JP2022504958A - 活性物質の放出速度の制御を可能にする、前記活性物質を封入するための脂質組成物 - Google Patents
活性物質の放出速度の制御を可能にする、前記活性物質を封入するための脂質組成物 Download PDFInfo
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- JP2022504958A JP2022504958A JP2021520588A JP2021520588A JP2022504958A JP 2022504958 A JP2022504958 A JP 2022504958A JP 2021520588 A JP2021520588 A JP 2021520588A JP 2021520588 A JP2021520588 A JP 2021520588A JP 2022504958 A JP2022504958 A JP 2022504958A
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- lipid composition
- sorbitan
- acid
- ethylene oxide
- lipid
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- 229960003080 taurine Drugs 0.000 description 1
- 150000003505 terpenes Chemical class 0.000 description 1
- IMCGHZIGRANKHV-AJNGGQMLSA-N tert-butyl (3s,5s)-2-oxo-5-[(2s,4s)-5-oxo-4-propan-2-yloxolan-2-yl]-3-propan-2-ylpyrrolidine-1-carboxylate Chemical compound O1C(=O)[C@H](C(C)C)C[C@H]1[C@H]1N(C(=O)OC(C)(C)C)C(=O)[C@H](C(C)C)C1 IMCGHZIGRANKHV-AJNGGQMLSA-N 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 229960003604 testosterone Drugs 0.000 description 1
- 229960002180 tetracycline Drugs 0.000 description 1
- 229930101283 tetracycline Natural products 0.000 description 1
- 235000019364 tetracycline Nutrition 0.000 description 1
- 150000003522 tetracyclines Chemical class 0.000 description 1
- ZUUZGQPEQORUEV-UHFFFAOYSA-N tetrahydrate;hydrochloride Chemical compound O.O.O.O.Cl ZUUZGQPEQORUEV-UHFFFAOYSA-N 0.000 description 1
- 229940124597 therapeutic agent Drugs 0.000 description 1
- 235000019190 thiamine hydrochloride Nutrition 0.000 description 1
- 239000011747 thiamine hydrochloride Substances 0.000 description 1
- 229960000344 thiamine hydrochloride Drugs 0.000 description 1
- UIERGBJEBXXIGO-UHFFFAOYSA-N thiamine mononitrate Chemical compound [O-][N+]([O-])=O.CC1=C(CCO)SC=[N+]1CC1=CN=C(C)N=C1N UIERGBJEBXXIGO-UHFFFAOYSA-N 0.000 description 1
- 235000019191 thiamine mononitrate Nutrition 0.000 description 1
- 239000011748 thiamine mononitrate Substances 0.000 description 1
- 229960004860 thiamine mononitrate Drugs 0.000 description 1
- 229960002363 thiamine pyrophosphate Drugs 0.000 description 1
- 235000008170 thiamine pyrophosphate Nutrition 0.000 description 1
- 239000011678 thiamine pyrophosphate Substances 0.000 description 1
