JPS59139317A - Prolonged release "nifedipine(r)" pharmaceutical - Google Patents
Prolonged release "nifedipine(r)" pharmaceuticalInfo
- Publication number
- JPS59139317A JPS59139317A JP1297383A JP1297383A JPS59139317A JP S59139317 A JPS59139317 A JP S59139317A JP 1297383 A JP1297383 A JP 1297383A JP 1297383 A JP1297383 A JP 1297383A JP S59139317 A JPS59139317 A JP S59139317A
- Authority
- JP
- Japan
- Prior art keywords
- capsules
- nifedipine
- coating
- prolonged release
- soft capsules
- 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
Landscapes
- Hydrogenated Pyridines (AREA)
- Medicinal Preparation (AREA)
Abstract
Description
【発明の詳細な説明】
本発明は、力ｈシウム拮抗作用によシ血管を拡張させる
ニフェジピン製剤に関する。DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a nifedipine formulation that dilates blood vessels through antagonism.
ニフェジピン、４−（２’−二トロフェニル）−２，６
−ジメチル−３，５−ジカルボメトキシー１．４−ジヒ
ドロピリジンはきわめて強力なカルシウム拮抗薬であり
、その優れた冠血管拡張作用によシ狭心症治療薬として
広く使用されている。また、他の末梢血管平滑筋にも作
用し、血圧降下作用を有するので、優れた抗高血圧剤と
しても使用されている。しかしながら、従来のニフェジ
ピン製剤は速効的であシその効果の持続時間は短かいの
で、患者の血圧の変動が大きいという問題点があυ、特
に抗高血圧剤としては持続性のものが望まれていた。Nifedipine, 4-(2'-nitrophenyl)-2,6
-Dimethyl-3,5-dicarbomethoxy-1,4-dihydropyridine is an extremely powerful calcium antagonist and is widely used as a therapeutic agent for angina pectoris due to its excellent coronary vasodilatory action. It also acts on other peripheral vascular smooth muscles and has a blood pressure lowering effect, so it is also used as an excellent antihypertensive agent. However, conventional nifedipine preparations are fast-acting and their effects last only for a short time, so there is a problem in that patients' blood pressure fluctuates widely, so long-lasting antihypertensive drugs are particularly desired. Ta.
本発明者らは、速効性と共に持続性を有するニフェジピ
ン製剤について鋭意研究の結果、本発明に到達した。The present inventors have arrived at the present invention as a result of intensive research into nifedipine preparations that have both immediate action and long-lasting effects.
即ち、本発明は、；フエジビンを内包するゼラチンソフ
トカプセルと、該ソフトカプセルに腸溶性物質をコーテ
ィングして得られた徐放性のゼラチンソフトカプセルと
を、１〜９：９〜１の重量比で混合して々る持続性のニ
フェジピン製剤である。That is, the present invention is characterized by mixing gelatin soft capsules containing fuedibine and sustained-release gelatin soft capsules obtained by coating the soft capsules with an enteric material in a weight ratio of 1 to 9:9 to 1. It is a long-acting nifedipine preparation.
本発明のニフェジピンを内包するゼラチンソフトカプセ
ルは、ニフェジピンを、例えばポリエチレングリコール
、トリエチレ、ンクリコール。The gelatin soft capsule containing nifedipine of the present invention contains nifedipine, for example, polyethylene glycol, triethyl, or ncricol.
グリセリン、グリセリン脂肪酸ニスデル等に溶解し、こ
れにハツカ油等の嬌味剤やサッカリン。It is dissolved in glycerin, glycerin fatty acid Nisdel, etc., and flavoring agents such as peppermint oil and saccharin are added to this.
グリチルリチン又はその塩等の甘味料を添加して得られ
る溶液を、平板法、四−タリー法、シームレス法等の公
知の方法で、ゼラチンを主体とする皮膜で被覆しソフト
カプセル化することによって得られる。溶液中のニフェ
ジピンの濃度としては０．１〜１０重貴チが好ましい。Obtained by adding a sweetener such as glycyrrhizin or its salt to a solution obtained by coating it with a film mainly composed of gelatin and encapsulating it in a soft capsule using a known method such as the plate method, four-tally method, or seamless method. . The concentration of nifedipine in the solution is preferably 0.1 to 10 HCl.
ゼラチンを主体とする皮膜としては公知のいか力るもの
でも使用できるが、例えば、ゼラチンとグリセリンの混
合物やゼラチンとフルビトールの混合物がある。Any known material can be used as the film mainly composed of gelatin, and examples thereof include a mixture of gelatin and glycerin and a mixture of gelatin and fulbitol.
