JP2020132594A - Tablets containing silodosin - Google Patents
Tablets containing silodosin Download PDFInfo
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- JP2020132594A JP2020132594A JP2019030472A JP2019030472A JP2020132594A JP 2020132594 A JP2020132594 A JP 2020132594A JP 2019030472 A JP2019030472 A JP 2019030472A JP 2019030472 A JP2019030472 A JP 2019030472A JP 2020132594 A JP2020132594 A JP 2020132594A
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- coating layer
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- titanium oxide
- rutile
- silodosin
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- PNCPYILNMDWPEY-QGZVFWFLSA-N silodosin Chemical compound N([C@@H](CC=1C=C(C=2N(CCCO)CCC=2C=1)C(N)=O)C)CCOC1=CC=CC=C1OCC(F)(F)F PNCPYILNMDWPEY-QGZVFWFLSA-N 0.000 title claims abstract description 18
- 229960004953 silodosin Drugs 0.000 title claims abstract description 18
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N titanium dioxide Inorganic materials O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims abstract description 39
- 239000011247 coating layer Substances 0.000 claims abstract description 36
- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 claims abstract description 31
- 230000000052 comparative effect Effects 0.000 description 11
- 239000010410 layer Substances 0.000 description 9
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 8
- 239000007864 aqueous solution Substances 0.000 description 8
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 8
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 8
- 239000000454 talc Substances 0.000 description 8
- 229910052623 talc Inorganic materials 0.000 description 8
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 7
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 7
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 7
- 229960003943 hypromellose Drugs 0.000 description 7
- 239000000126 substance Substances 0.000 description 5
- 239000011248 coating agent Substances 0.000 description 4
- 239000013078 crystal Substances 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 239000002775 capsule Substances 0.000 description 3
- 238000000576 coating method Methods 0.000 description 3
- 150000001875 compounds Chemical class 0.000 description 3
- 239000000203 mixture Substances 0.000 description 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 2
- 229920000881 Modified starch Polymers 0.000 description 2
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 238000004811 liquid chromatography Methods 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 239000008213 purified water Substances 0.000 description 2
- 229910052719 titanium Inorganic materials 0.000 description 2
- 239000010936 titanium Substances 0.000 description 2
- 210000003708 urethra Anatomy 0.000 description 2
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 2
- 206010004446 Benign prostatic hyperplasia Diseases 0.000 description 1
- 208000004403 Prostatic Hyperplasia Diseases 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 206010013990 dysuria Diseases 0.000 description 1
- 238000009472 formulation Methods 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 238000004806 packaging method and process Methods 0.000 description 1
- 210000002307 prostate Anatomy 0.000 description 1
- 229940036914 silodosin 4 mg Drugs 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
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- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
本発明は、光安定性が改善されたシロドシン含有錠剤に関する。 The present invention relates to silodosin-containing tablets with improved photostability.
シロドシン製剤は尿道や前立腺のα１−受容体を遮断することで、尿道内部の圧力を下げ、前立腺肥大症に伴う排尿障害を改善する作用を有する。
シロドシンは光安定性に劣り、遮光性の有するコーティング剤で被覆したコーティング錠あるいは、遮光性のカプセルに充填されたカプセル剤として提案されている（特許文献１，２）。
しかし、カプセル剤では服用に難があり、これまで市販されているコーティング錠では光安定性が不充分であった。
Silodosin preparations have the effect of reducing the pressure inside the urethra by blocking α 1 -receptors in the urethra and prostate, and improving dysuria associated with benign prostatic hyperplasia.
Silodosin is inferior in photostability and has been proposed as a coated tablet coated with a light-shielding coating agent or a capsule filled in a light-shielding capsule (Patent Documents 1 and 2).
However, capsules are difficult to take, and coated tablets on the market have insufficient photostability.
本発明は、シロドシンの光安定性が改善された錠剤の提供を目的とする。 An object of the present invention is to provide a tablet having improved photostability of silodosin.
シロドシンは光に対して不安定であり、デヒドロ体及びその他の多くの類縁物質が分解生成される。
酸化チタンは遮光剤として使用されているものの、結晶構造にアナターゼ型，ルチル型及びブルッカイト型の３種類が存在し、シロドシンに対する光安定性が結晶型によって差があるのか否かも、これまで検討された報告はない。
そこで本発明者らは、酸化チタンの結晶型とシロドシンの光安定性及びシロドシンの分解物との関係を研究調査した結果、本発明に至ったものである。
Silodosin is unstable to light and decomposes and produces dehydros and many other related substances.
