JP2006342178A - 舌下又はバッカル医薬組成物 - Google Patents
舌下又はバッカル医薬組成物 Download PDFInfo
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- JP2006342178A JP2006342178A JP2006217762A JP2006217762A JP2006342178A JP 2006342178 A JP2006342178 A JP 2006342178A JP 2006217762 A JP2006217762 A JP 2006217762A JP 2006217762 A JP2006217762 A JP 2006217762A JP 2006342178 A JP2006342178 A JP 2006342178A
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- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/407—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
-
- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
-
- 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
- A61K9/006—Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
-
- 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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/22—Anxiolytics
-
- 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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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Psychiatry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
- Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)
- Plural Heterocyclic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
【解決手段】ピロール化合物又はその医薬上許容し得る塩と医薬上許容し得る水溶性又は水分散性担体材料、並びに場合によって医薬上許容し得る助剤及び賦形剤を含む水性組成物を鋳型に移し、その後で、組成物を凍結し、好ましくは凍結乾燥して溶媒を昇華させる。水溶性又は水分散性担体材料は、加水分解デキストラン、デキストリン、マンニトール及びアルギネートのような多糖類若しくはその混合物、好ましい担体材料はゼラチン、特に部分加水分解ゼラチンである。
【選択図】なし
Description
該組成物は、トランス−5−クロロ−2−メチル−2,3,3a,12b−テトラヒドロ−1H−ジベンズ[2,3:6,7]オキセピノ[4,5−c]ピロール又はその医薬上許容し得る塩及び該組成物における使用に適した医薬上許容し得る助剤を含む。
ゼラチン(30g)を加熱及び一定攪拌下に1Lの蒸留水に溶解した。得られた溶液をオートクレーブに入れ、121℃(105Pa)で1時間滅菌した。その後、溶液を室温に冷まして、加水分解ゼラチン(3%w/v)を得た。
円筒形くぼみを含む塩化ポリビニル(PVC)シートをドライアイスで冷却した。0.2gのOrg 5222[5−クロロ−2−メチル−2,3,3a,12b−テトラヒドロ−1H−ジベンズ[2,3:6,7]オキセピノ[4,5−c]ピロールマレエート(1:1)]を攪拌下に1Lの加水分解ゼラチンに溶解した。攪拌を続けながら、各くぼみに0.5mlの溶液を入れた。くぼみの内容物が凍結してから、PVCシートを凍結乾燥系に入れた。最後に凍結乾燥した医薬剤形を含むくぼみを密閉するように該シートをアルミホイルで密封した。各くぼみは、0.10mgの5−クロロ−2−メチル−2,3,3a,12b−テトラヒドロ−1H−ジベンズ[2,3:6,7]オキセピノ[4,5−c]ピロールマレエート(1:1)を含む医薬単位用量を含む。
方法
麻酔下にビーグル犬(10〜20kg,Harlan,France)に器具を取り付けた。大動脈弓近くの大動脈と左心室にマイクロマノメーター(Konigsberg Instruments)を装入した。心臓内左心室壁に一対のセグメント長圧電性結晶を約1cmの間隔を置いて縫合した。連結用の針金は全て皮下を通し、首の後ろで体外に露出させた。術後2週間して、イヌをパブロフスタンドに置き、変換器を8チャンネルレコーダー(Gould ES3000)に接続した。慣用の双極四肢導出を用いて心電図(標準導出II)も記録した。
傾斜に対する低血圧応答は、投与経路には関係なく僅かであり、Org 5222により用量依存的に増大した。しかし、等量のOrg 5222血漿レベルの場合、付随する頻脈はOrg 5222を経口投与した後では常に舌下投与後より著しかった(表1)。
頻脈を伴う起立性低血圧は、Org 5222の舌下投与後より経口投与の方が著しかった。直接血行動態及び電気生理学作用も、負変力及びQTc延長に関して経口投与後より舌下投与後の方が少なかった。
Claims (1)
- 医薬活性化合物としてトランス−5−クロロ−2−メチル−2,3,3a,12b−テトラヒドロ−1H−ジベンズ[2,3:6,7]オキセピノ[4,5−c]ピロールまたはその医薬上許容される塩を含む医薬組成物であって、固形組成物であり37℃の水中で30秒以内に崩壊することを特徴とする医薬組成物。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP94200521 | 1994-03-02 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP52270395A Division JP4099224B2 (ja) | 1994-03-02 | 1995-03-01 | 舌下又はバッカル医薬組成物 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2006342178A true JP2006342178A (ja) | 2006-12-21 |
JP4616810B2 JP4616810B2 (ja) | 2011-01-19 |
Family
ID=8216678
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP52270395A Expired - Lifetime JP4099224B2 (ja) | 1994-03-02 | 1995-03-01 | 舌下又はバッカル医薬組成物 |
JP2006217762A Expired - Lifetime JP4616810B2 (ja) | 1994-03-02 | 2006-08-10 | 舌下又はバッカル医薬組成物 |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP52270395A Expired - Lifetime JP4099224B2 (ja) | 1994-03-02 | 1995-03-01 | 舌下又はバッカル医薬組成物 |
Country Status (23)
Country | Link |
---|---|
US (1) | US5763476A (ja) |
EP (1) | EP0746317B1 (ja) |
JP (2) | JP4099224B2 (ja) |
KR (1) | KR100330942B1 (ja) |
CN (1) | CN1079670C (ja) |
AT (1) | ATE167057T1 (ja) |
AU (1) | AU692530B2 (ja) |
BR (2) | BR9506924A (ja) |
CA (1) | CA2182981C (ja) |
CZ (1) | CZ284633B6 (ja) |
DE (2) | DE122010000050I2 (ja) |
DK (1) | DK0746317T3 (ja) |
