JP2915653B2 - Masked granules - Google Patents
Masked granulesInfo
- Publication number
- JP2915653B2 JP2915653B2 JP3298966A JP29896691A JP2915653B2 JP 2915653 B2 JP2915653 B2 JP 2915653B2 JP 3298966 A JP3298966 A JP 3298966A JP 29896691 A JP29896691 A JP 29896691A JP 2915653 B2 JP2915653 B2 JP 2915653B2
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- Japan
- Prior art keywords
- water
- drug
- granular material
- particle size
- granules
- 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.)
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Description
【０００１】本発明は、薬物の不快な味がマスクされた
粒状物に関する。[0001] The present invention relates to granules in which the unpleasant taste of drugs is masked.
【０００２】[0002]
【従来の技術】医薬品における錠剤、カプセル剤など種
々の剤型にあって、顆粒剤あるいは細粒剤などの粒状製
剤の果たす役割は、特に小児や老齢者の服用性及びコン
プライアンスの向上において極めて重要である。そして
近年、患者の高齢化が急速に進む中で益々その需要は高
まってきている。しかしながら粒状製剤であっても苦味
や酸味あるいは刺激性などの不快な味を有する薬物が含
まれている場合においては、必ずしも服用しやすい製剤
とはなり得ない。2. Description of the Related Art The role of granular preparations such as granules and fine granules in various dosage forms such as tablets and capsules in pharmaceuticals is extremely important, especially in improving the ingestibility and compliance of children and the elderly. It is. And, in recent years, as the aging of patients has progressed rapidly, the demand has been increasing more and more. However, even in the case of a granular preparation, when a drug having an unpleasant taste such as bitterness, acidity or irritation is contained, the preparation is not necessarily easy to take.
【０００３】このため、一般に不快な味を有する粒状製
剤には、不快な味をマスキングするための製剤的工夫が
なされるのが通例である。一般に最も多く用いられる製
剤手法としては、ワックスや水不溶性高分子など口中で
溶解しないコーティング剤を粒状物表面にコーティング
する方法がある。この場合、従来ではコーティング剤を
有機溶媒に溶かすか、または水に懸濁させてスプレーコ
ーティングを施す方法が用いられていた。しかしなが
ら、有機溶媒を用いることは、作業者への衛生上の悪影
響、環境汚染及び製剤中への残留など問題点が多い。こ
のため最近ではコーティング剤を可塑剤とともに水に分
散させてコーティングを施す方法が見いだされ、広く用
いられるようになった。しかしこの方法もまた、水に不
安定な薬物には不適当であり、更には水易溶性の薬物に
適用した場合では薬物がコーティング液に溶けやすいた
め、コーティング時の粒状物同士の付着による凝集物の
発生や被膜形成不良等の欠点を有する。また、スプレー
コーティングの場合、コーティング速度や温度など製造
条件の変動要因が多いため、常に一定品質の製剤を得る
ための精度の高い条件管理が必要となる。特に、粒状製
剤のマスキングにおいては、水不溶性のコーティング剤
を用いるため、条件変動による被膜形成性のバラツキや
被膜量のわずかな変動により品質上重要となる薬物の溶
出特性に大きな影響を及ぼすことを注意しなければなら
ない。[0003] For this reason, generally, granular preparations having an unpleasant taste are usually devised with a formulation for masking the unpleasant taste. The most commonly used formulation technique is to coat the surface of the granular material with a coating agent that does not dissolve in the mouth, such as a wax or a water-insoluble polymer. In this case, conventionally, a method of dissolving the coating agent in an organic solvent or suspending the coating agent in water to perform spray coating has been used. However, the use of the organic solvent has many problems such as adverse effects on hygiene to workers, environmental pollution, and residues in the preparation. For this reason, recently, a method of applying a coating by dispersing a coating agent in water together with a plasticizer has been found, and has been widely used. However, this method is also unsuitable for water-unstable drugs, and when applied to a water-soluble drug, the drug is easily dissolved in the coating solution. It has drawbacks such as generation of substances and poor film formation. Further, in the case of spray coating, since there are many fluctuation factors of manufacturing conditions such as coating speed and temperature, it is necessary to control conditions with high accuracy to always obtain a preparation of constant quality. In particular, since water-insoluble coating agents are used in the masking of granular preparations, it is important to note that variations in film formation due to changes in conditions and slight fluctuations in the amount of films have a significant effect on the elution characteristics of drugs that are important in quality. You have to be careful.
