JP2017517490A - 医療用チューインガム - Google Patents
医療用チューインガム Download PDFInfo
- Publication number
- JP2017517490A JP2017517490A JP2016561702A JP2016561702A JP2017517490A JP 2017517490 A JP2017517490 A JP 2017517490A JP 2016561702 A JP2016561702 A JP 2016561702A JP 2016561702 A JP2016561702 A JP 2016561702A JP 2017517490 A JP2017517490 A JP 2017517490A
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- JP
- Japan
- Prior art keywords
- chewing gum
- medical
- gum
- nicotine
- weight
- 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.)
- Granted
Links
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- 229940112822 chewing gum Drugs 0.000 title claims abstract description 287
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- 239000011347 resin Substances 0.000 claims abstract description 78
- RSWGJHLUYNHPMX-UHFFFAOYSA-N Abietic-Saeure Natural products C12CCC(C(C)C)=CC2=CCC2C1(C)CCCC2(C)C(O)=O RSWGJHLUYNHPMX-UHFFFAOYSA-N 0.000 claims abstract description 58
- KHPCPRHQVVSZAH-HUOMCSJISA-N Rosin Natural products O(C/C=C/c1ccccc1)[C@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 KHPCPRHQVVSZAH-HUOMCSJISA-N 0.000 claims abstract description 58
- KHPCPRHQVVSZAH-UHFFFAOYSA-N trans-cinnamyl beta-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OCC=CC1=CC=CC=C1 KHPCPRHQVVSZAH-UHFFFAOYSA-N 0.000 claims abstract description 58
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- 239000008186 active pharmaceutical agent Substances 0.000 claims abstract description 46
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- 239000002023 wood Substances 0.000 claims abstract description 26
- 239000003784 tall oil Substances 0.000 claims abstract description 24
- 150000003097 polyterpenes Chemical class 0.000 claims abstract description 23
- SNICXCGAKADSCV-JTQLQIEISA-N (-)-Nicotine Chemical compound CN1CCC[C@H]1C1=CC=CN=C1 SNICXCGAKADSCV-JTQLQIEISA-N 0.000 claims description 106
- 229960002715 nicotine Drugs 0.000 claims description 90
- SNICXCGAKADSCV-UHFFFAOYSA-N nicotine Natural products CN1CCCC1C1=CC=CN=C1 SNICXCGAKADSCV-UHFFFAOYSA-N 0.000 claims description 90
- 239000002585 base Substances 0.000 claims description 83