ES (1) | ES2118584T3 (ja) |
FI (1) | FI117923B (ja) |
FR (1) | FR10C0056I2 (ja) |
HK (1) | HK1008417A1 (ja) |
HU (1) | HU225051B1 (ja) |
LU (1) | LU91751I2 (ja) |
NO (2) | NO308772B1 (ja) |
NZ (1) | NZ282394A (ja) |
PL (1) | PL180465B1 (ja) |
RU (1) | RU2139051C1 (ja) |
WO (1) | WO1995023600A1 (ja) |
Families Citing this family (65)
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AU2004237951A1 (en) * | 2003-05-16 | 2004-11-25 | Pfizer Products Inc. | Therapeutic combinations of atypical antipsychotics with GABA modulators, anticonvulsants or benzodiazapines |
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JPS62292733A (ja) * | 1986-06-05 | 1987-12-19 | ユ−ロセルテイツク・エス・ア− | 徐放性医薬組成物 |
JPH03169816A (ja) * | 1989-10-17 | 1991-07-23 | Jr Everett H Ellinwood | トリフロロベンゾジアゼピン類を投与する口内投薬法 |
JPH0656840A (ja) * | 1992-05-08 | 1994-03-01 | Akzo Nv | デポー製剤 |
Family Cites Families (4)
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IE45770B1 (en) * | 1976-10-06 | 1982-11-17 | Wyeth John & Brother Ltd | Pharmaceutical dosage forms |
GB1548022A (en) * | 1976-10-06 | 1979-07-04 | Wyeth John & Brother Ltd | Pharmaceutial dosage forms |
EP0578823B1 (en) * | 1991-04-08 | 2002-01-23 | Sumitomo Pharmaceuticals Company, Limited | Porous solid preparation containing physiologically active protein substance |
EP0569096A1 (en) * | 1992-05-08 | 1993-11-10 | Akzo Nobel N.V. | Depot preparation |
-
1995
- 1995-03-01 PL PL95316080A patent/PL180465B1/pl unknown
- 1995-03-01 ES ES95912188T patent/ES2118584T3/es not_active Expired - Lifetime
- 1995-03-01 HU HU9602383A patent/HU225051B1/hu active Protection Beyond IP Right Term
- 1995-03-01 JP JP52270395A patent/JP4099224B2/ja not_active Expired - Lifetime
- 1995-03-01 DE DE201012000050 patent/DE122010000050I2/de active Active
- 1995-03-01 CA CA002182981A patent/CA2182981C/en not_active Expired - Lifetime
- 1995-03-01 CZ CZ962541A patent/CZ284633B6/cs not_active IP Right Cessation
- 1995-03-01 AU AU19478/95A patent/AU692530B2/en not_active Expired
- 1995-03-01 WO PCT/EP1995/000765 patent/WO1995023600A1/en active IP Right Grant
- 1995-03-01 AT AT95912188T patent/ATE167057T1/de active
- 1995-03-01 NZ NZ282394A patent/NZ282394A/en not_active IP Right Cessation
- 1995-03-01 KR KR1019960704774A patent/KR100330942B1/ko not_active IP Right Cessation
- 1995-03-01 BR BR9506924A patent/BR9506924A/pt not_active Application Discontinuation
- 1995-03-01 CN CN95191906A patent/CN1079670C/zh not_active Expired - Lifetime
- 1995-03-01 DE DE69502939T patent/DE69502939T2/de not_active Expired - Lifetime
- 1995-03-01 RU RU96120090/14A patent/RU2139051C1/ru active Protection Beyond IP Right Term
- 1995-03-01 US US08/693,064 patent/US5763476A/en not_active Expired - Lifetime
- 1995-03-01 EP EP95912188A patent/EP0746317B1/en not_active Expired - Lifetime
- 1995-03-01 DK DK95912188T patent/DK0746317T3/da active
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1996
- 1996-08-30 FI FI963398A patent/FI117923B/fi not_active IP Right Cessation
- 1996-08-30 NO NO19963639A patent/NO308772B1/no not_active IP Right Cessation
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1997
- 1997-05-13 BR BR1100625-0A patent/BR1100625A/pt active IP Right Grant
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1998
- 1998-07-14 HK HK98109126A patent/HK1008417A1/xx not_active IP Right Cessation
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2006
- 2006-08-10 JP JP2006217762A patent/JP4616810B2/ja not_active Expired - Lifetime
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2010
- 2010-11-04 LU LU91751C patent/LU91751I2/fr unknown
- 2010-12-13 NO NO2010024C patent/NO2010024I2/no unknown
- 2010-12-23 FR FR10C0056C patent/FR10C0056I2/fr active Active
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