【０００４】[0004]
【発明が解決しようとする課題】本発明は、薬物のにが
みなどの不快な味を効率的にマスクした粒状物を提供す
ることを目的とする。SUMMARY OF THE INVENTION It is an object of the present invention to provide a granular material in which an unpleasant taste such as a bite of a drug is efficiently masked.
【０００５】[0005]
【課題を達成するための手段】本発明は不快な味を有す
る薬物と水不溶性高分子を粉粒状の水溶性低融点物質を
用いて造粒すると、薬物の不快な味が効率良くマスクで
きるとの知見に基づいてなされたのである。すなわち、
本発明は、粉粒状の薬物及び粉粒状の水不溶性高分子が
粉粒状の水溶性低融点物質により溶融造粒されているこ
とを特徴とする粒状物を提供する。ここで、水溶性低融
点物質は、融点が４０℃〜９０℃の、多価アルコール、
水溶性界面活性剤およびそれらの混合物から選ばれ、
「水不溶性高分子」はアクリル酸系高分子、セルロース
系高分子及びそれらの混合物から選ばれる。 SUMMARY OF THE INVENTION The present invention is intended to provide a method for efficiently masking an unpleasant taste of a drug by granulating a drug having an unpleasant taste and a water-insoluble polymer using a powdery water-soluble low-melting substance. It was based on the findings of That is,
The present invention provides a granular material characterized in that a granular drug and a granular water-insoluble polymer are melt-granulated with a granular water-soluble low-melting substance. Where water-soluble low-melting
The point substance is a polyhydric alcohol having a melting point of 40 ° C to 90 ° C,
Selected from water-soluble surfactants and mixtures thereof,
"Water-insoluble polymer" refers to acrylic acid polymer, cellulose
It is selected from system polymers and mixtures thereof.
【０００６】本発明で用いる水溶性低融点物質として
は、その融点が４０〜９０℃、好適には５０〜８０℃の
ものが望ましく、例えば、マクロゴール２００００、マ
クロゴール６０００、マクロゴール４０００などの多価
アルコール類、水溶性界面活性剤もしくはこれらの混合
物が挙げられる。また、高級脂肪酸などの水不溶性の低
融点物質であっても、マクロゴール類などの水溶性低融
点物質と共融して得られる混合物も使用することができ
る。その使用量は粒状物１重量部に対し通常0.１５〜0.
３５重量部である。又、粉粒状のものを使用するのが好
ましく、その粒径は目的とする粒状物の粒径に応じて決
定すればよく、通常１００〜８４０μm の範囲のものを
用いるのがよい。The water-soluble low-melting substance used in the present invention preferably has a melting point of 40 to 90 ° C., preferably 50 to 80 ° C., for example, Macrogol 20000, Macrogol 6000, Macrogol 4000 and the like. Examples include polyhydric alcohols, water-soluble surfactants, and mixtures thereof. In addition, even a water-insoluble low-melting substance such as a higher fatty acid can be used as a mixture obtained by eutectic with a water-soluble low-melting substance such as macrogol. The amount of use is usually 0.15 to 0.1 per part by weight of the granular material.
35 parts by weight. It is preferable to use a powdery and granular material, and the particle size may be determined according to the particle size of the target granular material, and it is generally preferable to use a particle size in the range of 100 to 840 μm.