- YXVCLPJQTZXJLH-UHFFFAOYSA-N thiamine(1+) diphosphate chloride Chemical compound [Cl-].CC1=C(CCOP(O)(=O)OP(O)(O)=O)SC=[N+]1CC1=CN=C(C)N=C1N YXVCLPJQTZXJLH-UHFFFAOYSA-N 0.000 description 1
- 229960002898 threonine Drugs 0.000 description 1
- FGMPLJWBKKVCDB-UHFFFAOYSA-N trans-L-hydroxy-proline Natural products ON1CCCC1C(O)=O FGMPLJWBKKVCDB-UHFFFAOYSA-N 0.000 description 1
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 description 1
- 238000013519 translation Methods 0.000 description 1
- 229960001727 tretinoin Drugs 0.000 description 1
- 229960002622 triacetin Drugs 0.000 description 1
- WEAPVABOECTMGR-UHFFFAOYSA-N triethyl 2-acetyloxypropane-1,2,3-tricarboxylate Chemical compound CCOC(=O)CC(C(=O)OCC)(OC(C)=O)CC(=O)OCC WEAPVABOECTMGR-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
- 229960004799 tryptophan Drugs 0.000 description 1
- 229960004441 tyrosine Drugs 0.000 description 1
- OUYCCCASQSFEME-UHFFFAOYSA-N tyrosine Natural products OC(=O)C(N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-UHFFFAOYSA-N 0.000 description 1
- 238000000825 ultraviolet detection Methods 0.000 description 1
- 229960005486 vaccine Drugs 0.000 description 1
- 229960004295 valine Drugs 0.000 description 1
- 239000004474 valine Substances 0.000 description 1
- 235000013311 vegetables Nutrition 0.000 description 1
- 235000019156 vitamin B Nutrition 0.000 description 1
- 239000011720 vitamin B Substances 0.000 description 1
- 235000019164 vitamin B2 Nutrition 0.000 description 1
- 235000019159 vitamin B9 Nutrition 0.000 description 1
- 239000011727 vitamin B9 Substances 0.000 description 1
- 235000019165 vitamin E Nutrition 0.000 description 1
- 229940046009 vitamin E Drugs 0.000 description 1
- 239000011709 vitamin E Substances 0.000 description 1
- 235000019143 vitamin K2 Nutrition 0.000 description 1
- 239000011728 vitamin K2 Substances 0.000 description 1
- 229940041603 vitamin k 3 Drugs 0.000 description 1
- 239000004207 white and yellow bees wax Substances 0.000 description 1
- 239000011670 zinc gluconate Substances 0.000 description 1
- 235000011478 zinc gluconate Nutrition 0.000 description 1
- 229960000306 zinc gluconate Drugs 0.000 description 1
- 229910052726 zirconium Inorganic materials 0.000 description 1
- OENHQHLEOONYIE-JLTXGRSLSA-N β-Carotene Chemical compound CC=1CCCC(C)(C)C=1\C=C\C(\C)=C\C=C\C(\C)=C\C=C\C=C(/C)\C=C\C=C(/C)\C=C\C1=C(C)CCCC1(C)C OENHQHLEOONYIE-JLTXGRSLSA-N 0.000 description 1
