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WO2010098482A1 - Préparation de capsules stable et son procédé de fabrication - Google Patents

Préparation de capsules stable et son procédé de fabrication Download PDF

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Publication number
WO2010098482A1
WO2010098482A1 PCT/JP2010/053194 JP2010053194W WO2010098482A1 WO 2010098482 A1 WO2010098482 A1 WO 2010098482A1 JP 2010053194 W JP2010053194 W JP 2010053194W WO 2010098482 A1 WO2010098482 A1 WO 2010098482A1
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WO
WIPO (PCT)
Prior art keywords
pitavastatin
capsule
fenofibrate
composition
capsules
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2010/053194
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English (en)
Japanese (ja)
Inventor
伸一郎 小林
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kowa Co Ltd
Original Assignee
Kowa Co Ltd
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Filing date
Publication date
Application filed by Kowa Co Ltd filed Critical Kowa Co Ltd
Publication of WO2010098482A1 publication Critical patent/WO2010098482A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics

Definitions

  • the present invention relates to a capsule preparation composition containing pitavastatin and fenofibrate as active ingredients, and a capsule preparation filled with the composition.
  • Statin drugs such as pitavastatin have an inhibitory action on HMG-CoA reductase, and are known to be useful as a therapeutic agent for hyperlipidemia and a therapeutic agent for atherosclerosis (Japanese Patent Laid-Open No. 01-297866). See the official gazette).
  • various measures have been taken for the formulation of compounds that are unstable at low pH (Japanese Patent Laid-Open Nos. 02-006406 and 05-246844, And Japanese Patent Publication No. 11-503763).
  • fibrates such as fenofibrate have an action of lowering blood cholesterol and blood triglycerides (see New Current, 7 (6), 9-19 (1996)).
  • compositions containing these statin drugs and fibrate drugs as active ingredients have been studied for use as therapeutic agents for hypercholesterolemia, therapeutic agents for diabetes, and the like (Pamphlet of International Publication No. 2006/011495 and International Publication No. 2008). / 015763 pamphlet).
  • the inventors have examined a capsule preparation containing pitavastatin, which is a statin drug, and fenofibrate, a fibrate drug, as active ingredients.
  • pitavastatin which is a statin drug
  • fenofibrate a fibrate drug
  • magnesium oxide and / or water are contained in the composition for capsule formulations containing pitavastatin and fenofibrate.
  • the present invention is a capsule preparation composition containing pitavastatin or a salt thereof and fenofibrate, wherein the composition contains magnesium oxide and / or magnesium hydroxide.
  • this invention is a capsule formulation obtained by filling the composition which mix
  • the present invention relates to a method for producing a capsule preparation containing pitavastatin or a salt thereof and fenofibrate, comprising a composition containing pitavastatin and magnesium oxide and / or magnesium hydroxide and a composition containing fenofibrate. It is the manufacturing method of the capsule formulation which each prepares and fills a capsule.
  • composition for capsule preparation of the present invention and the capsule preparation filled with the composition can suppress the formation of pitavastatin degradation product (lactone form) that occurs when pitavastatin and fenofibrate are filled into the capsule as active ingredients.
  • the capsule has the effect of improving the stability over time.
  • the graph which compared the stability after storage for one week at 60 degreeC by the kind of stabilizer in the capsule containing pitavastatin and fenofibrate.
  • the capsule of the present invention is a capsule preparation obtained by filling a composition for capsule preparation containing pitavastatin and fenofibrate as active ingredients.
  • pitavastatin has a strong HMG-CoA reductase inhibitory action and is useful as a hyperlipidemia treatment agent or an atherosclerosis treatment agent, but has a problem in stability at low pH and is stable. It is a compound for which various studies have been made.
