JP4394447B2 - アセトアミノフェン組成物 - Google Patents
アセトアミノフェン組成物 Download PDFInfo
- Publication number
- JP4394447B2 JP4394447B2 JP2003546810A JP2003546810A JP4394447B2 JP 4394447 B2 JP4394447 B2 JP 4394447B2 JP 2003546810 A JP2003546810 A JP 2003546810A JP 2003546810 A JP2003546810 A JP 2003546810A JP 4394447 B2 JP4394447 B2 JP 4394447B2
- Authority
- JP
- Japan
- Prior art keywords
- acetaminophen
- composition
- capsule
- lactate
- dosage form
- 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.)
- Expired - Lifetime
Links
Classifications
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
Landscapes
- Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pain & Pain Management (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Description
種々の溶媒および溶媒組成物にアセトアミノフェンを含む種々の製剤を比較した。各製剤は、最初に、ポリエチレングリコール(Union Carbide, Danbury, CTから入手可能なポリエチレングリコール400および600)と、ポリビニルピロリドン(BASF, Mount Olive, NJ and ISP, Freetown, MAから入手可能なPovidone 25)とを、30℃で約15から20分間、ポリビニルピロリドン(Povidone 25)がポリエチレングリコールに完全に可溶化するまで混合することによって調製した。次いで、アセトアミノフェンを、この混合物に、高速で約30分から約45分間にわたって加えた。このとき、混合物の温度をゆっくりと約65℃まで上昇させて維持した。続いて、塩と水を添加し、混合物の温度を約70℃まで上昇させた。この混合物を、約1時間から約2時間にわたって連続的に撹拌した。透明性と結晶化の観察を、混合の最終段階に行った。
以下のバッチ製剤を上記方法に従って調製した。
二つのアセトアミノフェン含有バッチ組成物を上記方法に従って調製した。成分と相対量は以下の通りである。
以下のバッチ製剤を上述の方法を用いて調製した。
本発明に係る組成物は、有効量のアセトアミノフェンの使用をより小さいカプセルサイズを用いて調製可能にする。これは、製造コストを顕著に低減し、患者の快適性を増大させる。さらに、透明なソフトカプセルをアセトアミノフェンに使用した場合、本発明の組成物の透明性および色がより魅力的な最終製品とする。
Claims (13)
- 活性成分であるアセトアミノフェンと、1-乳酸ナトリウムを含む溶媒系とを含む、カプセル投与形態での使用に適合した薬剤組成物。
- 前記組成物の溶媒系がアルカリ金属酢酸塩をさらに含む、請求項1記載の薬剤組成物。
- 前記アルカリ金属酢酸塩が酢酸カリウムである、請求項2記載の薬剤組成物。
- 前記溶媒系が、ポリエチレングリコールおよびポリビニルピロリドンをさらに含む、請求項1記載の薬剤組成物。
- 少なくとも40重量%の量のアセトアミノフェン;
少なくとも4.0重量%の量のl-乳酸ナトリウム;および
少なくとも4.0重量%の量の酢酸カリウム;
を含む薬剤組成物。 - 前記アセトアミノフェンが42重量%の量で存在する、請求項5記載の薬剤組成物。
- 活性成分であるアセトアミノフェンと、1-乳酸ナトリウムを含む溶媒系とを含む、薬剤組成物を含むカプセル投与形態。
- 前記組成物の溶媒系がアルカリ金属酢酸塩をさらに含む、請求項7記載のカプセル投与形態。
- 前記アルカリ金属酢酸塩が酢酸カリウムである、請求項8記載のカプセル投与形態。
- 前記組成物の溶媒系が、ポリエチレングリコールおよびポリビニルピロリドンをさらに含む、請求項7記載のカプセル投与形態。
- 前記組成物が、以下の組成:
少なくとも40重量%の量のアセトアミノフェン;
少なくとも4.0重量%の量のl-乳酸ナトリウム;および
少なくとも4.0重量%の量の酢酸カリウム;
を含む、請求項7記載のカプセル投与形態。 - 前記アセトアミノフェンが42重量%の量で存在する、請求項11記載のカプセル投与形態。
- カプセル物質がゼラチンを含む、請求項7記載のカプセル投与形態。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/990,497 US7029698B2 (en) | 2001-11-21 | 2001-11-21 | Acetaminophen compositions |
PCT/US2002/036398 WO2003045305A2 (en) | 2001-11-21 | 2002-11-14 | Acetaminophen compositions |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2005514367A JP2005514367A (ja) | 2005-05-19 |
JP4394447B2 true JP4394447B2 (ja) | 2010-01-06 |
Family
ID=25536219
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2003546810A Expired - Lifetime JP4394447B2 (ja) | 2001-11-21 | 2002-11-14 | アセトアミノフェン組成物 |
Country Status (8)
Country | Link |
---|---|
US (1) | US7029698B2 (ja) |
EP (1) | EP1453489B1 (ja) |
JP (1) | JP4394447B2 (ja) |
AR (1) | AR042598A1 (ja) |
AU (1) | AU2002356936B2 (ja) |
CA (1) | CA2466770C (ja) |
MX (1) | MXPA04004907A (ja) |
WO (1) | WO2003045305A2 (ja) |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20060088590A1 (en) * | 2004-10-22 | 2006-04-27 | Banner Pharmacaps, Inc. | Non-blooming gelatin and non-gelatin formulations |
EP1909746B1 (en) * | 2005-08-01 | 2019-01-30 | Laboratorios Miret, S.A. | Preservative systems comprising cationic surfactants |
US8333989B2 (en) * | 2005-10-26 | 2012-12-18 | Banner Pharmacaps, Inc. | Hydrophilic vehicle-based dual controlled release matrix system |
JP2010522135A (ja) | 2006-10-09 | 2010-07-01 | チャールストン ラボラトリーズ,インコーポレイテッド | 医薬組成物 |