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- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 18
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- URAYPUMNDPQOKB-UHFFFAOYSA-N triacetin Chemical compound CC(=O)OCC(OC(C)=O)COC(C)=O URAYPUMNDPQOKB-UHFFFAOYSA-N 0.000 claims description 10
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- 239000001788 mono and diglycerides of fatty acids Substances 0.000 claims description 7
- 239000002304 perfume Substances 0.000 claims description 7
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 claims description 6
- VHOQXEIFYTTXJU-UHFFFAOYSA-N Isobutylene-isoprene copolymer Chemical compound CC(C)=C.CC(=C)C=C VHOQXEIFYTTXJU-UHFFFAOYSA-N 0.000 claims description 6
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- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 6
- 229940069688 nicotine bitartrate Drugs 0.000 claims description 6
- LDMPZNTVIGIREC-ZGPNLCEMSA-N nicotine bitartrate Chemical compound O.O.OC(=O)[C@H](O)[C@@H](O)C(O)=O.OC(=O)[C@H](O)[C@@H](O)C(O)=O.CN1CCC[C@H]1C1=CC=CN=C1 LDMPZNTVIGIREC-ZGPNLCEMSA-N 0.000 claims description 6
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- 239000008107 starch Substances 0.000 claims description 6
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- 235000000346 sugar Nutrition 0.000 claims description 6
- 239000000454 talc Substances 0.000 claims description 6
- 229910052623 talc Inorganic materials 0.000 claims description 6
- QLDPCHZQQIASHX-UHFFFAOYSA-N 2,3-dihydroxybutanedioic acid;3-(1-methylpyrrolidin-2-yl)pyridine Chemical compound OC(=O)C(O)C(O)C(O)=O.CN1CCCC1C1=CC=CN=C1 QLDPCHZQQIASHX-UHFFFAOYSA-N 0.000 claims description 5
- AIBWPBUAKCMKNS-PPHPATTJSA-N 2-hydroxybenzoic acid;3-[(2s)-1-methylpyrrolidin-2-yl]pyridine Chemical compound OC(=O)C1=CC=CC=C1O.CN1CCC[C@H]1C1=CC=CN=C1 AIBWPBUAKCMKNS-PPHPATTJSA-N 0.000 claims description 5
- MQWJVKLIBZWVEL-XRIOVQLTSA-N 3-[(2s)-1-methylpyrrolidin-2-yl]pyridine;dihydrochloride Chemical compound Cl.Cl.CN1CCC[C@H]1C1=CC=CN=C1 MQWJVKLIBZWVEL-XRIOVQLTSA-N 0.000 claims description 5
