JP3587869B2 - Pharmaceutical composition - Google Patents
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- JP3587869B2 JP3587869B2 JP31698493A JP31698493A JP3587869B2 JP 3587869 B2 JP3587869 B2 JP 3587869B2 JP 31698493 A JP31698493 A JP 31698493A JP 31698493 A JP31698493 A JP 31698493A JP 3587869 B2 JP3587869 B2 JP 3587869B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
- A61K33/08—Oxides; Hydroxides
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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
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
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Description
【０００１】
［発明の背景］
【産業上の利用分野】
本発明は、Ｈ２‐拮抗薬であるラニチジンを活性成分として含んでなる医薬組成物、特にラニチジンと制酸剤とを組み合わせた経口組成物に関する。
【０００２】
【従来の技術】
ラニチジン、すなわちＮ−［２−［［［５−（ジメチルアミノ）メチル−２−フラニル］メチル］チオ］エチル］−Ｎ′−メチル−２−ニトロ−１，１―エテンジアミン、とその生理学的に許容可能な塩は英国特許第１５６５９６６号明細書に記載されており、またラニチジン塩酸塩の特定の結晶形についてはＧＢ−Ｂ−２０８４５８０号明細書に記載されかつ特許請求の範囲にも記載されている。これらいずれの明細書においても、経口、局所、非経口または直腸投与用の製剤などの種々の処方剤についての言及がなされている。ラニチジンの経口製剤はＧＢ−Ｂ−２１４２８２０号、ＧＢ−Ｂ−２１９８３５２号、ＧＢ−Ｂ−２２１８３３６号、ＧＢ−Ｂ−２２１９９４０号、ＧＢ−Ｂ−２２２２７７２号およびＧＢ−Ｂ−２２２９０９４号明細書にも記載されている。ラニチジンと制酸剤の組み合わせ物は、欧州特許第２８６７８１号明細書およびＰＣＴ第９２／００１０２号および第９３／１２７７９号明細書に記載されている。
【０００３】
制酸剤は中和により胃酸過多の症状を速やかに緩和し、Ｈ２−拮抗薬は独立して酸の分泌を抑制する作用を示すので、Ｈ２−拮抗薬と制酸剤の組み合わせは医療組成物として有利である。
［発明の概要］
【発明が解決しようとする課題】
本発明は、ラニチジンと制酸剤とを組合わせとして含んでなる医薬組成物の提供をその目的としている。
【０００４】
【課題を解決するための手段】
本発明はラニチジンまたはその薬学上許容可能な塩、ケイ酸アルミン酸マグネシウム、水酸化アルミナマグネシウムおよび酸化マグネシウムを含んでなる経口医薬組成物を提供する。
【０００５】
［発明の具体的説明］
本発明で用いられる好適なラニチジンの薬学上許容可能な塩としては、塩酸塩、臭化水素酸塩、硫酸塩、酢酸塩、マレイン酸塩、コハク酸塩およびフマル酸塩のような無機または有機酸で形成される塩が挙げられ、特に好ましい塩は塩酸塩である。
本発明による組成物中のラニチジンの量は、ラニチジン遊離塩基の重量換算で、重量対重量基準で１〜９３％の範囲内にあることが好ましく、１〜２０％であることがより好ましい。
