JPWO2002089823A1 - How to store effervescent suppositories - Google Patents
How to store effervescent suppositoriesInfo
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- JPWO2002089823A1 JPWO2002089823A1 JP2002586956A JP2002586956A JPWO2002089823A1 JP WO2002089823 A1 JPWO2002089823 A1 JP WO2002089823A1 JP 2002586956 A JP2002586956 A JP 2002586956A JP 2002586956 A JP2002586956 A JP 2002586956A JP WO2002089823 A1 JPWO2002089823 A1 JP WO2002089823A1
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- effervescent
- suppository
- desiccant
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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
- A61K9/02—Suppositories; Bougies; Bases therefor; Ovules
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
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- 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
- A61P1/10—Laxatives
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Abstract
本発明は、発泡性坐剤を乾燥雰囲気下に置くことを特徴とする発泡性坐剤の保存方法、ならびに発泡性坐剤パッケージであって、当該発泡性坐剤が乾燥雰囲気下における保存形態をとりうる形態であることを特徴とする発泡性坐剤パッケージ、特に、発泡性坐剤と乾燥剤とを密封してなる発泡性坐剤パッケージに関し、本発明によれば、発泡性坐剤を室温、特に１５℃を超える温度でも安定に保存することができる。The present invention relates to a method for storing an effervescent suppository, which comprises placing an effervescent suppository in a dry atmosphere, and an effervescent suppository package, wherein the effervescent suppository is stored in a dry atmosphere. The present invention relates to an effervescent suppository package characterized by being in a form that can be taken, and more particularly to an effervescent suppository package obtained by sealing an effervescent suppository and a desiccant. In particular, it can be stably stored even at a temperature exceeding 15 ° C.
Description
技術分野
本発明は、発泡性坐剤の保存方法および発泡性坐剤の保存用パッケージに関し、より詳細には、室温でも発泡性坐剤が安定に存在しうる発泡性坐剤の保存方法および発泡性坐剤の保存用パッケージに関する。
背景技術
発泡性坐剤には、例えば、炭酸水素ナトリウムおよび無水リン酸二水素ナトリウムをそれぞれ塩基性薬物および酸性薬物として含有する発泡性坐剤が挙げられ、これは直腸投与用の緩下剤として繁用されている。
発泡性坐剤は、一般的に、直腸投与後、直腸分泌液中で融解し、上述したような塩基性薬物と酸性薬物との通常の中和反応（式１）によって炭酸ガスを放出する。