- HDJBTCAJIMNXEW-PPHPATTJSA-N 3-[(2s)-1-methylpyrrolidin-2-yl]pyridine;hydrochloride Chemical compound Cl.CN1CCC[C@H]1C1=CC=CN=C1 HDJBTCAJIMNXEW-PPHPATTJSA-N 0.000 claims description 5
- YHBIGBYIUMCLJS-UHFFFAOYSA-N 5-fluoro-1,3-benzothiazol-2-amine Chemical compound FC1=CC=C2SC(N)=NC2=C1 YHBIGBYIUMCLJS-UHFFFAOYSA-N 0.000 claims description 5
- RGHNJXZEOKUKBD-SQOUGZDYSA-N D-gluconic acid Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C(O)=O RGHNJXZEOKUKBD-SQOUGZDYSA-N 0.000 claims description 5
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 5
- 239000002174 Styrene-butadiene Substances 0.000 claims description 5
- 150000001413 amino acids Chemical class 0.000 claims description 5
- 239000001087 glyceryl triacetate Substances 0.000 claims description 5
- 235000013773 glyceryl triacetate Nutrition 0.000 claims description 5
- 239000008123 high-intensity sweetener Substances 0.000 claims description 5
- 239000004200 microcrystalline wax Substances 0.000 claims description 5
- 235000019808 microcrystalline wax Nutrition 0.000 claims description 5
- 235000013615 non-nutritive sweetener Nutrition 0.000 claims description 5
- 229960002622 triacetin Drugs 0.000 claims description 5
- FGAFEHZTRRYNDF-UHFFFAOYSA-L zinc;3-(1-methylpyrrolidin-2-yl)pyridine;dichloride Chemical compound [Cl-].[Cl-].[Zn+2].CN1CCCC1C1=CC=CN=C1 FGAFEHZTRRYNDF-UHFFFAOYSA-L 0.000 claims description 5
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 claims description 4
- 239000005995 Aluminium silicate Substances 0.000 claims description 4
- 235000012211 aluminium silicate Nutrition 0.000 claims description 4
- 239000004927 clay Substances 0.000 claims description 4
- HNPSIPDUKPIQMN-UHFFFAOYSA-N dioxosilane;oxo(oxoalumanyloxy)alumane Chemical group O=[Si]=O.O=[Al]O[Al]=O HNPSIPDUKPIQMN-UHFFFAOYSA-N 0.000 claims description 4
- 239000000835 fiber Substances 0.000 claims description 4
- 239000012458 free base Substances 0.000 claims description 4
- NLYAJNPCOHFWQQ-UHFFFAOYSA-N kaolin Chemical compound O.O.O=[Al]O[Si](=O)O[Si](=O)O[Al]=O NLYAJNPCOHFWQQ-UHFFFAOYSA-N 0.000 claims description 4
- ZLNQQNXFFQJAID-UHFFFAOYSA-L magnesium carbonate Chemical compound [Mg+2].[O-]C([O-])=O ZLNQQNXFFQJAID-UHFFFAOYSA-L 0.000 claims description 4