Classifications
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- 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
- A61K9/5005—Wall or coating material
- A61K9/5063—Compounds of unknown constitution, e.g. material from plants or animals
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- 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
- A61K9/5005—Wall or coating material
- A61K9/5015—Organic compounds, e.g. fats, sugars
-
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- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23K—FODDER
- A23K10/00—Animal feeding-stuffs
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- A23K10/00—Animal feeding-stuffs
- A23K10/20—Animal feeding-stuffs from material of animal origin
-
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- A23K—FODDER
- A23K20/00—Accessory food factors for animal feeding-stuffs
- A23K20/10—Organic substances
- A23K20/158—Fatty acids; Fats; Products containing oils or fats
-
- A—HUMAN NECESSITIES
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- A23K—FODDER
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- A23K20/189—Enzymes
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- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23K—FODDER
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- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
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- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/115—Fatty acids or derivatives thereof; Fats or oils
- A23L33/12—Fatty acids or derivatives thereof
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23P—SHAPING OR WORKING OF FOODSTUFFS, NOT FULLY COVERED BY A SINGLE OTHER SUBCLASS
- A23P10/00—Shaping or working of foodstuffs characterised by the products
- A23P10/30—Encapsulation of particles, e.g. foodstuff additives
- A23P10/35—Encapsulation of particles, e.g. foodstuff additives with oils, lipids, monoglycerides or diglycerides
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- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
- A61K31/52—Purines, e.g. adenine
- A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
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- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
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- A61K9/5089—Processes