  • pitavastatin may be not only free pitavastatin but also a salt with an inorganic base or an organic base, such as calcium salt, sodium salt, alkylamine salt, etc., and calcium salt is particularly preferable.
  • the above fenofibrate has an action of lowering blood cholesterol and blood triglycerides, and is useful as a prophylactic / therapeutic agent for hyperlipidemia.
  • Fenofibrate is preferably mixed and ground in advance with a solid surfactant in order to improve absorbability.
  • the solid surfactant include alkali metal sulfate of lauryl alcohol (eg, sodium lauryl sulfate), ethylene oxide / propylene oxide copolymer (eg, polyoxyethylene (105) polyoxypropylene (5) glycol), Sugar fatty acid esters and the like are used, and among these, sodium lauryl sulfate is particularly preferable.
  • the amount of the solid surfactant is preferably 1 to 10 parts by weight, particularly 2 to 5 parts by weight, based on 100 parts by weight of fenofibrate.
  • the solid surfactant and fenofibrate are mixed and pulverized by a pulverizing apparatus (eg, a jet mill, a hammer mill, a vibrating ball mill) usually used in the preparation of a preparation.
  • a pulverizing apparatus eg, a jet mill, a hammer mill, a vibrating ball mill
  • the mixing and pulverization can be performed, for example, according to the method described in JP-B-7-14876, and the average particle size thereof is preferably less than 15 ⁇ m, preferably less than 10 ⁇ m, particularly preferably less than 5 ⁇ m. .
  • the composition for capsule preparation of the present invention is characterized by containing magnesium oxide and / or magnesium hydroxide.
  • the inventors of the present invention have been studying capsules combining pitavastatin and fenofibrate. As a result, pitavastatin is decomposed in a capsule combining pitavastatin and fenofibrate, and a decomposition product such as a lactone form thereof is generated, thereby producing pitavastatin. It has been found that stability is impaired. The reason is not clear, but when pitavastatin and fenofibrate are combined, fenofibrate is acting on pitavastatin in some way, and the moisture contained in the capsule skin is somehow affecting it. The inventor thinks that.
  • magnesium oxide and / or magnesium hydroxide in the present invention, by adding magnesium oxide and / or magnesium hydroxide to a composition for capsule preparation containing both components, even when the composition is filled in a capsule, the formation of decomposition products is suppressed. Capsules that are stable over time can be obtained.
  • the composition for capsule preparation of the present invention usually contains the composition for capsule preparation within a range not impairing the effects of the present invention.
  • excipient examples include lactose hydrate, corn starch, D-mannitol, D-sorbitol, and crystalline cellulose.
  • binder examples include hydroxypropyl cellulose, hypromellose, povidone, polyvinyl Alcohol (partially saponified product), pregelatinized starch and the like can be used.
  • disintegrant examples include low-substituted hydroxypropylcellulose, carmellose, sodium carboxymethyl starch, carmellose calcium, corn starch, and partially pregelatinized starch. Croscarmellose sodium, crospovidone, etc. can be used.
  • Examples of the fluidizing agent include light anhydrous silicic acid, hydrous silicon dioxide, and talc.
  • Examples of the lubricant include magnesium stearate, stearic acid, calcium stearate, and talc. Can be used.
  • the capsule of the present invention can be produced by a method in which pitavastatin and fenofibrate, magnesium oxide and / or magnesium hydroxide and other components are all mixed to form a composition and then filled into a capsule. It can also be produced by separately preparing pitavastatin and fenofibrate as a pitavastatin-containing composition and a fenofibrate-containing composition, respectively, and filling them into capsules. Add magnesium.
  • capsules manufactured by filling capsules are preferable because they can further suppress the degradation of pitavastatin.
  • the composition include granules, and the particle size is not particularly limited as long as it is the size of the composition usually filled in a capsule.
  • the active ingredient pitavastatin is preferably 0.1 to 5% by weight, more preferably 0.2 to 3% by weight, and more preferably 0.3 to 3% by weight. It is particularly preferable to contain 1.5% by weight.