- 239000001095 magnesium carbonate Substances 0.000 claims description 4
- 229910000021 magnesium carbonate Inorganic materials 0.000 claims description 4
- HCWCAKKEBCNQJP-UHFFFAOYSA-N magnesium orthosilicate Chemical compound [Mg+2].[Mg+2].[O-][Si]([O-])([O-])[O-] HCWCAKKEBCNQJP-UHFFFAOYSA-N 0.000 claims description 4
- 239000000391 magnesium silicate Substances 0.000 claims description 4
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- QORWJWZARLRLPR-UHFFFAOYSA-H tricalcium bis(phosphate) Chemical compound [Ca+2].[Ca+2].[Ca+2].[O-]P([O-])([O-])=O.[O-]P([O-])([O-])=O QORWJWZARLRLPR-UHFFFAOYSA-H 0.000 claims description 4
- 229910000391 tricalcium phosphate Inorganic materials 0.000 claims description 4
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 claims description 3
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Abstract
Description
上記ガムベースポリマーがポリ酢酸ビニルとラウリン酸ビニル−酢酸ビニルコポリマーとを90重量%を超える量で含み、
上記ガムベースポリマーが20重量%〜95重量%のポリ酢酸ビニルと5重量%〜80重量%のラウリン酸ビニル−酢酸ビニルコポリマーとを含み、
該チューインガムがポリテルペン樹脂、及びガムロジン、ウッドロジン又はトール油樹脂ベースの樹脂を含有しない、医療用チューインガムに関する。
上記ガムベースポリマーが合成ガムベースポリマーからなり、
上記ガムベースポリマーがポリ酢酸ビニルとラウリン酸ビニル−酢酸ビニルコポリマーとを90重量%を超える量で含み、
上記ガムベースポリマーが20重量%〜95重量%のポリ酢酸ビニルと5重量%〜80重量%のラウリン酸ビニル−酢酸ビニルコポリマーとを含み、
上記チューインガムがポリテルペン樹脂、及びガムロジン、ウッドロジン又はトール油樹脂ベースの樹脂を含有しない。
上記ガムベースポリマーがポリ酢酸ビニルとラウリン酸ビニル−酢酸ビニルコポリマーとを90重量%を超える量で含み、
上記ガムベースポリマーが20重量%〜95重量%のポリ酢酸ビニルと5重量%〜80重量%のラウリン酸ビニル−酢酸ビニルコポリマーとを含み、
上記チューインガムがポリテルペン樹脂、及びガムロジン、ウッドロジン又はトール油樹脂ベースの樹脂を含有しない。
上記ガムベースポリマーが合成ガムベースポリマーからなり、
上記ガムベースポリマーがポリ酢酸ビニルとラウリン酸ビニル−酢酸ビニルコポリマーとを90重量%を超える量で含み、
上記ガムベースポリマーが20重量%〜95重量%のポリ酢酸ビニルと5重量%〜80重量%のラウリン酸ビニル−酢酸ビニルコポリマーとを含み、
上記チューインガムがポリテルペン樹脂、及びガムロジン、ウッドロジン又はトール油樹脂ベースの樹脂を含有しない。
上記ガムベースポリマーがポリ酢酸ビニルとラウリン酸ビニル−酢酸ビニルコポリマーとを90重量%を超える量で含み、
上記ガムベースポリマーが20重量%〜95重量%のポリ酢酸ビニルと5重量%〜80重量%のラウリン酸ビニル−酢酸ビニルコポリマーとを含み、
該チューインガムがポリテルペン樹脂、及びガムロジン、ウッドロジン又はトール油樹脂ベースの樹脂を含有しない、チューインガムに関する。
上記ガムベースポリマーがポリ酢酸ビニルとラウリン酸ビニル−酢酸ビニルコポリマーとを90重量%を超える量で含み、
上記ガムベースポリマーが20重量%〜95重量%のポリ酢酸ビニルと5重量%〜80重量%のラウリン酸ビニル−酢酸ビニルコポリマーとを含み、
チューインガムベースがポリテルペン樹脂、及びガムロジン、ウッドロジン又はトール油樹脂ベースの樹脂を含有しない、チューインガムに関する。