これらの皮膜材料中には、酸化チタン等の遮光剤や黄色
５号等の染料を、あるいはまたフェニルサルチル酸等の
光吸収剤を添加混合してもよい。A light shielding agent such as titanium oxide, a dye such as Yellow No. 5, or a light absorbing agent such as phenyl salicylic acid may be added and mixed into these coating materials.
ゼラチンソフトカプセルの形状は、特に限定されないが
、直径が０゜５〜５叫９重量が０．１〜ｉｏｏＴｎｇの
球形のものが好ましい。ラフｌカプセルの被膜享（カプ
セル総重量に対する被膜材の重量％）は５〜５０チが適
尚である。The shape of the gelatin soft capsule is not particularly limited, but it is preferably spherical with a diameter of 0.5 to 5.9 mm and a weight of 0.1 to 10.0 mm. The coating weight of the rough capsule (weight % of the coating material relative to the total weight of the capsule) is suitably 5 to 50 inches.
本発明においては、前記の如くして得られたゼラチンソ
フトカプセルは二分され、一方はそのま＼後述の混合に
用いられるが、他方のソフトカプセルには更に腸溶性物
質がゴーティングされる。かくして徐放性のゼラチンソ
フトカプセルが得られる。本発明において用いられる腸
溶性物質としては、例えば、ノ・イドロキシプロビルメ
チルセルロースフタレート、セルロースアセテート７タ
レート、カルボキシエチルセルロースアセテート、カル
ボキシエチルプロピルセルロースアセテート、カルボキ
シメチルエチルセルローズ、カルボキシブチルセルロー
ズ。In the present invention, the gelatin soft capsules obtained as described above are divided into two halves, one of which is used as is for the mixing described below, while the other soft capsule is further coated with an enteric substance. Thus, sustained release gelatin soft capsules are obtained. The enteric substances used in the present invention include, for example, idroxypropyl methylcellulose phthalate, cellulose acetate heptatalate, carboxyethylcellulose acetate, carboxyethylpropylcellulose acetate, carboxymethylethylcellulose, and carboxybutylcellulose.
カルボキシプロピルメチルセルローズ等のカルボキシア
ルキルセルローズ誘導体、あるいは（メタ）アクリル酸
と（メタ）アクリル醸エステルとからなる、遊離カルボ
キシル基を有する多塩基酸のビニル重合体及びこれらの
混合物が挙げられる。コーティングの方法は、公知のい
かなる方法でも採用することかで崖る。Examples include carboxyalkyl cellulose derivatives such as carboxypropyl methyl cellulose, vinyl polymers of polybasic acids having free carboxyl groups, and mixtures thereof, consisting of (meth)acrylic acid and (meth)acrylic ester. The coating method may be any known method.
本発明の持続性のニフェジピン製剤は、腸溶性物質をコ
ーティングしていないゼラチンソフトカプセルと、コー
ティングした徐放性のゼラチンソフトカプセルを混合す
るととｋよって得られる。混合比は重量比で１〜９：９
〜１、好ましくは２〜４：８〜６である。この２種類の
ソフトカプセルは、大きさの異なるものを用いてもよい
。かかるソフトカプセルの混合物は、胃液によって速や
かに溶解しニフェジピンを放出するものと、胃では溶解
せずｗｋｌｙ、によってはじめて溶解しニフェジピンを
放出するものとからなっているので、患者が服用した場
合に、ニフェジピンの効果が速やかに発現するだけでは
なく、その効果が持続するのである。本発明の持続性の
ニフェジピン製剤は、１回分の投与量ごとに、アルミニ
ウムラミネート袋などに分包しておくのが便利である。The long-acting nifedipine formulation of the present invention is thus obtained by mixing uncoated gelatin soft capsules with enteric material and coated sustained release gelatin soft capsules. Mixing ratio is 1 to 9:9 by weight
-1, preferably 2-4:8-6. These two types of soft capsules may have different sizes. The mixture of such soft capsules consists of one capsule that dissolves quickly in the gastric juices and releases nifedipine, and one that does not dissolve in the stomach but dissolves and releases nifedipine only by wkly, so when a patient takes it, nifedipine is released. Not only does the effect appear quickly, but it also lasts for a long time. The long-acting nifedipine preparation of the present invention is conveniently packaged in aluminum laminate bags or the like for each dose.
以下、実施例によυ本発明を詳述する。々お、部は重量
部を意味する。Hereinafter, the present invention will be explained in detail with reference to Examples. Parts mean parts by weight.
