JP2005518405A - 処方 - Google Patents
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- JP2005518405A JP2005518405A JP2003559491A JP2003559491A JP2005518405A JP 2005518405 A JP2005518405 A JP 2005518405A JP 2003559491 A JP2003559491 A JP 2003559491A JP 2003559491 A JP2003559491 A JP 2003559491A JP 2005518405 A JP2005518405 A JP 2005518405A
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- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
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- A—HUMAN NECESSITIES
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- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/4965—Non-condensed pyrazines
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- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
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- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
- A61K9/0058—Chewing gums
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- 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
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- 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
- A61K9/20—Pills, tablets, discs, rods
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- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
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- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
- A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/02—Nasal agents, e.g. decongestants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P17/00—Drugs for dermatological disorders
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P27/00—Drugs for disorders of the senses
- A61P27/02—Ophthalmic agents
- A61P27/14—Decongestants or antiallergics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
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Abstract
Description
式中、
R1は−COOH基又はCONH2基であり、
X1及びX2は、独立して、それぞれ水素原子、ハロゲン原子、直鎖又は分枝C1−C4アルコキシ基又はトリフルオロメチル基並びにそれらの医薬品的に許容できる塩、幾何学的異性体、鏡像異性体,ジアステレオマ及びそれらの混合物である。
一般式Iを有する2−[4−(ジフェニルメチル)−1−ピペラジニル]−酢酸及びそれらのアミドを含む第一の処方
式中、
R1は−COOH基又は−CONH2基であり、
X1及びX2は、独立して、それぞれ水素原子、ハロゲン原子、直鎖又は分枝C1−C4アルコキシ基又はトリフルオロメチル基並びにそれらの医薬品的に許容できる塩、幾何学的異性体、鏡像異性体,ジアステレオマ及びそれらの混合物であり、その第一の処方が、300未満の分子量のポリオールを、ポリオールと式Iの活性化合物の10を超すモル比で含まず、
分子量が3000未満の1つ又はそれ以上の固体ポリオールを含み、如何なる薬物も含まない第二の処方、
の少なくとも2つの別の処方を含む経口医薬組成物に関する。
2つの処方を別々に調製した。これらの処方の組成を表2と3に示す。
表2.二重層錠剤のためのセチリジン2塩酸の組成
成分 組成(mg/錠)
セチリジン2塩酸 10.00
βサイクロデキストリン 82.50
アセサルフエームK 3.50
コロイド状無水シリカ 1.10
微結晶性セルロース 43.86
フレーバー 0.80
ラクトース一水和物 55.00
染料 0.48
ステアリン酸マグネシウム 2.76
表3.二重層錠剤のためのマンニトール処方の組成
成分 組成(mg/錠)
マンニトール 241.21
アセサルフエームK 4.69
フレーバー 1.00
染料 0.60
ステアリン酸マグネシウム 2.50
表4.セチリジン二重層の噛める錠剤の安定性試験
包装 条件 セチリジン(%) 反応生成物(%)
HDPE瓶 25℃−60%RH 100.50 0.10
30℃−60%RH 100.00 0.20
40℃−75%RH 99.27 0.29
Alu/Alu 25℃−60%RH 96.28 0.10
ブリスター 30℃−60%RH 99.32 BLQ
40℃−75%RH 99.99 0.22
BLQ:定量の下限(=0.1%)