組成物中のケイ酸アルミン酸マグネシウムの量は、重量対重量基準で１〜９７％の範囲内にあることが好ましく、３０〜５０％であることがより好ましい。
組成物中の水酸化アルミナマグネシウムの量は、重量対重量基準で１〜９７％の範囲内にあることが好ましく、２０〜４０％であることがより好ましい。
組成物中の酸化マグネシウムの量は、重量対重量基準で１〜８５％の範囲内にあることが好ましく、５〜２０％であることがより好ましい。
【０００６】
本発明による医薬組成物の好ましい態様としては、ラニチジンをその遊離塩基の重量換算で１〜９３％、好ましくは１〜２０％（重量／重量）、ケイ酸アルミン酸マグネシウムを１〜９７％、好ましくは３０〜５０％（重量／重量）、水酸化アルミナマグネシウムを１〜９７％、好ましくは２０〜４０％（重量／重量）、酸化マグネシウムを１〜８５％、好ましくは５〜２０％（重量／重量）の割合で含んでなるもの、が挙げられる。
ラニチジン、ケイ酸アルミン酸マグネシウム、水酸化アルミナマグネシウムおよび酸化マグネシウムの割合の和は１００％（重量／重量）を超えないということは当業者に明らかであろう。
【０００７】
本組成物はラニチジンをその遊離塩基の重量換算で、投与単位当たり１０〜８００ｍｇ、好ましくは１０〜６００ｍｇ、更に好ましくは１０〜１５０ｍｇ、例えば１０〜７５ｍｇ、の範囲内で含有する。例えば、本組成物は投与単位当たり１５．７５ｍｇ、３１．５ｍｇまたは１６８ｍｇのラニチジン塩酸塩を含有することができる。本組成物は、投与単位当たり３１．５ｍｇのラニチジン塩酸塩を含有することが好ましい。
本組成物中のケイ酸アルミン酸マグネシウムの量は、投与単位当たり２０〜１３３０ｍｇの範囲内にあることが好ましく、例えば１２５ｍｇであることが好ましい。
本組成物中の水酸化アルミナマグネシウムの量は、投与単位当たり２０〜１３３０ｍｇの範囲内にあることが好ましく、例えば１００ｍｇであることが好ましい。
本組成物中の酸化マグネシウムの量は、投与単位当たり５〜３３０ｍｇの範囲内にあることが好ましく、例えば５０ｍｇであることが好ましい。
【０００８】
本発明による好ましい組成物としては、投与単位当たり、ラニチジンをその遊離塩基の重量換算で１０〜１５０ｍｇ（例えば１０〜７５ｍｇ）、例えばラニチジン塩酸塩を１５．７５ｍｇ、１６８ｍｇ、好ましくは３１．５ｍｇ、ケイ酸アルミン酸マグネシウムを２０〜１３３０ｍｇ（例えば１２５ｍｇ）水酸化アルミナマグネシウムを２０〜１３３０ｍｇ（例えば１００ｍｇ）および酸化マグネシウムを５〜３３０ｍｇ（例えば５０ｍｇ）含んでなるものが挙げられる。
【０００９】
投与は、用いる単位投与量、治療する症状の性質および重さ、および患者の年齢や体重によって、例えば１日６回まで行うことができる。したがって、例えば胃酸過多、飲み過ぎ、食べ過ぎ、酸性胃、胃の不快感、胸やけ（例えば一過性の胸やけ、夜間性胸やけおよび食事によって誘発された胸やけなど）、胃炎および消化不良のような症状であって胃酸度を低下させることが有効な軽度の症状を治療する場合には、ラニチジンを低用量でより頻繁に用いることができ、例えば、ラニチジンをその遊離塩基の重量換算で１０〜１５０ｍｇ（例えば１０〜７５ｍｇ）の投与量で、例えばラニチジン塩酸塩１５．７５ｍｇ、好ましくは３１．５ｍｇを、必要に応じてまたは必要な時に１日６回まで投与することができる。十二指腸潰瘍、胃潰瘍、逆流性食道炎およびゾリンジャー・エリソン症候群のような、より重度の症状に対しては、ラニチジンはより高用量で間隔を開けて投与され、例えば７５〜６００ｍｇ（例えば１５０ｍｇ）の単位投与量を１日１〜４回、好ましくは１回または２回投与する。
【００１０】
本発明による組成物は、経口投与用の形態をしており、口腔投与には錠剤、カプセル、顆粒、粉末、錠剤またはロゼンジの形態をとることができ、或いは懸濁液のような液体製剤の形態をとることができる。顆粒および粉末は直接摂取することができ、または水または他の適当なビヒクルに分散した後に投与することができる。カプセルは、軟質ゼラチンカプセルのような硬質または軟質ゼラチンタイプのものでよい。
