JP5085138B2 - 高濃度でミダゾラムを含む製薬組成物 - Google Patents
高濃度でミダゾラムを含む製薬組成物 Download PDFInfo
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Description
Allonen H, Ziegler G and Klotz U, Midazolam kinetics. Clin. Pharmacol. Ther. 30: 653-661 (1981). Bjorkman S, Rigemar G and Idvall J, Pharmacokinetics of midazolam given as an intranasal spray to adult surgical patients. Br. J. Anaesth. 79: 575-580 (1997). Burstein A H, Modica R, Hatton M, Forrest A and Gengo F M, Pharmacokinetics and pharmacodynamics of midazolam after intranasal administration. J. Clin. Pharmacol. 37: 711-718 (1997). Cheng ACK, Intranasal midazolam for rapidly sedating an adult patient. Anesth. Analg. 76: 904 (1993). Crevoisier Ch, Ziegler W H, Eckert M and Heizmann P, Relationship between plasma concentration and effect of midazolam after oral and intravenous administration. Br. J. Clin. Pharmacol. 16: 51S-61S (1983). Davis P J, Tome J A, McGowan F X, Cohen I T, Latta K and Felder H, Preanesthetic medication with intranasal midazolam for brief pediatric surgical procedures. Anesthesiology 82: 2-5 (1995). Gerecke M, Chemical structure and properties of midazolam compared with other benzodiazepines. Br. J. Clin. Pharmacol. 16: 11S-16S (1983). Gudmundsdottir H, Sigurjonsdottir J F, Masson M, Fjalldal O, Stefansson E and Loftsson T, Intranasal administration of midazolam in a cyclodextrin based formulation: bioavailability and clinical evaluation in humans. Pharmazie 56: 963-966 (2001). Heizmann P, Eckert M and Ziegler W H, Pharmacokinetics and bioavailability of midazolam in man. Br. J. Clin. Pharmacol. 16: 43S-49S (1983). Karl H W, Keifer A T, Rosenberger J L, Larach M G and Ruffle J M, Comparison of the safety and efficacy of intranasal midazolam or sufentanil for preinduction of anesthesia in pediatric patients. Anesthesiology 76: 209-215 (1992). Kendall J, Reynolds M and Goldberg R, Intranasal midazolam in patients with status epilepticus. Ann. Emerg. Med. 29: 415-417 (1997). Knoester P D, Jonker D M, Van der Hoeven R T M, Vermeij T A C, Edelbroek P M, and De Haan G J, Midazolam intranasaal toegepast, eventueel als noodmedicatie (in Dutch). Pharmaceutisch Weekblad 137: 112-117 (2002a) Knoester P D, Jonker D M, Van der Hoeven R T M, Vermeij T A C, Edelbroek P M, Brekelmans G J and De Haan G J, Pharmacokinetics and pharmacodynamics of midazolam administered as a concentrated nasal spray. A study in healthy volunteers. Br. J. Clin. Pharmacol. 53: 501-507 (2002). Kogan A, Katz J, Efrat R and Eidelman L A, Premedication with midazolam in young children: a comparison of four routes of administration. Paediatric Anaesthesia 12: 685-689 (2002). Lahat E, Goldman M, Barr J, Eshel G and Berkovitch M, Intranasal midazolam for childhood seizures. The Lancet 352: 620 (1998). Lahat E, Goldman M, Barr J, Bistritzer T and Berkovitch M, Comparison of intranasal midazolam with intravenous diazepam for treating febrile seizures in children: prospective randomised study. Br. Med. J. 321: 83-86 (2000). Loftsson T, Gudmundsdottir H, Sigurjonsdottir F J, Sigurosson H H, Sigfusson S D, Masson M and Stefansson E, Cyclodextrin solubilization of benzodiazepines: formulation of midazolam nasal spray. Int. J. Pharm. 212: 29-40 (2001). Lugo R A, Fishbein M, Nahata M C and Lininger B, Complication of intranasal midazolam. Pediatrics 92: 638 (1993). Lui C Y, Amidon G L and Goldberg A, Intranasal absorption of flurazepam, midazolam and triazolam in dogs. J. Pharm. Sci. 80: 1125-1129 (1991). Malinovsky J M, Lejus C, Servin F, Lepage J Y, Le Normand Y, Testa S, Cozian A and Pinaud M, Plasma concentrations after i.v., nasal or rectal administration in children. Br. J. Anaesth. 