2つの処方を別々に調製した。表5と6にこれらの処方の組成を示す。
表5.ドライシロップのためのセチリジン2塩酸処方の組成
成分 組成(mg)
A B C
セチリジン2塩酸 10.00 10.00 10.00
βサイクロデキストリン 82.50 82.50 82.50
アセサルフエームK 3.00 3.00 3.00
微結晶性セルロース 279.00 83.70 0.00
ラクトース一水和物 0.00 195.30 0.00
クエン酸ナトリウム 25.50 25.50 0.00
合計 400.00 400.00 95.50
表6.ドライシロップのためのマンニトール処方の組成
成分 組成(mg)
D
マンニトール 399.60
フレーバー 0.40
合計 400.00
表7.ドライシロップの組成
組成 成分(mg)
A’ B’ C’ D’
E 400.00 0.00 0.00 400.00
F 0.00 400.00 0.00 400.00
G 0.00 0.00 95.50 404.50
H 100.00 0.00 0.00 200.00
表8.10週後のドライシロップ中の望ましくない反応生成物の割合
組成 条件 反応生成物(%)
E 25℃−60%RH 0.00
30℃−60%RH 0.00
40℃−75%RH 0.26
F 25℃−60%RH 0.00
30℃−60%RH 0.00
40℃−75%RH 0.31
G 25℃−60%RH 0.00
30℃−60%RH 0.06
40℃−75%RH 0.34
H 25℃−60%RH 0.03
30℃−60%RH 0.04
40℃−75%RH 0.30
すべての処方が規格に適合する。
圧縮によって得られた、セチリジンを含むコアで作られたチューインガムとポリオールを含むコーティングの組成を表9に示す。
表9.チューインガムの組成
成分 組成(mg)
コア:
セチリジン塩酸 10.00
βサイクロデキストリン 100.00
ガム基材 660.00
アスパルテーム 3.00
アセサルフエームK 2.00
コロイド状シリカ 30.00
タルク 30.00
ステアリン酸マグネシウム 20.00
甘味料 65.00
フレーバー 80.00
コーティング:
キシリトール 382.50
マンニトール 85.00
ポリエチレングリコール 6000 10.00
二酸化チタン 10.00
アラビアゴム 10.00
フレーバー 2.50
カーナバ蝋 0.0015
これは二重錠及びドライシロップの場合であるので、チューインガムは安定性の要求に適合する。
Claims (22)
- 少なくとも2つの別の処方を含む経口医薬組成物であって:
一般式Iを有する2−[4−(ジフェニルメチル)−1−ピペラジニル]−酢酸及びそれらのアミドから選ばれた活性化合物を含む第一の処方
式中、
R1は−COOH基又は−CONH2基であり、
X1及びX2は、独立して、それぞれ水素原子、ハロゲン原子、直鎖又は分枝C1−C4アルコキシ基又はトリフルオロメチル基並びにそれらの医薬品的に許容できる塩、幾何学的異性体、鏡像異性体、ジアステレオマ及びそれらの混合物であり、その第一の処方が、ポリオールと式Iの活性化合物の10を超すモル比で、300未満の分子量のポリオールを含まない;及び
分子量が3000未満の1つ又はそれ以上の固体ポリオールを含み、如何なる薬物も含まない第二の処方、
を含む経口医薬組成物。 - 第一の処方が、ラクトースは例外として、ポリオールをポリオールと式Iの活性化合物の10を超すモル比で、分子量950未満のポリオールを含まない請求項1記載の組成物。
- 第一の処方が、ポリオールと式Iの活性化合物の5を超すモル比で、分子量300未満のポリオールを含まない請求項1記載の組成物。
- 第一の処方が、分子量300未満のポリオールを含まない請求項1〜3のいずれか一項に記載の組成物。
- 第一の処方が、ラクトースは例外として、ポリオールと式Iの活性化合物の5を超すモル比で、分子量950未満のポリオールを含まない請求項1記載の組成物。
- 第一の処方が、ラクトースは例外として、分子量950未満のポリオールを含まない請求項1〜5のいずれか一項に記載の組成物。
- 処方が粉末、顆粒、溶液又は懸濁液の形で調製される請求項1〜6のいずれか一項に記載の組成物。
- 第二の処方中のポリオールがマンニトールである請求項1〜7のいずれか一項に記載の組成物。
- 第二の処方中のポリオールが多糖類である請求項1〜7のいずれか一項に記載の組成物。
- 少なくとも1つの処方が、更にアルカリ化剤を含む請求項1〜7のいずれか一項に記載の組成物。
- アルカリ化剤がクエン酸ナトリウムである請求項10記載の組成物。
- 第一の処方が、サイクロデキストリン、コロイド状無水シリカ、微結晶セルロース、ステアリン酸マグネシウム、フレーバー又は着色剤から選ばれた1つ又はそれ以上の賦形剤を更に含む請求項1〜10のいずれか一項に記載の組成物。
- 第一の処方が、アセサルフエームK,アスパルテーム、サッカリン、サッカリンナトリウム又はシクラメートのような非ポリオール甘味剤を更に含む請求項1〜12のいずれか一項に記載の組成物。
- 第一の処方の活性化合物がセチリジンジハイドロクロライド、レボセチリジンジハイドロクロライド又はエフレトリジンジハイドロクロライドである請求項1〜13のいずれか一項に記載の組成物。
- チューインガム、錠剤又は沸騰錠剤の形である請求項1〜14のいずれか一項に記載の組成物。
- 各層が処方の1つから調製される多層錠剤の形である請求項15記載の組成物。
- 不活性層が2つの処方から調製された層を隔てる多層錠剤の形である請求項16記載の組成物。
- 処方の1つから調製された内部コアを有し、他の処方から調製される外部殻を有する錠剤である請求項15記載の組成物。
- 第一の処方から作られ、更にガム基材を含むコア、及び
第二の処方から作られたコーティング、
を含むチューインガムである請求項15記載の組成物。 - 第二の処方から作られ、更にガム基材を含むたコア、及び
第一の処方から作られたコーティング、
を含むチューインガムである請求項15記載の組成物。 - 1つの型の顆粒が、第一の処方の閉め固めで作られ、他の型の顆粒が、第二の処方の閉め固めで作られる、2つの型の顆粒の混合物から調製された乾燥シロップである請求項1〜14のいずれか一項に記載の組成物。
- 請求項1〜21のいずれか一項に記載の組成物を製造する方法であって、第一の処方と第二の処方を別々に調製し、2つの処方を組み合わせることによる製造方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP02000871 | 2002-01-15 | ||