  • fenofibrate which is an active ingredient, is preferably contained in an amount of 1 to 99% by weight, more preferably 10 to 80% by weight, and particularly preferably 30 to 70% by weight.
  • Magnesium oxide and / or magnesium hydroxide is preferably contained in an amount of 0.001 to 20% by weight, more preferably 0.01 to 2% by weight.
  • the capsule of the present invention may be in a dosage form once a day or in a divided dosage state several times a day, for example, 2 to 6 times, preferably 3 times a day.
  • the dosage is selected as pitavastatin in the range of 0.1 to 10 mg, preferably 0.5 to 5 mg per day for adults, and as fenofibrate in the range of 10 to 400 mg, preferably 50 to 250 mg per day for adults.
  • the pitavastatin-containing composition contains pitavastatin and magnesium oxide and / or magnesium hydroxide.
  • the weight ratio of the amount is 1: 0.001 to 1:20, particularly 1: 0.01 to 1: 3, a more stable capsule can be obtained.
  • the filling ratio of the pitavastatin-containing composition and the fenofibrate-containing composition is 1: 0.1 to 1: 200, particularly 1: 0.5, from the viewpoint that the medicinal effect can be sufficiently exerted. It is preferably ⁇ 1: 100.
  • the capsule of the present invention employs a production method in which the active ingredient is filled in the capsule as separate compositions, it can be produced, for example, by the following method.
  • pitavastatin, magnesium oxide and / or magnesium hydroxide, and if necessary, an excipient, a binder and a disintegrant are mixed.
  • water is added to the mixture, granulated with stirring, dried and sized to obtain dry granules containing pitavastatin.
  • fenofibrate, solid surfactant, if necessary, excipient, binder, fluidizer and disintegrant are mixed, water is added to the mixture, stirring granulation, drying and sizing, and phenotype. Dry granules containing fibrate.
  • both dry granules obtained are filled into capsules.
  • the capsules used in the present invention are generally readily available on the market, and can be used without particular limitation as the capsule skin.
  • examples of such a coating include gelatin, hypromellose, polyvinyl alcohol, pullulan and the like, and gelatin is particularly preferable.
  • the gelatin content in the capsules may be appropriately determined in consideration of the mechanical strength of the capsules and the uniformity of the coating film during molding. 5 wt% is preferable, and 65 to 99 wt% is more preferable.
  • the capsule skin usually contains about 4 to 15% of water, but the capsule formulation composition of the present invention is stable even when capsules having a water content outside this range are used. There is an effect.
  • gelatin capsules contain about 13 to 15% of moisture, and the capsules having such a high moisture content can exhibit stability.
  • various additives such as macrogol, glycerin, sorbit, preservative, colorant, titanium oxide and the like can be blended in the capsule skin as necessary.
  • a coating containing macrogol in the gelatin coating may be used from the viewpoint of preventing softening and cracking of the capsule.
  • the content of the macrogol may be appropriately examined in consideration of the mechanical strength of the capsule and the uniformity of the film during molding, but is preferably 0.5 to 15% by weight with respect to the total amount of the capsule film. 1 to 10% by weight is more preferable.
  • the average molecular weight of macrogol is not particularly limited, but is preferably from 950 to 25000, more preferably from 2500 to 7000, from the viewpoint of preventing capsule softening and cracking.
  • Macrogol 1000, Macrogol 1500, Macrogol 1540, macrogol 4000, and macrogol 6000 are more preferable, and macrogol 4000 is particularly preferable. Only one macrogol may be used, or a plurality of mixtures may be used.
  • a granulated pitavastatin-containing composition 2 was obtained in the same manner as the pitavastatin-containing composition 1 except that the magnesium oxide was changed to sodium bicarbonate.
  • a granulated pitavastatin-containing composition 3 was obtained in the same manner as the pitavastatin-containing composition 1 except that the magnesium oxide was changed to calcium carbonate.
  • a granulated pitavastatin-containing composition 4 was obtained in the same manner as the pitavastatin-containing composition 1 except that the magnesium oxide was changed to L-arginine.