実施例に
フエジビン粉末１８ｆを、ポリエチレングリコール４０
０の２６０ｆとｔ）グリセリン２６ｆの混合物に溶解し
、これを内包液とし、ゼラチン１５０部とグリセリン５
０部とからなる皮膜を用いて、ロータリー法でソフトカ
プセル化した。ソフトカプセルの乾燥彼の重量は、１個
が９８．５１９で、直径が５晒であった（内包液は５４
．６１１ｋり。In the example, Huedibin powder 18f and polyethylene glycol 40
Dissolve in a mixture of 260f of 0 and 26f of glycerin, use this as an encapsulating liquid, and add 150 parts of gelatin and 5 parts of glycerin.
Soft capsules were formed using a rotary method using a film consisting of 0 parts. The dry weight of the soft capsules was 98.519, and the diameter was 5.5 mm (the fluid inside was 5.4 mm).
．． 611k.
上記で得られたソフトカプセルを二分し、一方にコーテ
ィングパンを用いて腸溶性コーティングを行なった。腸
溶性コーテイング液組成は、オイドラギツドＬ−１００
−５５（アクリル酸−メタクリル酸の共重合体、ローム
アンドファース社製）５重量部、アセチル化モノグリセ
２イド（商品名マイバセット９−４０Ｔ、 イーストマ
ンケミカル社製） ０．５ ｆｉ重量部軽質無水ケイ酸
０．０５部、インプルピルアルコール４フ、５部及び塩
化メチレフ４７．５部である。The soft capsule obtained above was divided into two parts, and one part was enteric coated using a coating pan. Enteric coating liquid composition is Eudragit L-100
-55 (acrylic acid-methacrylic acid copolymer, manufactured by Rohm and Firth Co.) 5 parts by weight, acetylated monoglyceride 2ide (trade name Mybaset 9-40T, manufactured by Eastman Chemical Company) 0.5 parts by weight light 0.05 part of silicic anhydride, 4.5 parts of impulpyl alcohol, and 47.5 parts of methylene chloride.
得られたソフトカプセルの重量Ｍ、１個当り平均１０３
．４ｊ１９であった。このソフトカプセルは、日本薬局
方記載の崩壊試験を実施したところ、第一液中では３時
間経過後も元の形態を保持しており、第二液では５〜９
分で崩壊した。Weight M of the obtained soft capsules, average 103 per piece
．． It was 4j19. When this soft capsule was subjected to a disintegration test described in the Japanese Pharmacopoeia, it maintained its original form even after 3 hours in the first liquid, and 5-9% in the second liquid.
It collapsed in minutes.
前記の如くして得られた腸溶性コーティングを行なって
いないソフトカプセル（胃溶性カプセル）と、腸溶性コ
ーティングを行々つたソフトカプセル（Ｈｈ溶性カプセ
ル）を、２部：８部の割合に混合して本発明の持続性の
ニフェジピン製剤を作成した。これを、成人男子６人に
経口投与しくニフェジピン含量２０〜）、一定時間後の
ニフェジピンの血中濃度を測定した。比較のために、胃
溶性カプセルのみを成人男子２人に経口投与しくニフェ
ジピン含［１０１９）。The non-enteric-coated soft capsules (gastric-soluble capsules) obtained as described above and the enteric-coated soft capsules (Hh-soluble capsules) were mixed in a ratio of 2 parts: 8 parts. An inventive long-acting nifedipine formulation has been created. This was orally administered to six adult males (nifedipine content: 20~), and the blood concentration of nifedipine was measured after a certain period of time. For comparison, only gastric soluble capsules containing nifedipine were administered orally to two male adults [1019].
同様に血中濃度を泪１１足した。結果を第１図に示した
（実線が本発明）。Similarly, I added 11 to the blood concentration. The results are shown in FIG. 1 (the solid line indicates the present invention).
第１図から、本発明の持続性の製剤にフエジピン含量２
０ｑ）は、最高血中濃度はニフジビン含：！ｔｌＯ〜の
胃溶性カプセルとｔ１ホ同程度であるが、効果の持続性
が著しく向上していることがわかる。胃溶性カプセルを
ニフェジピン含量で２０■、同時に経口投与すれば、効
果の持続性はある程度期待できるとしても、この場合に
は、最高血中濃度が著しく高くなり副作用の発現が予憩
されるので、実用的ではない。From Figure 1, it can be seen that the long-acting formulation of the present invention contains 2
0q), the highest blood concentration contains nifzibin:! Although it is comparable to the gastric soluble capsules of tlO~ and tlO, it can be seen that the durability of the effect is significantly improved. If gastric soluble capsules containing 20 μg of nifedipine are administered orally at the same time, some degree of persistence of effect can be expected, but in this case, the maximum blood concentration will be significantly higher and the onset of side effects will be delayed. Not practical.
