JP2007517053A - 発泡性経口アヘン薬投薬形態およびアヘン薬の投与方法 - Google Patents
発泡性経口アヘン薬投薬形態およびアヘン薬の投与方法 Download PDFInfo
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Classifications
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- 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
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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
- A61K31/435—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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
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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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0007—Effervescent
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- 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
- A61P25/04—Centrally acting analgesics, e.g. opioids
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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
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (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)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Organic Chemistry (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Physiology (AREA)
- Pain & Pain Management (AREA)
- Biomedical Technology (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Rheumatology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Polysaccharides And Polysaccharide Derivatives (AREA)
Abstract
Description
本研究およびインフォームドコンセントフォーム(ICF)は、治験審査委員会(IRB)から承認を受けた。全ての被験体は、研究開始前にIRB承認ICFを読み、署名した。署名したICFをファイルする。
Adm1:ReVia(商標)50 mg(塩化ナルトレキソン錠剤)
Bristol Myers Squibb Company製
ロット番号:5C269A
使用期限:2004年4月
ロット番号:TB1798
使用期限:2005年3月
CIMA LABS INC製
ロット番号:930502
治療Aに任意抽出した被験体に、上歯肉と大臼歯上の頬との間に配置した1錠の1080μgのフェンタニル錠を経口に単回投与し、10分間崩壊させた。「OraVescent(商標)」は、本発明の処方物および投薬形態を示すことに留意のこと。
Cephalon,Inc.or Anesta製
ロット番号:02 689 W3
治療Bに任意抽出した被験体に、頬と下歯肉との間に配置した1単位の1600μgのActiq(商標)を経口に単回投与した。この単位を、ハンドルを使用して左右に移動させ、15分間溶解させた。
CIMA LABS INC製
ロット番号:930503
治療Cに任意抽出した被験体に、上歯肉と大臼歯上の頬との間に配置した1錠の1300μgのフェンタニル錠を経口に単回投与し、10分間崩壊させた。
CIMA LABS INC製
ロット番号:930501
治療Dに任意抽出した被験体に、上歯肉と大臼歯上の頬との間に配置した1錠の810μgのフェンタニル錠を経口に単回投与し、10分間崩壊させた。
CIMA LABS INC製
ロット番号:930500
治療Eに任意抽出した被験体に、上歯肉と大臼歯上の頬との間に配置した1錠の270μgのフェンタニル錠を経口に単回投与し、10分間崩壊させた。
ヒト血清中のフェンタニルのLC−MS/MS(液体クロマトグラフィ−質量分析/質量分析)
薬物動態学的分析および統計学的分析は、2001年1月発行の食品医薬品局の医薬品評価研究センター(CDER)の業界向けガイダンス(Guidance for Industry)(「生物学的等価性の確立への統計的アプローチ(Statistical Approaches to Establishing Bioequivalence)」)および2003年3月発行の業界向けガイダンス(「経口投与製剤の生物学的利用能および生物学的等価性の研究−概論(Bioavailability and Bioequivalence Studies for Orally Administered Drug Products General Considerations)」)に基づく。
時間0から時間tまでの線形台形の和を使用して計算したフェンタニル濃度−時間曲線下面積(式中、tは最後の測定可能な濃度の時間(Ct)である)。
