JP2000016932A - Oral rapid disintegration tablet including seamless capsule - Google Patents
Oral rapid disintegration tablet including seamless capsuleInfo
- Publication number
- JP2000016932A JP2000016932A JP10181709A JP18170998A JP2000016932A JP 2000016932 A JP2000016932 A JP 2000016932A JP 10181709 A JP10181709 A JP 10181709A JP 18170998 A JP18170998 A JP 18170998A JP 2000016932 A JP2000016932 A JP 2000016932A
- Authority
- JP
- Japan
- Prior art keywords
- fat
- rapidly disintegrating
- seamless capsule
- tablet
- disintegrating tablet
- 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.)
- Pending
Links
Abstract
Description
【０００１】[0001]
【発明の属する技術分野】本発明は、シームレスカプセ
ルを含有してなる口腔内速崩壊性錠剤及びその製造方法
に関する。The present invention relates to an orally rapidly disintegrating tablet containing a seamless capsule and a method for producing the same.
【０００２】[0002]
【従来の技術】口腔内速崩壊性錠剤は、口腔内で速やか
に崩壊する錠剤であり、例えばモールド錠は口腔内速崩
壊性錠剤の一種である。この錠剤は、服用後は、噛み砕
かずとも口腔内で速やかに崩壊し、水なしでも容易に服
薬可能なため、高齢者や小児等、嚥下機能が低下し服薬
困難な患者に適した剤形として最近注目されている。か
かる錠剤については、既にいくつかの製造方法等が知ら
れている。例えば、特開平５−２７１０５４号公報には
「薬効成分と糖類と前記糖類の粒子表面が湿る程度の水
分とを含む混合物を打錠する口腔内溶解型錠剤の製造方
法」、特願平５−５１１５４３号公報には「活性成分と
乳糖および／またはマンニトールからなる糖類と寒天か
らなる口腔内崩壊性の固形製剤」、また、特開平９−４
８７２６号公報には「薬物と糖類、糖アルコール、水溶
性高分子物質からなり、加湿、成形されることによりな
る口腔内速崩壊性製剤」に関する発明が開示されてい
る。2. Description of the Related Art A rapidly disintegrating tablet in the oral cavity is a tablet that rapidly disintegrates in the oral cavity. For example, a molded tablet is a kind of a rapidly disintegrating tablet in the oral cavity. After taking this tablet, it disintegrates quickly in the mouth without chewing and can be easily taken without water, making it a dosage form suitable for elderly and children who have difficulty swallowing and have difficulty swallowing. Has recently been attracting attention. For such tablets, several production methods are already known. For example, Japanese Patent Application Laid-Open No. H5-271054 discloses a "method of manufacturing an orally dissolvable tablet in which a mixture containing a medicinal ingredient, a saccharide, and water enough to moisten the surface of the saccharide particles" is disclosed in Japanese Patent Application No. Hei. Japanese Patent Application Laid-Open No. 511543/1991 discloses "an orally disintegrating solid preparation comprising an active ingredient, a saccharide comprising lactose and / or mannitol, and agar".
No. 8726 discloses an invention relating to "a rapidly disintegrating preparation in the oral cavity comprising a drug and a saccharide, a sugar alcohol, and a water-soluble polymer substance, which is humidified and molded".
【０００３】[0003]
【発明が解決しようとする課題】前記の錠剤の製造法
は、いずれも、主薬が親水性薬物である場合に最適であ
るが、薬効成分が脂溶性である場合、均質な錠剤の製造
が困難であるとか、また、油状薬物が製錠後に錠剤表面
に染み出てくるとか、いくつか問題が生じていた。ま
た、特開平５−２７１０５４号公報に開示されている錠
剤は、通常の単発打錠機やロータリー打錠機等の製錠装
置により製錠されるが、これら通常の打錠機を用いて打
錠する場合、薬物を含む湿潤粉体が打錠機の臼、杵等に
張り付き、錠剤重量のばらつきが大きくなったり、錠剤
表面が荒くなる等の問題を生じ、最悪の場合は打錠機の
破壊に至ることもあり得ることから、錠剤の製造方法と
して優れたものではない。速崩壊性錠剤の成形方法に関
しては、特開平８−１９５８９号公報に、「湿潤粉体を
錠剤成形用の穴に充填し、前記穴の中の湿潤粉体の少な
くとも一方の面を張り付き防止フィルムを介して成形用
金型により錠剤の形に成形することを含む錠剤製造方
法」及びその錠剤製造装置に関する発明が開示されてい
る。All of the above-mentioned methods for producing tablets are optimal when the main drug is a hydrophilic drug, but it is difficult to produce uniform tablets when the active ingredient is fat-soluble. And some problems have arisen, such as oily drugs oozing out on the tablet surface after tableting. The tablet disclosed in Japanese Patent Application Laid-Open No. 5-27054 is manufactured by a conventional tableting device such as a single-shot tableting machine or a rotary tableting machine. In the case of tableting, the wet powder containing the drug sticks to the mortar, punch, etc. of the tableting machine, causing problems such as a large variation in tablet weight and a rough surface of the tablet. It is not an excellent method for producing tablets because it may be broken. With respect to the method of forming a rapidly disintegrating tablet, JP-A-8-19589 discloses that “a wet powder is filled in a hole for tablet molding, and at least one surface of the wet powder in the hole is an anti-sticking film. And a tablet manufacturing apparatus including a method for manufacturing a tablet including forming a tablet into a tablet shape by using a forming mold via a mold.
