JP5038477B2 - 経口溶解性フィルム - Google Patents
経口溶解性フィルム Download PDFInfo
- Publication number
- JP5038477B2 JP5038477B2 JP2010228787A JP2010228787A JP5038477B2 JP 5038477 B2 JP5038477 B2 JP 5038477B2 JP 2010228787 A JP2010228787 A JP 2010228787A JP 2010228787 A JP2010228787 A JP 2010228787A JP 5038477 B2 JP5038477 B2 JP 5038477B2
- Authority
- JP
- Japan
- Prior art keywords
- nicotine
- film
- polymer
- active
- agent
- 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
- SNICXCGAKADSCV-JTQLQIEISA-N (-)-Nicotine Chemical compound CN1CCC[C@H]1C1=CC=CN=C1 SNICXCGAKADSCV-JTQLQIEISA-N 0.000 claims description 110
- SNICXCGAKADSCV-UHFFFAOYSA-N nicotine Natural products CN1CCCC1C1=CC=CN=C1 SNICXCGAKADSCV-UHFFFAOYSA-N 0.000 claims description 103
- 229960002715 nicotine Drugs 0.000 claims description 100
- 229920000642 polymer Polymers 0.000 claims description 51
- 239000000203 mixture Substances 0.000 claims description 48
- 238000002156 mixing Methods 0.000 claims description 9
- 230000003472 neutralizing effect Effects 0.000 claims description 8
- GDCRSXZBSIRSFR-UHFFFAOYSA-N ethyl prop-2-enoate;2-methylprop-2-enoic acid Chemical compound CC(=C)C(O)=O.CCOC(=O)C=C GDCRSXZBSIRSFR-UHFFFAOYSA-N 0.000 claims description 7
- 229920002959 polymer blend Polymers 0.000 claims description 5
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 claims description 4
- 238000005266 casting Methods 0.000 claims description 4
- 238000001035 drying Methods 0.000 claims description 2
- 229920003145 methacrylic acid copolymer Polymers 0.000 claims description 2
- 229910000030 sodium bicarbonate Inorganic materials 0.000 claims description 2
- 235000017557 sodium bicarbonate Nutrition 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims 1
- 229920006254 polymer film Polymers 0.000 claims 1
- 239000013550 soluble monolayer Substances 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
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- 206010057852 Nicotine dependence Diseases 0.000 description 28
- 239000013543 active substance Substances 0.000 description 26
- 241000208125 Nicotiana Species 0.000 description 23
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- 230000001953 sensory effect Effects 0.000 description 12
- 230000000391 smoking effect Effects 0.000 description 12
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 10
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- 238000013268 sustained release Methods 0.000 description 10
- 239000012730 sustained-release form Substances 0.000 description 10
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- 239000012729 immediate-release (IR) formulation Substances 0.000 description 9