AUC(0−inf)
時間0から無限時間までのフェンタニル濃度−時間曲線下面積(AUC(0−inf)=AUC(0−t)+Ct/Kel)(式中、Kelは、末端消失速度定数である)。
AUC(0−t)/AUC(0−inf)
AUC(0−inf)に対するAUC(0−t)の比。AUCRともいう。
AUC(0−tmax)
線形台形の和を使用して計算した基準処方物の時間0からTmax中央値までの部分領域。
Kel
Log濃度−時間曲線の末端線形部分の末端線形部分の線形回帰によって計算した末端消失速度定数(Kel=−勾配)。末端線形部分を目視検査によって決定した。
Tl/2
Ln(2)/Kelとして計算した消失半減期。
Cmax
最高測定フェンタニル濃度。
Tmax
最高フェンタニル濃度に達するまでの時間(内挿せずに得た)。
〔被験体の人口統計および性質〕
全員で42人の被験体(男性17人および女性25人)が研究に参加し、そのうち39人の被験体(男性17人および女性22人)が研究を完了した。
研究実施中に以下のプロトコルからの逸脱があった。
Physician's Desk Reference.56th ed.Montvale,NJ:Medical Economics Company,Inc.;2002.Actiq(商標);p.405-409。
Fentanyl.Micromedex[online]Vol.107:Health Series Integrated Index;2002[Date Accessed:2003/Jun/371.http://www.tomescps.com。
Streisand YB,et al.Dose Proportionality and Pharmacokinetics of Oral Transmucosal Fentanyl Citrate.Anesthesiology 88:305 309,1998。
Naltrexone.Micromedex[online]Vol.107:Health Series Integrated Index;2002[Date Accessed:2003/JunI6].http://www.tomescps.com。
SAS Institute,Inc.,SAS(商標)/STAT User's guide,Ver.6.4th ed.Vol.1.Cary,NC:SAS Institute;1989。
SAS Institute,Inc.,SAS(商標)/STAT User's guide,Ver.6,4th ed.Vol.2.Cary,NC:SAS Institute;1989。
SAS Institute,Inc.,SAS(商標)Procedures guide,Ver.6,3rd ed.Cary,NC:SAS Institute;1990。
Adml:ReVia(商標)(塩化ナルトレキソン錠剤)50mg
Duramed Pharmaceuticals,Inc.製
ロット番号:402753001T
使用期限:2006年6月
CIMA LABS INC製
ロット番号:930859
治療Aに任意抽出した被験体に、上歯肉と大臼歯上の頬との間に配置した1錠のOraVescent(商標)クエン酸フェンタニル(200μg)錠を経口に単回投与し、10分間崩壊させた。
CIMA LABS INC製
ロット番号:930860
治療Bに任意抽出した被験体に、上歯肉と大臼歯上の頬との間に配置した1錠のOraVescent(商標)クエン酸フェンタニル(500μg)錠を経口に単回投与し、10分間崩壊させた。
CIMA LABS INC製
ロット番号:930501
治療Cに任意抽出した被験体に、上歯肉と大臼歯上の頬との間に配置した1錠のOraVescent(商標)クエン酸フェンタニル(810μg)錠を経口に単回投与し、10分間崩壊させた。
CIMA LABS INC製
ロット番号:930502
治療Dに任意抽出した被験体に、上歯肉と大臼歯上の頬との間に配置した1錠のOraVescent(商標)クエン酸フェンタニル(1080μg)錠を経口に単回投与し、10分間崩壊させた。
時間0から時間tまでの線形台形の和を使用して計算したフェンタニル濃度−時間曲線下面積(式中、tは最後の測定可能な濃度の時間(Ct)である)。
AUC(0−inf)
時間0から無限時間までのフェンタニル濃度−時間曲線下面積(AUC(0−inf)=AUC(0−t)±Ct/Kel)(式中、Kelは、末端消失速度定数である)。
AUC(0−t)/AUC(0−inf)
AUC(0−inf)に対するAUC(0−t)の比。AUCRともいう。Kel Log濃度−時間曲線の末端線形部分の末端線形部分の線形回帰によって計算した末端消失速度定数(Kel=−勾配)。末端線形部分を目視検査によって決定した。
Tl/2
Ln(2)/Kelとして計算した消失半減期。
Cmax
最高測定フェンタニル濃度。
Tmax
最高フェンタニル濃度に達するまでの時間(内挿せずに得た)。
1)β1の90%CIが全て範囲(0.8677、1.1323)内に含まれる場合、用量に比例すると結論づけることとした。
2)β1の90%CIが完全にこの範囲の外側である場合、用量比例性を欠くと結論づけることとした。
3)β1の90%CIの一部がこの範囲に含まれ、且つ一部がこの範囲の外側である場合、結果は、「決定的でない」と見なされる。この場合、理想的な比例性からの逸脱の最良の推定値としてのβ1値ならびに90%CIの下界および上界を、薬物の安全性、有効性、または薬理効果データの文脈で考慮することができる。
ρ1=θH^[l/max(l−L,U−l)](式中、θH=1.25)、
L=90%CIの下限、
U=90%CIの上限。
ρ2=θH^[l/max(L−l,1−U)](θH、L、およびUを上記のように定義する)。
Smith BP,et al.Confidence Interval Criteria for Assessment of Dose Proportionality.Pharmaceutical Research 17:1278-1283,2000.