【０００４】その他、特開平６−２１８０２８号公報に
は、脂溶性薬物を直接に糖類、賦形剤等と混合し、水及
び／又は有機溶媒を添加して練合し、鋳型に充填して圧
縮して成形する湿製錠の製造方法に関する発明が開示さ
れているが、有機溶媒の濃度が高くなると混練合中に脂
溶性薬物が有機溶媒に溶解してしまうため、錠剤の硬度
が高くなったり口腔内崩壊時間が遅延しやすい。また、
これも薬物を直接錠剤に配合する方法であり、油状の薬
物の製剤に適しているとは言い難い。[0004] In addition, JP-A-6-218028 discloses that a fat-soluble drug is directly mixed with saccharides, excipients, etc., kneaded by adding water and / or an organic solvent, and filled in a mold. Although an invention relating to a method for manufacturing a wet tablet that is compressed and molded is disclosed, the fat-soluble drug is dissolved in the organic solvent during kneading and kneading when the concentration of the organic solvent is high, so that the hardness of the tablet increases. Or disintegration time in the oral cavity is easily delayed. Also,
This is also a method of directly compounding a drug into a tablet, and it is hard to say that it is suitable for the preparation of an oily drug.
【０００５】[0005]
【課題を解決するための手段】本発明者らは、脂溶性薬
物を含有する口腔内速崩壊性錠剤の製造方法を確立する
ことを目的に、鋭意検討を重ねた結果、以下のように本
発明を完成するに至った。すなわち、本発明は、脂溶性
薬物が充填されたシームレスカプセルと糖類とを含有し
てなる口腔内速崩壊性錠剤であり、また本発明は、脂溶
性薬物が充填されたシームレスカプセルと糖類を有機溶
媒により混練合後、鋳型に充填し、フィルムを介して成
形する口腔内速崩壊性錠剤の製造方法である。シームレ
スカプセルは、液状薬物をゼラチン皮膜で覆いカプセル
化した製剤で、薬物の酸化防止に効果的である同時に、
薬物含有量の均一性、速やかな吸収性に優れることで知
られる。The present inventors have conducted intensive studies with the aim of establishing a method for producing a rapidly disintegrating tablet in the oral cavity containing a fat-soluble drug. The invention has been completed. That is, the present invention is a rapidly disintegrating tablet in the oral cavity containing a seamless capsule filled with a fat-soluble drug and a saccharide, and the present invention provides a seamless capsule filled with a fat-soluble drug and an organic saccharide. This is a method for producing a rapidly disintegrating tablet in the mouth, which is kneaded and mixed with a solvent, filled in a mold, and molded through a film. A seamless capsule is a formulation in which a liquid drug is encapsulated by covering it with a gelatin film.
It is known for its excellent drug content uniformity and rapid absorption.
【０００６】以下、本明細書に記載されている語句を説
明し、本発明を詳細に説明する。Hereinafter, the terms described in the present specification will be explained, and the present invention will be described in detail.
【０００７】本発明における口腔内速崩壊性錠剤とは、
服用後、口腔内で速やかに崩壊し、水なしでも噛み砕か
ずに服薬できる錠剤を意味する。「速やかに崩壊する」
とは、服用後通常３分以内で崩壊することを意味する。The orally rapidly disintegrating tablet in the present invention is
It means a tablet that disintegrates quickly in the oral cavity after ingestion and can be taken without chewing without water. "It collapses quickly"
Means disintegrating usually within 3 minutes after taking.