70: 617-620 (1993). Malinovsky J M, Populaire C, Cozian A, Lepage J Y, Lejus C and Pinaud M, Premedication with midazolam in children. Effect of intranasal, rectal and oral routes on plasma midazolam concentrations. Anaesthesia 50: 351-354 (1995). Marttin E, Schipper N G, Verhoef J C and Merkus FWHM, Nasal mucociliary clearance as a factor in nasal drug delivery. Adv. Drug Del. Rev. 29: 13-38 (1998). Merkus P, Romeijn S G, Verhoef J C and Merkus FWHM, Classification of cilio inhibiting effects of nasal drugs. Laryngoscope 111: 595-602 (2001). Olivier J C, Djilani M, Fahmy S and Couet W, In situ nasal absorption of midazolam in rats. Int. J. Pharm. 213: 187-192 (2001). O'Regan M E, Brown J K and Clarke M, Nasal rather than rectal benzodiazepines in the management of acute childhood seizures? Develop. Med. Child Neurol. 38: 1037-1045 (1996). Payne K, Mattheyse F J, Liebenbenberg D and Dawes T, The pharmacokinetics of midazolam in paediatric patients. Eur. J. Clin. Pharmacol. 37: 267-272 (1989). Persson M P, Nilsson A and Hartvig P, Relation of sedation and amnesia to plasma concentrations of midazolam in surgical patients. Clin. Pharmacol. Ther. 43: 324-331 (1988). Randell T T and Kytt, Conscious sedation in patients undergoing surgical and investigational procedures. A guide to drug choice. CNS Drugs 10: 329-342 (1998). Rey E, Delaunay L, Pons G, Murat I, Richard M O, Saint-Maurice C and Olive G, Pharmacokinetics of midazolam in children: comparative study of intranasal and intravenous administration. Eur. J. Clin. Pharmacol. 41: 355-357 (1991). Saint-Maurice C, Meistelman C, Rey E, Esteve C, De Lauture D and Olive G, The pharmacokinetics of rectal midazolam for premedication in children. Anesthesiology 65: 536-538 (1986). Scheepers M, Scheepers B, Clarke M, Comish S and Ibitoye M, Is intranasal midazolam an effective rescue medication in adolescents and adults with severe epilepsy? Seizure 9: 417-422 (2000). Smith M T, Eadie M J and O'Rourke Brophy T, The pharmacokinetics of midazolam in man. Eur. J. Clin. Pharmacol. 19: 271-278 (1981). Taylor M B, Vine P R and Hatch D J, Intramuscular midazolam premedication in young children. Anaesthesia 41: 21-26 (1986). Tenk H, Jonker D M, Van der Hoeven R T M, Vermeij T A C, Edelbroek P M and De Haan G J, Midazolam neusspray bij patinten met epilepsie. Pharm. Weekbl. 138: 99-103 (2003). Theroux M C, West D W, Corddry D H, Hyde P M, Bachrach S J, Croman K M and Kettrick R G, Efficacy of intranasal midazolam in facilitating suturing of lacerations in preschool children in the emergency department. Pediatrics 91: 624-627 (1993). Tolle-Sander S, Rautio J, Wring S, Polli J W and Polli J E, Midazolam exhibits characteristics of a highly permeable P-glycoprotein substrate. Pharm. Res. 20: 757-764 (2003). Uygur-Bayramicli O, Dabak R, Kuzucuoglu T and Kavakli B, Sedation with intranasal midazolam in adults undergoing upper gastrointestinal endoscopy. J. Clin. Gastroenterol. 35: 133-137 (2002). Walbergh E J, Wills R J and Eckhert J, Plasma concentrations of midazolam following intranasal administration. Anesthesiology 74: 233-235 (1991). Wilton N C T, Leigh J, Rosen D R and Pandit U A, Preanesthetic sedation of preschool children using intranasal midazolam. Anesthesiology 69: 972-975 (1988).