【０００７】上記水溶性低融点物質を用いて溶融造粒さ
れる薬物としては、不快な味を有する薬物である塩酸セ
トラキサート、オフロキサシン、インドメタシン、アス
ピリン、３−（（２−（（２−（３，４−ジメトキシフ
ェニル）エチル）アミノ）−２−オキソエチル）アミ
ノ）−Ｎ−メチルベンズアミドなどをあげることがで
き、中でも難溶性の薬物を好適なものとして挙げること
ができる。これらは通常、粒状物１重量部に対し0.０１
〜0.５重量部使用するのがよい。上記被コーティング造
粒物は水溶性低融点物質と薬物のみで形成することがで
きるが、賦形剤としてとうもろこしデンプン、乳糖等を
使用することができ、目的物の重量に応じて、適当量使
用すればよい。又、賦形剤としては粒径が通常１〜１５
０μm のものを使用するのがよい。又、分散剤としてタ
ルク、合成ケイ酸アルミニウム、ケイ酸マグネシウム等
を使用することができ、その使用量は粒状物１重量部に
対し通常0.０５〜0.３重量部である。又、タルクとして
は粒径が１０μm 前後のものを使用すればよく、合成ケ
イ酸アルミニウム、ケイ酸マグネシウムとしては２０μ
m 以下のものを使用すればよい。[0007] Drugs that are melt-granulated using the above water-soluble low-melting substances include cetraxate hydrochloride, ofloxacin, indomethacin, aspirin, 3-((2-((2- (3 , 4-dimethoxyphenyl) ethyl) amino) -2-oxoethyl) amino) -N-methylbenzamide and the like. Among them, a poorly soluble drug can be mentioned as a preferable one. These are usually 0.01 to 1 part by weight of the granular material.
It is preferred to use 0.5 parts by weight. The granules to be coated can be formed only of a water-soluble low-melting substance and a drug, but corn starch, lactose, etc. can be used as an excipient, and an appropriate amount is used according to the weight of the target substance. do it. In addition, the particle size is usually 1 to 15 as an excipient.
It is preferable to use the one of 0 μm. Further, talc, synthetic aluminum silicate, magnesium silicate, and the like can be used as a dispersant, and the amount of use is usually 0.05 to 0.3 part by weight based on 1 part by weight of the granular material. Talc having a particle size of about 10 μm may be used, and synthetic aluminum silicate and magnesium silicate having a particle diameter of about 20 μm may be used.
m or less should be used.
【０００８】本発明の粒状物にかかわる水不溶性の高分
子としてはオイドラギットＳ、オイドラギットＬ、オイ
ドラギットＲＳ、オイドラギットＲＬなどのアクリル酸
系高分子、セルロースアセテートフタレート、カルボキ
シメチルエチルセルロースなどのセルロース系高分子等
が挙げられ、該基剤の大きさは、一般に２０μm 以下に
粉砕されて用いられ、その使用量は粒状物１重量部に対
し通常0.０１〜0.１重量部である。Examples of the water-insoluble polymer relating to the granular material of the present invention include acrylic polymers such as Eudragit S, Eudragit L, Eudragit RS and Eudragit RL, and cellulose polymers such as cellulose acetate phthalate and carboxymethylethyl cellulose. The size of the base is generally used after being pulverized to 20 μm or less, and the amount of the base is usually 0.01 to 0.1 part by weight based on 1 part by weight of the granular material.
