JP6091721B2 - 製剤 - Google Patents
製剤 Download PDFInfo
- Publication number
- JP6091721B2 JP6091721B2 JP2016546533A JP2016546533A JP6091721B2 JP 6091721 B2 JP6091721 B2 JP 6091721B2 JP 2016546533 A JP2016546533 A JP 2016546533A JP 2016546533 A JP2016546533 A JP 2016546533A JP 6091721 B2 JP6091721 B2 JP 6091721B2
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- Prior art keywords
- particles
- acid
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- surfactant
- Prior art date
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- 239000000203 mixture Substances 0.000 title description 25
- 238000009472 formulation Methods 0.000 title description 8
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- 238000004519 manufacturing process Methods 0.000 claims description 6
- -1 Tartilelin Chemical compound 0.000 description 69
- 238000002360 preparation method Methods 0.000 description 47
- 239000003814 drug Substances 0.000 description 40
- PRAKJMSDJKAYCZ-UHFFFAOYSA-N squalane Chemical compound CC(C)CCCC(C)CCCC(C)CCCCC(C)CCCC(C)CCCC(C)C PRAKJMSDJKAYCZ-UHFFFAOYSA-N 0.000 description 33
- 229940079593 drug Drugs 0.000 description 31
- 238000000034 method Methods 0.000 description 30
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- 230000000052 comparative effect Effects 0.000 description 20
- 238000012360 testing method Methods 0.000 description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 18
- 125000000217 alkyl group Chemical group 0.000 description 17
- 239000003381 stabilizer Substances 0.000 description 17
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- XDOFQFKRPWOURC-UHFFFAOYSA-N 16-methylheptadecanoic acid Chemical compound CC(C)CCCCCCCCCCCCCCC(O)=O XDOFQFKRPWOURC-UHFFFAOYSA-N 0.000 description 8
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- GVJHHUAWPYXKBD-UHFFFAOYSA-N (±)-α-Tocopherol Chemical compound OC1=C(C)C(C)=C2OC(CCCC(C)CCCC(C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-UHFFFAOYSA-N 0.000 description 7
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- LDDHMLJTFXJGPI-UHFFFAOYSA-N memantine hydrochloride Chemical compound Cl.C1C(C2)CC3(C)CC1(C)CC2(N)C3 LDDHMLJTFXJGPI-UHFFFAOYSA-N 0.000 description 6
- VLKZOEOYAKHREP-UHFFFAOYSA-N n-Hexane Chemical compound CCCCCC VLKZOEOYAKHREP-UHFFFAOYSA-N 0.000 description 6
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- XWAIAVWHZJNZQQ-UHFFFAOYSA-N donepezil hydrochloride Chemical compound [H+].[Cl-].O=C1C=2C=C(OC)C(OC)=CC=2CC1CC(CC1)CCN1CC1=CC=CC=C1 XWAIAVWHZJNZQQ-UHFFFAOYSA-N 0.000 description 5