ＮａＨＣＯ３＋ＮａＨ２ＰＯ４→ＣＯ２↑＋Ｈ２Ｏ＋Ｎａ２ＨＰＯ４ （式１）
この放出された炭酸ガスが、大腸の蠕動運動を誘発し、反射や刺激も加わって、生理的な排便をもたらすことが知られている。
発泡性坐剤は、通常の中和反応を利用する剤形であるため、保存時、周辺環境湿度の影響を受けやすい。なぜなら、水分の存在下では（式１）に示したような中和反応が進行してしまうからである。
現在、発泡性坐剤は、一次容器としての塩化ビニル製コンテナに坐剤が充填され、それを紙箱に直接入れるという包装形態で市販されている。
通常、発泡性坐剤のパッケージングに用いられている塩化ビニル製コンテナは、コンテナそれ自体が水分透過性を有することから、室温下（特に１５℃超〜３０℃）で発泡性坐剤が吸湿するような相対湿度下に保存した場合、吸湿した水分によって塩基性薬物と酸性薬物との中和反応が進行してしまう。そのため、両薬物の含量が低下してしまい、投与時に放出される炭酸ガス量が減少し、それにより治療効果が減少してしまう。
また、製造時に発泡性坐剤の水分含量をできるだけ少なくするために、通常、製造工程において水分を除去する操作が行われているが、水分を完全に取り除くことはできない。そのため、塩化ビニル製コンテナの代わりに水分を透過しないアルミ製コンテナ等に発泡性坐剤を詰めた場合、室温等で保存すると、坐剤自体に含まれる水分によって反応が進行し、生じたガスがアルミを透過しないため、コンテナの膨張・破損等が発生し、商品価値がなくなってしまう。
これらを防ぐため、従来の包装では発泡性坐剤は冷所（１５℃以下）で保存する必要があった。
本発明は、発泡性坐剤の従来用いられていた保存方法が有する欠点を克服し、周囲温度１５℃を超える温度下でも発泡性坐剤を安定に保存することができる発泡性坐剤の保存方法およびそのためのパッケージを開発することを目的とする。
発明の開示
本発明者らは上記課題を鑑み鋭意研究した結果、発泡性坐剤を乾燥雰囲気下に置くこと、特に発泡性坐剤と乾燥剤（就中、シリカゲル）とを密封系に保存することによって、周囲温度１５℃を超える温度下でも発泡性坐剤を安定に保存することができることを見出し、さらに研究を重ねて本発明を完成するに至った。すなわち、本発明は、以下の通りである。
〔１〕発泡性坐剤を乾燥雰囲気下に置くことを特徴とする、発泡性坐剤の保存方法。
〔２〕発泡性坐剤と乾燥剤とを密封系で保存することを特徴とする、発泡性坐剤の保存方法。
〔３〕上記発泡性坐剤が、酸性薬物と塩基性薬物とを含有する、上記〔１〕または〔２〕記載の保存方法。
〔４〕上記酸性薬物が無水リン酸二水素ナトリウムであり、上記塩基性薬物が炭酸水素ナトリウムである、上記〔３〕記載の保存方法。
〔５〕上記乾燥剤が、シリカゲル、酸化カルシウム、および塩化カルシウムからなる群から選択される少なくとも１つの乾燥剤である、上記〔２〕記載の保存方法。
〔６〕上記乾燥剤がシリカゲルである、上記〔２〕記載の保存方法。
〔７〕発泡性坐剤を含む発泡性坐剤パッケージであって、当該発泡性坐剤が乾燥雰囲気下における保存形態をとりうる形態であることを特徴とする発泡性坐剤パッケージ。
〔８〕発泡性坐剤と乾燥剤とを密封してなる発泡性坐剤パッケージ。
〔９〕上記発泡性坐剤が、酸性薬物と塩基性薬物とを含有する、上記〔７〕または〔８〕記載のパッケージ。
〔１０〕上記酸性薬物が無水リン酸二水素ナトリウムであり、上記塩基性薬物が炭酸水素ナトリウムである、上記〔９〕記載のパッケージ。
〔１１〕上記乾燥剤が、シリカゲル、酸化カルシウム、および塩化カルシウムからなる群から選択される少なくとも１つの乾燥剤である、上記〔８〕記載のパッケージ。
〔１２〕上記乾燥剤がシリカゲルである、上記〔８〕記載のパッケージ。
本発明において、発泡性坐剤としては、塩基性薬物と酸性薬物との中和反応によって、投薬時に気体を発生する製剤が挙げられる。具体的には、炭酸塩と酸性薬物との反応によって二酸化炭素を発生する緩下剤である直腸投与製剤が例示される。また、この製剤は様々な目的の添加剤を含みうる。
本発明において、「発泡性坐剤を乾燥雰囲気下に置くこと」としては、例えば発泡性坐剤と乾燥剤とを密封系で保存する手法が例示される。
乾燥剤としては、医薬品とともに用いることができる乾燥剤であれば特に限定されないが、例えば、シリカゲル、酸化カルシウム、塩化カルシウム、シリカアルミナゲル（モンモリロナイト、アロフェン、ゼオライト、モレキュラーシーブなど）などが挙げられ、シリカゲル、酸化カルシウム、塩化カルシウムがより好ましく、その中でも特にシリカゲルが好ましい。これらの乾燥剤は単独で用いてもよいし、また組み合わせて用いてもよい。使用する乾燥剤量は、発泡性坐剤１重量部に対して、通常、０．００４重量部〜０．０７７重量部であり、好ましくは、０．０１９重量部〜０．０３８重量部である。