Although titanium oxide is used as a light-shielding agent, there are three types of crystal structures, anatase type, rutile type, and brookite type, and it has been investigated whether the photostability to silodosin differs depending on the crystal type. There is no report.
Therefore, the present inventors have arrived at the present invention as a result of researching and investigating the relationship between the crystal form of titanium oxide, the photostability of silodosin, and the decomposition product of silodosin.
本発明に係る錠剤は、シロドシンを含有する素錠と、コーティング層とを有する錠剤であって、前記コーティング層はルチル型酸化チタンを含有することを特徴とする。
本発明者らがシロドシン含有製剤に光照射試験を行い、アナターゼ型とルチル型を比較調査した結果、シロドシンに対してはアナターゼ型よりもルチル型の方がデヒドロ体の生成を抑制していた。
The tablet according to the present invention is a tablet having a silodosin-containing uncoated tablet and a coating layer, and the coating layer is characterized by containing rutile-type titanium oxide.
As a result of conducting a light irradiation test on a silodosin-containing preparation and comparing the anatase type and the rutile type, the present inventors suppressed the production of dehydro form for silodosin in the rutile type rather than in the anatase type.
本発明において、前記コーティング層のルチル型酸化チタンの含有量は、錠剤の表面積に対して０．２ｍｇ／ｃｍ２以上であってよく、好ましくは前記コーティング層のルチル型酸化チタンの含有量は、錠剤の表面積に対して０．４ｍｇ／ｃｍ２以上であって、０．９ｍｇ／ｃｍ２以下である。 In the present invention, the content of rutile-type titanium oxide in the coating layer may be 0.2 mg / cm 2 or more with respect to the surface area of the tablet, and preferably the content of rutile-type titanium oxide in the coating layer is. It is 0.4 mg / cm 2 or more and 0.9 mg / cm 2 or less with respect to the surface area of the tablet.
また、本発明においてコーティング層は２層以上の複層構造であってもよく、前記コーティング層は素錠側の第１コーティング層と、その上に形成した第２コーティング層とを有し、前記第１コーティング層には酸化チタンを含有していないものであってもよい。 Further, in the present invention, the coating layer may have a multi-layer structure of two or more layers, and the coating layer has a first coating layer on the uncoated side and a second coating layer formed on the first coating layer. The first coating layer may not contain titanium oxide.
本発明は、シロドシン錠の遮光剤としてルチル型酸化チタンを用いたことにより、従来の添加量よりも少ない添加量にてシロドシンの光安定性を向上させることができる。 In the present invention, by using rutile-type titanium oxide as a light-shielding agent for silodosin tablets, the photostability of silodosin can be improved with an addition amount smaller than the conventional addition amount.
酸化チタンの結晶型の相違によるシロドシンに対する光安定性を比較評価したので、以下説明する。 Since the photostability for silodosin due to the difference in the crystal type of titanium oxide was compared and evaluated, it will be described below.
一錠当たりシロドシン４ｍｇ，Ｄ−マンニトール１４８ｍｇ，部分アルファー化デンプン２２ｍｇ，低置換度ヒドロキシプロピルセルロース１６ｍｇになるように混合し、一錠当たり６ｍｇになるようにヒドロキシプロピルセルロースを精製水にて溶解した水溶液を用いて、噴霧造粒し、造粒物を得た。
次に、乾燥後にステアリン酸マグネシウムを一錠当たり４ｍｇになるように混合してロータリー打錠機に打錠成型して素錠を得た。
次に一錠当たり、ヒドロキシプロピルセルロース２．４ｍｇ，ヒプロメロース２．４ｍｇを精製水にて溶解した水溶液にルチル型酸化チタン１．６ｍｇ，タルク１．６ｍｇを分散させたものを、前記素錠に噴霧コーティングし、コーティング錠を得た。
本錠剤は、表面積当たりのルチル型酸化チタンの含有量は０．９ｍｇ／ｃｍ２となる。
以下、添加量は特に説明しない限り、一錠当たりの配合量をいう。
An aqueous solution in which silodosin 4 mg, D-mannitol 148 mg, partially pregelatinized starch 22 mg, and low-substituted hydroxypropyl cellulose 16 mg were mixed per tablet, and hydroxypropyl cellulose was dissolved in purified water so as to be 6 mg per tablet. Was used for spray granulation to obtain a granulated product.