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- 235000013305 food Nutrition 0.000 description 5
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- 239000001993 wax Substances 0.000 description 5
- KBPLFHHGFOOTCA-UHFFFAOYSA-N 1-Octanol Chemical compound CCCCCCCCO KBPLFHHGFOOTCA-UHFFFAOYSA-N 0.000 description 4
- HIQIXEFWDLTDED-UHFFFAOYSA-N 4-hydroxy-1-piperidin-4-ylpyrrolidin-2-one Chemical compound O=C1CC(O)CN1C1CCNCC1 HIQIXEFWDLTDED-UHFFFAOYSA-N 0.000 description 4
- XDTMQSROBMDMFD-UHFFFAOYSA-N Cyclohexane Chemical compound C1CCCCC1 XDTMQSROBMDMFD-UHFFFAOYSA-N 0.000 description 4
- 229910019142 PO4 Inorganic materials 0.000 description 4
- 239000004721 Polyphenylene oxide Substances 0.000 description 4
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 4
- 235000021355 Stearic acid Nutrition 0.000 description 4
- 230000000996 additive effect Effects 0.000 description 4
- 239000003125 aqueous solvent Substances 0.000 description 4
- 238000000576 coating method Methods 0.000 description 4
- 239000006071 cream Substances 0.000 description 4
- GHVNFZFCNZKVNT-UHFFFAOYSA-N decanoic acid Chemical compound CCCCCCCCCC(O)=O GHVNFZFCNZKVNT-UHFFFAOYSA-N 0.000 description 4
- 229940008099 dimethicone Drugs 0.000 description 4
- UKMSUNONTOPOIO-UHFFFAOYSA-N docosanoic acid Chemical compound CCCCCCCCCCCCCCCCCCCCCC(O)=O UKMSUNONTOPOIO-UHFFFAOYSA-N 0.000 description 4
- POULHZVOKOAJMA-UHFFFAOYSA-N dodecanoic acid Chemical compound CCCCCCCCCCCC(O)=O POULHZVOKOAJMA-UHFFFAOYSA-N 0.000 description 4
- 238000001035 drying Methods 0.000 description 4
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 description 4
- 239000000865 liniment Substances 0.000 description 4
- 150000002632 lipids Chemical class 0.000 description 4
- 230000014759 maintenance of location Effects 0.000 description 4
- 229960000967 memantine hydrochloride Drugs 0.000 description 4
- 239000007923 nasal drop Substances 0.000 description 4
- 229940100662 nasal drops Drugs 0.000 description 4
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 4
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 4
- HGASFNYMVGEKTF-UHFFFAOYSA-N octan-1-ol;hydrate Chemical compound O.CCCCCCCCO HGASFNYMVGEKTF-UHFFFAOYSA-N 0.000 description 4
- WWZKQHOCKIZLMA-UHFFFAOYSA-N octanoic acid Chemical compound CCCCCCCC(O)=O WWZKQHOCKIZLMA-UHFFFAOYSA-N 0.000 description 4
- 238000005192 partition Methods 0.000 description 4
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- CXMXRPHRNRROMY-UHFFFAOYSA-N sebacic acid Chemical compound OC(=O)CCCCCCCCC(O)=O CXMXRPHRNRROMY-UHFFFAOYSA-N 0.000 description 4