本明細書で使用される場合、「チューインガム」という語句は押出チューインガム、フィリング入り(centre-filled)チューインガム、タフィー様(toffee-imitating)チューインガム又は圧縮チューインガム、スラブ又はスティック等の任意のチューインガムを意味する。
本発明によると、緩衝剤が医療用チューインガムに添加される。
ガムベースの組成
10個の異なるガムベース(GB;GB番号101〜110を付けた)を以下のプロセスによって調製した。
ニコチンチューインガムの組成
表1のガムベース番号101〜110を用いるニコチンチューインガム(NCG;CHG番号1001〜1010を付けた)をそれぞれ以下のように調製した。
実施例2のチューインガムXI、XII、XIV、XV及びΧIΧからの放出の評価
下記表3に実施例2のチューインガムXI、XII、XIV、XV及びXIX(実施例1のガムベースI、II、IV、V及びIXに対応する)のAPI放出(本実施例におけるニコチンの放出)を示す。
実施例2のチューインガムXI、XII、XIV、XV及びXIXのテクスチャの評価
下記表4に実施例2のチューインガムXI、XII、XIV、XV及びXIX(実施例1のガムベースI、II、IV、V及びIXに対応する)のテクスチャ評価を示す。
実施例2のニコチンチューインガムXV、XVI、XVII、XVIII及びXIXの灼熱感発現の評価
灼熱感の発現を5人の訓練を受けた者の試験パネルによって評価した。訓練を受けた者はサンプルを1分当たり60回の咀嚼という速度で咀嚼し、各サンプルを灼熱感の発現について記録した。
実施例2のニコチンチューインガムXV、XVI、XVIII及びXIXからのニコチン放出の評価
下記表6に実施例2のチューインガムXV、XVI、XVIII及びXIX(実施例1のガムベースV、VI、VIII及びIXに対応する)、並びに天然樹脂、エラストマーを含み、酢酸ビニル−ラウリン酸ビニルコポリマーを含まない標準ガムベースをベースとするチューインガムのAPI放出(本実施例におけるニコチンの放出)を示す。
実施例2のニコチンチューインガムXV、XVI、XVII、XVIII及びXIXのテクスチャの評価
下記表7に実施例2のチューインガムXV、XVI、XVII、XVIII及びXIX(実施例1のガムベースV、VI、VII、VIII及びIXに対応する)、並びに標準ガムベースXをベースとするチューインガムXXのテクスチャを示す。
実施例2のニコチンチューインガムXIIIからのニコチン放出の評価
下記表8に実施例2のチューインガムXIII(実施例1のガムベースIIIに対応する)、並びに天然樹脂、エラストマーを含み、酢酸ビニル−ラウリン酸ビニルコポリマーを含まない標準ガムベースXをベースとするチューインガムXXのAPI放出(本実施例におけるニコチンの放出)を示す。
実施例2のニコチンチューインガムXVIIIからのニコチン放出の評価
下記表9に実施例2のチューインガムXVIII(実施例1のガムベースVIIIに対応する)、並びに天然樹脂、エラストマーを含み、酢酸ビニル−ラウリン酸ビニルコポリマーを含まない標準ガムベースXXをベースとするチューインガムXXのAPI放出(本実施例におけるニコチンの放出)を示す。
Claims (62)
- ガムベースポリマーと医薬品有効成分とを含む医療用チューインガムであって、
前記ガムベースポリマーがポリ酢酸ビニルとラウリン酸ビニル−酢酸ビニルコポリマーとを90重量%を超える量で含み、
前記ガムベースポリマーが20重量%〜95重量%のポリ酢酸ビニルと5重量%〜80重量%のラウリン酸ビニル−酢酸ビニルコポリマーとを含み、
該チューインガムがポリテルペン樹脂、及びガムロジン、ウッドロジン又はトール油樹脂ベースの樹脂を含有しない、医療用チューインガム。 - 前記医療用チューインガムがガムベースポリマーと医薬品有効成分とを含み、
前記ガムベースポリマーが合成ガムベースポリマーからなり、
前記ガムベースポリマーがポリ酢酸ビニルとラウリン酸ビニル−酢酸ビニルコポリマーとを90重量%を超える量で含み、
前記ガムベースポリマーが20重量%〜95重量%のポリ酢酸ビニルと5重量%〜80重量%のラウリン酸ビニル−酢酸ビニルコポリマーとを含み、
前記チューインガムがポリテルペン樹脂、及びガムロジン、ウッドロジン又はトール油樹脂ベースの樹脂を含有しない、請求項1に記載の医療用チューインガム。 - 前記医療用チューインガムがガムベースポリマーと、医薬品有効成分と、緩衝剤とを含み、
前記ガムベースポリマーがポリ酢酸ビニルとラウリン酸ビニル−酢酸ビニルコポリマーとを90重量%を超える量で含み、
前記ガムベースポリマーが20重量%〜95重量%のポリ酢酸ビニルと5重量%〜80重量%のラウリン酸ビニル−酢酸ビニルコポリマーとを含み、
前記チューインガムがポリテルペン樹脂、及びガムロジン、ウッドロジン又はトール油樹脂ベースの樹脂を含有しない、請求項1又は2に記載の医療用チューインガム。 - 前記医療用チューインガムがガムベースポリマーと、医薬品有効成分と、緩衝剤とを含み、