【０００８】本発明における脂溶性薬物とは、医薬とし
て許容されるあらゆる脂溶性の成分を意味する。具体的
に例えば、酢酸レチノール、パルミチン酸レチノール等
のビタミンＡ類；コレカルシフェロール、エルゴカルシ
フェロール等のビタミンＤ類；トコフェロール、コハク
酸トコフェロール、酢酸トコフェロール、ニコチン酸ト
コフェロール等のビタミンＥ類；フィトナジオン、メナ
テトレノン等のビタミンＫ類；ユビデカレノン等の補酵
素Ｑ類；テプレノン等があげられる。[0008] The fat-soluble drug in the present invention means any fat-soluble component that is pharmaceutically acceptable. Specifically, for example, vitamin A such as retinol acetate and retinol palmitate; vitamin D such as cholecalciferol and ergocalciferol; vitamin E such as tocopherol, tocopherol succinate, tocopherol acetate and tocopherol nicotinate; phytonadione; Vitamin Ks such as menatetrenone; coenzymes Q such as ubidecarenone; teprenone and the like.
【０００９】本発明における糖類とは糖及び糖アルコー
ルを意味する。糖類としては、具体的に例えば、ショ
糖、乳糖、ブドウ糖、トレハロース等があげられ、糖ア
ルコールとしては、例えば、マンニトール、エリスリト
ール、キシリトール、ソルビトール等があげられるが、
好ましくはショ糖、マンニトール、乳糖、ブドウ糖、エ
リスリトール、キシリトールであり、より好ましくはマ
ンニトール、乳糖、エリスリトール、キシリトールであ
り、さらに好ましくは、マンニトール、乳糖である。The saccharide in the present invention means sugar and sugar alcohol. Specific examples of the saccharides include sucrose, lactose, glucose, trehalose and the like, and examples of the sugar alcohols include mannitol, erythritol, xylitol, sorbitol and the like.
Preferred are sucrose, mannitol, lactose, glucose, erythritol and xylitol, more preferred are mannitol, lactose, erythritol and xylitol, and still more preferred are mannitol and lactose.
【００１０】本発明において、脂溶性薬物が充填された
シームレスカプセルは、以下に示す通常の方法により製
造することができる。すなわち、まず、ゼラチン、可塑
剤、防腐剤、色素等を水に溶解させ減圧脱泡したカプセ
ル皮膜の原料と、薬物をそのまままたは薬物を有機溶媒
に溶解したカプセル内溶液とを調製する。ここで、薬物
含有溶液の溶媒としては、例えばトリグリセリドなどを
用いることができるが、粘度の低い室温で液状の脂溶性
薬物はそのまま内容液とすることができる。次に、同じ
二重構造を有するノズルの外側のノズルから前記のカプ
セル皮膜原料を、内側のノズルから前記薬物含有溶液を
同時に滴下し、冷却媒で冷却して、シームレスカプセル
を得ることができる。本発明で用いるシームレスカプセ
ルの粒子径は０.２mm〜３.０mmであり、好ましくは０.
６mm〜２.０mm、より好ましくは０.８mm〜１.５mmであ
る。In the present invention, a seamless capsule filled with a fat-soluble drug can be produced by the following ordinary method. That is, first, a gelatin capsule, a plasticizer, a preservative, a pigment, and the like are dissolved in water to prepare a capsule film raw material which is defoamed under reduced pressure, and a solution of the drug as it is or a drug in an organic solvent is prepared. Here, as a solvent of the drug-containing solution, for example, triglyceride or the like can be used, but a fat-soluble drug that is low in viscosity and liquid at room temperature can be used as it is as a content liquid. Next, the capsule coating raw material is simultaneously dropped from the outer nozzle of the nozzle having the same double structure, and the drug-containing solution is dropped from the inner nozzle, and cooled by a cooling medium to obtain a seamless capsule. The particle diameter of the seamless capsule used in the present invention is 0.2 mm to 3.0 mm, preferably 0.2 mm.
It is 6 mm to 2.0 mm, more preferably 0.8 mm to 1.5 mm.