本発明による経口組成物は、従来の方法によって調製することができる。例えば錠剤の場合、賦形剤を乾式スラッグ法、湿式造粒または乾式混合を施した後、好適なパンチを備えた適当な錠剤プレスを用いて圧縮して錠剤に成形することができる。
【００１１】
本発明による医薬組成物は、フレーバ、甘味料、充填剤、結合剤、崩壊剤、潤滑剤および乾燥剤のような当該技術分野において通常用いられる他の賦形剤を含有することもできる。好適な賦形剤としては、当業者に周知であるものが挙げられる。
好適なフレーバとしては、例えば、果実フレーバまたは自然もしくは合成のミントまたはペパーミントフレーバが挙げられる。好適な甘味料としては、例えばサッカリンまたはアスパルタームが挙げられる。
錠剤の製造に好適に用いられる結合剤としては、メチルセルロース、カルボキシメチルセルロースナトリウム、ヒドロキシプロピルメチルセルロース、アルギン酸、エチルセルロース、アラビアゴム、ゼラチン、予備ゼラチン化澱粉、スクロースシロップ、ポリビニルピロリドンおよびグアールガムが挙げられる。好ましい結合剤はポリビニルピロリドン（ポビドン）である。
【００１２】
錠剤の製造に好適に用いられる潤滑剤としては、ステアリン酸マグネシウム、ステアリン酸亜鉛、ステアリン酸カルシウム、ステアリン酸、ステアリルフマル酸ナトリウム、水素化した植物油、パルミトステアリン酸グリセリル、ベヘン酸グリセリル、安息香酸ナトリウム、ラウリル硫酸ナトリウム、ラウリル硫酸マグネシウム、鉱油、タルクおよびそれらの混合物が挙げられる。好ましい潤滑剤はステアリン酸マグネシウムである。
錠剤の製造に好適に用いられる乾燥剤としては、シリカゲルが挙げられる。
【００１３】
もう一つのまたは別の態様では、本発明は、ラニチジンもしくはその薬学上許容可能な塩および制酸剤を含んでなる経口医薬組成物の、胃酸度を低下させることが有利である症状を治療するための医薬の製造のための使用であって、制酸剤がケイ酸アルミン酸マグネシウム、水酸化アルミナマグネシウムおよび酸化マグネシウムの混合物を含んでなることを特徴とする使用、を提供する。
【００１４】
【実施例】
本発明を更に下記の例によって説明するが、本発明はこれらの例に限定されるものではない。
実施例１ 製剤例
下記の成分を混合した後、従来の方法で錠剤に成型した。
ラニチジン塩酸塩 ３１．５ｍｇ
ケイ酸アルミン酸マグネシウム １２５ｍｇ
水酸化アルミナマグネシウム １００ｍｇ
酸化マグネシウム ５０ｍｇ
実施例２ 中和能力
この試験は、フックス（Ｆｕｃｈｓ ）の方法に従って行った。具体的には、下記の組成の錠剤２つを、３７℃の０．１Ｎ−ＨＣｌ水溶液５０ｍｌに加え、その溶液を１０分間撹拌した。次いで、追加の０．１Ｎ−ＨＣｌ溶液を、毎分２ｍｌの割合で溶液に加えた。試験中に、溶液のｐＨを測定して記録した。以下に示した錠剤の組成は、本発明による組成物であるが、ラニチジンは除外してある。
ケイ酸アルミン酸マグネシウム ２５０ｍｇ
水酸化アルミナマグネシウム ２００ｍｇ
酸化マグネシウム １００ｍｇ
理論上の制酸量（ｍｌ） １７０．９ｍｌ
ｐＨ３以上とするまでに要する時間 ５２．９分[0001]
[Background of the Invention]
[Industrial applications]
The present invention relates to a pharmaceutical composition comprising ranitidine, an H 2 -antagonist, as an active ingredient, particularly an oral composition combining ranitidine and an antacid.