本明細書中で用いる「密封」との語は、日常の取り扱いにおいて、または通常の保存状態において、気体状の水分が侵入しない状態を意味する（第１３改正日本薬局方）。
発泡性坐剤および乾燥剤を密封系で保存するための容器としては、密封して外部からの水分の侵入を防ぐことができるものであれば特に限定されないが、例えば多層フィルム袋等の容器が挙げられ、好ましいものとしては、セロハンアルミラミネートフィルム（セロニウム）袋、ポリエチレンテレフタレートアルミラミネートフィルム（ペットニウム）袋、延伸ポリプロピレンアルミラミネートフィルム（ＯＰＰニウム）袋等のプラスチックとアルミニウムのラミネートフィルム袋が挙げられる。
本発明において坐剤を充填するコンテナとしては、水分を透過する材質からなるコンテナであれば特に限定されないが、好ましいものとしては、塩化ビニル製コンテナ、ポリエチレンテレフタレート製コンテナ、ポリプロピレン製コンテナなどが挙げられ、塩化ビニル製コンテナが特に好ましい。
本発明によれば、発泡性坐剤を、１５℃を超える温度、例えば室温で、より詳細には１５℃超〜３０℃で保存することができる。
本発明によって発泡性坐剤が保存可能となる温度範囲の上限は、坐剤に含まれる基剤および添加剤等の高温での安定性などによって変化する。例えば、油脂性基剤を用いる場合、通常、体温で融解するように３６℃以下の融点の基剤が選択されるため少なくともその融点を超えない温度下で保存するのが好ましい。
本発明において、発泡性坐剤は、炭酸水素ナトリウムおよび無水リン酸二水素ナトリウムを、油脂性基剤（例えば、ウイテプゾール、ファーマゾール、カカオ脂、ラウリン脂、ニッケイ脂、硬化油など）を用いて坐剤の形態としたものであり、基剤の他に、増粘剤、分散剤などを配合してもよい。
その調製は自体既知の手段にて行われる。
本発明をさらに詳細に説明する目的で以下に実施例を記載するが、本発明はこれらの実施例に何ら限定されない。
実施例
〔調製例〕 発泡性坐剤の製造
基剤ウイテプゾール（ミツバ貿易）２７２４ｇを溶融し、これに炭酸水素ナトリウム１０００ｇ、無水リン酸二水素ナトリウム１３６０ｇ、軽質無水ケイ酸および大豆レチシンを適量混和した後、２．６ｇずつ塩化ビニル製コンテナに充填し、坐剤を得た。
〔実施例１〕 シリカゲルを乾燥剤として用いた保存用パッケージ
調製例で製造した塩化ビニル製コンテナ入りの坐剤１０個および包装用シリカゲル乾燥剤Ａ型（富士シリシア化学）０．１ｇ、０．２ｇ、０．５ｇおよび１．０ｇをセロニウム（ＺＰＦＰ−３０１５０９３０、藤森プラケミカル）袋に入れ、袋を押さえることにより内部の空気を追い出した後、電動シーラーを用いて加熱シールすることにより密封した。
〔実施例２〕 塩化カルシウムを乾燥剤として用いた保存用パッケージ
調製例で製造した塩化ビニル製コンテナ入りの坐剤１０個および塩化カルシウム０．１ｇ、０．２ｇ、０．５ｇおよび１．０ｇをセロニウム（ＺＰＦＰ−３０１５０９３０、藤森プラケミカル）袋に入れ、袋を押さえることにより内部の空気を追い出した後、電動シーラーを用いて加熱シールすることにより密封した。
〔実施例３〕 酸化カルシウムを乾燥剤として用いた保存用パッケージ
調製例で製造した塩化ビニル製コンテナ入りの坐剤１０個および酸化カルシウム０．１ｇ、０．２ｇ、０．５ｇおよび１．０ｇをセロニウム（ＺＰＦＰ−３０１５０９３０、藤森プラケミカル）袋に入れ、袋を押さえることにより内部の空気を追い出した後、電動シーラーを用いて加熱シールすることにより密封した。
〔比較例１〕 乾燥剤を用いないパッケージ
調製例で製造した塩化ビニル製コンテナ入りの坐剤１０個をセロニウム（ＺＰＦＰ−３０１５０９３０、藤森プラケミカル）袋に入れ、袋を押さえることにより内部の空気を追い出した後、電動シーラーを用いて加熱シールすることにより密封した。
〔比較例２〕 コンテナを紙箱に直接入れたパッケージ
調製例で製造した塩化ビニル製コンテナ入りの坐剤１０個を紙箱に直接入れた。
〔実験例〕
実施例および比較例で製造したパッケージを、３５℃相対湿度７５％（長期保存試験のための加速試験条件）の環境下に放置し、炭酸水素ナトリウム含有量、およびセロニウム袋の外観を経時的に観察した。
炭酸水素ナトリウムの定量
あらかじめ恒量とした秤量ビンに坐剤２．６ｇを量りとり、これに乾燥した無水リン酸二水素ナトリウム０．１７５ｇを量って加えた。これに水１ｍＬを加え、５０℃で２０分間加温し、完全に炭酸ガスを発生させた後、１３０℃で３時間乾燥した。デシケーター中で放冷後、重量を量り、発生した炭酸ガス量から炭酸水素ナトリウムの含量を求めた。