Next, after drying, magnesium stearate was mixed so as to be 4 mg per tablet and tableted into a rotary tableting machine to obtain an uncoated tablet.
Next, per tablet, 1.6 mg of rutile-type titanium oxide and 1.6 mg of talc were dispersed in an aqueous solution prepared by dissolving 2.4 mg of hydroxypropyl cellulose and 2.4 mg of hypromellose in purified water, and sprayed onto the uncoated tablet. It was coated and a coated tablet was obtained.
This tablet has a rutile-type titanium oxide content of 0.9 mg / cm 2 per surface area.
Hereinafter, the addition amount refers to the blending amount per tablet unless otherwise specified.
実施例１にて、ルチル型酸化チタンの量を一錠当たり０．８ｍｇ，タルク２．４ｍｇになるようにし、他は実施例１と同様にして錠剤を得た。
実施例２は、錠剤の表面積当たり０．４５ｍｇ／ｃｍ２のルチル型酸化チタンの含有量になる。
In Example 1, the amount of rutile-type titanium oxide was adjusted to 0.8 mg per tablet and 2.4 mg of talc, and tablets were obtained in the same manner as in Example 1.
Example 2 has a rutile-type titanium oxide content of 0.45 mg / cm 2 per tablet surface area.
実施例３は、二層コーティング錠であり、実施例１の素錠に対して第１コーティング層（１層目コーティング）として、ヒドロキシプロピルセルロース１．５ｍｇ，ヒプロメロース１．５ｍｇの水溶液にタルク１．０ｍｇを分散させたコーティング層をコーティングした。
従って、第１コーティング層には酸化チタンは含まれていない。
次に、第１コーティング層の上に、ヒドロキシプロピルセルロース２．４ｍｇ，ヒプロメロース２．４ｍｇの水溶液にルチル型酸化チタン１．６ｍｇ，タルク１．６ｍｇを分散させたものを第２コーティング層（２層目コーティング）とした錠剤を得た。
Example 3 is a two-layer coated tablet, and talc is added to an aqueous solution of 1.5 mg of hydroxypropyl cellulose and 1.5 mg of hypromellose as a first coating layer (first layer coating) with respect to the uncoated tablet of Example 1. A coating layer in which 0 mg was dispersed was coated.
Therefore, the first coating layer does not contain titanium oxide.
Next, on the first coating layer, a second coating layer (two layers) in which 1.6 mg of rutile-type titanium oxide and 1.6 mg of talc were dispersed in an aqueous solution of 2.4 mg of hydroxypropyl cellulose and 2.4 mg of hypromellose. A tablet was obtained as an eye coating).
実施例４は、実施例１においてＤ−マントール１５０ｍｇ，部分アルファー化デンプン２０ｍｇに変え、その他は実施例１と同じ配合の素錠を得た。
次に、上記素錠に酸化チタンが含まれず、ヒドロキシプロピルセルロース１．４ｍｇ，ヒプロメロース１．４ｍｇの水溶液にタルク１．２ｍｇを分散させて第１コーティング層を形成し、次にヒドロキシプロピルセルロース１．２ｍｇ，ヒプロメロース１．２ｍｇの水溶液にルチル型酸化チタン０．８ｍｇ，タルク０．８ｍｇを分散させて第２コーティング層を形成した錠剤を得た。
In Example 4, D-mantol was changed to 150 mg and partially pregelatinized starch was changed to 20 mg in Example 1, and uncoated tablets having the same composition as in Example 1 were obtained.
Next, the uncoated tablet does not contain titanium oxide, and 1.2 mg of talc is dispersed in an aqueous solution of 1.4 mg of hydroxypropyl cellulose and 1.4 mg of hypromellose to form a first coating layer, and then hydroxypropyl cellulose 1. A tablet having a second coating layer formed by dispersing 0.8 mg of rutile-type titanium oxide and 0.8 mg of talc in an aqueous solution of 2 mg and 1.2 mg of hypromellose was obtained.