第１図は、本発明の持続性のニフェジピン製剤を成人男
子に投与した場合の、投与後経過時間とニフェジピンの
血中濃度の関係を示す。FIG. 1 shows the relationship between the time elapsed after administration and the blood concentration of nifedipine when the long-acting nifedipine preparation of the present invention was administered to an adult male.
Claims (1)
と、該ソフトカプセルに腸溶性物質をコーティングして
得られた徐放性のゼラチンソフトカプセルとを、１〜９
：９〜ｌの重量比で混合してなる持続性のニフェジピン
製剤。1. Gelatin soft capsules containing nifedipine and sustained-release gelatin soft capsules obtained by coating the soft capsules with an enteric substance, 1 to 9
: A long-acting nifedipine preparation prepared by mixing in a weight ratio of 9 to 1.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP1297383A JPS59139317A (en) | 1983-01-31 | 1983-01-31 | Prolonged release "nifedipine(r)" pharmaceutical |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP1297383A JPS59139317A (en) | 1983-01-31 | 1983-01-31 | Prolonged release "nifedipine(r)" pharmaceutical |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPS59139317A true JPS59139317A (en) | 1984-08-10 |
Family
ID=11820169
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP1297383A Pending JPS59139317A (en) | 1983-01-31 | 1983-01-31 | Prolonged release "nifedipine(r)" pharmaceutical |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPS59139317A (en) |
Cited By (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH01283222A (en) * | 1988-05-10 | 1989-11-14 | Tokai Kapuseru Kk | Soft capsule agent of sodium picosulfate |
| US4981695A (en) * | 1986-08-26 | 1991-01-01 | Lejus Medical Aktiebolag | Composition comprising L-dopa |
| US5651983A (en) * | 1993-02-26 | 1997-07-29 | The Procter & Gamble Company | Bisacodyl dosage form for colonic delivery |
| US5686106A (en) * | 1995-05-17 | 1997-11-11 | The Procter & Gamble Company | Pharmaceutical dosage form for colonic delivery |
| US5843479A (en) * | 1993-02-26 | 1998-12-01 | The Procter & Gamble Company | Bisacodyl dosage form with multiple enteric polymer coatings for colonic delivery |
| US5914132A (en) * | 1993-02-26 | 1999-06-22 | The Procter & Gamble Company | Pharmaceutical dosage form with multiple enteric polymer coatings for colonic delivery |
| US6436453B1 (en) | 2000-06-16 | 2002-08-20 | General Mills, Inc. | Production of oil encapsulated minerals and vitamins in a glassy matrix |
| US6468568B1 (en) | 2000-06-16 | 2002-10-22 | General Mills, Inc. | Oligosaccharide encapsulated mineral and vitamin ingredients |
| US6500463B1 (en) | 1999-10-01 | 2002-12-31 | General Mills, Inc. | Encapsulation of sensitive components into a matrix to obtain discrete shelf-stable particles |
| US6558718B1 (en) | 2000-06-19 | 2003-05-06 | General Mills, Inc. | Nutrient clusters for food products and methods of preparation |
| WO2003094897A1 (en) * | 2002-05-09 | 2003-11-20 | Chugai Seiyaku Kabushiki Kaisha | Photostabilized soft capsule |
| US6723358B1 (en) | 1998-03-23 | 2004-04-20 | General Mills, Inc. | Encapsulation of components into edible products |
| US7201923B1 (en) | 1998-03-23 | 2007-04-10 | General Mills, Inc. | Encapsulation of sensitive liquid components into a matrix to obtain discrete shelf-stable particles |
| US7431986B2 (en) | 2002-07-24 | 2008-10-07 | General Mills, Inc. | Encapsulation of sensitive components using pre-emulsification |
| US7803414B2 (en) | 2005-10-31 | 2010-09-28 | General Mills Ip Holdings Ii, Llc | Encapsulation of readily oxidizable components |
| JP2015086158A (en) * | 2013-10-30 | 2015-05-07 | 株式会社ファンケル | Controlled release soft capsule |
| WO2015115072A1 (en) | 2014-01-31 | 2015-08-06 | 富士カプセル株式会社 | Capsule formulation |
| JP2023504292A (en) * | 2020-04-24 | 2023-02-02 | ヴィコール ファルマ アーベー | A new delayed release composition for oral administration |
-
1983
- 1983-01-31 JP JP1297383A patent/JPS59139317A/en active Pending