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- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L91/00—Compositions of oils, fats or waxes; Compositions of derivatives thereof
- C08L91/06—Waxes
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- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
- A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
【選択図】なし
Description
- 40重量%~99.9重量%、より特に40重量%~98重量%、なおより特に40重量%~95重量%の成分であって、その重量の100%あたり90重量%~100重量%の蜜蝋及び最大で10重量%の少なくとも1つの他の脂質賦形剤を含む成分、
- 0.1重量%~60重量%、より特に2重量%~60重量%、なおより特に5重量%~60重量%の、ポリエトキシル化脂肪酸、脂肪二塩基酸及びポリエチレングリコールのエステル、ポリグリセロール及び脂肪酸のエステル、プロピレングリコール及び脂肪酸のエステル、プロピレングリコールのエステル及びグリセロールのエステルの混合物、脂肪酸ジグリセリド、ステロール及びステロールの誘導体、脂肪酸及びソルビタンのエステル、ソルビタン、ポリエチレングリコール及び脂肪酸のエステル、ポリエチレングリコール及びアルキルのエーテル、サッカロースエステル並びにポリオキシエチレン-ポリオキシプロピレンブロックコポリマーから選択される少なくとも1つの親油性界面活性剤
を含む脂質組成物である。
- 脂質賦形剤は、動物性ワックス、植物性ワックス、鉱物性ワックス、合成ワックス又は水素化植物油から選択される;
- 親油性界面活性剤は、脂肪酸及び糖のエステルから選択される;
- 親油性界面活性剤は、ソルビタンエステルの系統群、より特にモノラウリン酸ソルビタン、モノパルミチン酸ソルビタン、モノステアリン酸ソルビタン及びモノオレイン酸ソルビタンからなる群からの要素、なおより特にモノパルミチン酸ソルビタン又はモノステアリン酸ソルビタン、なおより特にモノステアリン酸ソルビタンからの親油性界面活性剤である;
- 前記組成物は、0~20重量%、より特に0重量%~10重量%の1つ以上の親水性界面活性剤を含む;
- 1つ又は複数の親水性界面活性剤は、大豆レシチン、ポリエトキシル化ソルビタンエステル、ポリエトキシル化アルコール、ポリエトキシル化酸、ポリグリセロールエステル、グルコースエーテル並びにエチレンオキシド及びプロピレンオキシドのブロックコポリマーから選択される;
- 親油性界面活性剤は、ソルビタンエステルであり、且つ親水性界面活性剤は、ポリエトキシル化ソルビタンエステルから選択される;
- 前記組成物は、80%の蜜蝋、20%のステアリン酸ソルビタンを含む;
- 前記組成物は、94%の蜜蝋、1%のステアリン酸ソルビタン及び5%の、20モルのエチレンオキシドでポリエトキシル化されたオレイン酸ソルビタン(ポリソルベート80とも呼ばれる)を含む;
- 前記組成物は、75%の蜜蝋、20%のステアリン酸ソルビタン及び5%の、20モルのエチレンオキシドでポリエトキシル化されたオレイン酸ソルビタン(ポリソルベート80とも呼ばれる)を含む;
- 前記組成物は、50%の蜜蝋、45%のステアリン酸ソルビタン及び5%の、20モルのエチレンオキシドでポリエトキシル化されたオレイン酸ソルビタン(ポリソルベート80とも呼ばれる)を含む;
- 前記組成物は、0~20重量%、より特に0~10重量%の少なくとも1つのコーティング補助剤を含む;
- 1つ又は複数のコーティング補助剤は、希釈剤、調味料、食欲促進剤、着色剤、酸化防止剤、可塑剤、消泡剤及び崩壊剤から選択される。
- 動物性ワックスとしては、52~55℃の融点を有する鯨蝋、37~44℃の融点を有するラノリン及び77~90℃の融点を有するセラックが挙げられ得;
- 植物性ワックスとしては、78~88℃の融点を有するカルナウバ蝋、67~79℃の融点を有するカンデリラ蝋及び78℃までの融点を有する米糠ワックスが挙げられ得;
- 鉱物性ワックスとしては、50~71℃の融点を有するパラフィン及び54~102℃の融点を有する微結晶ワックスが挙げられ得;
- 合成ワックスとしては、フィッシャー-トロプシュワックス、ポリエチレン(若しくはポリプロピレン)ワックス、ポリ(エチレンオキシド)又はポリ(プロピレンオキシド)ワックスなどが挙げられ得;
- 水素化植物油としては、58~62℃の融点を有するパーム油及び61~65℃の融点を有するステアリンが挙げられ得る。
- ステアリン酸、パルミチン酸、ケトステアリン酸、アラキジン酸及びベヘン酸から選択される脂肪酸と、グリセロールとのエステル;
- ステアリン酸、パルミチン酸、ケトステアリン酸、アラキジン酸及びベヘン酸のアルコールである脂肪アルコールと、例えば還元糖、より特にグルコース、キシロース、アラビノース、マンノース又はサッカロースである糖とのエーテル;
- ステアリン酸、パルミチン酸、ケトステアリン酸、アラキジン酸及びベヘン酸のマグネシウム、亜鉛又はカルシウム塩などの脂肪酸の二価塩;