EP02000871.0 | 2002-01-15 | ||
PCT/EP2003/000260 WO2003059328A1 (en) | 2002-01-15 | 2003-01-14 | Formulations |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP2010035633A Division JP5467685B2 (ja) | 2002-01-15 | 2010-02-22 | 処方 |
Publications (3)
Publication Number | Publication Date |
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JP2005518405A true JP2005518405A (ja) | 2005-06-23 |
JP2005518405A5 JP2005518405A5 (ja) | 2006-01-05 |
JP4724367B2 JP4724367B2 (ja) | 2011-07-13 |
Family
ID=8185261
Family Applications (4)
Application Number | Title | Priority Date | Filing Date |
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JP2003559491A Expired - Lifetime JP4724367B2 (ja) | 2002-01-15 | 2003-01-14 | 処方 |
JP2010035633A Expired - Lifetime JP5467685B2 (ja) | 2002-01-15 | 2010-02-22 | 処方 |
JP2012051259A Expired - Lifetime JP5623447B2 (ja) | 2002-01-15 | 2012-03-08 | 処方 |
JP2013228128A Abandoned JP2014024866A (ja) | 2002-01-15 | 2013-11-01 | 処方 |
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JP2010035633A Expired - Lifetime JP5467685B2 (ja) | 2002-01-15 | 2010-02-22 | 処方 |
JP2012051259A Expired - Lifetime JP5623447B2 (ja) | 2002-01-15 | 2012-03-08 | 処方 |
JP2013228128A Abandoned JP2014024866A (ja) | 2002-01-15 | 2013-11-01 | 処方 |
Country Status (20)
Country | Link |
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US (3) | US20050038039A1 (ja) |
EP (1) | EP1467715B1 (ja) |
JP (4) | JP4724367B2 (ja) |
KR (1) | KR101005648B1 (ja) |
CN (2) | CN100455287C (ja) |
AT (1) | ATE486587T1 (ja) |
AU (3) | AU2003201161B2 (ja) |
BR (1) | BR0306870A (ja) |
CA (1) | CA2472396A1 (ja) |
CO (1) | CO5590918A2 (ja) |
DE (1) | DE60334773D1 (ja) |
ES (1) | ES2354688T3 (ja) |
HK (1) | HK1076605A1 (ja) |
MX (1) | MXPA04006775A (ja) |
NO (1) | NO333936B1 (ja) |
NZ (1) | NZ534039A (ja) |
PL (1) | PL212123B1 (ja) |
RU (1) | RU2004123612A (ja) |
WO (1) | WO2003059328A1 (ja) |
ZA (1) | ZA200404796B (ja) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2005526104A (ja) * | 2002-04-04 | 2005-09-02 | ファイザー・プロダクツ・インク | 味の良い咀嚼可能な錠剤 |
JP2016094364A (ja) * | 2014-11-14 | 2016-05-26 | ニプロ株式会社 | 安定化および苦味抑制された口腔内崩壊製剤 |
JP2017508761A (ja) * | 2014-03-27 | 2017-03-30 | ユセベ ファルシム ソシエテ アノニム | レボセチリジンを含む医薬組成物 |
Families Citing this family (28)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
ATE504316T1 (de) * | 2004-04-01 | 2011-04-15 | Pf Medicament | Einschlusskomplexe enthaltend piroxicam, ein cyklodextrin und arginin |
US7622137B2 (en) * | 2004-05-21 | 2009-11-24 | Accu-Break Technologies, Inc. | Dosage forms contained within a capsule or sachet |
ES2439572T3 (es) * | 2004-05-21 | 2014-01-23 | Accu-Break Technologies, Inc. | Comprimidos farmacéuticos de liberación inmediata de mayor altura que anchura |
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