【００１１】本発明において、シームレスカプセルと糖
類との重合比は、０.００１〜０.７であり、好ましくは
０.００５〜０.６、より好ましくは０.０１〜０.５であ
る。In the present invention, the polymerization ratio between the seamless capsule and the saccharide is from 0.001 to 0.7, preferably from 0.005 to 0.6, and more preferably from 0.01 to 0.5.
【００１２】本発明において、脂溶性薬物の重量比は、
通常、錠剤１重量部に対し０.００３〜０.３重量部であ
り、好ましくは０.００６〜０.２８重量部、より好まし
くは０.００７〜０.２４重量部である。また、本発明に
おける糖類の重量比は、錠剤１重量部に対し、０.５７
〜０.９８重量部、好ましくは０.６０〜０.９０重量
部、より好ましくは０.６６〜０.８２重量部である。In the present invention, the weight ratio of the fat-soluble drug is
Usually, the amount is 0.003 to 0.3 part by weight, preferably 0.006 to 0.28 part by weight, more preferably 0.007 to 0.24 part by weight per part by weight of the tablet. The weight ratio of the saccharide in the present invention is 0.57 to 1 part by weight of the tablet.
0.98 parts by weight, preferably 0.60 to 0.90 parts by weight, more preferably 0.66 to 0.82 parts by weight.
【００１３】本発明における口腔内速崩壊性錠剤には、
必要に応じて結合剤を含有させることもできる。かかる
結合剤としては、例えば、ヒドロキシプロピルセルロー
ス、ヒドロキシプロピルメチルセルロース、カルボキシ
ビニルポリマー、ポリビニルアルコール、ポリビニルピ
ロリドン、メチルセルロース、アラビアゴム、デンプン
等があげられ、特にポリビニルピロリドンが好ましい。
錠剤１重量部における結合剤の重量比は０.００１〜０.
１重量部であり、所望の崩壊性、硬度等となるように適
宜増減できる。結合剤は、脂溶性薬物をシームレスカプ
セルと糖類の混合物に粉体として添加してもよいし、有
機溶媒に溶解してから添加してもよい。The orally rapidly disintegrating tablet of the present invention includes:
If necessary, a binder may be contained. Examples of such a binder include hydroxypropylcellulose, hydroxypropylmethylcellulose, carboxyvinyl polymer, polyvinyl alcohol, polyvinylpyrrolidone, methylcellulose, gum arabic, starch and the like, with polyvinylpyrrolidone being particularly preferred.
The weight ratio of the binder in 1 part by weight of the tablet is 0.001-0.1.
It is 1 part by weight, and can be appropriately increased or decreased so as to obtain desired disintegration, hardness and the like. The binder may be added as a powder to the mixture of the seamless capsule and the saccharide as the fat-soluble drug, or may be added after being dissolved in an organic solvent.
【００１４】シームレスカプセルの皮膜を構成するゼラ
チンは水により膨潤する性質を有するため、本発明にお
いて、脂溶性薬物を充填したシームレスカプセルと糖類
とを混練合する溶媒としては、有機溶媒が好ましい。か
かる有機溶媒としては、例えば、エタノール、プロパノ
ール、イソプロパノール等があげられ、好ましくはエタ
ノールである。Since gelatin constituting the shell of the seamless capsule has a property of swelling with water, an organic solvent is preferably used as a solvent for kneading and mixing the saccharide with the seamless capsule filled with the fat-soluble drug in the present invention. Such organic solvents include, for example, ethanol, propanol, isopropanol and the like, with ethanol being preferred.
【００１５】本発明における口腔内速崩壊性錠剤は、脂
溶性薬物を充填したシームレスカプセルと糖類、さらに
必要に応じて結合剤とを、有機溶媒を用いて混練合し、
いわゆるモールド錠の製造方法、即ちモールドに充填、
排出、乾燥して製造することができる。また、本発明に
かかる湿潤粉体の成形は、特開平８-１９５８９号公報
において開示されている錠剤製造装置により、容易に製
造することができる。即ち、脂溶性薬物を充填したシー
ムレスカプセルと糖類、さらに必要に応じて結合剤を有
機溶媒を用いて混練合後、当該装置の錠剤成型用の穴に
充填し、少なくとも一方の面を張り付き防止フィルムを
介して成形することにより、湿潤粉体が成型用金型等に
張り付くのを防止して、効率よく速崩壊性錠剤の製造を
実現することができる。The orally rapidly disintegrating tablet in the present invention is obtained by kneading a seamless capsule filled with a fat-soluble drug, a saccharide, and, if necessary, a binder with an organic solvent.