前記ガムベースポリマーが合成ガムベースポリマーからなり、
前記ガムベースポリマーがポリ酢酸ビニルとラウリン酸ビニル−酢酸ビニルコポリマーとを90重量%を超える量で含み、
前記ガムベースポリマーが20重量%〜95重量%のポリ酢酸ビニルと5重量%〜80重量%のラウリン酸ビニル−酢酸ビニルコポリマーとを含み、
前記チューインガムがポリテルペン樹脂、及びガムロジン、ウッドロジン又はトール油樹脂ベースの樹脂を含有しない、請求項1〜3のいずれか一項に記載の医療用チューインガム。 - 前記医薬品有効成分がニコチンである、請求項1〜4のいずれか一項に記載の医療用チューインガム。
- ニコチンが0.5mg〜8mg、好ましくは1mg〜5mg、例えば2mg又は4mgの量で存在する、請求項5に記載の医療用チューインガム。
- ニコチンがニコチン塩、ニコチンの遊離塩基形態、ニコチン誘導体、例えばニコチン陽イオン交換体、例えばニコチンポラクリレックス樹脂、ニコチン包接錯体、又は任意の非共有結合状態のニコチン、ゼオライトに結合したニコチン、微結晶質等のセルロース若しくはデンプンミクロスフェアに結合したニコチン、及びそれらの混合物からなる群から選択される、請求項5又は6に記載の医療用チューインガム。
- 前記ニコチン塩がニコチン塩酸塩、ニコチン二塩酸塩、一酒石酸ニコチン、重酒石酸ニコチン、硫酸ニコチン、ニコチン塩化亜鉛、サリチル酸ニコチン又はそれらの任意の組合せを含む群から選択される、請求項5〜7のいずれか一項に記載の医療用チューインガム。
- ニコチンがニコチンポラクリレックス樹脂として存在する、請求項5又は6に記載の医療用チューインガム。
- ニコチンをタバコ粉末として前記チューインガムに添加する、請求項5又は6に記載の医療用チューインガム。
- 前記ニコチンの少なくとも一部がタバコ粉末中に含有される、請求項5〜8のいずれか一項に記載の医療用チューインガム。
- ポリ酢酸ビニルとラウリン酸ビニル−酢酸ビニルコポリマーとの重量比が8:1〜2:3である、請求項1〜11に記載の医療用チューインガム。
- ポリ酢酸ビニルとラウリン酸ビニル−酢酸ビニルコポリマーとの重量比が5:1〜2:3である、請求項1〜12のいずれか一項に記載の医療用チューインガム。
- ポリ酢酸ビニルとラウリン酸ビニル−酢酸ビニルコポリマーとの重量比が3:2〜2:3である、請求項1〜13のいずれか一項に記載の医療用チューインガム。
- ラウリン酸ビニル−酢酸ビニルコポリマーの酢酸ビニルモノマーとラウリン酸ビニル−酢酸ビニルコポリマーのラウリン酸ビニルモノマーとの重量比が90:10未満、例えば80:20、例えば60:40である、請求項1〜14のいずれか一項に記載の医療用チューインガム。
- ポリ酢酸ビニルの重量平均分子量Mwが5000〜120000、例えば5000〜70000、例えば7000〜25000であり、酢酸ビニル−ラウリン酸ビニルコポリマーの重量平均分子量Mwが80000〜700000、例えば100000〜600000、例えば120000〜250000である、請求項1〜15のいずれか一項に記載の医療用チューインガム。
- ポリ酢酸ビニルの重量平均分子量Mwが5000〜120000、例えば5000〜70000、例えば7000〜25000である、請求項1〜15のいずれか一項に記載の医療用チューインガム。
- 酢酸ビニル−ラウリン酸ビニルコポリマーの重量平均分子量Mwが80000〜700000、例えば100000〜600000、例えば120000〜250000である、請求項1〜15のいずれか一項に記載の医療用チューインガム。
- 可塑剤を含む、請求項1〜18のいずれか一項に記載の医療用チューインガム。
- 蝋を含む、請求項1〜19のいずれか一項に記載の医療用チューインガム。
- 脂肪を含む、請求項1〜20のいずれか一項に記載の医療用チューインガム。
- 乳化剤を含む、請求項1〜21のいずれか一項に記載の医療用チューインガム。
- 1つ又は複数の充填剤を含む、請求項1〜22のいずれか一項に記載の医療用チューインガム。
- 前記合成ガムベースポリマーが一部を形成するガムベースを有する、請求項1〜23のいずれか一項に記載の医療用チューインガム。
- 前記ガムベースが15重量%〜45重量%のポリ酢酸ビニル、10重量%〜30重量%のラウリン酸ビニル−酢酸ビニルコポリマー、15重量%〜45重量%の充填剤、5重量%〜30重量%の蝋又は脂肪、1重量%〜10重量%の可塑剤及び1重量%〜10重量%の乳化剤を含む、請求項24に記載の医療用チューインガム。
- 前記ガムベースが20重量%〜35重量%のポリ酢酸ビニル、12重量%〜25重量%のラウリン酸ビニル−酢酸ビニルコポリマー、20重量%〜30重量%の充填剤、10重量%〜20重量%の蝋又は脂肪、2重量%〜8重量%の可塑剤、及び2重量%〜8重量%の乳化剤を含む、請求項25に記載の医療用チューインガム。
