of from about 1:2.6 to about
`
`1:3.4 by weight, and further wherein the storage-stable omeprazole system is constituted with
`
`water prior to administration.
`
`43.
`
`The storage-stable omeprazole system of any one of claims 1-42, wherein the storage-stable
`
`omeprazole system is enclosed within a sealed aluminium foil pouch.
`
`44,
`
`A storage-stable omeprazole powder system,
`
`the system comprising (i) a first powder
`
`mixture
`
`comprising (a)
`
`a
`
`therapeutically effective
`
`amount of omeprazole,
`
`or
`
`a
`
`pharmaceutically acceptable salt thereof, (b) sodium alginate, and (c) a first buffering agent;
`
`and (ii) a second powder mixture comprising sodium alginate and a second buffering agent,
`
`wherein the first powder mixture and the second powder mixture are stored separately from
`
`each other and are mixed together on or just before constitution with water, and wherein the
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`system contains sodium and potassium at a ratio of from about 1:2.6 to about 1:3.4 by
`
`-53-
`
`weight.
`
`45.
`
`The storage-stable omeprazole powder system of claim 44, wherein the omeprazole or the
`
`pharmaceutically acceptable salt thereof is micronized.
`
`46.
`
`The storage-stable omeprazole powder system of claim 44 or 45, wherein the omeprazole or
`
`the pharmaceutically acceptable salt thereof is a mixture of micronized and non-micronized
`
`omeprazole, or the pharmaceutically acceptable salt thereof.
`
`47.
`
`The storage-stable omeprazole powder system of claim 46, wherein the omeprazole or the
`
`pharmaceutically acceptable salt thereof comprises about 30 to about 70 % micronized
`
`omeprazole, or the pharmaceutically acceptable salt thereof, and the rest of the omeprazole or
`
`the pharmaceutically acceptable salt thereof is non-micronized.
`
`48.
`
`The storage-stable omeprazole powder system of claim 46, wherein the omeprazole is a 1:1
`
`mixture, by weight, of micronized and non-micronized omeprazole or the pharmaceutically
`
`acceptable salt thereof.
`
`49.
`
`The storage-stable omeprazole powder system of any one of claims 44-48, wherein the
`
`omeprazole, or the pharmaceutically acceptable salt thereof, and about 20 to about 30% of
`
`the sodium alginate present in the first powder mixture are homogenously distributed over
`
`the surface ofthe first buffering agent.
`
`50.
`
`The storage-stable omeprazole powder system of claim 49, wherein the omeprazole, or the
`
`pharmaceutically acceptable salt thereof, and about 20 to about 25% of the sodium alginate
`
`present in the first powder mixture are homogenously distributed over the surface ofthe first
`
`buffering agent.
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`51.
`
`The storage-stable omeprazole powder system of claim 49 or 50, wherein the sodium alginate
`
`not distributed over the surface of the first buffering agent in the first powder mixtureis dry.
`
`-54-
`
`52.
`
`The storage-stable omeprazole powder system of any one of claims 44-51, wherein the
`
`sodium alginate present in the second powder mixture is dry.
`
`53.
`
`The storage-stable omeprazole powder system of claim 51 or 52, wherein the dry sodium
`
`alginate has a moisture content of about 0.5% to about 1.5%.
`
`54.
`
`The storage-stable omeprazole powder system of any one of claims 44-53, wherein the
`
`sodium alginate is low viscosity grade sodium alginate.
`
`55.
`
`The storage-stable omeprazole powder system of any one of claims 44-54, wherein the first
`
`and second buffering agents are present in an amountsufficient to increase gastric fluid pH to
`
`a pH that prevents degradation of at least some of the omeprazole, or the pharmaceutically
`
`acceptable salt thereof, in the gastric fluid.
`
`56.
`
`The storage-stable omeprazole powder system of any one of claims 44-55, wherein the first
`
`and second buffering agents together provide a buffering capacity of about 2 mEq/ml dose of
`
`constituted powder with water.
`
`57.
`
`The storage-stable omeprazole powder system of any one of claims 44-56, wherein the first
`
`and second buffering agents are each independently selected from the group consisting of
`
`alkali metal or alkaline earth metal carbonates, bicarbonates, phosphates, citrates, borates,
`
`acetates, phthalates, tartrates, succinates, and mixturesthereof.
`
`58.
`
`The storage-stable omeprazole powder system of any one of claims 44-57, wherein the first
`
`and second buffering agents are each independently selected from the group consisting of
`
`sodium bicarbonate, potassium bicarbonate, and a mixture thereof.
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`59.
`
`The storage-stable omeprazole powder system of any one of claims 44-58, wherein the first
`
`buffering agent is sodium bicarbonate.
`
`-55-
`
`60.