- 239000004014 plasticizer Substances 0.000 description 9
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 8
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- 239000002356 single layer Substances 0.000 description 5
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- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 description 3
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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 description 3
- 239000013020 final formulation Substances 0.000 description 3
- UPBDXRPQPOWRKR-UHFFFAOYSA-N furan-2,5-dione;methoxyethene Chemical compound COC=C.O=C1OC(=O)C=C1 UPBDXRPQPOWRKR-UHFFFAOYSA-N 0.000 description 3
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- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 description 3
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- MXYUKLILVYORSK-HBMCJLEFSA-N (-)-lobeline Chemical compound C1([C@@H](O)C[C@H]2N([C@H](CCC2)CC(=O)C=2C=CC=CC=2)C)=CC=CC=C1 MXYUKLILVYORSK-HBMCJLEFSA-N 0.000 description 2
- 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 description 2
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- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 2
- 229920001661 Chitosan Polymers 0.000 description 2
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 2
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 2
- 229920003134 Eudragit® polymer Polymers 0.000 description 2
- 229920000084 Gum arabic Polymers 0.000 description 2
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 2
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- HSHXDCVZWHOWCS-UHFFFAOYSA-N N'-hexadecylthiophene-2-carbohydrazide Chemical compound CCCCCCCCCCCCCCCCNNC(=O)c1cccs1 HSHXDCVZWHOWCS-UHFFFAOYSA-N 0.000 description 2
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- YKPUWZUDDOIDPM-SOFGYWHQSA-N capsaicin Chemical compound COC1=CC(CNC(=O)CCCC\C=C\C(C)C)=CC=C1O YKPUWZUDDOIDPM-SOFGYWHQSA-N 0.000 description 2
- OSASVXMJTNOKOY-UHFFFAOYSA-N chlorobutanol Chemical compound CC(C)(O)C(Cl)(Cl)Cl OSASVXMJTNOKOY-UHFFFAOYSA-N 0.000 description 2
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- BNIILDVGGAEEIG-UHFFFAOYSA-L disodium hydrogen phosphate Chemical compound [Na+].[Na+].OP([O-])([O-])=O BNIILDVGGAEEIG-UHFFFAOYSA-L 0.000 description 2
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Description
本発明は、口腔内での活性剤の放出のための迅速に溶解する経口フィルム調製物に関する。一の具体例において、本発明は、良好なバッカル経由吸収を達成し、ニコチン渇望軽減を提供するニコチン・アクティブ(nicotine active)を含んでなる迅速に溶解する経口フィルムに関する。
一般に、紙巻きタバコ、葉巻およびパイプタバコなどのタバコ製品の喫煙は、深刻な健康上のリスクを使用者および間接的な喫煙に曝された人々に与えることが知られている。また、噛みタバコなどの他の形態のタバコの使用もまた、深刻な健康上のリスクを使用者にもたらすことが知られている。
