JP2016204359A - 医薬製剤 - Google Patents
医薬製剤 Download PDFInfo
- Publication number
- JP2016204359A JP2016204359A JP2015251825A JP2015251825A JP2016204359A JP 2016204359 A JP2016204359 A JP 2016204359A JP 2015251825 A JP2015251825 A JP 2015251825A JP 2015251825 A JP2015251825 A JP 2015251825A JP 2016204359 A JP2016204359 A JP 2016204359A
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- rebamipide
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- 229910017604 nitric acid Inorganic materials 0.000 description 1
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- 125000001436 propyl group Chemical group [H]C([*])([H])C([H])([H])C([H])([H])[H] 0.000 description 1
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- ZUFQODAHGAHPFQ-UHFFFAOYSA-N pyridoxine hydrochloride Chemical compound Cl.CC1=NC=C(CO)C(CO)=C1O ZUFQODAHGAHPFQ-UHFFFAOYSA-N 0.000 description 1
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- 239000011769 retinyl palmitate Substances 0.000 description 1
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- 239000002151 riboflavin Substances 0.000 description 1
- XWGJFPHUCFXLBL-UHFFFAOYSA-M rongalite Chemical compound [Na+].OCS([O-])=O XWGJFPHUCFXLBL-UHFFFAOYSA-M 0.000 description 1
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- 229910052710 silicon Inorganic materials 0.000 description 1
- 239000010703 silicon Substances 0.000 description 1
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- GQTHJBOWLPZUOI-FJXQXJEOSA-M sodium D-pantothenate Chemical compound [Na+].OCC(C)(C)[C@@H](O)C(=O)NCCC([O-])=O GQTHJBOWLPZUOI-FJXQXJEOSA-M 0.000 description 1
- 239000001632 sodium acetate Substances 0.000 description 1
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- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical compound [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 description 1
- 235000010234 sodium benzoate Nutrition 0.000 description 1
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- 239000001509 sodium citrate Substances 0.000 description 1
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 description 1
- 235000011083 sodium citrates Nutrition 0.000 description 1
- 235000019259 sodium dehydroacetate Nutrition 0.000 description 1
- 229940079839 sodium dehydroacetate Drugs 0.000 description 1
- AJPJDKMHJJGVTQ-UHFFFAOYSA-M sodium dihydrogen phosphate Chemical compound [Na+].OP(O)([O-])=O AJPJDKMHJJGVTQ-UHFFFAOYSA-M 0.000 description 1
- HRZFUMHJMZEROT-UHFFFAOYSA-L sodium disulfite Chemical compound [Na+].[Na+].[O-]S(=O)S([O-])(=O)=O HRZFUMHJMZEROT-UHFFFAOYSA-L 0.000 description 1
- 235000010267 sodium hydrogen sulphite Nutrition 0.000 description 1
- 235000010262 sodium metabisulphite Nutrition 0.000 description 1
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- 239000001488 sodium phosphate Substances 0.000 description 1
- 235000010265 sodium sulphite Nutrition 0.000 description 1
- DSOWAKKSGYUMTF-GZOLSCHFSA-M sodium;(1e)-1-(6-methyl-2,4-dioxopyran-3-ylidene)ethanolate Chemical compound [Na+].C\C([O-])=C1/C(=O)OC(C)=CC1=O DSOWAKKSGYUMTF-GZOLSCHFSA-M 0.000 description 1
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- GEYJUFBPCGDENK-UHFFFAOYSA-M sodium;3,8-dimethyl-5-propan-2-ylazulene-1-sulfonate Chemical compound [Na+].CC(C)C1=CC=C(C)C2=C(S([O-])(=O)=O)C=C(C)C2=C1 GEYJUFBPCGDENK-UHFFFAOYSA-M 0.000 description 1