- 前記緩衝剤が前記チューインガムの0.5重量%〜5重量%、例えば1%〜4%、例えば2%〜5%、例えば3%〜5%、例えば3%〜4%、例えば1%〜3%の量で存在する、請求項1〜26のいずれか一項に記載の医療用チューインガム。
- 前記緩衝剤がアルカリ金属、例えばカリウム又はナトリウムの重炭酸塩若しくはセスキ炭酸塩を含む炭酸塩、グリセリン酸塩、リン酸塩、グリセロリン酸塩、酢酸塩、グリコン酸塩又はクエン酸塩、例えばクエン酸三ナトリウム及びクエン酸三カリウム、又はアンモニウム、トリス緩衝剤、アミノ酸、並びにそれらの混合物からなる群から選択される、請求項1〜27のいずれか一項に記載の医療用チューインガム。
- 前記緩衝剤が炭酸ナトリウム、重炭酸ナトリウム又はそれらの任意の組合せを含む、請求項1〜28のいずれか一項に記載の医療用チューインガム。
- 前記ガムベースポリマーがスチレン−ブタジエンコポリマー(SBR)、ポリイソブチレン、イソブチレン−イソプレンコポリマー、ポリエチレン、ポリウレタン又はそれらの任意の組合せからなる群から選択される1つ又は複数のエラストマーを更に含む、請求項1〜29のいずれか一項に記載の医療用チューインガム。
- 前記ガムベースポリマーが0.1重量%〜10重量%の量、例えば1重量%〜8重量%の量、例えば1.5重量%〜6重量%の量の1つ又は複数のエラストマーを更に含む、請求項1〜30のいずれか一項に記載の医療用チューインガム。
- 前記チューインガムの0.1重量%〜25重量%、例えば該チューインガムの1重量%〜10重量%、例えば該チューインガムの2重量%〜8重量%の量の乳化剤を含む、請求項22〜31のいずれか一項に記載の医療用チューインガム。
- 前記乳化剤がアセチル化モノグリセリド、モノステアリン酸グリセロール等の脂肪酸のモノグリセリド及び/又はジグリセリド、アセテム、レシチン、並びにそれらの任意の組合せの群から選択される、請求項22〜32のいずれか一項に記載の医療用チューインガム。
- 炭酸マグネシウム及び炭酸カルシウム、硫酸ナトリウム、粉砕石灰石、ケイ酸マグネシウム及びケイ酸アルミニウム等のケイ酸塩化合物、カオリン及びクレイ、酸化アルミニウム、酸化ケイ素、タルク、酸化チタン、リン酸一カルシウム、リン酸二カルシウム及びリン酸三カルシウム、木材等のセルロースポリマー、デンプンポリマー、繊維、並びにそれらの組合せを含む1つ又は複数の充填剤を含む、請求項23〜33のいずれか一項に記載の医療用チューインガム。
- 前記充填剤が炭酸カルシウム、タルク、セルロースポリマー又はそれらの組合せである、請求項23〜34のいずれか一項に記載の医療用チューインガム。
- 前記充填剤が前記チューインガムの5重量%〜45重量%の量、例えば該チューインガムの10重量%〜40重量%の量で存在する、請求項23〜35のいずれか一項に記載の医療用チューインガム。
- 前記可塑剤がジアセチン及び/又はトリアセチンを含む、請求項19〜36のいずれか一項に記載の医療用チューインガム。
- 前記可塑剤がグリセロール及び/又は中鎖トリグリセリドを含む、請求項19〜36のいずれか一項に記載の医療用チューインガム。
- 前記蝋がパラフィン蝋、微結晶蝋、ポリエチレン蝋及び天然蝋からなる群から選択される、請求項20〜38のいずれか一項に記載の医療用チューインガム。
- 前記脂肪が動物性脂肪及び植物性脂肪からなる群から選択される、請求項21〜39のいずれか一項に記載の医療用チューインガム。
- 前記チューインガムの0.01重量%〜10重量%の量、例えば該チューインガムの0.01重量%〜5重量%の量の香料を含む、請求項1〜40のいずれか一項に記載の医療用チューインガム。
- 高甘味度甘味料を含む、請求項1〜41のいずれか一項に記載の医療用チューインガム。
- 糖及び/又は無糖成分を含むバルク甘味料を含む、請求項1〜42のいずれか一項に記載の医療用チューインガム。
- 前記チューインガムの5重量%〜約95重量%、より典型的には該チューインガムの20重量%〜約80重量%、より一般的には30重量%〜60重量%の量のバルク甘味料を含む、請求項1〜43のいずれか一項に記載の医療用チューインガム。
- 前記合成ガムベースポリマーが樹脂及びエラストマーである、請求項1〜44のいずれか一項に記載の医療用チューインガム。
- 酸化防止剤を含まない、請求項1〜45のいずれか一項に記載の医療用チューインガム。
- 任意に適用されるいずれかのコーティングの前に前記チューインガムの30重量%〜75重量%、例えば該チューインガムの35重量%〜70重量%、又は該チューインガムの40重量%〜65重量%、又は該チューインガムの45重量%〜60重量%の量のガムベースを含む、請求項1〜46のいずれか一項に記載の医療用チューインガム。
- 前記チューインガムが二工程プロセスで製造され、第1の工程が第1の混合プロセスにおいてガムベースを準備するプロセスを含み、更なる工程がガムベースと更なるチューインガム成分とを更なる混合プロセスにおいて混合するプロセスを含む、請求項1〜47のいずれか一項に記載の医療用チューインガム。