[0002]
[Prior art]
Ranitidine, N- [2-[[[5- (dimethylamino) methyl-2-furanyl] methyl] thio] ethyl] -N'-methyl-2-nitro-1,1-ethenediamine and its physiological Salts that are acceptable for use are described in GB 1565966, and certain crystalline forms of ranitidine hydrochloride are described and claimed in GB-B-2084580. ing. In each of these specifications, various formulations are mentioned, such as formulations for oral, topical, parenteral or rectal administration. Oral formulations of ranitidine are also described in GB-B-2142820, GB-B-2198352, GB-B-22218336, GB-B-22199940, GB-B-2222772 and GB-B-2229094. Has been described. Combinations of ranitidine and antacids are described in EP 286781 and PCT 92/00102 and 93/12779.
[0003]
Antacids quickly neutralize the symptoms of gastric hyperacidity by neutralization, and H 2 -antagonists independently act to suppress acid secretion, so the combination of H 2 -antagonists and antacids is medical It is advantageous as a composition.
[Summary of the Invention]
[Problems to be solved by the invention]
An object of the present invention is to provide a pharmaceutical composition comprising ranitidine and an antacid in combination.
[0004]
[Means for Solving the Problems]
The present invention provides an oral pharmaceutical composition comprising ranitidine or a pharmaceutically acceptable salt thereof, magnesium aluminate silicate, magnesium aluminate hydroxide and magnesium oxide.
[0005]
[Specific description of the invention]
Suitable pharmaceutically acceptable salts of ranitidine for use in the present invention include inorganic or organic salts such as hydrochloride, hydrobromide, sulfate, acetate, maleate, succinate and fumarate. A salt formed with an acid is mentioned, and a particularly preferred salt is a hydrochloride.
The amount of ranitidine in the composition according to the invention is preferably in the range from 1 to 93%, more preferably from 1 to 20% by weight of ranitidine free base on a weight to weight basis.
The amount of magnesium aluminate silicate in the composition is preferably in the range of 1 to 97% on a weight to weight basis, more preferably 30 to 50%.
The amount of magnesium aluminate hydroxide in the composition is preferably in the range of 1 to 97% on a weight to weight basis, more preferably 20 to 40%.
The amount of magnesium oxide in the composition is preferably in the range from 1 to 85% on a weight to weight basis, more preferably from 5 to 20%.
[0006]
In a preferred embodiment of the pharmaceutical composition according to the present invention, ranitidine is used in an amount of 1 to 93%, preferably 1 to 20% (weight / weight) in terms of the weight of its free base, and magnesium aluminosilicate is used in an amount of 1 to 97%, preferably 1 to 97%. Is 30 to 50% (weight / weight), 1 to 97% alumina magnesium hydroxide, preferably 20 to 40% (weight / weight), 1 to 85% magnesium oxide, preferably 5 to 20% (weight / weight). Weight).
It will be apparent to those skilled in the art that the sum of the proportions of ranitidine, magnesium aluminate silicate, magnesium aluminate hydroxide and magnesium oxide does not exceed 100% (w / w).
[0007]
The present composition contains ranitidine in a range of 10 to 800 mg, preferably 10 to 600 mg, more preferably 10 to 150 mg, for example 10 to 75 mg, per dosage unit in terms of the weight of its free base. For example, the composition may contain 15.75 mg, 31.5 mg, or 168 mg of ranitidine hydrochloride per dosage unit. Preferably, the composition contains 31.5 mg of ranitidine hydrochloride per dosage unit.
The amount of magnesium aluminate silicate in the present composition is preferably in the range of 20 to 1330 mg per dosage unit, for example, preferably 125 mg.
The amount of magnesium aluminate hydroxide in the present composition is preferably in the range of 20 to 1330 mg per dosage unit, for example, preferably 100 mg.
The amount of magnesium oxide in the present composition is preferably in the range of 5-330 mg per dosage unit, for example, preferably 50 mg.