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- 229940035048 sorbitan monostearate Drugs 0.000 description 1
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- 239000001589 sorbitan tristearate Substances 0.000 description 1
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- 239000000600 sorbitol Substances 0.000 description 1
- 235000010356 sorbitol Nutrition 0.000 description 1
- 235000012424 soybean oil Nutrition 0.000 description 1
- 239000003549 soybean oil Substances 0.000 description 1
- 235000019721 spearmint oil Nutrition 0.000 description 1
- 241000894007 species Species 0.000 description 1
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- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
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- 235000000346 sugar Nutrition 0.000 description 1
- 150000008163 sugars Chemical class 0.000 description 1
- 229960000654 sulfafurazole Drugs 0.000 description 1
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- BDHFUVZGWQCTTF-UHFFFAOYSA-M sulfonate Chemical compound [O-]S(=O)=O BDHFUVZGWQCTTF-UHFFFAOYSA-M 0.000 description 1
- 150000003871 sulfonates Chemical class 0.000 description 1
- JLKIGFTWXXRPMT-UHFFFAOYSA-N sulphamethoxazole Chemical compound O1C(C)=CC(NS(=O)(=O)C=2C=CC(N)=CC=2)=N1 JLKIGFTWXXRPMT-UHFFFAOYSA-N 0.000 description 1
- 239000000829 suppository Substances 0.000 description 1
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- 229940116411 terpineol Drugs 0.000 description 1
- 229940021790 tetrahydrozoline hydrochloride Drugs 0.000 description 1
- BJORNXNYWNIWEY-UHFFFAOYSA-N tetrahydrozoline hydrochloride Chemical compound Cl.N1CCN=C1C1C2=CC=CC=C2CCC1 BJORNXNYWNIWEY-UHFFFAOYSA-N 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
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- 239000011732 tocopherol Substances 0.000 description 1
- 229940042585 tocopherol acetate Drugs 0.000 description 1
- JOXIMZWYDAKGHI-UHFFFAOYSA-M toluene-4-sulfonate Chemical compound CC1=CC=C(S([O-])(=O)=O)C=C1 JOXIMZWYDAKGHI-UHFFFAOYSA-M 0.000 description 1
- JOXIMZWYDAKGHI-UHFFFAOYSA-N toluene-4-sulfonic acid Chemical compound CC1=CC=C(S(O)(=O)=O)C=C1 JOXIMZWYDAKGHI-UHFFFAOYSA-N 0.000 description 1
- 210000002105 tongue Anatomy 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- GYDJEQRTZSCIOI-LJGSYFOKSA-N tranexamic acid Chemical compound NC[C@H]1CC[C@H](C(O)=O)CC1 GYDJEQRTZSCIOI-LJGSYFOKSA-N 0.000 description 1
- 229960000401 tranexamic acid Drugs 0.000 description 1
- NZHGWWWHIYHZNX-CSKARUKUSA-N tranilast Chemical compound C1=C(OC)C(OC)=CC=C1\C=C\C(=O)NC1=CC=CC=C1C(O)=O NZHGWWWHIYHZNX-CSKARUKUSA-N 0.000 description 1
- 229960005342 tranilast Drugs 0.000 description 1
- WYXIGTJNYDDFFH-UHFFFAOYSA-Q triazanium;borate Chemical compound [NH4+].[NH4+].[NH4+].[O-]B([O-])[O-] WYXIGTJNYDDFFH-UHFFFAOYSA-Q 0.000 description 1
- 150000003918 triazines Chemical class 0.000 description 1
- 235000013337 tricalcium citrate Nutrition 0.000 description 1
- BSVBQGMMJUBVOD-UHFFFAOYSA-N trisodium borate Chemical compound [Na+].[Na+].[Na+].[O-]B([O-])[O-] BSVBQGMMJUBVOD-UHFFFAOYSA-N 0.000 description 1
- RYFMWSXOAZQYPI-UHFFFAOYSA-K trisodium phosphate Chemical compound [Na+].[Na+].[Na+].[O-]P([O-])([O-])=O RYFMWSXOAZQYPI-UHFFFAOYSA-K 0.000 description 1
- 229910000406 trisodium phosphate Inorganic materials 0.000 description 1