【０００９】本発明の薬物の不快な味がマスクされた粒
状物は以下の方法により製造することができる。粉粒状
の水溶性低融点物質と薬物粉体及び水不溶性高分子を、
場合によっては適当な賦形剤及び分散剤とともに流動混
合下、低融点物質の融点以上の温度に加熱しながら造粒
し、冷却することにより本願発明の粒状物を得ることが
できる。得られた粒状物はこのままでも十分なマスキン
グ効果を有するが、場合によってはさらにタルクなどの
微粉末状添加物を同様の操作でコーティングすることが
できる。その場合、タルクなどの使用量は、先の造粒過
程で使用した分散剤の使用量と合わせて、コーティング
された粒状物１重量部に対し、通常0.０１〜0.３重量部
である。[0009] Granules with the unpleasant taste of the drug of the present invention masked can be produced by the following method. Powdered water-soluble low-melting substance, drug powder and water-insoluble polymer,
In some cases, the granulated product of the present invention can be obtained by granulating while heating to a temperature equal to or higher than the melting point of the low-melting substance under fluid mixing with an appropriate excipient and dispersant, and cooling. The obtained granules have a sufficient masking effect as they are, but in some cases, fine powder additives such as talc can be further coated by the same operation. In that case, the amount of talc or the like used is usually 0.01 to 0.3 part by weight, based on 1 part by weight of the coated granular material, together with the amount of the dispersant used in the previous granulation process. .
【００１０】加熱操作は通常熱風により行われその温度
は一般に、用いる水溶性低融点物質の融点より５〜３０
℃高い温度で操作され、その時間は用いる原材料の種類
や製造スケールによって異なるが、通常１〜１０kg程度
のスケールにおいては１０〜３０分である。[0010] The heating operation is usually performed by hot air, and the temperature is generally 5 to 30 degrees below the melting point of the water-soluble low-melting substance used.
The operation is carried out at a high temperature of 10 ° C., and the time varies depending on the type of raw materials used and the production scale, but is usually 10 to 30 minutes on a scale of about 1 to 10 kg.
【００１１】[0011]
【発明の効果】本発明のマスキング粒状物は、口中にお
ける味のマスキング性、溶出性、外観、強度、安定性等
粒状製剤として優れた品質を有する。また、その他にも
極めて有用な以下の利点を有する。 (1) 一般のマスキング粒状物の製造に比べて、結合液
やコーティング液を調製する必要がない上、製造時間が
大幅に短縮でき、また複雑な条件設定を必要とせず簡単
な装置によって一定品質の製品を収率よく製造できる。 (2) 溶媒を用いる必要がないため、安全面、衛生面、
公害面、製品中への残留などの危険性がなく、更に薬物
の安定性も損なうことがない。 (3) 水溶性低融点物質の粒度を変えることにより、容
易に製品の粒度をコントロールすることができる。例え
ば、造粒時１５０〜２５０μm の水溶性低融点物質を用
いると、粒径２５０〜５００μm の細粒剤が得られ、３
００〜８５０μm の水溶性低融点物質を用いると、粒径
５００〜１４００μm の顆粒剤を得ることができる。 (4) 水溶性低融点物質及び水不溶性高分子の種類や量
を調節することにより、口中におけるマスキングの程度
及び体内での溶出性を自由にコントロールすることがで
きる。次に実施例をあげて本発明を具体的に説明する。EFFECT OF THE INVENTION The masked granules of the present invention have excellent quality as granulated preparations such as taste masking properties in the mouth, dissolution properties, appearance, strength and stability. In addition, it has the following very useful advantages. (1) Compared to the production of general masking granules, there is no need to prepare a binding solution or coating solution, the production time can be significantly reduced, and a constant quality can be achieved with simple equipment without the need for complicated conditions. Can be manufactured in good yield. (2) Since there is no need to use solvents, safety, hygiene,
There is no danger of pollution, residue in the product, etc., and the stability of the drug is not impaired. (3) The particle size of the product can be easily controlled by changing the particle size of the water-soluble low-melting substance. For example, when a water-soluble low-melting substance having a particle size of 150 to 250 μm is used during granulation, a fine granule having a particle size of 250 to 500 μm can be obtained.
When a water-soluble low melting point substance having a particle size of from 500 to 850 µm is used, a granule having a particle size of from 500 to 1400 µm can be obtained. (4) By controlling the type and amount of the water-soluble low-melting substance and the water-insoluble polymer, the degree of masking in the mouth and dissolution in the body can be freely controlled. Next, the present invention will be specifically described with reference to examples.