  • a granulated pitavastatin-containing composition 5 was obtained in the same manner as the pitavastatin-containing composition 1 except that the magnesium oxide was changed to dipotassium hydrogen phosphate.
  • a granulated pitavastatin-containing composition 6 was obtained in the same manner as the pitavastatin-containing composition 1 except that the magnesium oxide was changed to magnesium aluminate metasilicate.
  • fenofibrate-containing composition 7 200 g of fenofibrate and 7 g of sodium lauryl sulfate were mixed and ground to obtain micronized fenofibrate. 207 g of the finely divided fenofibrate obtained, 5.5 g of lactose hydrate, 30 g of pregelatinized starch, 5 g of crospovidone, and 2.5 g of light anhydrous silicic acid are mixed, and 50 g of purified water is added, kneaded, dried and sized. A granular fenofibrate-containing composition 7 was obtained.
  • Example 1 (one granule capsule)> 200 g of fenofibrate and 7 g of sodium lauryl sulfate were mixed and ground to obtain micronized fenofibrate.
  • Example 2 (capsule containing pitavastatin and fenofibrate)> 5 g of pitavastatin-containing composition 1 and 25 g of fenofibrate-containing composition 7 were uniformly mixed, and the mixture was filled into No. 1 gelatin capsules to give 300 mg per capsule to prepare 5 capsules.
  • ⁇ Test example> 1 1 g of pitavastatin-containing compositions 1 to 6 was filled in each brown No. 2 bottle, and the production rate of degradation products (lactones) after storage at 60 ° C. for 1 week was confirmed. The results are shown in Table 3. 2) Five capsules of Production Examples 1 to 6 were filled in a brown No. 2 bottle, and the rate of formation of degradation products (lactones) after one week storage at 60 ° C. was confirmed. The results are shown in Table 4. 3) Five capsules of Examples 1 and 2 and Comparative Examples 1 to 5 were filled in a brown No. 2 bottle, and the rate of formation of degradation products (lactones) after storage at 60 ° C. for 1 week was confirmed. The results are shown in Table 5.
  • the degradation product was quantified by a liquid chromatography method under the following conditions.
  • Detector UV absorptiometer (measurement wavelength: 245 nm)
  • Column temperature Constant temperature around 40 ° C.
  • Examples 3 to 7 In the same manner as in Example 2, capsules were prepared according to the formulation shown in Table 6, and the production rate of the degradation product after storage at 60 ° C. for 1 week was confirmed by the same method as in the test example. The results are shown in Table 6.
  • Examples 8 and 9> In the same manner as in Example 2, capsules were prepared according to the formulation shown in Table 7, and the production rate of the degradation product after storage at 40 ° C. for 6 months was confirmed by the same method as in the test example. The results are shown in Table 7.
  • Example 10 Capsules were prepared in the same manner as in Example 2 except that the magnesium oxide was changed to magnesium hydroxide, and the rate of degradation products after storage at 60 ° C. for 1 week was confirmed by the same method as in the test examples. The results are shown in Table 8.
  • capsules containing pitavastatin and fenofibrate in a composition containing magnesium oxide or magnesium hydroxide were stable over time because the formation of decomposition products was suppressed.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Engineering & Computer Science (AREA)
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  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Emergency Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Biophysics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention porte sur une préparation de capsules contenant de la pitavastatine et du fénofibrate en tant qu'ingrédients actifs. La préparation de capsules contenant de la pitavastatine et du fénofibrate est réalisée par remplissage au moyen d'une composition préparée par mélange d'oxyde de magnésium et/ou d'hydroxyde de magnésium avec les ingrédients actifs dans une capsule. La préparation des capsules est stable au cours du temps.
PCT/JP2010/053194 2009-02-27 2010-03-01 Préparation de capsules stable et son procédé de fabrication Ceased WO2010098482A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2009045023A JP2012096998A (ja) 2009-02-27 2009-02-27 安定なカプセル製剤及びその製造方法
JP2009-045023 2009-02-27