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- 239000008158 vegetable oil Substances 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
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- 239000011782 vitamin Substances 0.000 description 1
- 238000010792 warming Methods 0.000 description 1
- 238000005406 washing Methods 0.000 description 1
- 239000008215 water for injection Substances 0.000 description 1
- 239000000811 xylitol Substances 0.000 description 1
- 235000010447 xylitol Nutrition 0.000 description 1
- HEBKCHPVOIAQTA-SCDXWVJYSA-N xylitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)CO HEBKCHPVOIAQTA-SCDXWVJYSA-N 0.000 description 1
- 229960002675 xylitol Drugs 0.000 description 1
- 239000011592 zinc chloride Substances 0.000 description 1
- 235000005074 zinc chloride Nutrition 0.000 description 1
- 239000011576 zinc lactate Substances 0.000 description 1
- 235000000193 zinc lactate Nutrition 0.000 description 1
- 229940050168 zinc lactate Drugs 0.000 description 1
- XSMMCTCMFDWXIX-UHFFFAOYSA-N zinc silicate Chemical compound [Zn+2].[O-][Si]([O-])=O XSMMCTCMFDWXIX-UHFFFAOYSA-N 0.000 description 1
- 235000019352 zinc silicate Nutrition 0.000 description 1
- NWONKYPBYAMBJT-UHFFFAOYSA-L zinc sulfate Chemical compound [Zn+2].[O-]S([O-])(=O)=O NWONKYPBYAMBJT-UHFFFAOYSA-L 0.000 description 1
- 229960001763 zinc sulfate Drugs 0.000 description 1
- 229910000368 zinc sulfate Inorganic materials 0.000 description 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical compound OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
Landscapes
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Description
K=(1.5logηrel−1)/(0.15+0.003c)+[300clogηrel +(c+1.5clogηrel)2]1/2/(0.15c+0.003c2) ……(1)
ηrel:ポリビニルピロリドン水溶液の水に対する相対粘度
c:ポリビニルピロリドン水溶液中のポリビニルピロリドン濃度(%)
また、(A)成分と共に含有されることにより医薬製剤の粘度安定性が向上される観点から、好ましくは0.00001w/v%〜1w/v%、より好ましくは、0.0001w/v%〜0.5w/v%、さらに好ましくは0.0001〜0.1w/v%、更により好ましくは0.001〜0.1w/v%、最も好ましくは0.01〜0.1w/v%であるである。
(日本薬局方で)規定されており、医薬製剤の容器は内部を観察できる透明の容器であることが要求されている。また、使用者にとっては、残存量の確認のためにも内部を肉眼で観察できる程度の透明性を備えている容器が望ましいといえる。よって、容器は、品質管理における異物確認試験の観点から、内部を肉眼で観察可能な程度の内部視認性(透明性)を有する容器であることが好ましい。内部視認性(透明性)を有する容器は、特に、品質管理において異物確認試験が薬事法上(日本薬局方で)規定されている、点眼剤、洗眼剤、注射剤等に適している。一方、残存量の確認の観点からも、全ての種類の水性医薬組成物において、内部視認性(透明性)を有する容器に収容されていることが好ましい。
(R)900、チヌビン(R)928、チヌビン(R)1130、パラメトキシケイ皮酸2−エチルヘキシル、ジパラメトキシケイ皮酸モノ−2−エチルヘキサン酸グリセリル、2,4,6−トリス[4−(2−エチルヘキシルオキシカルボニル)アニリノ]1,3,5−トリアジン、フェニルベンズイミダゾールスルホン酸、2−(4−ジエチルアミノ−2−ヒドロキシベンゾイル)−安息香酸ヘキシル、ジメトキシベンジリデンジオキソイミダゾリジンプロピオン酸2−エチルヘキシルが挙げられ、特に好ましくは酸化亜鉛、酸化チタン、チヌビン(R)328、チヌビン(R)384−2、チヌビン(R)400、チヌビン(R)400−2、チヌビン(R)900、チヌビン(R)928、チヌビン(R)1130である。酸化亜鉛、酸化チタンは、更にシリカ、シリコン、ケイ酸亜鉛などで被覆されていてもよい。
表1に示す組成の水性医薬組成物を常法に従って調製した。具体的には、各成分を100mL容量ビーカーに量り取り、必要量の蒸留水を添加した。加温しながら攪拌し、pHを調節して均一な製剤を得た。ここで、レバミピドとしては、日本薬局方適合のレバミピドを用いた。調製直後の実施例1について、660nmにおける吸光度を測定した(U−3300 Spectrophotometer HITACHI)。
表1の実施例1に示すレバミピド含有水性医薬組成物(点眼剤)を調製後、すぐに表2に示す各種容器に5mLずつ収容し、密閉して医薬製剤とした。容器としては、表2に示す通り、無色の、ポリエチレンテレフタレート(PET)製容器、ポリブチレンサクシネート(PBS)製容器、ポリスチレン(PS)製容器、ポリプロピレン(PP)製容器、低密度ポリエチレン(LDPE)製容器又はガラス製容器を用いた。このように得られた各種容器入りレバミピド含有医薬製剤に、光安定性試験装置(「Light−Tron LT−120 D3CJ型」、ナガノ科学株式会社製)を用いて、D65蛍光ランプを光源として、室温25℃の下、0.5万lxの光を20時間又は60時間連続照射することにより、それぞれ積算照射量10万lx・h又は30万lx・hの光を曝光した。その後、高速液体クロマトグラフィー(HPLC)により、光照射前後のレバミピドの濃度を定量した。定量したレバミピドの濃度から、下記(式2)に従ってレバミピド残存率(%)を算出した。結果を表3に示す。
検出器:紫外吸光光度計(測定波長:254nm)
カラム:内径4.6mm,長さ15cmのステンレス管に5μmの液体クロマトグラフィー用オクタデシルシリル化シリカゲルを充てんする.
