WHAT IS CLAIMEDIS:
`
`-74-
`
`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 |: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
`
`present at 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.
`
`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
`
`Atty. Dkt. No. 4384.0010003/MSB/THN
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`

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`consisting of alkali metal or alkaline earth metal carbonates, bicarbonates, phosphates,
`
`citrates, borates, acetates, phthalates, tartrates, and succinates.
`
`_75-
`
`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 present at 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.
`
`A storage-stable omeprazole system, the system comprising (1) 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 (11) 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 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.
`
`16.
`
`The storage-stable omeprazole system of claim 15, wherein the sodium and potassium are
`
`present at a ratio of about 1:3.2 by weight.
`
`Atty. Dkt. No. 4384.0010003/MSB/THN
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`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%.
`
`- 76 -
`
`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 thefirst
`
`desiccant and the second desiccant are sodium alginate.
`
`20.
`
`The storage-stable omeprazole system of any one of claims 15-19, wherein thefirst
`
`mixture further comprises (c) a first buffering agent.
`
`21.
`
`The storage-stable omeprazole system of any one of claims 15-20, wherein thefirst
`
`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.
`
`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, 1s 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.
`
`Atty. Dkt. No. 4384.0010003/MSB/THN
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`-77-
`
`26.
`
`The storage-stable omeprazole system of any one of claims 15-25, wherein the first
`
`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 mixtures
`
`thereof.
`
`29,
`
`The storage-stable omeprazole system of any one of claims 14-28, 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 mixturethereof.
`
`30.
`
`The storage-stable omeprazole system of any one of claims 20-29, wherein thefirst
`
`buffering agent is sodium bicarbonate.
`
`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.
`
`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.
`
`Atty. Dkt. No. 4384.0010003/MSB/THN
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`34.
`
`The storage-stable omeprazole system of any one of claims 15-29, wherein the first
`
`buffering agent and the second buffering agent are potassium bicarbonate.
`
`- 78 -
`
`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 meansfor 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 (1)
`
`the container body contains the second mixture and has a container opening formed in an
`
`upper end thereof; (ii) 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 whenthe capis twisted, the first mixture is released into the container body.
`
`40.
`
`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
`
`powder system remains stable at 25°C / 60% relative humidity for at least 2 years.
`
`Atty. Dkt. No. 4384.0010003/MSB/THN
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`42.
`
`A storage-stable omeprazole system formulated in a drug delivery device suitable for
`
`-79 -
`
`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 ata 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.
`
`A4.
`
`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 system contains sodium and potassium at a ratio of from
`
`about 1:2.6 to about 1:3.4 by 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.
`
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`-80-
`
`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.
`
`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
`
`mixture is dry.
`
`52.
`
`The storage-stable omeprazole powder system of any one of claims 44-51, wherein the
`
`sodium alginate present in the second powder mixtureis 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 amount sufficient 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.
`
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`-81-
`
`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 mixtures thereof.
`
`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,
`
`59.
`
`The storage-stable omeprazole powder system of any one of claims 44-58, wherein the
`
`first buffering agent is sodium bicarbonate.
`
`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.
`
`ol.
`
`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.
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`-82-
`
`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, wherein (1)
`
`the container body contains the second powder mixture and has a
`
`container opening formed in an upper end thereof: (41) 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 (iii) the cap is mounted in the
`
`container opening of the container body, wherein when the cap is 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 amber polyethylene terephthalate bottle and the cap is a polypropylene tamper evident
`
`cap.
`
`69.
`
`The storage-stable omeprazole powder system of any one of claims 44-68, wherein the
`
`powder system remains stable 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.
`
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`- 33 -
`
`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.
`
`TA.
`
`The oral pharmaceutical suspension of claim 73, wherein about | 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.
`
`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.
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`79.
`
`The oral pharmaceutical suspension of claim 78, wherein the one buffering agent is
`
`potassium bicarbonate.
`
`- 84 -
`
`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 bicarbonate at 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 ml of the suspension.
`
`83.
`
`The oral pharmaceutical suspension of any one of claims 71-77 and 80-82, wherein the
`
`sodium and potassium are present at a ratio of about 1:3.2 by weight.
`
`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 Cmax and a first and
`
`second Tmax following oral administration in a subject in need thereof.
`
`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.
`
`80.
`
`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.
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`-85-
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`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.
`
`91.
`
`The oral pharmaceutical suspension of any one of claims 71-90, wherein the suspension is
`
`providedin a drug delivery device suitable for multi-dose administration of omeprazole.
`
`92.
`
`A method of 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 method of 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 1 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 | ml of the suspension contains about |
`
`mg, about 2 mg, about 4 mg or about 8 mg of omeprazole, or the pharmaceutically
`
`acceptable salt thereof.
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`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.
`
`- 86 -
`
`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 combininga 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 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.
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`103.
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`The method of any one of claims 99-102, wherein the first desiccant and the second
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`desiccant are sodium alginate.
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`104.
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`The method of any one of claims 99-103, wherein the first mixture further comprises (c) a
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`first buffering agent.
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`105.
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`The method of any one of claims 99-104, wherein the first mixture and the second
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`mixture are each independently in a form of a powder, a pellet, a granule, a seed, a bead,
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`a spheroid, a microsphere, or a mixture thereof.
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`106.
`
`The method of any one of claims 99-105, wherein the omeprazole, or
`
`the
`
`pharmaceutically acceptable salt thereof, is micronized.
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`107.
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`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
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`omeprazole, or the pharmaceutically acceptable salt thereof.
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`108.
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`The method of claim 107, wherein the omeprazole comprises about 30 to about 70 %
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`micronized omeprazole, or the pharmaceutically acceptable salt thereof, and the rest of
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`the omeprazole, or the pharmaceutically acceptable salt thereof, is non-micronized.
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`109.
`
`The method of claim 107, wherein the omeprazole is a 1:1 mixture, by weight, of
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`micronized and non-micronized omeprazole, or the pharmaceutically acceptable salt
`
`thereof.
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`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.
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`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.
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`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.
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`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.
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`114.
`
`The method of any one of claims 104-113, wherein the first buffering agent is sodium
`
`bicarbonate.
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`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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`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.
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`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.
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`119.
`
`The method of any one of claims 99-118, wherein the second mixture further comprises a
`
`sweetenerand 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,
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`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
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`wherein the oral pharmaceutical suspension is prepared as claimed in any one of claims
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`99-120.
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`122.
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`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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