炭酸水素ナトリウム含有量の測定結果を表１に、セロニウム袋の外観の観察結果を表２に示す。また、表２中の外観の各記号は次の判定基準に示す状態を呈したことを表す。
− ：変化なし
± ：セロニウム袋の膨張がわずかに認められる。
＋ ：セロニウム袋の膨張が若干認められる。
＋＋ ：セロニウム袋の膨張がかなり認められる。
＋＋＋：セロニウム袋の膨張が著しく認められる。
産業上の利用分野
発泡性坐剤を室温、特に１５℃を超える温度でも安定に保存することができる。
本出願は、日本で出願された特願２００１−１３２７８３を基礎としておりその内容は本明細書に全て包含されるものである。TECHNICAL FIELD The present invention relates to a method for storing an effervescent suppository and a package for storing the effervescent suppository, and more particularly to a method for storing an effervescent suppository in which the effervescent suppository can be stably present even at room temperature. The present invention relates to a package for storing a suppository.
BACKGROUND OF THE INVENTION Effervescent suppositories include, for example, effervescent suppositories containing sodium bicarbonate and anhydrous sodium dihydrogen phosphate as basic and acidic drugs, respectively, which are commonly used as laxatives for rectal administration. Have been.
Effervescent suppositories generally melt in rectal secretions after rectal administration and release carbon dioxide by the usual neutralization reaction (Equation 1) between a basic drug and an acidic drug as described above.
NaHCO 3 + NaH 2 PO 4 → CO 2 ↑ + H 2 O + Na 2 HPO 4 (Formula 1)
It is known that the released carbon dioxide gas induces a peristaltic movement of the large intestine and, in addition to reflexes and stimuli, causes physiological defecation.
Effervescent suppositories are dosage forms that utilize a normal neutralization reaction, and are therefore susceptible to the effects of ambient environmental humidity during storage. This is because the neutralization reaction as shown in (Equation 1) proceeds in the presence of moisture.
At present, effervescent suppositories are commercially available in a packaging form in which a suppository is filled in a vinyl chloride container as a primary container and the suppository is directly placed in a paper box.
