JP5038477B2 - 経口溶解性フィルム - Google Patents
経口溶解性フィルム Download PDFInfo
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- 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
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
-
- 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
- A61K31/4427—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems
- A61K31/4439—Non condensed pyridines; Hydrogenated derivatives thereof containing further heterocyclic ring systems containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole
-
- 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
- A61K31/465—Nicotine; Derivatives thereof
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/716—Glucans
- A61K31/724—Cyclodextrins
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K9/0012—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
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7007—Drug-containing films, membranes or sheets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/02—Stomatological preparations, e.g. drugs for caries, aphtae, periodontitis
-
- 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
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
-
- 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
- A61P25/30—Drugs for disorders of the nervous system for treating abuse or dependence
- A61P25/34—Tobacco-abuse
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P39/00—General protective or antinoxious agents
- A61P39/02—Antidotes
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Neurosurgery (AREA)
- Addiction (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Inorganic Chemistry (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Psychiatry (AREA)
- Toxicology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicines Containing Plant Substances (AREA)
- Cosmetics (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
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。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US48985503P | 2003-07-24 | 2003-07-24 | |
US60/489,855 | 2003-07-24 |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2006521266A Division JP2006528636A (ja) | 2003-07-24 | 2004-07-22 | 経口溶解性フィルム |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2011172951A Division JP5572133B2 (ja) | 2003-07-24 | 2011-08-08 | 経口溶解性フィルム |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2011037879A JP2011037879A (ja) | 2011-02-24 |
JP5038477B2 true JP5038477B2 (ja) | 2012-10-03 |
Family
ID=34102944
Family Applications (4)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2006521266A Pending JP2006528636A (ja) | 2003-07-24 | 2004-07-22 | 経口溶解性フィルム |
JP2010040716A Active JP5378270B2 (ja) | 2003-07-24 | 2010-02-25 | 経口溶解性フィルム |
JP2010228787A Active JP5038477B2 (ja) | 2003-07-24 | 2010-10-08 | 経口溶解性フィルム |
JP2011172951A Active JP5572133B2 (ja) | 2003-07-24 | 2011-08-08 | 経口溶解性フィルム |
Family Applications Before (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2006521266A Pending JP2006528636A (ja) | 2003-07-24 | 2004-07-22 | 経口溶解性フィルム |
JP2010040716A Active JP5378270B2 (ja) | 2003-07-24 | 2010-02-25 | 経口溶解性フィルム |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2011172951A Active JP5572133B2 (ja) | 2003-07-24 | 2011-08-08 | 経口溶解性フィルム |
Country Status (24)
Country | Link |
---|---|
US (1) | US9675548B2 (ja) |
EP (2) | EP2446881B1 (ja) |
JP (4) | JP2006528636A (ja) |
CN (1) | CN100508976C (ja) |
AR (1) | AR045076A1 (ja) |
AU (2) | AU2004259006B2 (ja) |
BR (1) | BRPI0412752B8 (ja) |
CA (1) | CA2533577C (ja) |
CL (2) | CL2008002406A1 (ja) |
DK (2) | DK2446881T3 (ja) |
ES (2) | ES2466943T3 (ja) |