`
`The storage-stable omeprazole powder system of any one of claims 44-59, wherein the
`
`second buffering agent is a mixture of sodium bicarbonate and potassium bicarbonate.
`
`61.
`
`The storage-stable omeprazole powder system of claim 60, wherein the mixture comprises
`
`about 11% sodium bicarbonate and about 89% potassium bicarbonate, by weight.
`
`62.
`
`The storage-stable omeprazole powder system of any one of claims 44-61, wherein the first
`
`powder mixture and the second powder mixture together comprise sodium bicarbonate and
`
`potassium bicarbonate at a ratio of about 1:2.7 by weight.
`
`63.
`
`The storage-stable omeprazole powder system of any one of claims 44-62, wherein the
`
`second powder mixture further comprises a sweetener and a preservative.
`
`64.
`
`The storage-stable omeprazole powder system of any one of claims 44-63, wherein the
`
`storage-stable omeprazole powder system is provided in a drug delivery device suitable for
`
`multi-dose administration of omeprazole.
`
`65.
`
`The storage-stable omeprazole powder system of claim 64, wherein the drug delivery device
`
`comprises a first chamber comprising the first powder mixture and a second chamber
`
`comprising the second powder mixture.
`
`66.
`
`The storage-stable omeprazole powder system of claim 65, wherein the drug delivery device
`
`further comprises a means for releasing the first powder mixture into the second chamber
`
`without removing the cap from the drug delivery device.
`
`67.
`
`The storage-stable omeprazole powder system of any one of claims 44-66, wherein the
`
`storage-stable omeprazole powder system is provided in a container body comprising a cap,
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`-56-
`
`wherein (i) the container body contains the second powder mixture and has a container
`
`opening formed in an upper end thereof; (i1) the cap comprises a cylindrical accommodation
`
`portion comprising the first powder mixture and a cap portion sealing an upper end of the
`
`accommodation portion, and wherein (111) the cap is mounted in the container opening of the
`
`container body, wherein when the capis twisted, the first powder mixture is released into the
`
`container body.
`
`68.
`
`The storage-stable omeprazole powder system of claim 67, wherein the container body is an
`
`amberpolyethylene terephthalate bottle and the cap is a polypropylene tamperevident cap.
`
`69.
`
`The storage-stable omeprazole powder system of any one of claims 44-68, wherein the
`
`powdersystem remainsstable at 25°C / 60% relative humidity for at least 2 years.
`
`70.
`
`The storage-stable omeprazole powder system of any one of claims 44-69, wherein the
`
`storage-stable omeprazole system is enclosed within a sealed aluminium foil pouch.
`
`71.
`
`An oral pharmaceutical suspension, comprising water, a pharmaceutically effective amount
`
`of omeprazole, or a pharmaceutically acceptable salt thereof, dispersed in the water, and one
`
`or more buffering agents, and wherein the suspension contains no sodium from a sodium-
`
`containing buffering agent or the suspension contains sodium and potassium at a ratio of
`
`from about 1:2.6 to about 1:3.4 by weight.
`
`72.
`
`The oral pharmaceutical suspension of claim 71, further comprising sodium alginate.
`
`73.
`
`The oral pharmaceutical suspension of claim 71 or 72, wherein about 1 ml of the suspension
`
`contains from about 1 mg to about 10 mg of omeprazole, or the pharmaceutically acceptable
`
`salt thereof.
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`-57-
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`74.
`
`The oral pharmaceutical suspension of claim 73, wherein about
`
`1 ml of the suspension
`
`contains about
`
`1 mg, about 2 mg, about 4 mg, or about 8 mg of omeprazole, or the
`
`pharmaceutically acceptable salt thereof.
`
`75.
`
`The oral pharmaceutical suspension of claim 74, wherein about
`
`1 ml of the suspension
`
`contains about 2 mg or about 4 mg of omeprazole, or the pharmaceutically acceptable salt
`
`thereof.
`
`76.
`
`The oral pharmaceutical suspension of any one of claims 71-75, wherein the one or more
`
`buffering agents provide a buffering capacity of about 2 mEq per ml of the suspension.
`
`77.
`
`The oral pharmaceutical suspension of any one of claims 71-76, wherein the one or more
`
`buffering agents are each independently selected from the group consisting of alkali metal or
`
`alkaline earth metal carbonates, bicarbonates, phosphates,
`
`citrates, borates,
`
`acetates,
`
`phthalates, tartrates, and succinates.
`
`78.
`
`The oral pharmaceutical suspension of any one of claims 71-77, comprising one buffering
`
`agent.
`
`79.
`
`The oral pharmaceutical suspension of claim 78, wherein the one buffering agent
`
`is
`
`potassium bicarbonate.
`
`80.