CA3066426A1 (en) | 2008-01-09 | 2009-07-16 | Charleston Laboratories, Inc. | Pharmaceutical compositions comprising an antiemetic and an opioid analgesic |
WO2011006012A1 (en) | 2009-07-08 | 2011-01-13 | Charleston Laboratories Inc. | Pharmaceutical compositions |
US8518438B2 (en) | 2011-01-14 | 2013-08-27 | Enspire Group, Llc | Highly concentrated liquid acetaminophen solutions |
GB201103397D0 (ja) * | 2011-02-28 | 2011-04-13 | Shire Movetis N V | |
US8969416B2 (en) | 2012-03-29 | 2015-03-03 | Enspire Group LLC | Polyvinylpyrrolidone-containing acetaminophen liquid formulations |
US10179109B2 (en) | 2016-03-04 | 2019-01-15 | Charleston Laboratories, Inc. | Pharmaceutical compositions comprising 5HT receptor agonist and antiemetic particulates |
EP3793535A1 (en) | 2018-05-16 | 2021-03-24 | Bayer Healthcare LLC | High concentration suspension formulation for cold and flu soft gel capsule medications |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US505961A (en) * | 1893-10-03 | Printing-machine | ||
US3956490A (en) | 1972-05-22 | 1976-05-11 | Interx Research Corporation | Administration of alkaline earth metal salts of salicylamide |
US4505928A (en) | 1979-06-20 | 1985-03-19 | Engelhard Corporation | Pharmaceutical composition containing cis-platinum (II) amine lactate and a method of using same |
US4786725A (en) | 1982-06-28 | 1988-11-22 | Engelhard Corporation | Solubilized platinum (II) complexes |
US6020007A (en) * | 1984-06-22 | 2000-02-01 | Btg International Limited | Fluid therapy with l-lactate and/or pyruvate anions |
US4708834A (en) * | 1986-05-01 | 1987-11-24 | Pharmacaps, Inc. | Preparation of gelatin-encapsulated controlled release composition |
US5071643A (en) * | 1986-10-17 | 1991-12-10 | R. P. Scherer Corporation | Solvent system enhancing the solubility of pharmaceuticals for encapsulation |
GB9226238D0 (en) | 1992-12-16 | 1993-02-10 | Scherer Ltd R P | Encapsulation apparatus and process |
US5505961A (en) * | 1993-08-05 | 1996-04-09 | R. P. Scherer Corporation | Gelatin capsules containing a highly concentrated acetaminophen solution |
US5529923A (en) * | 1994-02-14 | 1996-06-25 | Isomeric Corporation | Flavobacterium strain |
US6160020A (en) | 1996-12-20 | 2000-12-12 | Mcneill-Ppc, Inc. | Alkali metal and alkaline-earth metal salts of acetaminophen |
JPWO2002064120A1 (ja) * | 2001-02-13 | 2004-06-10 | 大正製薬株式会社 | 内服ゲル製剤 |
-
2001
- 2001-11-21 US US09/990,497 patent/US7029698B2/en not_active Expired - Lifetime
-
2002
- 2002-11-14 AU AU2002356936A patent/AU2002356936B2/en not_active Expired
- 2002-11-14 WO PCT/US2002/036398 patent/WO2003045305A2/en active IP Right Grant
- 2002-11-14 MX MXPA04004907A patent/MXPA04004907A/es active IP Right Grant
- 2002-11-14 CA CA2466770A patent/CA2466770C/en not_active Expired - Lifetime
- 2002-11-14 AR ARP020104374A patent/AR042598A1/es not_active Application Discontinuation
- 2002-11-14 JP JP2003546810A patent/JP4394447B2/ja not_active Expired - Lifetime
- 2002-11-14 EP EP02803975A patent/EP1453489B1/en not_active Expired - Lifetime
Also Published As
Publication number | Publication date |
---|---|
AU2002356936A1 (en) | 2003-06-10 |
JP2005514367A (ja) | 2005-05-19 |
EP1453489A4 (en) | 2008-12-17 |
EP1453489B1 (en) | 2012-08-08 |
MXPA04004907A (es) | 2004-07-30 |
CA2466770C (en) | 2010-09-21 |
CA2466770A1 (en) | 2003-06-05 |
WO2003045305A2 (en) | 2003-06-05 |
WO2003045305A3 (en) | 2003-11-13 |
EP1453489A2 (en) | 2004-09-08 |
US7029698B2 (en) | 2006-04-18 |
AR042598A1 (es) | 2005-06-29 |
US20030096872A1 (en) | 2003-05-22 |
AU2002356936B2 (en) | 2007-04-26 |
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