- 押出機を用いる一工程プロセスで製造される、請求項1〜48のいずれか一項に記載の医療用チューインガム。
- 1.2未満、例えば1.1未満、例えば1.0未満のtan(δ)を有する、請求項1〜49のいずれか一項に記載の医療用チューインガム。
- 前記医療用チューインガムが1.2未満、例えば1.1未満、例えば1.0未満のtanδを有し、該tan(δ)がおよそ1Hzの振動周波数で測定される、請求項1〜50のいずれか一項に記載の医療用チューインガム。
- 前記医療用チューインガムが1.2未満、例えば1.1未満、例えば1.0未満のtanδを有し、該tan(δ)がおよそ1Hzの振動周波数で測定され、該tanδが約8μN・m〜12μN・mの振動トルクで測定される、請求項1〜51のいずれか一項に記載の医療用チューインガム。
- 前記医療用チューインガムが1.2未満、例えば1.1未満、例えば1.0未満のtanδを有し、該tan(δ)がおよそ1Hzの振動周波数で測定され、該tanδが約8μN・m〜12μN・mの振動トルクで測定され、該tanδがTA Instruments製のAR 1000レオメータにより37℃の温度で測定される、請求項1〜52のいずれか一項に記載の医療用チューインガム。
- 前記医療用チューインガムが1.2未満、例えば1.1未満、例えば1.0未満のtanδを有し、該tan(δ)がおよそ1Hzの振動周波数で測定され、該tanδが線形粘弾性応答(LVR)をもたらす振動トルクで測定される、請求項1〜51のいずれか一項に記載の医療用チューインガム。
- 前記医療用チューインガムが1.2未満、例えば1.1未満、例えば1.0未満のtanδを有し、該tan(δ)がおよそ1Hzの振動周波数で測定され、該tanδが線形粘弾性応答(LVR)をもたらす振動トルクで測定され、該tanδがTA Instruments製のAR 1000レオメータにより37℃の温度で測定される、請求項1〜51のいずれか一項に記載の医療用チューインガム。
- 前記tan(δ)が(損失弾性率G’’/貯蔵弾性率G’)として規定される、請求項50〜56のいずれか一項に記載の医療用チューインガム。
- 前記ガムベースポリマーが合成ガムベースポリマーからなるか、又は該ガムベースポリマーが天然ガムベースポリマー及び合成ガムベースポリマーを含む、請求項1〜57のいずれか一項に記載の医療用チューインガム。
- 前記ガムベースポリマーが1重量%未満、好ましくは0.5重量%未満、より好ましくは0.2重量%未満、最も好ましくは0.1重量%未満の量の天然ガムベースポリマーを含む、請求項1〜557のいずれか一項に記載の医療用チューインガム。
- ガムベースポリマーと医薬品有効成分とを含むチューインガムであって、
前記ガムベースポリマーがポリ酢酸ビニルとラウリン酸ビニル−酢酸ビニルコポリマーとを90重量%を超える量で含み、
前記ガムベースポリマーが20重量%〜95重量%のポリ酢酸ビニルと5重量%〜80重量%のラウリン酸ビニル−酢酸ビニルコポリマーとを含み、
該チューインガムがポリテルペン樹脂、及びガムロジン、ウッドロジン又はトール油樹脂ベースの樹脂を含有しない、チューインガム。 - 請求項60及び請求項1〜59のいずれか一項に記載のチューインガム。
- ガムベースポリマーと医薬品有効成分とを含むチューインガムであって、
前記ガムベースポリマーがポリ酢酸ビニルとラウリン酸ビニル−酢酸ビニルコポリマーとを90重量%を超える量で含み、
前記ガムベースポリマーが20重量%〜95重量%のポリ酢酸ビニルと5重量%〜80重量%のラウリン酸ビニル−酢酸ビニルコポリマーとを含み、
該チューインガムベースがポリテルペン樹脂、及びガムロジン、ウッドロジン又はトール油樹脂ベースの樹脂を含有しない、チューインガム。 - 請求項62及び請求項1〜61のいずれか一項に記載のチューインガム。
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US10426726B2 (en) | 2019-10-01 |
EP3129011A1 (en) | 2017-02-15 |
JP6682450B2 (ja) | 2020-04-15 |
CN106456560A (zh) | 2017-02-22 |
EP3129011B1 (en) | 2023-06-07 |
CN106456560B (zh) | 2021-04-06 |
ES2948672T3 (es) | 2023-09-15 |
WO2015154780A1 (en) | 2015-10-15 |
EP3129011C0 (en) | 2023-06-07 |
US20170020812A1 (en) | 2017-01-26 |
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