- LPXPTNMVRIOKMN-UHFFFAOYSA-M sodium nitrite Chemical compound [Na+].[O-]N=O LPXPTNMVRIOKMN-UHFFFAOYSA-M 0.000 description 4
- 239000008117 stearic acid Substances 0.000 description 4
- MGSRCZKZVOBKFT-UHFFFAOYSA-N thymol Chemical compound CC(C)C1=CC=C(C)C=C1O MGSRCZKZVOBKFT-UHFFFAOYSA-N 0.000 description 4
- ULQISTXYYBZJSJ-UHFFFAOYSA-N 12-hydroxyoctadecanoic acid Chemical compound CCCCCCC(O)CCCCCCCCCCC(O)=O ULQISTXYYBZJSJ-UHFFFAOYSA-N 0.000 description 3
- RSWGJHLUYNHPMX-UHFFFAOYSA-N Abietic-Saeure Natural products C12CCC(C(C)C)=CC2=CCC2C1(C)CCCC2(C)C(O)=O RSWGJHLUYNHPMX-UHFFFAOYSA-N 0.000 description 3
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- NLZUEZXRPGMBCV-UHFFFAOYSA-N Butylhydroxytoluene Chemical compound CC1=CC(C(C)(C)C)=C(O)C(C(C)(C)C)=C1 NLZUEZXRPGMBCV-UHFFFAOYSA-N 0.000 description 3
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 description 3
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- 125000001147 pentyl group Chemical group C(CCCC)* 0.000 description 1
- BPHQIXJDBIHMLT-UHFFFAOYSA-N perfluorodecane Chemical compound FC(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)F BPHQIXJDBIHMLT-UHFFFAOYSA-N 0.000 description 1
- YVBBRRALBYAZBM-UHFFFAOYSA-N perfluorooctane Chemical compound FC(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)F YVBBRRALBYAZBM-UHFFFAOYSA-N 0.000 description 1
- 239000010702 perfluoropolyether Substances 0.000 description 1
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- 229910052708 sodium Inorganic materials 0.000 description 1
- 235000010378 sodium ascorbate Nutrition 0.000 description 1
- PPASLZSBLFJQEF-RKJRWTFHSA-M sodium ascorbate Substances [Na+].OC[C@@H](O)[C@H]1OC(=O)C(O)=C1[O-] PPASLZSBLFJQEF-RKJRWTFHSA-M 0.000 description 1
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- TUHBEKDERLKLEC-UHFFFAOYSA-N squalene Natural products CC(=CCCC(=CCCC(=CCCC=C(/C)CCC=C(/C)CC=C(C)C)C)C)C TUHBEKDERLKLEC-UHFFFAOYSA-N 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
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- CEIJFEGBUDEYSX-FZDBZEDMSA-N tandospirone Chemical compound O=C([C@@H]1[C@H]2CC[C@H](C2)[C@@H]1C1=O)N1CCCCN(CC1)CCN1C1=NC=CC=N1 CEIJFEGBUDEYSX-FZDBZEDMSA-N 0.000 description 1
- DMLGUJHNIWGCKM-DPFKZJTMSA-N tandospirone citrate Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O.O=C([C@@H]1[C@H]2CC[C@H](C2)[C@@H]1C1=O)N1CCCCN(CC1)CCN1C1=NC=CC=N1 DMLGUJHNIWGCKM-DPFKZJTMSA-N 0.000 description 1