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WO2010098482A1 true WO2010098482A1 (fr) 2010-09-02

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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012029913A1 (fr) * 2010-09-01 2012-03-08 興和株式会社 Préparation orale
WO2012057103A1 (fr) * 2010-10-25 2012-05-03 興和株式会社 Composition pharmaceutique
JP2013221029A (ja) * 2012-04-18 2013-10-28 Orient Pharma Co Ltd ピタバスタチンの安定した製剤
EP2698159A4 (fr) * 2011-04-12 2014-11-05 Sawai Seiyaku Kk Préparation contenant de la pitavastatine et son procédé de production

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013224285A (ja) * 2012-06-27 2013-10-31 Kowa Co 医薬
US20220273652A1 (en) * 2019-07-31 2022-09-01 Intas Pharmaceuticals Ltd. Pharmaceutical composition comprising hmg-coa reductase inhibitors and fenofibrate

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2774037B2 (ja) * 1991-12-12 1998-07-09 ノバルテイス・アクチエンゲゼルシヤフト ＨＭＧ−ＣｏＡリダクターゼ抑制活性を有する化合物を含んでなる安定化された製薬学的組成物
JP2004523552A (ja) * 2001-02-22 2004-08-05 スカイファーマ・カナダ・インコーポレーテッド 低減した摂食−絶食効果を伴うフィブラート−スタチンの組合わせ
WO2006011495A1 (fr) * 2004-07-30 2006-02-02 Kowa Company, Ltd. Remede pour l'hypercholesterolemie et/ou l'hypertriglyceridemie
JP2006176498A (ja) * 2004-11-26 2006-07-06 Sankyo Co Ltd 血中遊離脂肪酸低下作用を有する医薬組成物
JP2007008923A (ja) * 2005-05-31 2007-01-18 Aska Pharmaceutical Co Ltd フィブラート系薬剤を含有する製剤及びその製造方法
JP2007508249A (ja) * 2003-10-10 2007-04-05 ライフサイクル ファーマ アクティーゼルスカブ フィブラートとスタチンを含む固体剤型
JP2008063322A (ja) * 2006-08-10 2008-03-21 Daiichi Sankyo Healthcare Co Ltd ＨＭＧ−ＣｏＡリダクターゼ阻害剤、トコフェロール類及びＣｏＱ１０を含有する医薬組成物

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2774037B2 (ja) * 1991-12-12 1998-07-09 ノバルテイス・アクチエンゲゼルシヤフト ＨＭＧ−ＣｏＡリダクターゼ抑制活性を有する化合物を含んでなる安定化された製薬学的組成物
JP2004523552A (ja) * 2001-02-22 2004-08-05 スカイファーマ・カナダ・インコーポレーテッド 低減した摂食−絶食効果を伴うフィブラート−スタチンの組合わせ
JP2007508249A (ja) * 2003-10-10 2007-04-05 ライフサイクル ファーマ アクティーゼルスカブ フィブラートとスタチンを含む固体剤型
WO2006011495A1 (fr) * 2004-07-30 2006-02-02 Kowa Company, Ltd. Remede pour l'hypercholesterolemie et/ou l'hypertriglyceridemie
JP2006176498A (ja) * 2004-11-26 2006-07-06 Sankyo Co Ltd 血中遊離脂肪酸低下作用を有する医薬組成物
JP2007008923A (ja) * 2005-05-31 2007-01-18 Aska Pharmaceutical Co Ltd フィブラート系薬剤を含有する製剤及びその製造方法
JP2008063322A (ja) * 2006-08-10 2008-03-21 Daiichi Sankyo Healthcare Co Ltd ＨＭＧ−ＣｏＡリダクターゼ阻害剤、トコフェロール類及びＣｏＱ１０を含有する医薬組成物

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012029913A1 (fr) * 2010-09-01 2012-03-08 興和株式会社 Préparation orale
WO2012057103A1 (fr) * 2010-10-25 2012-05-03 興和株式会社 Composition pharmaceutique
EP2698159A4 (fr) * 2011-04-12 2014-11-05 Sawai Seiyaku Kk Préparation contenant de la pitavastatine et son procédé de production
JP5988963B2 (ja) * 2011-04-12 2016-09-07 沢井製薬株式会社 ピタバスタチン含有製剤及びその製造方法
JP2013221029A (ja) * 2012-04-18 2013-10-28 Orient Pharma Co Ltd ピタバスタチンの安定した製剤
US20130310420A1 (en) * 2012-04-18 2013-11-21 Orient Pharma Co., Ltd. Stable formulations of pitavastatin

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