実施例１に用いた素錠に対して、実施例３と同じ第１コーティング層を形成し、第２コーティング層のルチル型チタンの含有量を０．４ｍｇに減らした錠剤を得た。
これは錠剤表面積に対して０．２ｍｇ／ｃｍ２のルチル型酸化チタン含有量になる。
The same first coating layer as in Example 3 was formed on the uncoated tablets used in Example 1, and the content of rutile-type titanium in the second coating layer was reduced to 0.4 mg to obtain tablets.
This results in a rutile-type titanium oxide content of 0.2 mg / cm 2 relative to the tablet surface area.
（比較例１）
比較例１は実施例１に用いた素錠に対して、ヒドロキシプロピルセルロース２．４ｍｇ，ヒプロメロース２．４ｍｇの水溶液にアナターゼ型酸化チタン１．６ｍｇ，タルク１．６ｍｇ分散させたコーティング液を噴霧してコーティング錠を得た。
(Comparative Example 1)
In Comparative Example 1, the uncoated tablets used in Example 1 were sprayed with a coating solution in which 1.6 mg of anatase-type titanium oxide and 1.6 mg of talc were dispersed in an aqueous solution of 2.4 mg of hydroxypropyl cellulose and 2.4 mg of hypromellose. Obtained a coated tablet.
（比較例２）
比較例２は、二層コーティング錠であり、実施例５に用いた素錠と第１コーティング層の上に、ヒドロキシプロピルセルロース２．４ｍｇ，ヒプロメロース２．４ｍｇの水溶液にタルク１．６ｍｇと、今回はアナターゼ型酸化チタン１．６ｍｇを分散させて用いた第２コーティング層を有する錠剤を得た。
(Comparative Example 2)
Comparative Example 2 is a two-layer coated tablet, and on the uncoated tablet and the first coating layer used in Example 5, an aqueous solution of 2.4 mg of hydroxypropyl cellulose and 2.4 mg of hypromellose and 1.6 mg of talc, this time. Obtained a tablet having a second coating layer in which 1.6 mg of anatase-type titanium oxide was dispersed.
上記実施例１〜５及び比較例１，２の処方の一覧表を表１に示す。
光安定性試験を下記の条件で行った。
「無包装，２５℃，６０％ＲＨ，シャーレ開放，４０００Ｌｕｘ（Ｄ６５ランプ）」の条件で総照度が１２０万Ｌｕｘ・ｈｒとなるまで保存し、液体クロマトグラフィーで類縁物質量の測定を行った。
液体クロマトグラフィーの試験条件は、以下に従うものとする。
The mixture was stored under the conditions of "no packaging, 25 ° C., 60% RH, open petri dish, 4000 Lux (D65 lamp)" until the total illuminance reached 1.2 million Lux · hr, and the amount of related substances was measured by liquid chromatography.
The test conditions for liquid chromatography shall be as follows.
その試験結果を下記表２に示す。
表２中、その他の個々最大とは、デヒドロ体以外の類縁物質のうち、最も発生量の高いものの量を示す。
In Table 2, the other individual maximums indicate the amounts of related substances other than the dehydro form that are generated most frequently.
上記表２に示した試験結果から、次のことが明らかになった。
実施例１と比較例１との違いは、実施例１がルチル型の酸化チタンを用いたものであり、比較例１はアナターゼ型の酸化チタンを用いた点にある。
試験後において、実施例１の方が比較例１に対してデヒドロ体の発生量が半減している。
実施例２は、実施例１よりもルチル型酸化チタンの添加量を半分にしたものであるが、これでもデヒドロ体の物質量に関しては比較例１よりも少ない。
よって、デヒドロ体の生成の抑制効果は、実施例２の錠剤表面積当たり０．４５ｍｇ／ｃｍ２でも充分に認められていることが分かる。
この点において、コーティング層中のルチル型酸化チタンの含有量は、錠剤表面積当たり０．５ｍｇ／ｃｍ２未満であってもよい。
From the test results shown in Table 2 above, the following was clarified.
The difference between Example 1 and Comparative Example 1 is that Example 1 uses rutile-type titanium oxide, and Comparative Example 1 uses anatase-type titanium oxide.