`
`The oral pharmaceutical suspension of any one of claims 71-77, comprising a mixture of two
`
`buffering agents.
`
`81.
`
`The oral pharmaceutical suspension of claim 80, comprising a mixture of sodium bicarbonate
`
`and potassium bicarbonateat a ratio of about 1:2.7 by weight.
`
`82.
`
`The oral pharmaceutical suspension of any one of claims 71-77 and 80-81, wherein the
`
`suspension comprises about 86 mg of sodium per 5 mlof the suspension.
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`83.
`
`The oral pharmaceutical suspension of any one of claims 71-77 and 80-82, wherein the
`
`sodium and potassium are presentat a ratio of about 1:3.2 by weight.
`
`-58 -
`
`84.
`
`The oral pharmaceutical suspension of any one of claims 71-83, wherein the suspension
`
`provides a biphasic pharmacokinetic profile having a first and second Cimax and a first and
`
`second Tmax following oral administration in a subject in need thereof.
`
`85.
`
`The oral pharmaceutical suspension of any of claims 66-77, wherein a 5 ml dose comprises
`
`about 10 mg or about 20 mg omeprazole, or the pharmaceutically acceptable salt thereof,
`
`about 256 mg sodium bicarbonate, about 695 mg of potassium bicarbonate, and about 125
`
`mg of sodium alginate.
`
`86.
`
`The oral pharmaceutical suspension of claim 78, further comprising about 11.45 mg methyl
`
`paraben sodium salt and about 25 mg sodium benzoate.
`
`87.
`
`The oral pharmaceutical suspension of any one of claims 71-86, wherein the omeprazole or
`
`the pharmaceutically acceptable salt thereof is micronized.
`
`88.
`
`The oral pharmaceutical suspension of any one of claims 71-86, wherein the omeprazole or
`
`the pharmaceutically acceptable salt thereof is a mixture of micronized and non-micronized
`
`omeprazole, or the pharmaceutically acceptable salt thereof.
`
`89.
`
`The oral pharmaceutical
`
`suspension of claim 88, wherein the omeprazole or
`
`the
`
`pharmaceutically acceptable salt thereof comprises about 30 to about 70 % micronized
`
`omeprazole, or the pharmaceutically acceptable salt thereof, and the rest of the omeprazole or
`
`the pharmaceutically acceptable salt thereof is non-micronized.
`
`90.
`
`The oral pharmaceutical suspension of claim 88, wherein the omeprazole is a 1:1 mixture, by
`
`weight, of micronized and non-micronized omeprazole or the pharmaceutically acceptable
`
`salt thereof.
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`91.
`
`The oral pharmaceutical suspension of any one of claims 71-90, wherein the suspension is
`
`provided in a drug delivery device suitable for multi-dose administration of omeprazole.
`
`-59-
`
`92.
`
`A methodof inhibiting gastric acid secretion, comprising administering to a subject in need
`
`thereof an effective amount of the oral pharmaceutical suspension of any one of claims 71-
`
`91.
`
`93.
`
`The methodof claim 92, wherein the subject is a child.
`
`94.
`
`The method of claim 93, wherein the child is an infant, a toddler, a preadolescent, or an
`
`adolescent.
`
`95.
`
`The method of any one of claims 92-94, wherein about | ml of the suspension contains from
`
`about 1 mg to about 10 mg of omeprazole, or the pharmaceutically acceptable salt thereof.
`
`96.
`
`The method of any one of claims 92-95, wherein 1 ml of the suspension contains about 1 mg,
`
`about 2 mg, about 4 mg or about 8 mg of omeprazole, or the pharmaceutically acceptable salt
`
`thereof.
`
`97.
`
`The method of any one of claims 92-96, wherein 1 ml of the suspension contains about 2 mg
`
`of omeprazole, or the pharmaceutically acceptable salt thereof.
`
`98.
`
`The method of any one of claims 92-96, wherein 1 ml of the suspension contains about 4 mg
`
`of omeprazole, or the pharmaceutically acceptable salt thereof.
`
`99.
`
`A method of preparing an oral pharmaceutical suspension, comprising combining a first
`
`mixture
`
`comprising (a)
`
`a
`
`therapeutically effective
`
`amount of omeprazole,
`
`or
`
`a
`
`pharmaceutically acceptable salt thereof, wherein the first mixture contains a percentage of
`
`moisture of no more than about 2.5%; with a second mixture comprising a second buffering
`
`agent, wherein the second mixture contains a percentage of moisture of no more than about
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`2.5%; to obtain a combined mixture, wherein the combined mixture contains no sodium from
`
`a sodium-containing buffering agent or the combined mixture contains sodium and potassium
`
`at a ratio of from about 1:2.6 to about 1:3.4 by weight; and adding water to the combined
`
`mixture.
`
`100.