HK (1) | HK1169802A1 (ja) |
HR (1) | HRP20171944T1 (ja) |
HU (1) | HUE037508T2 (ja) |
LT (1) | LT1648421T (ja) |
MX (1) | MXPA06000852A (ja) |
PE (1) | PE20050496A1 (ja) |
PL (2) | PL2446881T3 (ja) |
PT (2) | PT1648421T (ja) |
RU (2) | RU2351315C2 (ja) |
SI (1) | SI1648421T1 (ja) |
TW (1) | TW200514579A (ja) |
UY (1) | UY28431A1 (ja) |
WO (1) | WO2005009386A2 (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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 |
Families Citing this family (106)
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US8627828B2 (en) * | 2003-11-07 | 2014-01-14 | U.S. Smokeless Tobacco Company Llc | Tobacco compositions |
JP4931596B2 (ja) | 2003-11-07 | 2012-05-16 | ユーエス スモークレス タバコ カンパニー リミテッド ライアビリティ カンパニー | タバコ組成物 |
DE102005033943A1 (de) * | 2005-07-20 | 2007-02-22 | Hexal Ag | Nicht-ausspuckbarer, oraler, schnell-zerfallender Film für ein Neuroleptikum |
DE102005058569B4 (de) * | 2005-12-08 | 2010-07-15 | Lts Lohmann Therapie-Systeme Ag | Schaumwafer mit Polyvinylalkohol-Polyethylenglycol-Pfropfcopolymer |
US7810507B2 (en) | 2006-02-10 | 2010-10-12 | R. J. Reynolds Tobacco Company | Smokeless tobacco composition |
EP1993509A2 (en) * | 2006-02-17 | 2008-11-26 | Novartis AG | Disintegrable oral films |
WO2008005509A2 (en) * | 2006-07-06 | 2008-01-10 | Massachusetts Institute Of Technology | Methods and compositions for altering biological surfaces |
WO2008080773A1 (de) * | 2006-12-29 | 2008-07-10 | Basf Se | Verfahren zur herstellung von festen dosierungsformen enthaltend pfropfcopolymere |
FR2912915B1 (fr) * | 2007-02-28 | 2012-11-16 | Pf Medicament | Film a desintegration rapide pour l'administration buccale de substances actives. |
CA2678876C (en) * | 2007-03-07 | 2015-11-24 | Novartis Ag | Orally administrable films |
SI2152250T1 (sl) * | 2007-05-07 | 2020-06-30 | Evonik Operations Gmbh | Trdne dozirne oblike, ki vsebujejo enterično oplaščenje s pospešenim sproščanjem zdravila |
WO2009015142A2 (en) | 2007-07-23 | 2009-01-29 | R.J.Reynolds Tobacco Company | Smokeless tobacco compositions and methods for treating tobacco for use therein |
WO2009043588A2 (en) * | 2007-10-02 | 2009-04-09 | LABTEC Gesellschaft für technologische Forschung und Entwicklung mbH | Ph regulating antibacterial films for the oral or vaginal cavity |
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JP2009102287A (ja) * | 2007-10-19 | 2009-05-14 | Seiji Sakao | 禁煙用の辛い唐辛子 |
WO2009073190A1 (en) * | 2007-12-04 | 2009-06-11 | Swedish Match North America, Inc. | Fast dissolving films and coatings for controlled release of flavors, active pharmaceutical ingredients, food substances, and nicotine |
AU2008334684A1 (en) * | 2007-12-11 | 2009-06-18 | Novartis Ag | Multi-zone films |
WO2009080021A1 (en) | 2007-12-20 | 2009-07-02 | Fertin Pharma A/S | Compressed chewing gum tablet |
WO2009080022A1 (en) * | 2007-12-20 | 2009-07-02 | Fertin Pharma A/S | Compressed chewing gum tablet |
CN102014883A (zh) * | 2008-01-31 | 2011-04-13 | 麦克内尔-Ppc股份有限公司 | 具有调释型活性成分的可食用膜条片 |
CN102014882A (zh) * | 2008-01-31 | 2011-04-13 | 麦克内尔-Ppc股份有限公司 | 即刻释放活性成分的可食用膜条片 |
US20110052699A1 (en) * | 2008-02-13 | 2011-03-03 | Adrian Funke | Drug delivery system with stabilising effect |
CN102006863A (zh) * | 2008-04-15 | 2011-04-06 | 盐野义制药株式会社 | 膜组合物 |
AU2009315898B2 (en) * | 2008-11-13 | 2015-07-23 | Nogra Pharma Limited | Antisense compositions and methods of making and using same |
EP2210595A1 (en) * | 2009-01-14 | 2010-07-28 | LEK Pharmaceuticals d.d. | Active coating of pharmaceutical dosage forms |
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