【００１２】[0012]
実施例 １ 流動層造粒機（グラットＷＳＧ−５型）に塩酸セトラキ
サート（粒径：１５０μm 以下）2.８kg、タルク0.５k
g、粉砕したオイドラギットＳ１００（平均粒径５μm
）0.５kg及びマクロゴール６０００（１５０〜２５０
μm 、日本油脂製）1.２kgを入れ、吸気温度８０℃で加
熱流動させながら造粒したのち冷却し、５00μm のふる
いにて篩過し、粒状物（細粒剤）を得た。Example 1 2.8 kg of cetraxate hydrochloride (particle size: 150 μm or less) and 0.5 k of talc in a fluidized bed granulator (Grat WSG-5 type)
g, pulverized Eudragit S100 (average particle size 5 μm
) 0.5 kg and Macrogol 6000 (150-250
1.2 kg), and granulated while heating and fluidizing at an intake air temperature of 80 ° C., cooled, and sieved through a 500 μm sieve to obtain granules (fine granules).
【００１３】実施例 ２ 実施例１と同様にして得られた粒状物4.２kgを、タルク
1.５６kgとともに再び流動層造粒機に入れ、吸気温度８
５℃で加熱しながら流動させ、粉末がすべて被コーティ
ング粒状物に付着した（約２０分）のち、ダンパー操作
により熱風を室内空気に替え試料温度４０℃まで冷却し
て粒状物（細粒剤）を得た。Example 2 4.2 kg of the granular material obtained in the same manner as in Example 1 was
Re-enter the fluidized bed granulator together with 1.56 kg, intake air temperature 8
After flowing the powder while heating at 5 ° C., and all the powder adhered to the coated granular material (approximately 20 minutes), the hot air was replaced with room air by a damper operation and cooled to a sample temperature of 40 ° C. to obtain a granular material (fine granule). I got
【００１４】実施例 ３ 流動層造粒機にオフロキサシン1.４kg（粒径：１０μm
以下）、オイドラギットＳ100(平均粒径５μm)0.５kg、
乳糖1.５kg、タルク0.３kg及びマクロゴール６０００
（１５０〜２５０μm ）1.３kgを入れ、吸気温度８０℃
で実施例１と同様にして粒状物（細粒剤）を得た。Example 3 1.4 kg of ofloxacin (particle size: 10 μm) was added to a fluidized bed granulator.
Below), Eudragit S100 (average particle size 5 μm) 0.5 kg,
Lactose 1.5kg, talc 0.3kg and macrogol 6000
(150-250μm) Put 1.3kg, intake temperature 80 ℃
In the same manner as in Example 1, a granular material (fine granule) was obtained.
【００１５】試験例１ 実施例１、２及び３で得られた粒状物につき、口中マス
キング試験及び溶出試験を実施した。口中マスキング試
験は、試料のそれぞれ0.５ｇを口に含み苦味あるいは酸
味を感じるまでの時間を測定しマスキング時間とした。
なお試験者は５名とした。Test Example 1 A mouth masking test and a dissolution test were carried out on the granules obtained in Examples 1, 2 and 3. In the mouth masking test, 0.5 g of each of the samples was contained in the mouth, and the time until bitterness or sourness was felt was measured and defined as masking time.
The number of testers was five.
【００１６】溶出試験は、日局一般試験法溶出試験法第
１法により行い、日局第１液を用いて試験開始後５分お
きに３０分までの試験液をサンプリングし、塩酸セトラ
サートまたはオフロキサシンの吸光度を測定しその溶出
率７５％に達する時間（Ｔ75％）を計算により求めた。
これらの結果を表１に示した。The dissolution test is carried out according to the Japanese Pharmacopoeia General Test Method, Dissolution Test Method 1, using the Japanese Pharmacopoeia first solution, sampling the test solution for up to 30 minutes every 5 minutes after the start of the test, and then using settrasert hydrochloride or ofloxacin. Was measured and the time to reach the elution rate of 75% (T 75 %) was determined by calculation.