So-called mold tablet manufacturing method, i.e. filling the mold,
It can be manufactured by discharging and drying. Further, the molding of the wet powder according to the present invention can be easily performed by a tablet manufacturing apparatus disclosed in JP-A-8-19589. That is, a seamless capsule filled with a fat-soluble drug and a saccharide, and if necessary, a binder is kneaded and kneaded with an organic solvent, and then filled into a hole for tablet molding of the device, and at least one surface is a sticking prevention film. Thus, the wet powder can be prevented from sticking to a molding die or the like, and efficient production of a rapidly disintegrating tablet can be realized.
【００１６】本発明における口腔内速崩壊性錠剤には、
必要に応じて通常用いられる滑沢剤、着色剤、矯味矯臭
剤等を使用することができる。The orally rapidly disintegrating tablet of the present invention includes:
If necessary, lubricating agents, coloring agents, flavoring agents and the like which are usually used can be used.
【００１７】滑沢剤としては、例えばステアリン酸マグ
ネシウム、タルク、シリカ等が、着色剤としては、天然
色素、合成色素が、矯味矯臭剤としては、ココア末、ハ
ッカ脳、芳香酸、ハッカ油、龍脳、桂皮末等があげられ
る。As lubricants, for example, magnesium stearate, talc, silica and the like, as coloring agents, natural pigments and synthetic pigments, as flavoring agents, cocoa powder, peppermint brain, aromatic acid, peppermint oil, Long brain, cinnamon powder and the like.
【００１８】本発明における成形は、２〜１５０kg/cm2
程度の圧力で行うことができるが、好ましくは２〜６０
kg/cm2程度であり、より好ましくは２〜３５kg/cm2程度
である。In the present invention, the molding is performed at 2 to 150 kg / cm 2
It can be carried out at a pressure of about
It is about kg / cm 2 , more preferably about 2 to 35 kg / cm 2 .
【００１９】また、本発明における錠剤の乾燥温度は、
通常２０〜９０℃、好ましくは２５〜７５℃、より好ま
しくは３０〜６０℃である。The drying temperature of the tablet in the present invention is as follows:
Usually, it is 20 to 90 ° C, preferably 25 to 75 ° C, more preferably 30 to 60 ° C.
【００２０】以上の製造方法により得られる口腔内速崩
壊性錠剤の錠剤硬度は、通常１.５〜１５kg、より好ま
しくは２〜１０kg、さらに好ましくは３〜６kgを有す
る。また、本発明に係る口腔内速崩壊性錠剤の口中崩壊
時間は、通常０.０５〜３分であり、より好ましくは０.
１〜１分、さらに好ましくは０.１〜０.５分である。The tablet hardness of the orally rapidly disintegrating tablet obtained by the above production method is usually 1.5 to 15 kg, more preferably 2 to 10 kg, and further preferably 3 to 6 kg. Further, the disintegration time in the mouth of the orally rapidly disintegrating tablet according to the present invention is usually 0.05 to 3 minutes, and more preferably 0.5 to 3 minutes.
It is 1-1 minute, more preferably 0.1-0.5 minute.
【００２１】[0021]
【実施例】以下、実施例を示して本発明をさらに詳細に
説明するが、本発明がこれらに限定されるものでないこ
とはいうまでもない。EXAMPLES Hereinafter, the present invention will be described in more detail with reference to Examples, but it goes without saying that the present invention is not limited to these.
【００２２】実施例１口腔内速崩壊性錠剤の製造 ：酢酸ｄ-α-トコフェロール
を３５mg含有する、直径１mmのシームレスカプセル１２
０gとマンニトール１５２６.４gをスーパーミキサー（S
MV2、(株)カワタ製）で３分間混合した後、更に２０％
のポリビニルピロリドンを含有するエタノール１６８g
を添加して練合した。かかる練合物を特開平８−１９５
８９号公報に開示される錠剤製造方法に従って９.５mm
φ平型パンチで１錠２８０mgの錠剤に成形した後、４０
℃で１６時間乾燥して速崩壊性錠剤を得た。Example 1 Production of a rapidly disintegrating tablet in the oral cavity : Seamless capsule 12 having a diameter of 1 mm and containing 35 mg of d-α-tocopherol acetate
0g and 1526.4g of mannitol are mixed with a super mixer (S
MV2, manufactured by Kawata Co., Ltd.) for 3 minutes.