Usually, the container made of vinyl chloride used for the packaging of the effervescent suppository absorbs the effervescent suppository at room temperature (particularly more than 15 ° C. to 30 ° C.) because the container itself has moisture permeability. When stored under such relative humidity, the neutralized reaction between the basic drug and the acidic drug proceeds due to the absorbed moisture. As a result, the content of both drugs is reduced, and the amount of carbon dioxide released upon administration is reduced, thereby reducing the therapeutic effect.
Further, in order to minimize the water content of the foaming suppository at the time of production, an operation of removing water is usually performed in the production process, but the water cannot be completely removed. Therefore, when foaming suppositories are packed in an aluminum container or the like that does not allow water to permeate in place of a vinyl chloride container, when stored at room temperature or the like, the reaction proceeds due to the moisture contained in the suppository itself, and the generated gas is released. Since it does not transmit aluminum, the container expands and breaks, etc., and its commercial value is lost.
In order to prevent these, in the conventional packaging, the foamable suppository had to be stored in a cool place (15 ° C. or lower).
The present invention overcomes the drawbacks of the conventionally used preservation methods for effervescent suppositories, and enables the preservation of effervescent suppositories that can stably store effervescent suppositories even at an ambient temperature of more than 15 ° C. The aim is to develop a method and a package therefor.
DISCLOSURE OF THE INVENTION The inventors of the present invention have made intensive studies in view of the above problems, and as a result, have found that effervescent suppositories are placed in a dry atmosphere, and in particular, effervescent suppositories and desiccant (especially, silica gel) are stored in a sealed system. As a result, they have found that the foamable suppository can be stably stored even at an ambient temperature of more than 15 ° C., and have further studied to complete the present invention. That is, the present invention is as follows.
[1] A method for storing an effervescent suppository, comprising placing the effervescent suppository in a dry atmosphere.
[2] A method for storing an effervescent suppository, comprising storing the effervescent suppository and a desiccant in a sealed system.
[3] The method of the above-mentioned [1] or [2], wherein the effervescent suppository contains an acidic drug and a basic drug.
[4] The storage method according to [3], wherein the acidic drug is anhydrous sodium dihydrogen phosphate and the basic drug is sodium hydrogen carbonate.
[5] The storage method according to [2], wherein the desiccant is at least one desiccant selected from the group consisting of silica gel, calcium oxide, and calcium chloride.
[6] The storage method according to [2], wherein the desiccant is silica gel.
[7] An effervescent suppository package comprising an effervescent suppository, wherein the effervescent suppository is in a form that can be stored in a dry atmosphere.
[8] An effervescent suppository package in which an effervescent suppository and a desiccant are sealed.
[9] The package of the above-mentioned [7] or [8], wherein the effervescent suppository contains an acidic drug and a basic drug.
[10] The package of the above-mentioned [9], wherein the acidic drug is anhydrous sodium dihydrogen phosphate and the basic drug is sodium hydrogen carbonate.
[11] The package according to [8], wherein the desiccant is at least one desiccant selected from the group consisting of silica gel, calcium oxide, and calcium chloride.
[12] The package of the above-mentioned [8], wherein the desiccant is silica gel.
In the present invention, examples of the effervescent suppository include preparations which generate gas upon administration by a neutralization reaction between a basic drug and an acidic drug. Specifically, a rectal preparation which is a laxative which generates carbon dioxide by a reaction between a carbonate and an acidic drug is exemplified. The formulation may also include additives for various purposes.
In the present invention, examples of the “putting an effervescent suppository in a dry atmosphere” include, for example, a method of storing an effervescent suppository and a desiccant in a sealed system.
The desiccant is not particularly limited as long as it can be used with pharmaceuticals, and examples thereof include silica gel, calcium oxide, calcium chloride, and silica alumina gel (montmorillonite, allophane, zeolite, molecular sieve, and the like), Silica gel, calcium oxide and calcium chloride are more preferred, and silica gel is particularly preferred. These drying agents may be used alone or in combination. The amount of the desiccant to be used is generally 0.004 to 0.077 parts by weight, preferably 0.019 to 0.038 parts by weight, per part by weight of the effervescent suppository. .