Cited By (29)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4981695A (en) * | 1986-08-26 | 1991-01-01 | Lejus Medical Aktiebolag | Composition comprising L-dopa |
| JPH01283222A (en) * | 1988-05-10 | 1989-11-14 | Tokai Kapuseru Kk | Soft capsule agent of sodium picosulfate |
| US5651983A (en) * | 1993-02-26 | 1997-07-29 | The Procter & Gamble Company | Bisacodyl dosage form for colonic delivery |
| US5843479A (en) * | 1993-02-26 | 1998-12-01 | The Procter & Gamble Company | Bisacodyl dosage form with multiple enteric polymer coatings for colonic delivery |
| US5914132A (en) * | 1993-02-26 | 1999-06-22 | The Procter & Gamble Company | Pharmaceutical dosage form with multiple enteric polymer coatings for colonic delivery |
| US5686106A (en) * | 1995-05-17 | 1997-11-11 | The Procter & Gamble Company | Pharmaceutical dosage form for colonic delivery |
| US6723358B1 (en) | 1998-03-23 | 2004-04-20 | General Mills, Inc. | Encapsulation of components into edible products |
| US8313757B2 (en) | 1998-03-23 | 2012-11-20 | General Mills, Inc. | Encapsulation of sensitive liquid components into a matrix to obtain discrete shelf-stable particles |
| US7201923B1 (en) | 1998-03-23 | 2007-04-10 | General Mills, Inc. | Encapsulation of sensitive liquid components into a matrix to obtain discrete shelf-stable particles |
| US6500463B1 (en) | 1999-10-01 | 2002-12-31 | General Mills, Inc. | Encapsulation of sensitive components into a matrix to obtain discrete shelf-stable particles |
| US6468568B1 (en) | 2000-06-16 | 2002-10-22 | General Mills, Inc. | Oligosaccharide encapsulated mineral and vitamin ingredients |
| US6436453B1 (en) | 2000-06-16 | 2002-08-20 | General Mills, Inc. | Production of oil encapsulated minerals and vitamins in a glassy matrix |
| US6837682B2 (en) | 2000-06-19 | 2005-01-04 | General Mills, Inc. | Nutrient clusters for food products and methods of preparation |
| US6558718B1 (en) | 2000-06-19 | 2003-05-06 | General Mills, Inc. | Nutrient clusters for food products and methods of preparation |
| JPWO2003094897A1 (en) * | 2002-05-09 | 2005-09-08 | 中外製薬株式会社 | Light-stabilized soft capsule |
| JP2010174043A (en) * | 2002-05-09 | 2010-08-12 | Chugai Pharmaceut Co Ltd | Photostabilized soft capsule |
| US8703182B2 (en) | 2002-05-09 | 2014-04-22 | Chugai Seiyaku Kabushiki Kaisha | Light-stabilized soft capsule formulations |
| JP5105705B2 (en) * | 2002-05-09 | 2012-12-26 | 中外製薬株式会社 | Light-stabilized soft capsule |
| WO2003094897A1 (en) * | 2002-05-09 | 2003-11-20 | Chugai Seiyaku Kabushiki Kaisha | Photostabilized soft capsule |
| US7431986B2 (en) | 2002-07-24 | 2008-10-07 | General Mills, Inc. | Encapsulation of sensitive components using pre-emulsification |
| US8142831B2 (en) | 2005-10-31 | 2012-03-27 | General Mills Ip Holdings Ii, Llc | Encapsulation of readily oxidizable components |
| US7803413B2 (en) | 2005-10-31 | 2010-09-28 | General Mills Ip Holdings Ii, Llc. | Encapsulation of readily oxidizable components |
| US7803414B2 (en) | 2005-10-31 | 2010-09-28 | General Mills Ip Holdings Ii, Llc | Encapsulation of readily oxidizable components |
| JP2015086158A (en) * | 2013-10-30 | 2015-05-07 | 株式会社ファンケル | Controlled release soft capsule |
| WO2015115072A1 (en) | 2014-01-31 | 2015-08-06 | 富士カプセル株式会社 | Capsule formulation |
| JP2023504292A (en) * | 2020-04-24 | 2023-02-02 | ヴィコール ファルマ アーベー | A new delayed release composition for oral administration |
| US11654115B2 (en) | 2020-04-24 | 2023-05-23 | Vicore Pharma Ab | Delayed release composition for peroral administration |
| JP2024001089A (en) * | 2020-04-24 | 2024-01-09 | ヴィコール ファルマ アーベー | New delayed release composition for peroral administration |
| US12121614B2 (en) | 2020-04-24 | 2024-10-22 | Vicore Pharma Ab | Delayed release composition for peroral administration |
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