`
`The method of claim 99, wherein the sodium and potassium are present at a ratio of about
`
`1:3.2 by weight.
`
`101.
`
`The method of claim 99 or 100, wherein the first mixture has a moisture content of about
`
`0.5% to about 1.5%.
`
`102.
`
`The method of any one of claims 99-101, wherein the first mixture further comprises (b) a
`
`first desiccant and/or the second mixture further comprises a second desiccant.
`
`103.
`
`The method of any one of claims 99-102, wherein the first desiccant and the second desiccant
`
`are sodium alginate.
`
`104.
`
`The method of any one of claims 99-103, wherein the first mixture further comprises (c) a
`
`first buffering agent.
`
`105.
`
`The method of any one of claims 99-104, wherein the first mixture and the second mixture
`
`are each independently in a form of a powder, a pellet, a granule, a seed, a bead, a spheroid, a
`
`microsphere, or a mixture thereof.
`
`106.
`
`The method of any one of claims 99-105, wherein the omeprazole, or the pharmaceutically
`
`acceptable salt thereof, is micronized.
`
`107.
`
`The method of any one of claims 99-105, wherein the omeprazole, or the pharmaceutically
`
`acceptable salt thereof, is a mixture of micronized and non-micronized omeprazole, or the
`
`pharmaceutically acceptable salt thereof.
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`108.
`
`The method of claim 107, wherein the omeprazole comprises about 30 to about 70 %
`
`micronized omeprazole, or the pharmaceutically acceptable salt thereof, and the rest of the
`
`omeprazole, or the pharmaceutically acceptable salt thereof, is non-micronized.
`
`109.
`
`The method of claim 107, wherein the omeprazole is a 1:1 mixture, by weight, of micronized
`
`and non-micronized omeprazole, or the pharmaceutically acceptable salt thereof.
`
`110.
`
`The method of any one of claims 99-109, wherein the first buffering agent and the second
`
`buffering agent are present in an amountsufficient to increase gastric fluid pH to a pH that
`
`prevents degradation of at least some of the omeprazole in the gastric fluid.
`
`111.
`
`The method of any one of claims 104-110, wherein the first buffering agent and the second
`
`buffering agent
`
`together provide a buffering capacity of about 2 mEq/ml dose of the
`
`suspension.
`
`112.
`
`The method of any one of claims 99-111, wherein the first buffering agent and the second
`
`buffering agent are each independently selected from the group consisting of alkali metal or
`
`alkaline earth metal carbonates, bicarbonates, phosphates,
`
`citrates, borates,
`
`acetates,
`
`phthalates, tartrates, and succinates.
`
`113.
`
`The method of any one of claims 99-112, wherein the first buffering agent and the second
`
`buffering agent are each independently selected from the group consisting of sodium
`
`bicarbonate, potassium bicarbonate, and a mixture thereof.
`
`114.
`
`The method of any one of claims 104-113, wherein the first buffering agent is sodium
`
`bicarbonate.
`
`115.
`
`The method of any one of claims 99-113, wherein the second buffering agent is a mixture of
`
`sodium bicarbonate and potassium bicarbonate.
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`116.
`
`The method of claim 115, wherein the mixture comprises about 11% sodium bicarbonate and
`
`about 89% potassium bicarbonate, by weight.
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`-62-
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`117.
`
`The method of any one of claims 99-116, wherein the first mixture and the second mixture
`
`together comprise sodium bicarbonate and potassium bicarbonate at a ratio of about 1:2.7 by
`
`weight.
`
`118.
`
`The method of any one of claims 99 and 101-113, wherein the first buffering agent and the
`
`second buffering agent are potassium bicarbonate.
`
`119.
`
`The method of any one of claims 99-118, wherein the second mixture further comprises a
`
`sweetener and a preservative.
`
`120.
`
`The method of any one of claims 99-119, wherein the oral pharmaceutical suspension is
`
`provided in a drug delivery device suitable for multi-dose administration of omeprazole.
`
`121.
`
`A method of inhibiting gastric acid secretion, comprising administering to a subject in need
`
`thereof an effective amount of an oral pharmaceutical suspension comprising water, a
`
`pharmaceutically effective amount of omeprazole, or a pharmaceutically acceptable salt
`
`thereof, dispersed in the water, and one or more buffering agents, wherein the suspension
`
`contains no sodium from a sodium-containing buffering agent or the suspension contains
`
`sodium and potassium at a ratio of from about 1:2.6 to about 1:3.4 by weight; and wherein
`
`the oral pharmaceutical suspension is prepared as claimed in any one of claims 99-120.
`
`122.
`
`The oral pharmaceutical suspension of any one of claims 71-90, wherein the suspension
`
`remains stable for at least one month at 2°C-8°C after constitution with water.
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