As used herein, the term "sealed" refers to a state in which gaseous moisture does not enter in daily handling or in a normal storage state (the 13th revised Japanese Pharmacopoeia).
The container for storing the effervescent suppository and the desiccant in a sealed system is not particularly limited as long as it can be sealed to prevent the invasion of moisture from the outside.For example, a container such as a multilayer film bag is used. Preferable examples include plastic and aluminum laminate film bags such as cellophane aluminum laminate film (cellonium) bags, polyethylene terephthalate aluminum laminate film (petnium) bags, stretched polypropylene aluminum laminate film (OPPnium) bags, and the like. .
In the present invention, the container to be filled with the suppository is not particularly limited as long as it is a container made of a material permeable to moisture, and preferred examples include a container made of vinyl chloride, a container made of polyethylene terephthalate, a container made of polypropylene, and the like. Particularly preferred are containers made of vinyl chloride.
According to the present invention, effervescent suppositories can be stored at a temperature above 15 ° C, for example at room temperature, more particularly above 15 ° C to 30 ° C.
The upper limit of the temperature range in which an effervescent suppository can be stored according to the present invention varies depending on the stability at high temperature of the base and additives contained in the suppository. For example, when an oily base is used, a base having a melting point of 36 ° C. or lower is usually selected so as to melt at body temperature, and thus it is preferable to store the base at a temperature not exceeding at least the melting point.
In the present invention, an effervescent suppository is prepared by using sodium bicarbonate and anhydrous sodium dihydrogen phosphate with an oily base (for example, witepsol, pharmazol, cocoa butter, laurin butter, Nikkei butter, and hardened oil). It is in the form of a suppository, and may contain a thickener, a dispersant, and the like in addition to the base.
The preparation is carried out by means known per se.
Examples are described below for the purpose of describing the present invention in more detail, but the present invention is not limited to these examples.
Example [Preparation Example] 2724 g of a base for producing an effervescent suppository, Witepsol (Mitsuba Trading), was melted, and 1,000 g of sodium hydrogen carbonate, 1360 g of anhydrous sodium dihydrogen phosphate, light anhydrous silicic acid and soybean reticin were mixed in appropriate amounts. Thereafter, 2.6 g of each was filled in a vinyl chloride container to obtain a suppository.
[Example 1] 10 suppositories in a container made of vinyl chloride produced in a storage package preparation example using silica gel as a desiccant, and 0.1 g and 0.2 g of a silica gel desiccant type A for packaging (Fuji Silysia Chemical Ltd.) , 0.5 g and 1.0 g were put in a cellonium (ZPFP-30150930, Fujimori Plastic Chemical) bag, the inside air was expelled by pressing the bag, and then sealed by heat sealing using an electric sealer.
Example 2 Ten suppositories in a container made of vinyl chloride manufactured in a storage package preparation example using calcium chloride as a desiccant and 0.1 g, 0.2 g, 0.5 g and 1.0 g of calcium chloride were prepared. It was put in a cellonium (ZPFP-30150930, Fujimori Plastic Chemical) bag, the inside air was expelled by pressing the bag, and then sealed by heat sealing using an electric sealer.
[Example 3] Ten suppositories in a container made of vinyl chloride manufactured in a storage package preparation example using calcium oxide as a desiccant and 0.1 g, 0.2 g, 0.5 g and 1.0 g of calcium oxide were prepared. It was put in a cellonium (ZPFP-30150930, Fujimori Plastic Chemical) bag, the inside air was expelled by pressing the bag, and then sealed by heat sealing using an electric sealer.
[Comparative Example 1] Ten suppositories in a vinyl chloride container manufactured in a package preparation example using no desiccant were put in a cellonium (ZPFP-30150930, Fujimori Plastic Chemical) bag, and the inside air was released by pressing the bag. After being expelled, it was sealed by heat sealing using an electric sealer.