カラム温度:40℃付近の一定温度
移動相:水/アセトニトリル/酢酸(100)混液(70:30:1)
流量:レバミピドの保持時間が約8分になるように調整する.
注入量:5μL
レバミピド残存率(%)=光照射後のレバミピド濃度/光照射前のレバミピド濃度×100
<評価基準>
◎ 内部の水性医薬組成物の量及び異物を明瞭に視認できる
○ 内部の水性医薬組成物の量及び異物を視認できる
△ 内部の水性医薬組成物の量については視認できるが、異物については視認しにくい
× 内部の水性医薬組成物の量及び異物を視認できない
表1に示す実施例1に従ってレバミピド含有水性医薬組成物(点眼剤)を調製後、すぐに表4に示す点眼容器2−1、2−2又は2−3に5mLずつ収容し、密栓して医薬製剤とした。得られた各種容器入りレバミピド含有医薬製剤について、上述の試験例1−1と同様の方法で、光照射(積算照射量10万lx・h)、及び光照射前後のレバミピド濃度の定量を行い、レバミピド残存率(%)を算出した。結果を表4に示す。
表1に示す実施例1に従ってレバミピド含有水性医薬組成物(点眼剤)を調製後、すぐに表2に示す容器1−1に5mL収容し、密栓して医薬製剤とした。
これを正立静置させた状態で、60℃で1週間保存した。
その後、上述の試験例1−1と同様の方法で、高速液体クロマトグラフィー(HPLC)により、保存前後のレバミピドの濃度を定量し、下記式(式3)に従ってレバミピド残存率(%)を算出した。
レバミピド残存率(%)=保存後のレバミピド濃度/保存前のレバミピド濃度×100
表5の参考例1〜4に示すレバミピド含有水性医薬組成物(点眼剤)を調製した。参考例1は、実施例1から(B)成分を除いた組成であり、参考例2は、実施例1の(B)成分を2倍量含有する組成であり、参考例3は、(C)成分を除いた組成であり、参考例4は、実施例1の(C)成分を2倍量含有する組成である。実施例1及びこれらの参考例1〜4の水性医薬組成物を、調製後すぐにガラス製容器にそれぞれ5mLずつ収容し、試験例1−1と同様に光照射(積算照射量30万lx・h)、及び曝光後のレバミピド残存濃度定量を行い、光照射前のレバミピド濃度に対する残存率(%)を算出した。実施例1の残存率に対する参考例1〜4の残存率の割合(%)を算出し、結果を表5に示す。
表7の実施例3−1、比較例3−1に示す水性医薬組成物(点眼剤)を、表6に示す各種容器に5mLずつ収容し、密閉して医薬製剤とした。容器としては、表6に示す通り、無色の、ポリエチレンテレフタレート(PET)製容器、ポリプロピレン(PP)製容器、低密度ポリエチレン(LDPE)製容器又はガラス製容器を用いた。このように得られた各種容器入りレバミピド含有医薬製剤を、遮光下60℃にて3日間保存した。保存前後の各溶液について、回転粘度計(TOKIMEC TV−20 VISCOMETER SN1109)を使用して粘度を測定し、その前後の値を用いて、粘度保持率を算出した。その後、下記式(式4)を用いて、比較例3−1に対する粘度保持率の上昇率を算出した。算出した結果を表7に示す。
粘度保持率の上昇率(%)={(実施例3−1の粘度保持率−比較例3−1の粘度保持率)/比較例3−1の粘度保持率}×100
下記表8、9に記載の処方で、点眼剤(処方例1〜19)、洗眼剤(処方例20、21)、装着液 (処方例22)が調製され、以下に記載の容器に収容される。表8、9の処方例中、塩酸及び水酸化ナトリウムはpH調整に用いられ、水性医薬組成物が表8、9に記載のpHとなるように加えられる。精製水は各液剤の全量が100mLとなるよう加えられる。
下記表10に記載の処方で、点眼剤(処方例23〜38)が調製され、以下に記載の容器に収容される。表10の処方例中、塩酸及び水酸化ナトリウムはpH調整に用いられ、水性医薬組成物が表10に記載のpHとなるように加えられる。精製水は各液剤の全量が100mLとなるよう加えられる。
Claims (9)
- (A)レバミピド、レバミピド誘導体、及びそれらの塩からなる群から選択される少なくとも1種を含有する水性医薬組成物が、波長270〜280nmの光線を遮断する容器に収容されていることを特徴とする、医薬製剤。