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- WUBVEMGCQRSBBT-UHFFFAOYSA-N tert-butyl 4-(trifluoromethylsulfonyloxy)-3,6-dihydro-2h-pyridine-1-carboxylate Chemical compound CC(C)(C)OC(=O)N1CCC(OS(=O)(=O)C(F)(F)F)=CC1 WUBVEMGCQRSBBT-UHFFFAOYSA-N 0.000 description 1
- 229960002372 tetracaine Drugs 0.000 description 1
- GKCBAIGFKIBETG-UHFFFAOYSA-N tetracaine Chemical compound CCCCNC1=CC=C(C(=O)OCCN(C)C)C=C1 GKCBAIGFKIBETG-UHFFFAOYSA-N 0.000 description 1
- TUNFSRHWOTWDNC-HKGQFRNVSA-N tetradecanoic acid Chemical compound CCCCCCCCCCCCC[14C](O)=O TUNFSRHWOTWDNC-HKGQFRNVSA-N 0.000 description 1
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- RTKIYNMVFMVABJ-UHFFFAOYSA-L thimerosal Chemical compound [Na+].CC[Hg]SC1=CC=CC=C1C([O-])=O RTKIYNMVFMVABJ-UHFFFAOYSA-L 0.000 description 1
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- JOXIMZWYDAKGHI-UHFFFAOYSA-M toluene-4-sulfonate Chemical class CC1=CC=C(S([O-])(=O)=O)C=C1 JOXIMZWYDAKGHI-UHFFFAOYSA-M 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- HYVJNYYVNIYMDK-QSEXIABDSA-N triarachidonin Chemical compound CCCCC\C=C/C\C=C/C\C=C/C\C=C/CCCC(=O)OCC(OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC)COC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC HYVJNYYVNIYMDK-QSEXIABDSA-N 0.000 description 1
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Images
Classifications
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/51—Nanocapsules; Nanoparticles
- A61K9/5107—Excipients; Inactive ingredients
- A61K9/5123—Organic compounds, e.g. fats, sugars
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/51—Nanocapsules; Nanoparticles
- A61K9/5107—Excipients; Inactive ingredients
- A61K9/513—Organic macromolecular compounds; Dendrimers
- A61K9/5161—Polysaccharides, e.g. alginate, chitosan, cellulose derivatives; Cyclodextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/51—Nanocapsules; Nanoparticles
- A61K9/5192—Processes
Description
このため、経皮吸収性製剤等外用薬においては、体内への吸収性と持続性の両方を兼ね備えたものが求められていた。また、一般的な特性として、外用薬においては、有効成分を含有する粒子の保存安定性も求められる。
項1. 有効成分を含有する第1画分と界面活性剤を含有する第2画分とを含み、且つ個数平均粒子径が1〜100nmである、粒子。
項2. 前記第1画分の表面の一部又は全部が前記第2画分に被覆されている、項1に記載の粒子。
項3. 前記個数平均粒子径が1nm〜20nmである、項1又は2に記載の粒子。
項4. 水分含有率が20重量%以下である、項1〜3のいずれかに記載の粒子。
項5. 項1〜4のいずれかに記載の粒子を含む、製剤。
項6. 水分含有率が20重量%以下である、項5に記載の製剤。
項7. 有効成分と界面活性剤との重量比が1:10〜1:50である、項5又は6に記載の製剤。
項8. 項5〜7のいずれかに記載の製剤を含有する、外用薬。
項9. 項5〜7のいずれかに記載の製剤を含有する、化粧品。
項10. 有効成分を含有する第1画分と界面活性剤を含有する第2画分とを含む粒子の製造方法であって、水相に有効成分を含有するW/Oエマルション及び/又は該W/Oエマルションの乾燥物を加熱処理する工程を含む、粒子の製造方法。
項11. 前記粒子の個数平均粒子径が1nm〜20nmである、項10に記載の製造方法。
項12. 前記粒子の水分含有率が20重量%以下である、項10又は11に記載の製造方法。