35-75mg/mlのミダゾラム(遊離塩基)に相当する塩酸ミダゾラム
適量(ミダゾラムを可溶化するのに十分な量)のプロピレングリコール
水
ポリエチレングリコール、グリセロール、ポビドン、エタノール、甘味料、香料物質、防腐剤、pH調節剤、及び安定化剤。
35-75mg/mlのミダゾラムに相当する塩酸ミダゾラム
プロピレングリコール5-50%(v/v)
グリセロール5-50%(v/v)
ポリエチレングリコール5-50%(v/v)
ポビドン1-20%(v/v)
水
35、40、45、または50mg/mlのミダゾラムに相当する塩酸ミダゾラム
プロピレングリコール15-30%(v/v)
グリセロール15-30%(v/v)
サッカリンナトリウム10-50mg/ml
水
35、40、45、または50mg/mlのミダゾラムに相当する塩酸ミダゾラム
プロピレングリコール20-50%(v/v)
ポビドン1-10%(w/v)
水
50g/mlのミダゾラムに相当する塩酸ミダゾラム
プロピレングリコール45%(v/v)
水55%(v/v)
この溶液のpHを3に調節する。
1)診断術及び手術を受けた子供用の鎮静剤及び抗不安剤として;
2)胃腸内視鏡及び他の診断術を受けた成人用の鎮静剤及び抗不安剤として;
3)医療センター及び過程での子供の急性癲癇性発作及び発熱性発作の処理として;
4)医療センター及び過程での重度の癲癇を有する成人における発作の治療のための短期的な管理として。
Claims (20)
- 少なくとも35mg/mlの濃度のミダゾラムと、プロピレングリコール、グリセロール、ポリエチレングリコール、ポビドン、エタノール及びそれらの組み合わせから選択される可溶化剤とを含む水溶液であり、pHが少なくとも2.5から4未満である鼻腔内投与用製薬組成物。
- pHが少なくとも3から4未満である、請求項1に記載の組成物。
- ミダゾラムの濃度が少なくとも40mg/mlである請求項1または2に記載の組成物。
- ミダゾラムの濃度が少なくとも50mg/mlである請求項1または2に記載の組成物。
- ミダゾラムが製薬学的に許容可能なその塩の形態で使用される請求項1から4のいずれか一項に記載の組成物。
- 製薬学的に許容可能なミダゾラムの塩が塩酸ミダゾラム、マレイン酸ミダゾラム、または乳酸ミダゾラムである請求項5に記載の組成物。
- 前記可溶化剤がプロピレングリコールを含み、任意にグリセロール、ポリエチレングリコール、ポビドン、及びエタノールの一つ以上を含む請求項1から6のいずれか一項に記載の組成物。
- 前記可溶化剤がグリセロールを含み、任意にプロピレングリコール、ポリエチレングリコール、ポビドン、及びエタノールの一つ以上を含む請求項1から6のいずれか一項に記載の組成物。
- 20-80%(v/v)の水と80-20%(v/v)の可溶化剤とを含むミダゾラムの溶液である請求項1から6のいずれか一項に記載の組成物。
- 前記可溶化剤がポリエチレングリコールを含む請求項9に記載の組成物。
- 40-50%(v/v)のプロピレングリコールと50-60%(v/v)の水とを含む請求項9または10に記載の組成物。
- 40-75mg/mlの濃度のミダゾラム
40-50%(v/v)のプロピレングリコール、及び
50-60%(v/v)の水
を含み、pHが少なくとも2.5から4未満に調節されている請求項11に記載の組成物。 - 40-75mg/mlの濃度のミダゾラム、
40-50%(v/v)のプロピレングリコール、及び
50-60%(v/v)の水、並びに
pHを少なくとも2.5から4未満に調節するのに十分な量の任意の製薬学的に許容可能な酸または塩基
からなる請求項11に記載の組成物。 - 一つ以上の甘味剤を含む請求項1から13のいずれか一項に記載の組成物。
- 香料剤、防腐剤、緩衝剤、安定化剤及びpH調節剤から選択される一つ以上の添加成分を含む請求項1から14のいずれか一項に記載の組成物。
- スプレー、鼻腔液、または鼻腔小滴の形態である請求項1から15のいずれか一項に記載の組成物。
- 鎮静剤もしくは抗不安剤としての、急性癲癇性もしくは発熱性発作の治療のための医薬としての、または癲癇に罹患している患者における発作の短期的な管理のための医薬としての使用のための請求項1から16のいずれか一項に記載の組成物。
- 鎮静剤もしくは抗不安剤の製造における、急性癲癇性もしくは発熱性発作の治療のための医薬の製造における、または癲癇に罹患している患者における発作の短期的な管理のための医薬の製造における請求項1から16のいずれか一項に記載の組成物の使用であって、前記鎮痛剤もしくは抗不安剤または前記医薬が鼻腔内投与用である、使用。
- 前記鎮痛剤もしくは抗不安剤または前記医薬が鼻孔当り50-100μlの量での投与用である、請求項18に記載の使用。
- 請求項1から17のいずれか一項に記載の組成物を含む鼻腔内送達用装置。
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GBGB0400804.1A GB0400804D0 (en) | 2004-01-14 | 2004-01-14 | Pharmaceutical compositions |
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PCT/EP2005/050133 WO2005067893A2 (en) | 2004-01-14 | 2005-01-13 | Pharmaceutical compositions comprising midazolam in a high concentration |
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US20040176359A1 (en) * | 2001-02-20 | 2004-09-09 | University Of Kentucky Research Foundation | Intranasal Benzodiazepine compositions |
NZ595196A (en) | 2005-11-09 | 2013-03-28 | Proteolix Inc | Peptide-based compounds for enzyme inhibition |
PL2041158T3 (pl) | 2006-06-19 | 2013-08-30 | Onyx Therapeutics Inc | Peptydowe epoksyketony do hamowania proteasomu |
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