[0008]
Preferred compositions according to the present invention comprise, per dosage unit, 10 to 150 mg (e.g. 10 to 75 mg) of ranitidine in terms of its free base, e.g. 15.75 mg, 168 mg, preferably 31.5 mg of ranitidine hydrochloride, Examples thereof include those containing 20 to 1330 mg (for example, 125 mg) of magnesium acid aluminate, 20 to 1330 mg (for example, 100 mg) of magnesium aluminate hydroxide, and 5 to 330 mg (for example, 50 mg) of magnesium oxide.
[0009]
Administration can be, for example, up to six times daily depending on the unit dose employed, the nature and severity of the condition being treated, and the age and weight of the patient. Thus, for example, hyperacidity, overdose, overeating, acid stomach, stomach discomfort, heartburn (eg, transient heartburn, nocturnal heartburn and meal-induced heartburn, etc.), gastritis and indigestion When treating mild conditions such as reducing gastric acidity where ranitidine is effective, lower doses of ranitidine can be used more frequently, e.g., ranitidine is expressed in terms of its free base by weight. For example, 15.75 mg, preferably 31.5 mg, of ranitidine hydrochloride can be administered as needed or as needed up to 6 times a day in a dose of 10-150 mg (eg 10-75 mg). For more severe conditions, such as duodenal ulcer, gastric ulcer, reflux esophagitis and Zollinger-Ellison syndrome, ranitidine is administered in higher doses at intervals, for example in units of 75-600 mg (eg 150 mg) The dose is administered one to four times a day, preferably once or twice.
[0010]
The composition according to the invention may be in the form for oral administration, for oral administration it may be in the form of tablets, capsules, granules, powders, tablets or lozenges, or in the form of a liquid formulation such as a suspension. It can take the form. Granules and powders can be taken directly or administered after dispersing in water or other suitable vehicle. Capsules may be of the hard or soft gelatin type, such as soft gelatin capsules.
The oral composition according to the present invention can be prepared by a conventional method. For example, in the case of tablets, excipients can be formed into tablets by subjecting them to a dry slug method, wet granulation or dry mixing and then compressing using a suitable tablet press equipped with suitable punches.
[0011]
Pharmaceutical compositions according to the present invention may also contain other excipients commonly used in the art such as flavors, sweeteners, fillers, binders, disintegrants, lubricants and desiccants. Suitable excipients include those well known to those skilled in the art.
Suitable flavors include, for example, fruit flavors or natural or synthetic mint or peppermint flavors. Suitable sweeteners include, for example, saccharin or aspartame.
Binders suitably used in the manufacture of tablets include methylcellulose, sodium carboxymethylcellulose, hydroxypropylmethylcellulose, alginic acid, ethylcellulose, acacia, gelatin, pregelatinized starch, sucrose syrup, polyvinylpyrrolidone and guar gum. A preferred binder is polyvinylpyrrolidone (povidone).
[0012]
Lubricants preferably used in the manufacture of tablets include magnesium stearate, zinc stearate, calcium stearate, stearic acid, sodium stearyl fumarate, hydrogenated vegetable oil, glyceryl palmitostearate, glyceryl behenate, sodium benzoate , Sodium lauryl sulfate, magnesium lauryl sulfate, mineral oil, talc and mixtures thereof. The preferred lubricant is magnesium stearate.
As a desiccant suitably used for the production of tablets, silica gel can be mentioned.
[0013]
In another or another embodiment, the present invention treats a condition of an oral pharmaceutical composition comprising ranitidine or a pharmaceutically acceptable salt thereof and an antacid in which it is advantageous to reduce gastric acidity. For the manufacture of a medicament, wherein the antacid comprises a mixture of magnesium aluminate silicate, magnesium aluminate hydroxide and magnesium oxide.
[0014]
【Example】
The present invention will be further described by the following examples, but the present invention is not limited to these examples.
Example 1 Formulation Example After mixing the following components, the mixture was molded into tablets by a conventional method.