168 g of ethanol containing polyvinylpyrrolidone
Was added and kneaded. Such a kneaded product is disclosed in JP-A-8-195.
9.5 mm according to the tablet manufacturing method disclosed in JP-A-89.
After forming into a tablet of 280mg per tablet with φ flat type punch,
Drying at 16 ° C. for 16 hours gave a rapidly disintegrating tablet.
【００２３】実施例２ 実施例１と同様のシームレスカプセル２４０gとマンニ
トール１４０６.４gをスーパーミキサー（SMV2、(株)カ
ワタ製）で３分間混合した後、更に２０％のポリビニル
ピロリドンを含有するエタノール１６８gを添加して練
合した。かかる練合物を特開平８−１９５８９号公報に
開示される錠剤製造方法に従って９.５mmφ平型パンチ
で１錠２８０mgの錠剤に成形した後、４０℃で１６時間
乾燥して速崩壊性錠剤を得た。Example 2 240 g of seamless capsules and 1406.4 g of mannitol as in Example 1 were mixed for 3 minutes with a super mixer (SMV2, manufactured by Kawata Co., Ltd.), and then 168 g of ethanol containing 20% polyvinylpyrrolidone. Was added and kneaded. The kneaded product is formed into 280 mg tablets using a 9.5 mmφ flat punch in accordance with the tablet manufacturing method disclosed in JP-A-8-19589, and then dried at 40 ° C. for 16 hours to obtain rapidly disintegrating tablets. Obtained.
【００２４】実施例３ 実施例１と同様のシームレスカプセル４８０gとマンニ
トール１１６６.４gをスーパーミキサー（SMV2、(株)カ
ワタ製）で３分間混合した後、更に２０％のポリビニル
ピロリドンを含有するエタノール１６８gを添加して練
合した。かかる練合物を特開平８−１９５８９号公報に
開示される錠剤製造方法に従って９.５mmφ平型パンチ
で１錠２８０mgの錠剤に成形した後、４０℃で１６時間
乾燥して速崩壊性錠剤を得た。Example 3 480 g of the same seamless capsules as in Example 1 and 1166.4 g of mannitol were mixed with a super mixer (SMV2, manufactured by Kawata Co., Ltd.) for 3 minutes, and then 168 g of ethanol containing 20% polyvinylpyrrolidone. Was added and kneaded. The kneaded product is formed into 280 mg tablets using a 9.5 mmφ flat punch in accordance with the tablet manufacturing method disclosed in JP-A-8-19589, and then dried at 40 ° C. for 16 hours to obtain rapidly disintegrating tablets. Obtained.
【００２５】上記実施例において得られた口腔内速崩壊
性錠剤の口中崩壊時間、日局崩壊時間、摩損度、硬度、
空隙率及び引張強度は、それぞれ以下の表１に示す通り
である。The disintegration time in the mouth, disintegration time in Japan, friability, hardness,
The porosity and the tensile strength are as shown in Table 1 below.
【００２６】[0026]
【表１】 [Table 1]
【００２７】[0027]
【発明の効果】本発明により、脂溶性薬物を含有する口
腔内速崩壊性錠剤を提供することができる。脂溶性薬物
はシームレスカプセルに充填され、錠剤に含有される。
シームレスカプセルのゼラチン皮膜は水で速やかに膨潤
し崩壊することから、薬物の放出・吸収が速やかにおこ
なわれ、また錠剤の服用感を損なうこともない。本発明
により、嚥下機能の低下した高齢者や服薬能力の低い小
児でも容易に服用可能な、脂溶性薬物含有口腔内速崩壊
性錠剤を提供することができた。According to the present invention, an orally rapidly disintegrating tablet containing a fat-soluble drug can be provided. The fat-soluble drug is filled into a seamless capsule and contained in a tablet.
Since the gelatin film of the seamless capsule swells and disintegrates quickly with water, the drug is quickly released and absorbed, and the feeling of taking the tablet is not impaired. ADVANTAGE OF THE INVENTION According to this invention, the rapidly disintegrating tablet in the oral cavity containing a fat-soluble drug which can be easily taken even by the elderly who the swallowing function fell and the child with low medication ability was able to be provided.