- プロピレンオキシド及び/又はブチレンオキシドによって縮合される脂肪アルコール;
- プロピレン又はブチレンオキシドが豊富であるアルコキシド(エチレン、プロピレン、ブチレンなど)のブロックコポリマー;
- ステアリン酸、パルミチン酸、ケトステアリン酸、アラキジン酸及びベヘン酸から選択される脂肪酸と、例えばグルコース、ソルビトール、マンニトース、マンニトール、サッカロース、マンノース、キシリトール又はキシロースである糖とのエステル;
- 脂肪酸及び糖のエステルの中で、脂肪酸及びソルビトールのエステル並びに脂肪酸及びソルビタンのエステルが挙げられ得る。
- 商標名Montane(商標)20でSEPPICにより、且つ商標名Span(商標)20でCrodaにより販売されるモノラウリン酸ソルビタン、及びそれにより、
- 商標名Montane(商標)40でSEPPICにより、且つ商標名Span(商標)40でCrodaにより販売されるモノパルミチン酸ソルビタン、
- 商標名Montane(商標)60でSEPPICにより、且つ商標名Span(商標)60でCrodaにより販売されるモノステアリン酸ソルビタン、
- 商標名Montane(商標)80でSEPPICにより、且つ商標名Span(商標)80でCrodaにより販売されるモノオレイン酸ソルビタン、
- 商標名Montane(商標)85でSEPPICにより、且つ商標名Span(商標)85でCrodaにより販売されるトリオレイン酸ソルビタン、
- 商標名Montane(商標)83でSEPPICにより、且つ商標名Crill(商標)43でCrodaにより販売されるセスキオレイン酸ソルビタン、及びそれにより、
- 商標名Montane(商標)65でSEPPICにより、且つ商標名Span(商標)65でCrodaにより販売されるトリステアリン酸ソルビタン、
- 商標名Montane(商標)70でSEPPICにより、且つ商標名Crill(商標)6でCrodaにより販売されるモノイソステアリン酸ソルビタン。
- 商標名Montanox(商標)20でSEPPICにより、且つ商標名Tween(商標)20でCrodaにより販売される、20モルのエチレンオキシドでエトキシル化されたモノラウリン酸ソルビタン、
- 商標名Tween(商標)21で販売される、4モルのエチレンオキシドでエトキシル化されたモノラウリン酸ソルビタン、
- 商標名Nikkol(商標)GL-IでNikkoにより販売される、6モルのエチレンオキシドでエトキシル化されたモノラウリン酸ソルビタン、
- 商標名Montanox(商標)40でSEPPICにより、且つ商標名Tween(商標)40でCrodaにより販売される、20モルのエチレンオキシドでエトキシル化されたモノパルミチン酸ソルビタン、
- 商標名Montanox(商標)60でSEPPICにより、且つ商標名Tween(商標)60でCrodaにより販売される、20モルのエチレンオキシドでエトキシル化されたモノステアリン酸ソルビタン、
- 商標名Montanox(商標)65でSEPPICにより、且つ商標名Tween(商標)65でCrodaにより販売される、20モルのエチレンオキシドでエトキシル化されたトリステアリン酸ソルビタン、
- 商標名Montanox(商標)80でSEPPICにより、且つ商標名Tween(商標)80でCrodaにより販売される、20モルのエチレンオキシドでエトキシル化されたモノオレイン酸ソルビタン、
- 商標名Montanox(商標)85でSEPPICにより、且つ商標名Tween(商標)85でCrodaにより販売される、20モルのエチレンオキシドでエトキシル化されたトリオレイン酸ソルビタン、
- 商標名Montanox(商標)70でSEPPICにより、且つ商標名Tween(商標)120でCrodaにより販売される、20モルのエチレンオキシドでエトキシル化されたモノイソステアリン酸ソルビタン、
- 商標名Tween(商標)61でCrodaにより販売される、4モルのエチレンオキシドでエトキシル化されたモノステアリン酸ソルビタン、
- 商標名Montanox(商標)81でSEPPICにより、且つ商標名Tween(商標)81でCrodaにより販売される、5モルのエチレンオキシドでエトキシル化されたモノオレイン酸ソルビタン。
- 少なくとも1つの活性製薬、予防又は食品物質
を含む徐放性組成物(CA)も本発明の主題である。
a)本発明による脂質組成物を調製するステップ、
b)活性製薬、予防又は食品物質を、ステップa)において調製された脂質組成物と混合及び封入して、本発明による組成物(CA)を得るステップ、及び
c)機械的応力を伴って、ステップb)で調製された組成物(CA)をガレノス形成するステップ
を含む方法である。
- 混合及び封入ステップb)は、ステップa)において調製された脂質組成物を、前記脂質組成物の種々の成分の最高融点よりも10~15℃高い温度まで加熱して、前記脂質組成物を融解させる第1のサブステップ、融解された脂質組成物を、分散又は融解された形態で活性物質と混合する第2のサブステップ、及び第2のサブステップにおいて得られた組成物を周囲又は冷却空気中若しくは冷却液体中に噴霧して、組成物(CA)の固体化された粒子を得る第3のサブステップを含む。「周囲空気」という用語は、一般に25℃付近の周囲温度にある空気を意味するものとして理解され;「冷却された空気」又は「冷却された液体」という用語は、周囲温度未満、換言すると25℃未満の温度にある空気又は液体を意味するものとして理解される。