Ranitidine hydrochloride 31.5mg
125mg of magnesium aluminate silicate
Alumina magnesium hydroxide 100mg
Magnesium oxide 50mg
Example 2 Neutralizing capacity This test was performed according to the method of Fuchs. Specifically, two tablets having the following composition were added to 50 ml of a 0.1 N aqueous HCl solution at 37 ° C, and the solution was stirred for 10 minutes. Then, additional 0.1 N HCl solution was added to the solution at a rate of 2 ml per minute. During the test, the pH of the solution was measured and recorded. The composition of the tablets given below is a composition according to the invention, but without ranitidine.
250mg magnesium aluminate silicate
Alumina magnesium hydroxide 200mg
Magnesium oxide 100mg
Theoretical antacid amount (ml) 170.9ml
Time required to reach pH 3 or higher 52.9 minutes
Claims (10)
Priority Applications (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP31698493A JP3587869B2 (en) | 1993-12-16 | 1993-12-16 | Pharmaceutical composition |
| ZA949962A ZA949962B (en) | 1993-12-16 | 1994-12-14 | Ranitidine composition |
| PCT/JP1994/002106 WO1995016446A1 (en) | 1993-12-16 | 1994-12-15 | Ranitidine compositions |
| AU12004/95A AU1200495A (en) | 1993-12-16 | 1994-12-15 | Ranitidine compositions |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP31698493A JP3587869B2 (en) | 1993-12-16 | 1993-12-16 | Pharmaceutical composition |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH07165590A JPH07165590A (en) | 1995-06-27 |
| JP3587869B2 true JP3587869B2 (en) | 2004-11-10 |
Family
ID=18083126
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP31698493A Expired - Lifetime JP3587869B2 (en) | 1993-12-16 | 1993-12-16 | Pharmaceutical composition |
Country Status (4)
| Country | Link |
|---|---|
| JP (1) | JP3587869B2 (en) |
| AU (1) | AU1200495A (en) |
| WO (1) | WO1995016446A1 (en) |
| ZA (1) | ZA949962B (en) |
Families Citing this family (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0867191A4 (en) * | 1995-11-27 | 2000-01-05 | Yamanouchi Pharma Co Ltd | Drug composition |
| WO1999000112A1 (en) * | 1997-06-30 | 1999-01-07 | Chugai Seiyaku Kabushiki Kaisha | Sucralfate-containing composition and process for the preparation thereof |
| JPH1171285A (en) * | 1997-06-30 | 1999-03-16 | Chugai Pharmaceut Co Ltd | Sucralfate-containing composition and its production |
| KR100412290B1 (en) * | 2001-11-27 | 2003-12-31 | 주식회사 동구제약 | Composition of suspension containing ranitidine and its manufacturing process |
| JP5560701B2 (en) * | 2008-12-26 | 2014-07-30 | ライオン株式会社 | Ranitidine-containing pharmaceutical solid preparation and method for producing ranitidine-carrying particles |
| JP5412966B2 (en) * | 2009-06-08 | 2014-02-12 | ライオン株式会社 | Granular preparation |
| JP5609105B2 (en) * | 2009-12-24 | 2014-10-22 | ライオン株式会社 | Ranitidine-containing coated particles and method for producing the same |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2085873A1 (en) * | 1990-06-22 | 1991-12-23 | Adrian Francis Davis | Treatment |
| CZ225893A3 (en) * | 1991-04-04 | 1994-04-13 | Procter & Gamble | Chewing antacid preparation |
| GB9127150D0 (en) * | 1991-12-20 | 1992-02-19 | Smithkline Beecham Plc | Novel treatment |
-
1993
- 1993-12-16 JP JP31698493A patent/JP3587869B2/en not_active Expired - Lifetime
-
1994
- 1994-12-14 ZA ZA949962A patent/ZA949962B/en unknown
- 1994-12-15 AU AU12004/95A patent/AU1200495A/en not_active Abandoned
- 1994-12-15 WO PCT/JP1994/002106 patent/WO1995016446A1/en active Application Filing
Also Published As
| Publication number | Publication date |
|---|---|
| WO1995016446A1 (en) | 1995-06-22 |
| AU1200495A (en) | 1995-07-03 |
| ZA949962B (en) | 1995-08-07 |
| JPH07165590A (en) | 1995-06-27 |
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