Comparative Example 2 Ten suppositories in a vinyl chloride container manufactured in the package preparation example in which the container was directly placed in a paper box were directly placed in a paper box.
[Experimental example]
The packages manufactured in the examples and comparative examples were left in an environment of 35 ° C. and a relative humidity of 75% (accelerated test conditions for a long-term storage test), and the sodium hydrogen carbonate content and the appearance of the cellonium bag were changed over time. Observed.
Determination of sodium bicarbonate 2.6 g of suppository was weighed in a weighing bottle which had been made constant in advance, and 0.175 g of dried anhydrous sodium dihydrogen phosphate was weighed and added thereto. 1 mL of water was added thereto, and the mixture was heated at 50 ° C for 20 minutes to completely generate carbon dioxide gas, and then dried at 130 ° C for 3 hours. After cooling in a desiccator, the weight was measured, and the content of sodium hydrogen carbonate was determined from the amount of generated carbon dioxide gas.
Table 1 shows the measurement results of the content of sodium hydrogencarbonate, and Table 2 shows the observation results of the appearance of the cellonium bag. Further, each symbol of the appearance in Table 2 indicates that the state shown in the following criterion was exhibited.
-: No change ±: Swelling of the cellonium bag is slightly observed.
+: Some expansion of the cellonium bag is observed.
++: Swelling of the cellonium bag is considerable.
+++: Expansion of the cellonium bag is remarkably observed.
INDUSTRIAL APPLICABILITY Effervescent suppositories can be stored stably at room temperature, especially at temperatures above 15 ° C.
This application is based on a patent application No. 2001-132783 filed in Japan, the contents of which are incorporated in full herein.
Claims (12)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2001132783 | 2001-04-27 | ||
| JP2001132783 | 2001-04-27 | ||
| PCT/JP2002/003424 WO2002089823A1 (en) | 2001-04-27 | 2002-04-05 | Method of preserving foaming suppository |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPWO2002089823A1 true JPWO2002089823A1 (en) | 2004-08-19 |
| JP4346311B2 JP4346311B2 (en) | 2009-10-21 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2002586956A Expired - Lifetime JP4346311B2 (en) | 2001-04-27 | 2002-04-05 | How to store effervescent suppositories |
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| Country | Link |
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| JP (1) | JP4346311B2 (en) |
| WO (1) | WO2002089823A1 (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ITMI20060629A1 (en) | 2006-03-31 | 2007-10-01 | Daniele Giovannone | ORAL SOLID COMPOSITIONS BASED ON S-ADENOSYLMETIONINE AND PROCESS FOR THEIR ACHIEVEMENT |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE2158943A1 (en) * | 1970-12-03 | 1972-06-29 | Scherico Ltd., Luzern (Schweiz) | Moussing preparations |
| JPS58152809A (en) * | 1982-03-05 | 1983-09-10 | Eisai Co Ltd | Stable foaming vaginal suppository |
| JPH0639374B2 (en) * | 1984-04-23 | 1994-05-25 | 花王株式会社 | Effervescent glycerin suppository |
| JPS6165823A (en) * | 1984-09-07 | 1986-04-04 | Kao Corp | Drug for rectal application |
| FR2633181B1 (en) * | 1988-06-24 | 1992-01-10 | Glaxo Lab Sa | RANITIDINE-BASED PHARMACEUTICAL COMPOSITION AND PROCESS FOR PREPARING THE SAME |
| JPH10182687A (en) * | 1996-10-21 | 1998-07-07 | Bayer Yakuhin Kk | Stabilization of storage of acarbose |
-
2002
- 2002-04-05 JP JP2002586956A patent/JP4346311B2/en not_active Expired - Lifetime
- 2002-04-05 WO PCT/JP2002/003424 patent/WO2002089823A1/en active Application Filing
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| JP4346311B2 (en) | 2009-10-21 |
| WO2002089823A1 (en) | 2002-11-14 |
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