The results are shown in Table 1.
【００１７】 表１ 試験結果 ──────────────────────────── マスキング時間 溶出時間（Ｔ75％） ──────────────────────────── 実施例１ １０〜３０秒 2.２分 実施例２ ３０〜５０秒 3.５分 実施例３ ２０〜４０秒 1.７分 ──────────────────────────── 表１から明らかなように、本発明の粒状物は十分な口中
マスキング性を有し、しかも速やかな溶出特性を示し
た。Table 1 Test results マ ス Masking time Elution time (T 75 %) ────── ────────────────────── Example 1 10 to 30 seconds 2.2 minutes Example 2 30 to 50 seconds 3.5 minutes Example 3 20 to 40 Seconds 1.7 minutes よ う As is clear from Table 1, the granules of the present invention It had masking properties and showed rapid elution characteristics.
───────────────────────────────────────────────────── フロントページの続き (51)Int.Cl.6 識別記号 ＦＩ Ｂ０１Ｊ 2/00 Ｂ０１Ｊ 2/00 Ｂ (58)調査した分野(Int.Cl.6，ＤＢ名) A61K 9/14 A61K 47/10 A61K 47/12 A61K 47/32 A61K 47/36 B01J 2/00 ＣＡ（ＳＴＮ)──────────────────────────────────────────────────の Continued on the front page (51) Int.Cl. 6 identification symbol FI B01J 2/00 B01J 2/00 B (58) Fields investigated (Int.Cl. 6 , DB name) A61K 9/14 A61K 47 / 10 A61K 47/12 A61K 47/32 A61K 47/36 B01J 2/00 CA (STN)
Claims (1)
リル酸系高分子、セルロース系高分子およびそれらの混
合物から選ばれる粉粒状の水不溶性高分子が、多価アル
コール、水溶性界面活性剤およびそれらの混合物から選
ばれる、融点が４０℃〜９０℃の粉粒状の水溶性低融点
物質と溶融造粒されていることを特徴とする前記薬物の
苦みがマスクされた粒状物。Claims: 1. A drug having a powdery and granular bitterness , and
Lylic acid polymers, cellulosic polymers and their mixtures
Of particulate selected from the compounds a water-insoluble polymer, a polyhydric Al
Coal, water-soluble surfactants and their mixtures.
The drug is characterized in that it is melt-granulated with a powdery water-soluble low-melting substance having a melting point of 40 ° C to 90 ° C.
Granular material with bitterness masked .
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP3298966A JP2915653B2 (en) | 1991-11-14 | 1991-11-14 | Masked granules |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP3298966A JP2915653B2 (en) | 1991-11-14 | 1991-11-14 | Masked granules |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH05194193A JPH05194193A (en) | 1993-08-03 |
| JP2915653B2 true JP2915653B2 (en) | 1999-07-05 |
Family
ID=17866493
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP3298966A Expired - Fee Related JP2915653B2 (en) | 1991-11-14 | 1991-11-14 | Masked granules |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2915653B2 (en) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU5997999A (en) * | 1998-09-30 | 2000-04-17 | Taisho Pharmaceutical Co., Ltd. | Grains for oral preparations |
| CN1247188C (en) * | 2000-09-19 | 2006-03-29 | 第一制药株式会社 | Medicinal composition |
| JP3405342B2 (en) * | 2001-09-11 | 2003-05-12 | 味の素株式会社 | Method for producing granular material to which flavor and odorant are attached |
| JP7487290B2 (en) * | 2020-03-11 | 2024-05-20 | 沢井製薬株式会社 | Granules and preparations using the same |
-
1991
- 1991-11-14 JP JP3298966A patent/JP2915653B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| JPH05194193A (en) | 1993-08-03 |
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