粒子は、有効成分を含有する第1画分と界面活性剤を含有する第2画分という少なくとも2つの画分を含む。なお、第1画分と第2画分とは、互いに(好ましくは分子間力によって)結び付きあって集合体を形成していればよい。粒子は、有効成分の吸収性及び徐放性の観点から、第1画分の表面の一部又は全部(例えば、第1画分の表面の30%以上、好ましくは50%以上、より好ましくは70%以上、さらに好ましくは85%以上、よりさらに好ましくは95%以上、特に好ましくは99%以上)が前記第2画分に被覆されていることが好ましい。粒子の態様の例として、第1画分がコア部、第2画分がコア部を包摂するシェル部に相当するコアシェル構造体が挙げられる。
第1画分は、少なくとも有効成分を含む。
分子量が10000以下であり、かつ
オクタノール水分配係数が−6〜6である。
第2画分は、少なくとも界面活性剤を含む。
HLB値の加重平均値は、以下のようにして算出する。
(xA+yB+zC)÷(x+y+z)
本発明の製剤は、少なくとも前記粒子を含有する。
本発明の製剤は、さらに基剤を含有する相(基剤相)を含有し、前記基剤相が前記粒子を含有するものであってもよい。このとき、前記粒子は、前記基剤相中に分散又は溶解している。
が挙げられる。
本発明の製剤は、その剤形や使用目的等に応じて、その他の添加成分を含有していてもよい。
本発明の粒子は、特に限定されないが、例えば水相に有効成分を含有するW/Oエマルションを乾燥する工程を含む方法によって、製造することができる。
塩酸メマンチン0.1gを40gの純水に溶解し、これに、ショ糖ラウリン酸エステル(三菱化学フーズ社製、L−195、主成分はジエステル及びトリエステル)5gをシクロヘキサン80gに溶解した溶液を加え、ホモジナイザー撹拌(10,000rpm)した。この後に2日間凍結乾燥することによって、コアシェル構造体を調製した(薬物:アルキル鎖重量比=1:25程度)。当該生成物2.85gを11.4gのミリスチン酸イソプロピルに加え、スターラー撹拌して分散した後に、フィルタ(孔径0.2μm サンプラテック社製、PTFEフィルタF2513−4)で濾過して実施例1の外用剤とした。また、動的光散乱法(スペクトリス株式会社製、ゼータサイザ−ナノS)により算出した個数平均粒子径は、17nmであった。
ショ糖ラウリン酸エステルの代わりに、ショ糖エルカ酸エステル(三菱化学フーズ社製、ER−290、主成分はジエステル及びトリエステル)を用いたこと以外は実施例1と同様にして外用剤を製造した(薬物:アルキル鎖重量比=1:30程度)。また、動的光散乱法(スペクトリス株式会社製、ゼータサイザ−ナノS)により算出した個数平均粒子径は、12nmであった。
ショ糖エルカ酸エステルの量を3gにしたこと以外は実施例2と同様にして外用剤を製造した(薬物:アルキル鎖重量比=1:20程度)。また、動的光散乱法(スペクトリス株式会社製、ゼータサイザ−ナノS)により算出した個数平均粒子径は、39nmであった。
塩酸メマンチン0.1gを40gの純水に溶解し、これに、ショ糖ラウリン酸エステル(三菱化学フーズ社製、L−195、主成分はジエステル及びトリエステル)5gをシクロヘキサン80gに溶解した溶液を加え、ホモジナイザー撹拌(10,000rpm)した。この後に2日間凍結乾燥することによって、コアシェル構造体を調製した(薬物:アルキル鎖重量比=1:25程度)。当該生成物2.85gを11.4gのミリスチン酸イソプロピルに加え、スターラー撹拌して分散した。これを遠心処理(12000rpm)した沈渣を11.4gのミリスチン酸イソプロピルに加え、スターラー撹拌して分散して比較用外用剤を製造した。また、動的光散乱法(スペクトリス株式会社製、ゼータサイザ−ナノS)により算出した個数平均粒子径は、830nmであった。
メマンチン8.3部とアクリル粘着剤(Duro−Tak 87−2510)91.7部に、不揮発分が30%になるように酢酸エチルを加え、均一になるまで混合し膏体液を調製した。離型紙上に、得られた膏体液を均一に展開し、80℃で乾燥後、ポリエチレンテレフタレートフィルムからなる支持体を積層し、3cm2に打ち抜いて比較用外用剤を得た。
薬物皮膚透過試験セル(図1)にヘアレスラット皮膚(日本エスエルシー社、HWY/Slc8週齢より摘出)をセットした。この装置の上部に実施例1〜3及び比較例1で製造した各種外用剤を2mlもしくは比較例2で製造した外用剤を適用し、下部のレセプター層においては、蒸留水中にNaH2 PO4 を5×10ー4M、Na2 HPO4 を2×10−4M、NaClを1.5×10−4M、硫酸ゲンタマイシン(和光純薬社製、G1658)を10ppm含有させた液をNaOHでpH7.2に調整した緩衝液をいれ、試験開始後より32℃に保たれた恒温槽中に装置を設置した。試験開始後、所定時間後に下部のレセプター層より槽中の液のうち1mlを採取し直後に、同じ組成の液を1ml補充した。回収した各々のレセプター液試料にメタノールを添加して溶出脂質等を抽出し遠心分離した後に、上清中の塩酸メマンチン濃度を、GC(使用カラム:日本電子社製ZB1 30m長、内径0.32mm)により定量した。
製造した評価サンプルの安定性の確認は、光学顕微鏡(ニコン社製、エクリプスME600型番)(倍率200倍)を用いた製剤の形状を指標として行った。
25℃の室温条件下で2日経過したものを初期状態の形状と比較し、その指標には下記の評価項目を用いた。
(形状評価項目)
○:変化なし
△:一部変化あり
×:変化
ドネペジル塩酸塩(ナカライテスク社製)0.1gを40gの純水に溶解し、これに、ショ糖エルカ酸エステル(三菱化学フーズ社製、ER−290;HLB値2)1.5gをシクロヘキサン80gに溶解した溶液を加え、ホモジナイザー撹拌(25,000rpm)した。この後に2日間凍結乾燥後、40℃、5日間静置することによって、粒子を調製した。(薬物:アルキル鎖重量比=1:10)また、粒子をオリーブスクワラン(日光ケミカルズ社製)に分散後、動的光散乱法(スペクトリス株式会社製、ゼータサイザ−ナノS)により算出した個数平均粒子径は、9nmであった。