- 前記容器の波長270〜280nmの光線の平均光透過率が、15%以下である、請求項1に記載の医薬製剤。
- 前記容器の波長400〜700nmの光線の最大光透過率が、60%以上である、請求項1又は2に記載の医薬製剤。
- 前記容器が、さらに波長300〜310nmの光線を遮断する、請求項1〜3のいずれか一項に記載の医薬製剤。
- 前記容器が、前記水性医薬組成物と接触する面の一部又は全面にポリエステル系樹脂、ポリカーボネート系樹脂、又はスチレン系樹脂を含有する、請求項1〜4のいずれか一項に記載の医薬製剤。
- 前記水性医薬組成物が、さらに(B)ビニル系増粘剤を含有する、請求項1〜5のいずれか一項に記載の医薬製剤。
- 前記水性医薬組成物が、さらに(C)界面活性剤を含有する、請求項1〜6のいずれか一項に記載の医薬製剤。
- 眼粘膜適用医薬製剤である、請求項1〜7のいずれか一項に記載の医薬製剤。
- (A)レバミピド、レバミピド誘導体、及びそれらの塩からなる群より選択される少なくとも1種の、光による分解を抑制する方法であって、該(A)レバミピド、レバミピド誘導体、及びそれらの塩からなる群より選択される少なくとも1種を含有する水性医薬組成物を、波長270〜280nmの光線を遮断する容器に収容する工程を含む光分解抑制方法。
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JP2020534321A (ja) * | 2017-09-21 | 2020-11-26 | ダエウー ファーマシューティカル インダストリー カンパニー リミテッドDaewoo Pharmaceutical Ind. Co., Ltd. | レバミピドを含有する新規ドライアイ治療用点眼組成物及びその可溶化及び安定化方法 |
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JP2018168200A (ja) * | 2017-03-09 | 2018-11-01 | ロート製薬株式会社 | 眼科組成物の製造方法、眼科組成物にコンタクトレンズの摩擦を低減させる作用を付与する方法、及び眼科組成物にコンタクトレンズの眼表面への貼り付きを低減させる作用を付与する方法 |
US11190662B2 (en) | 2017-07-19 | 2021-11-30 | Fujifilm Business Innovation Corp. | Image processing apparatus for detecting a standing-up motion to change print mode and non-transitory computer readable medium |
JP2020534321A (ja) * | 2017-09-21 | 2020-11-26 | ダエウー ファーマシューティカル インダストリー カンパニー リミテッドDaewoo Pharmaceutical Ind. Co., Ltd. | レバミピドを含有する新規ドライアイ治療用点眼組成物及びその可溶化及び安定化方法 |
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WO2021199813A1 (ja) * | 2020-03-31 | 2021-10-07 | 参天製薬株式会社 | レバミピドまたはその塩および高分子を含有する水性懸濁液 |
JP7008886B1 (ja) * | 2020-03-31 | 2022-01-25 | 参天製薬株式会社 | レバミピドまたはその塩および高分子を含有する水性懸濁液 |
JP2022050562A (ja) * | 2020-03-31 | 2022-03-30 | 参天製薬株式会社 | レバミピドまたはその塩および高分子を含有する水性懸濁液 |
JP7144630B2 (ja) | 2020-03-31 | 2022-09-29 | 参天製薬株式会社 | レバミピドまたはその塩および高分子を含有する水性懸濁液 |
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