SAS Institute,Inc.,SAS(商標)/STAT User's guide,Ver.6.4th ed.Vol.1.Cary,NC:SAS Institute;1989.
SAS Institute,Inc.,SAS(商標)/STAT Users guide,Ver.6,4th ed.Vol.2.Cary,NC:SAS Institute;1989.
SAS Institute,Inc.,SAS(商標)Procedures guide,Ver.6,3rd ed.Cary,NC:SAS Institute;1990.
Summary Basis of Approval NDA 20-747(Actiq(商標)).Approval date November 4,1998,Clinical Pharmacology and Biopharmaceutics Review pp 6.
実施例1〜7および9〜11のそれぞれの場合、材料を使用前にスクリーニングし、Vブレンダーに入れるか、任意の他の適切な低剪断ブレンダーでブレンドし、適切な時間ブレンドすることができる。各実施例に記載のように、ブレンダーから取り出した後、材料を標準的なローターリー式打錠機で13ニュートンの標的の硬さおよび標的重量に圧縮した。
材料を使用前にスクリーニングし、Vブレンダーまたは任意の他の適切な低剪断ブレンダーに入れ、適切な時間ブレンドすることができる。ブレンダーから取り出した後、材料を標準的なローターリー式打錠機で13ニュートンの標的の硬さおよび200mg/錠剤の標的重量に圧縮した。
材料を使用前にスクリーニングし、Vブレンダーまたは任意の他の適切な低剪断ブレンダーに入れ、適切な時間ブレンドすることができる。ブレンダーから取り出した後、材料を標準的なローターリー式打錠機で13ニュートンの標的の硬さおよび200mg/錠剤の標的重量に圧縮した。
材料を使用前にスクリーニングし、Vブレンダーまたは任意の他の適切な低剪断ブレンダーに入れ、適切な時間ブレンドすることができる。ブレンダーから取り出した後、材料を標準的なローターリー式打錠機で13ニュートンの標的の硬さおよび200mg/錠剤の標的重量に圧縮した。
Claims (23)
- 約20μg〜約200,000μgのアヘン薬と、約0.5%w/wから約25%w/wの間の前記アヘン薬に適切なpH調整物質と、約5%w/wから約85%w/wの間の発泡性材料と、グリコール酸デンプンとを含む投薬形態であって、前記投薬形態が、頬側投与経路、歯内投与経路、または舌下投与経路を介した口腔粘膜を通過する前記アヘン薬の投与のためにデザインされている、投薬形態。
- 頬側投与経路、歯内投与経路、または舌下投与経路によって投与した場合、20%少ないアヘン薬の投与量で、グリコール酸デンプン、発泡性物質およびpH調整物質を含まない他は同一の処方物に匹敵するCmaxを有する、請求項1に記載の投薬形態。
- 前記pH調整物質が、局所pHをpH3からpH10の間とする、請求項1または2に記載の投薬形態。
- 前記pH調整物質が、局所pHを少なくとも0.5pH単位変化させることができる、請求項3に記載の投薬形態。
- 、
前記pH調整物質が、局所pHを少なくとも1.0pH単位変化させることができる、請求項4に記載の投薬形態。 - 前記pH調整物質が、炭酸塩または重炭酸塩である、請求項1または2に記載の投薬形態。
- 前記グリコール酸デンプンが、約0.25%w/wから約20%w/wの間の量で供される、請求項1または2に記載の投薬形態。
- 前記グリコール酸デンプンが、約0.5%w/wから約15%w/wの間の量で供される、請求項7に記載の投薬形態。
- 充填剤をさらに含む、請求項1または2に記載の投薬形態。
- 前記充填剤がマンニトールである、請求項9に記載の投薬形態。
- 前記充填剤が、約10%w/wから約80%w/wの間の量で供される、請求項9に記載の投薬形態。
- 前記マンニトールが、約25%w/wから約80%w/wの間の量で供される、請求項10に記載の投薬形態。
- 口内での最小限の操作で頬側経路、歯内経路または舌下経路で投与した場合、患者の口内中の平均滞留時間が約5分間から約30分間の間である、請求項1または2に記載の投薬形態。
- 結合剤、甘味料、着色料、香味物質、流動促進剤、潤滑剤、防腐剤、充填剤、および崩壊剤をさらに含む、請求項1または2に記載の投薬形態。
- F1またはF2ブリスター包装に包装されているた、請求項1または2に記載の投薬形態。