───────────────────────────────────────────────────── フロントページの続き (72)発明者 対馬 勇禧 埼玉県本庄市柏１−10−27 Ｆターム(参考） 4C076 AA36 AA57 BB01 CC21 CC23 DD37 DD67 EE16 FF06 FF33 ──────────────────────────────────────────────────の Continued on the front page (72) Inventor Yuki Tsushima 1-10-27 Kashiwa, Honjo-shi, Saitama F-term (reference) 4C076 AA36 AA57 BB01 CC21 CC23 DD37 DD67 EE16 FF06 FF33
Claims (10)
ルと糖類とを含有してなる口腔内速崩壊性錠剤。An orally rapidly disintegrating tablet comprising a seamless capsule filled with a fat-soluble drug and a saccharide.
３.０mmである請求項１記載の口腔内速崩壊性錠剤。2. The seamless capsule having a particle size of 0.2 mm or more.
The orally rapidly disintegrating tablet according to claim 1, which is 3.0 mm.
ル、糖類及び結合剤を含有する口腔内速崩壊性錠剤。3. An orally rapidly disintegrating tablet containing a seamless capsule filled with a fat-soluble drug, a saccharide and a binder.
ルと糖類を有機溶媒により混練合後、鋳型に充填し、フ
ィルムを介して成形する口腔内速崩壊性錠剤の製造方
法。4. A method for producing a rapidly disintegrating tablet in the oral cavity, wherein a seamless capsule filled with a fat-soluble drug and a saccharide are kneaded and mixed with an organic solvent, filled in a mold, and molded via a film.
類、ビタミンＤ類、ビタミンＫ類、補酵素Ｑ類及びテプ
レノンからなる群から選ばれる１種以上の脂溶性薬物で
ある請求項１または３記載の口腔内速崩壊性錠剤の製造
方法。5. The fat-soluble drug is a vitamin A or vitamin E.
The method for producing an orally rapidly disintegrating tablet according to claim 1 or 3, which is at least one fat-soluble drug selected from the group consisting of vitamins, vitamin Ds, vitamin Ks, coenzyme Qs, and teprenone.
イソプロパノールからなる群から選ばれる１種以上の有
機溶媒である請求項１または３記載の口腔内速崩壊性錠
剤の製造方法。6. The method according to claim 1, wherein the organic solvent is at least one organic solvent selected from the group consisting of ethanol, propanol and isopropanol.
ハロース、キシリトール、エリスリトール、グルコース
から選ばれる１種以上の糖類である請求項１または３記
載の口腔内速崩壊性錠剤の製造方法。7. The method according to claim 1, wherein the saccharide is one or more saccharides selected from sucrose, mannitol, lactose, trehalose, xylitol, erythritol, and glucose.
重量部の脂溶性薬物を充填されたシームレスカプセルを
用いる請求項１または３記載の口腔内速崩壊性錠剤の製
造方法。(8) 0.0007 to 0.5 with respect to 1 part by weight of the tablet.
The method for producing an orally rapidly disintegrating tablet according to claim 1 or 3, wherein a seamless capsule filled with parts by weight of a fat-soluble drug is used.
ルと糖類の重量比が１／１０００〜７／１０である請求
項１または３記載の口腔内速崩壊性錠剤。9. The orally rapidly disintegrating tablet according to claim 1, wherein the weight ratio of the seamless capsule filled with the fat-soluble drug to the saccharide is 1/1000 to 7/10.
求項３記載の口腔内速崩壊性錠剤。10. An orally rapidly disintegrating tablet according to claim 3, wherein the binder is polyvinylpyrrolidone.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP10181709A JP2000016932A (en) | 1998-06-29 | 1998-06-29 | Oral rapid disintegration tablet including seamless capsule |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP10181709A JP2000016932A (en) | 1998-06-29 | 1998-06-29 | Oral rapid disintegration tablet including seamless capsule |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JP2000016932A true JP2000016932A (en) | 2000-01-18 |
Family
ID=16105494
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP10181709A Pending JP2000016932A (en) | 1998-06-29 | 1998-06-29 | Oral rapid disintegration tablet including seamless capsule |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2000016932A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2006503855A (en) * | 2002-09-25 | 2006-02-02 | カプサルーション ナノサイエンス アクチェン ゲゼルシャフト | Quick-release dosage form containing poorly soluble active ingredients |
-
1998
- 1998-06-29 JP JP10181709A patent/JP2000016932A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2006503855A (en) * | 2002-09-25 | 2006-02-02 | カプサルーション ナノサイエンス アクチェン ゲゼルシャフト | Quick-release dosage form containing poorly soluble active ingredients |
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