After the test, the amount of dehydro compound generated in Example 1 was halved as compared with Comparative Example 1.
In Example 2, the amount of rutile-type titanium oxide added was halved as compared with Example 1, but the amount of substance of the dehydro compound was still smaller than that of Comparative Example 1.
Therefore, it can be seen that the effect of suppressing the formation of the dehydro form is sufficiently observed even at 0.45 mg / cm 2 per tablet surface area of Example 2.
In this regard, the content of rutile-type titanium oxide in the coating layer may be less than 0.5 mg / cm 2 per tablet surface area.
実施例３は二層コーティング錠にし、内側の第１コーティング層中には酸化チタンを含有しないようにし、第２コーティング層に錠剤表面積当たりルチル型酸化チタンを０．９ｍｇ／ｃｍ２含有させ、実施例４はその含有量を０．４５ｍｇ／ｃｍ２に半減させた例である。
実施例５は更にその含有量を、０．２ｍｇ／ｃｍ２に減らした例である。
これらの光安定性試験結果を比較例１と比較すると、二層コーティング錠としたことによりデヒドロ体以外の類縁物質の発生の抑制効果が高くなり、その結果に関しては実施例５のルチル型チタン含有量錠剤表面積当たり０．２ｍｇ／ｃｍ２でも認められた。
比較例２は二層コーティング錠であって、第２コーティング層に従来のアナターゼ型酸化チタンを０．９ｍｇ／ｃｍ２含有させたものであるが、デヒドロ体の低減効果は認められなかった。
Example 3 is a two-layer coated tablet, so that the inner first coating layer does not contain titanium oxide, and the second coating layer contains 0.9 mg / cm 2 of rutile-type titanium oxide per tablet surface area. Example 4 is an example in which the content is halved to 0.45 mg / cm 2 .
Example 5 is an example in which the content is further reduced to 0.2 mg / cm 2 .
Comparing these photostability test results with Comparative Example 1, the effect of suppressing the generation of related substances other than the dehydro compound was enhanced by using the two-layer coated tablet, and the result was that the rutile-type titanium contained in Example 5 was contained. Amount 0.2 mg / cm 2 per tablet surface area was also observed.
Comparative Example 2 was a two-layer coated tablet in which the second coating layer contained 0.9 mg / cm 2 of conventional anatase-type titanium oxide, but the effect of reducing the dehydro form was not observed.
Claims (4)
前記コーティング層はルチル型酸化チタンを含有することを特徴とする錠剤。 A tablet having a plain tablet containing silodosin and a coating layer.
The coating layer is a tablet containing rutile-type titanium oxide.
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| JP2019030472A JP2020132594A (en) | 2019-02-22 | 2019-02-22 | Tablets containing silodosin |
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| JP2019030472A JP2020132594A (en) | 2019-02-22 | 2019-02-22 | Tablets containing silodosin |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2002129062A (en) * | 2000-10-25 | 2002-05-09 | Toho Titanium Co Ltd | Titanium dioxide for coating, coating liquid for forming of coating layer, and coating pellet and granule |
| JP2004210711A (en) * | 2002-12-27 | 2004-07-29 | Ono Pharmaceut Co Ltd | Coated preparation and method for producing the same |
| JP2008044960A (en) * | 2002-12-16 | 2008-02-28 | Kissei Pharmaceut Co Ltd | Solid drug for oral use |
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2019
- 2019-02-22 JP JP2019030472A patent/JP2020132594A/en not_active Ceased
Patent Citations (3)
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| JP2002129062A (en) * | 2000-10-25 | 2002-05-09 | Toho Titanium Co Ltd | Titanium dioxide for coating, coating liquid for forming of coating layer, and coating pellet and granule |
| JP2008044960A (en) * | 2002-12-16 | 2008-02-28 | Kissei Pharmaceut Co Ltd | Solid drug for oral use |
| JP2004210711A (en) * | 2002-12-27 | 2004-07-29 | Ono Pharmaceut Co Ltd | Coated preparation and method for producing the same |
Non-Patent Citations (1)
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| K. KAKINOKI ET.AL, JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 93(3), JPN6022019833, March 2004 (2004-03-01), pages 582 - 589, ISSN: 0004925321 * |
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