- 必要とする患者の痛みの治療方法であって、約20μg〜約200,000μgのアヘン薬、約0.5%w/wから約25%w/wの間の前記アヘン薬に適切なpH調整物質、約5%w/wから約85%w/wの間の発泡性材料、およびグリコール酸デンプンを含む投薬形態であって、前記投薬形態が、前記投薬形態を前記患者の口腔粘膜と密接に接触させることによる頬側投与経路、歯内投与経路または舌下投与経路を介した前記経口粘膜を通過する前記アヘン薬の投与のためにデザインされている投薬形態中に含まれるアヘン薬量を患者に投与するステップと、前記口腔粘膜を通過して前記用量の少なくとも治療に有意な部分を輸送するのに十分な時間、前記投薬形態を前記口腔粘膜に密接に接触させて保持するステップとを含む、方法。
- 少なくとも実質的に全ての前記用量が、前記口腔粘膜を通過して輸送される、請求項16に記載の方法。
- 前記投薬形態が、最小限の移動で約5分間から約30分間の間前記口腔粘膜に接触した状態に維持される、請求項16に記載の方法。
- グリコール酸デンプン、pH調整物質および発泡性物質を含まない処方物に匹敵するCmaxを達成し、さらに前記処方物よりもアヘン薬が20%少ない、請求項16に記載の方法。
- 前記痛みが癌由来の突出痛である、請求項16に記載の方法。
- 前記痛みが背痛である、請求項16に記載の方法。
- 前記痛みが手術痛または術後の痛みである、請求項16に記載の方法。
- 前記痛みが神経障害性の痛みである、請求項16に記載の方法。
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US10285953B2 (en) | 2010-12-16 | 2019-05-14 | Sunovion Pharmaceuticals Inc. | Sublingual films |
US11419769B2 (en) | 2010-12-16 | 2022-08-23 | Sunovion Pharmaceuticals Inc. | Sublingual films |
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AU2004311879A1 (en) | 2005-07-21 |
EP1708685A2 (en) | 2006-10-11 |
IL176452A0 (en) | 2006-10-05 |
JP2013121983A (ja) | 2013-06-20 |
ZA200606173B (en) | 2008-01-08 |
CA2549642C (en) | 2012-10-30 |
NO20063429L (no) | 2006-09-28 |
WO2005065318A2 (en) | 2005-07-21 |
US20110071181A1 (en) | 2011-03-24 |
ATE500821T1 (de) | 2011-03-15 |
IL176452A (en) | 2014-12-31 |
AU2004311879B2 (en) | 2010-08-05 |
US7862833B2 (en) | 2011-01-04 |
DE602004031771D1 (de) | 2011-04-21 |
JP5244318B2 (ja) | 2013-07-24 |
US20050163838A1 (en) | 2005-07-28 |
WO2005065318A3 (en) | 2005-12-15 |
CA2549642A1 (en) | 2005-07-21 |
MXPA06007453A (es) | 2007-01-31 |
EP1708685A4 (en) | 2007-12-26 |
KR20060127945A (ko) | 2006-12-13 |
JP5685611B2 (ja) | 2015-03-18 |
US8298577B2 (en) | 2012-10-30 |
EP1708685B1 (en) | 2011-03-09 |
NZ548215A (en) | 2009-08-28 |
HK1100166A1 (en) | 2007-09-07 |
NO338567B1 (no) | 2016-09-05 |
BRPI0418213A (pt) | 2007-04-27 |
KR101212437B1 (ko) | 2012-12-14 |
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