PCT出願WO02/43657は、有効量の少なくとも1つのフィルム形成剤、少なくとも1つのバルク充填剤および少なくとも1つの可塑剤を含んでなるプルラン不含食用フィルム組成物を開示する。
Warner Lambert CompanyのPCT出願WO01/70194は、広く、消費者の口内に接着し、溶解するように適応させた消費可能なフィルムであって、少なくとも1つの水溶性ポリマー、少なくとも1つの活性剤および少なくとも1つの味マスキング剤を含むフィルムに関する。
別の具体例において、フィルム組成物において使用される腸溶性ポリマーは、フィルム組成物の調製の間に、予め中和される。予め中和された腸溶性ポリマーを用いる場合、最終的な処方は、ニコチン吸収の促進を助けるために、少なくとも1つの付加的なアルカリ性緩衝剤を含有する。本発明において使用されるアルカリ性中和剤および/または付加的なアルカリ性緩衝剤は、投与前に、ニコチン・アクティブと該アルカリ性緩衝剤との不利な反応を回避するために、フィルム処方内において2つの分離した成分中に配合されていてもよい。
一の具体例において、該フィルムは、ニコチン・アクティブ、中和された腸溶性ポリマーおよび可塑剤を含む第1成分、および緩衝剤および水溶性充填剤を含む第2成分を含んでなる。
これらの経口溶解性フィルム組成物は、独立型のニコチン置換療法(NRT)として、または別のニコチン置換療法と一緒にコンプライアンスを改善するのに有用である。かかる経口溶解性フィルム組成物は、迅速なニコチン渇望軽減、持続したニコチン渇望軽減、またはそれらを組み合わせたニコチン渇望軽減をそれを必要とする個体に提供するために使用することができる。
別記しないかぎり、本明細書中で使用される場合、「a」または「an」なる語は、その語で修飾された成分の1以上を包含する。
本発明は、別記しないかぎり、下記で示される成分を含んでいてもよく、該成分から構成されていてもよく、または実質的に該成分から構成されていてもよい。
適当な着色料は、食品および薬品への適用に適当ないずれかの顔料、色素、レーキまたは天然食用着色料、例えば、FD&C色素およびレーキを包含する。
本発明の溶解性フィルム処方の実例を下記する。
単層フィルムを下記の方法によって製造する。
溶液調製:
(a)オイドラギット(Eudragit)L100−55およびニコチン油を除く全ての賦形剤をヒドロアルコール/水溶液(エタノール/水 60/40)中に量り入れる。
(b)高速ミキサーを用いて、全ての固体を該ヒドロアルコール/水溶液中に溶解する。
(c)混合速度を上げ、徐々に、オイドラギットL100−55粉末を該ヒドロアルコール混合液中に加える。
(d)中和過程が完了し、もはや発泡が検出されなくなるまで混合を続ける。
(e)混合速度を下げ、オイドラギット・ヒドロアルコール溶液中にニコチン油を加える。
(f)瓶の蓋を閉め、さらなる混合および脱気のために、それをローラーミキサー上に少なくとも2時間置く。
キャスティング工程:
(a)上記の溶液を約10〜約20milのウェット膜厚(wet thickness)で、ポリエチレンキャスティングライナー上にキャストし、それを約60℃で約10分間、乾燥させる。
(b)約2〜約4milの厚さの乾燥フィルム厚が得られ、該フィルムを約2mgのニコチン単位投与量にダイカットしてもよい。
腸溶性ポリマー層:
(a)オイドラギットL100−55およびニコチン油を除く全ての賦形剤をヒドロアルコール/水溶液(エタノール/水 60/40)中に量り入れる。
(b)高速ミキサーを用いて、全ての固体を該ヒドロアルコール/水溶液中に溶解する。
(c)混合速度を上げ、徐々に、オイドラギットL100−55粉末を該ヒドロアルコール混合液中に加える。
(d)中和過程が完了し、もはや発泡が検出されなくなるまで混合を続ける。
(e)混合速度を下げ、オイドラギット・ヒドロアルコール溶液中にニコチン油を加える。
(f)瓶の蓋を閉め、さらなる混合および脱気のために、それをローラーミキサー上に少なくとも2時間置く。
第2溶液、すなわち、緩衝溶液は、アルカリ化剤を含むが、フィルム形成ポリマーを含まない。該緩衝溶液は、アルカリ化剤(リン酸二ナトリウム)、水溶性充填剤(ラクトース)、甘味料(メガスウィート)、ポリグリコール(グリセリン)、フレーバー剤(メントール)、増粘剤(シリカ)および非イオン性乳化剤(ポリソルベート80)を水中において含有する。緩衝層は、下記のように調製される。
緩衝層:
(a)シリカを除く全ての賦形剤を水中に量り入れる。
(a)高速ホモジナイザーを用いて、該混合物をホモジナイズする。
(b)該混合物を真空ミキサー容器中に移す。
(c)該混合物にシリカを加え、シリカを該分散液中に真空混合する。
(d)該分散液を蓋付き瓶に移し、使用するまで、それをローラーミキサー上に置く。
次いで、該ポリマー溶液をポリエチレンキャスティングライナー上に、約2〜約4milのウェット膜厚でキャストし、オーブン中で乾燥させる。乾燥後、透明で光沢のあるフィルムが得られる。次いで、該緩衝層を該ポリマー層の上にキャストし、次いで、オーブン中で乾燥させる。該フィルムは、室内条件で1または2日間、平衡化させるべきであり、次いで、約2mgのニコチン単位投与量にダイカットしてもよい。
Claims (1)
- (a)溶媒の存在下で重炭酸ナトリウムと混合することによって、 ポリ(エチルアクリレートメタクリル酸)コポリマーである腸溶性ポリマーを中和して、ポリマー混合物を提供し;
(b)さらに、該ポリマー混合物にニコチン油を加え;
(c)該ポリマー混合物を適当な表面上にキャストし;
(d)該ポリマー混合物を乾燥させて、ポリマーフィルムを提供する
工程を含む経口溶解性単層フィルムの形態の組成物の製造法。
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JP7361547B2 (ja) | 2019-09-10 | 2023-10-16 | 三菱電機ビルソリューションズ株式会社 | ロボットシステム |
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