- 機械的応力を伴うガレノス形成ステップは、固体経口剤形を与えるプロセス、例えば圧縮、ハードカプセルへの形成(カプセル充填/成形)、コンパクティング(圧密、ローラー圧密)、パッケージング、サシェ中への配置、スティックへの形成(スティック及びサシェ充填)、押出成形、粒状化及びペレット化から選択される。これらの技術により、(非包括的な)以下の形態の製造をもたらすことができる:経口粉末、ビーズ、ハードカプセル(カプセル)、顆粒、糖衣顆粒、パール、ペレット、球体(小球)、タブレット、サシェ、スティック、チュー(chew)、ガム、チュアブルタブレット、チューインガム。
分子式:C8H10N4O2;分子量:194.194g/モル。
それぞれの試験に関して、ワックス状液体分散体を調製する。このワックス状液体分散は、以下:
・融解形態の本発明の主題である組成物;
・分散固体形態のモデル活性剤
からなる。一般的に、活性剤は、その融点値次第で分散された形態又は液体形態で存在し得ることに留意すべきである。
本発明の主題である組成物でコーティングされ、次いでタブレットフォーマットに組み込まれた活性剤の放出プロフィールは、European Pharmacopoeia、7.3版、パラグラフ2.9.3の推薦に従い、Erweka溶解試験機によって確立される。
abs[%放出(Txi)tab-%放出(Txi)μビーズ]≦y%
式中、
%放出(Txi)tab=製剤がタブレット化プロセスを受けたときの試料採取点Txiにおいて放出された活性剤の%。
%放出(Txi)μビーズ=製剤が機械的応力を受けないときの試料採取点Txiにおいて放出された活性剤の%。
また、値yに関して、2時間までの溶解時間に関して30+/-2%以下であり、且つ残りの評価時間において20+/-2%以下である。
Txi>=180分
%放出(Txi)tab=製剤が(圧縮ステップを含む)タブレット化プロセスを受けたときの試料採取点Txiにおいて放出された活性剤の%。
%放出(Txi)μビーズ=製剤が機械的応力を受けないときの試料採取点Txiにおいて放出された活性剤の%。
本実施例において、脂質組成物は、成分Aとして同一の蜜蝋、同一の量のポリソルベート80及び成分Bとしての同一の割合の種々の親油性界面活性剤を含有する。調製される脂質組成物の構成は、以下の表1中に報告される。これらの脂質組成物は、活性成分としてカフェインを用いる、上記で詳述されたプリル化プロセスによるコーティングに関して使用される。この実施例の目的は、場合により、それらが圧縮ステップを受ける前に、蜜蝋と親油性界面活性剤との適切な特定の組合せとして考えられないように、経時的に放出プロフィールの維持又は非維持を観察することによる、活性剤カフェインのプリル化プロセスによるコーティングに関する蜜蝋と特定の親油性界面活性剤との組合せの有効性を示すことである。
abs[%放出(120x’i)μビーズ-%放出(120xi)μビーズ]y%
式中、
%放出(120x’i)μビーズ=製剤が、周囲温度において、定義された期間貯蔵されたときの120分の試料採取点において放出された活性剤の%。
%放出(120xi)μビーズ=製剤が貯蔵されないときの120分の試料採取点において放出された活性剤の%、すなわちミクロビーズの製造からT0における値。
本実施例において、上記で詳述された活性剤カフェインのプリル化プロセスによるコーティングのために使用される種々の供給源からのワックス及び油を成分Aとして含有する脂質組成物である。本実施例の目的は、ガレノス形成プロセス/その後の機械的応力後のコーティングされた活性剤の類似/又は大きく異ならない放出プロフィールを維持することを可能にすることに関する、他の成分と組み合わされた蜜蝋の特異性を実証することである。
本実施例において、活性剤カフェインのプリル化プロセスによるコーティングのために使用される蜜蝋及びカンデリラ蝋の比率を成分Aとして含有する脂質組成物である。本実施例の目的は、ガレノス形成プロセス/その後の機械的応力後のコーティングされた活性剤の類似/又は大きく異ならない放出プロフィールを維持することを可能にしながら、他の成分と組み合わされた、特定の比率まで別の脂質化合物と蜜蝋とを混合することの可能性を実証することである。
本実施例において、活性剤カフェインのプリル化プロセスによるコーティングのために使用される成分A(蜜蝋)及び成分B(ソルビタンエステル型の親水性界面活性剤)を有する脂質組成物である。
Claims (18)
- 脂質組成物であって、その重量の100%あたり、
- 40重量%~99.9重量%の成分であって、その重量の100%あたり90重量%~100重量の蜜蝋及び最大で10重量%の少なくとも1つの他の脂質賦形剤を含む成分、
- 0.1重量%~60重量%の、ポリエトキシル化脂肪酸、脂肪二塩基酸及びポリエチレングリコールのエステル、ポリグリセロール及び脂肪酸のエステル、プロピレングリコール及び脂肪酸のエステル、プロピレングリコールのエステル及びグリセロールのエステルの混合物、脂肪酸ジグリセリド、ステロール及びステロールの誘導体、脂肪酸及びソルビタンのエステル、ソルビタン、ポリエチレングリコール及び脂肪酸のエステル、ポリエチレングリコール及びアルキルのエーテル、サッカロースエステル並びにポリオキシエチレン-ポリオキシプロピレンブロックコポリマーから選択される少なくとも1つの親油性界面活性剤