実施例4で得られた粒子1.5gを1.5gのプラスチベース(大正製薬社製、日本薬局方)に加え、混合して分散して外用剤を製造した。
ショ糖エルカ酸エステルの代わりに、ショ糖オレイン酸エステル(三菱化学フーズ社製、O−170;HLB値1)を用いたこと以外は実施例4と同様にして粒子を調整した。(薬物:アルキル鎖重量比=1:10)また、粒子をオリーブスクワランに分散後、動的光散乱法(スペクトリス株式会社製、ゼータサイザ−ナノS)により算出した個数平均粒子径は、8nmであった。
ショ糖エルカ酸エステルの量を3.0gにしたこと以外は実施例4と同様にして粒子を調整した。(薬物:アルキル鎖重量比=1:20)また、粒子をオリーブスクワランに分散後、動的光散乱法(スペクトリス株式会社製、ゼータサイザ−ナノS)により算出した個数平均粒子径は、4nmであった。
ドネペジル塩酸塩の代わりにバルデナフィル塩酸塩を用いたこと以外は実施例4と同様にして粒子を調整した。(薬物:アルキル鎖重量比=1:10)また、粒子をオリーブスクワランに分散後、動的光散乱法(スペクトリス株式会社製、ゼータサイザ−ナノS)により算出した個数平均粒子径は、12nmであった。
凍結乾燥後、40℃、1日間静置したこと以外は実施例4と同様にして粒子を調整した。(薬物:アルキル鎖重量比=1:10)また、粒子をオリーブスクワランに分散後、動的光散乱法(スペクトリス株式会社製、ゼータサイザ−ナノS)により算出した個数平均粒子径は、46nmであった。
凍結乾燥後、40℃、1日間静置したこと以外は実施例8と同様にして粒子を調整した。(薬物:アルキル鎖重量比=1:10)また、粒子をオリーブスクワランに分散後、動的光散乱法(スペクトリス株式会社製、ゼータサイザ−ナノS)により算出した個数平均粒子径は、82nmであった。
ショ糖エルカ酸エステルの量を0.5gにしたこと以外は実施例4と同様にして粒子を調整した。(薬物:アルキル鎖重量比=1:3.3)また、粒子をオリーブスクワランに分散後、動的光散乱法(スペクトリス株式会社製、ゼータサイザ−ナノS)により算出した個数平均粒子径は、26nmであった。
40℃、5日間静置を行わなかったこと以外は実施例4と同様にして粒子を調整した。(薬物:アルキル鎖重量比=1:10)また、粒子をオリーブスクワランに分散後、動的光散乱法(スペクトリス株式会社製、ゼータサイザ−ナノS)により算出した個数平均粒子径は、210nmであった。
比較例3で得られた粒子を用いたこと以外は、実施例5と同様にして外用剤を製造した。
40℃、5日間静置を行わなかったこと以外は実施例7と同様にして粒子を調整した。(薬物:アルキル鎖重量比=1:20)また、粒子をオリーブスクワランに分散後、動的光散乱法(スペクトリス株式会社製、ゼータサイザ−ナノS)により算出した個数平均粒子径は、280nmであった。
40℃、5日間静置を行わなかったこと以外は実施例8と同様にして粒子を調整した。(薬物:アルキル鎖重量比=1:10)また、粒子をオリーブスクワランに分散後、動的光散乱法(スペクトリス株式会社製、ゼータサイザ−ナノS)により算出した個数平均粒子径は、350nmであった。
ドネペジル塩酸塩0.094gを1.5gのプラスチベースに加え、混合して分散して外用剤を製造した。
実施例4及び6〜11及び比較例3及び5〜6の粒子を、酢酸エチル(和光純薬工業社製)に30重量%の濃度で分散後、60℃で溶媒除去した後に、オリーブスクワランに分散し、実施例4及び6〜11及び比較例3及び5〜6の粒子をオリーブスクワランに分散した状態からの変化をそれぞれ目視観察した。
その指標には下記の評価項目を用いた。
(形状評価項目)
○:変化なし
△:一部変化あり
×:変化
薬物皮膚透過試験セル(図1)にヘアレスラット皮膚(日本エスエルシー社、HWY/Slc8週齢より摘出)をセットした。この装置の上部に実施例5及び比較例4、7で製造した各種外用剤を0.5g(約3cm2)適用し、下部のレセプター層においては、蒸留水中にNaH2 PO4 を5×10ー4M、Na2 HPO4 を2×10−4M、NaClを1.5×10−4M、硫酸ゲンタマイシン(和光純薬社製、G1658)を10ppm含有させた液をNaOHでpH7.2に調整した緩衝液をいれ、試験開始後より32℃に保たれた恒温槽中に装置を設置した。試験開始後、所定時間後に下部のレセプター層より槽中の液のうち1mlを採取し直後に、同じ組成の液を1ml補充した。回収した各々のレセプター液試料にメタノールを添加して溶出脂質等を抽出し遠心分離した後に、上清中のドネペジル塩酸塩濃度を、高速液体クロマトグラフィー(HPLC)により定量した(装置:システムコントローラー;島津製作所社製 CBM−20A、送液ユニット;島津製作所社製 LC−20AD、カラムオーブン;島津製作所社製 CTO−20A、検出器;島津製作所社製 SPD−20A、検出波長;271nm、使用カラム:Thermoscientific社製Hypersi GOLD 150×4.6mm 3μm、移動相:0.15%過塩素酸水/アセトニトリル=1300/700、カラム温度35℃、流速1.25ml/min)。
2 皮膚
3 製剤
4 レセプター液(pH=7.2リン酸緩衝液)
5 撹拌子
Claims (2)
- 親水性の有効成分を含有する第1画分とHLB値の加重平均値が10以下の界面活性剤
を含有する第2画分とを含む粒子の製造方法であって、
水相に有効成分を含有するW/Oエマルションの乾燥物を加熱処理し、個数平均粒子径
が1〜20nmの粒子を得る工程を含む、粒子の製造方法。 - 前記粒子の個数平均粒子径が2nm〜10nmである、請求項1に記載の粒子の製造方
法。
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