を含む脂質組成物。 - 前記脂質賦形剤は、動物性ワックス、植物性ワックス、鉱物性ワックス、合成ワックス又は水素化植物油から選択されることを特徴とする、請求項1に記載の脂質組成物。
- 前記親油性界面活性剤は、脂肪酸及び糖のエステルから選択されることを特徴とする、請求項1又は2に記載の脂質組成物。
- 前記親油性界面活性剤は、ソルビタンエステルの系統群、より特にモノラウリン酸ソルビタン、モノパルミチン酸ソルビタン、モノステアリン酸ソルビタン及びモノオレイン酸ソルビタンからなる群からの要素、なおより特にモノパルミチン酸ソルビタン又はモノステアリン酸ソルビタン、なおより特にモノステアリン酸ソルビタンからの親油性界面活性剤であることを特徴とする、請求項1又は3に記載の脂質組成物。
- 0~20%の1つ以上の親水性界面活性剤を含むことを特徴とする、請求項1~4のいずれか一項に記載の脂質組成物。
- 前記1つ又は複数の親水性界面活性剤は、大豆レシチン、エトキシル化ソルビタンエステル、ポリエトキシル化アルコール、ポリエトキシル化酸、ポリグリセロールエステル、グルコースエーテル並びにエチレンオキシド及びプロピレンオキシドのブロックコポリマーから選択されることを特徴とする、請求項5に記載の脂質組成物。
- 疎水性界面活性剤は、ソルビタンエステルであり、且つ前記親水性界面活性剤は、ポリエトキシル化ソルビタンエステルから選択されることを特徴とする、請求項5に記載の脂質組成物。
- - 75%の蜜蝋、
- 20%のステアリン酸ソルビタン、及び
- 5%の、20モルのエチレンオキシドでポリエトキシル化されたオレイン酸ソルビタン(又はポリソルベート80)
を含むことを特徴とする、請求項7に記載の脂質組成物。 - - 50%の蜜蝋、
- 45%のステアリン酸ソルビタン、及び
- 5%の、20モルのエチレンオキシドでポリエトキシル化されたオレイン酸ソルビタン(又はポリソルベート80)
を含むことを特徴とする、請求項7に記載の脂質組成物。 - 0~20%の少なくとも1つのコーティング補助剤を含むことを特徴とする、請求項1~7のいずれか一項に記載の脂質組成物。
- 前記1つ又は複数のコーティング補助剤は、希釈剤、調味料、食欲促進剤、着色剤、酸化防止剤、可塑剤、消泡剤及び崩壊剤から選択されることを特徴とする、請求項8に記載の脂質組成物。
- - 請求項1~11のいずれか一項に記載の少なくとも1つの脂質組成物、及び
- 少なくとも1つの活性製薬、予防又は食品物質
を含む徐放性組成物(CA)。 - ヒト又は動物への経口投与のために意図されることを特徴とする、請求項12に記載の組成物(CA)。
- 固体形態であることを特徴とする、請求項12又は13に記載の組成物(CA)。
- ガレノス製剤中における、ヒト又は動物のための活性製薬、治療、予防又は食品物質の封入のための、請求項1~11のいずれか一項に記載の脂質組成物の使用。
- 請求項12~14のいずれか一項に記載の組成物(CA)を含むガレノス製剤を製造する方法であって、少なくとも、
a)請求項1~11のいずれか一項に記載の脂質組成物を調製するステップ、
b)活性製薬、予防又は食品物質を、ステップa)において調製された前記脂質組成物と混合及び封入して、請求項12~14のいずれか一項に記載の組成物(CA)を得るステップ、及び
c)機械的応力を伴って、ステップb)で調製された前記組成物(CA)をガレノス形成するステップ
を含む方法。 - 前記混合及び封入ステップb)は、
- ステップa)において調製された前記脂質組成物を、前記脂質組成物の種々の成分の最高融点よりも10~15℃高い温度まで加熱して、前記脂質組成物を融解させる第1のサブステップ、
- 前記融解された脂質組成物を、分散又は融解された形態で前記活性物質と混合する第2のサブステップ、及び
- 前記第2のサブステップにおいて得られた前記組成物を周囲又は冷却空気中若しくは冷却液体中に噴霧して、組成物(CA)の固体化された粒子を得る第3のサブステップ
を含むことを特徴とする、請求項16に記載の製造方法。 - 機械的応力を伴う前記ガレノス形成ステップは、圧縮、ハードカプセルへの形成、コンパクティング、パッケージング、サシェ中への配置、スティックへの形成、押出成形、粒状化及びペレット化から選択されることを特徴とする、請求項16又は17に記載の製造方法。
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PCT/FR2019/052454 WO2020079367A1 (fr) | 2018-10-19 | 2019-10-16 | Composition lipidique pour l'encapsulation d'une substance active et permettant le contrôle de la vitesse de libération de ladite substance active |
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JPS54110318A (en) * | 1978-02-13 | 1979-08-29 | Nippon Kayaku Co Ltd | Bleomycin solid preparation |
JPS5799170A (en) * | 1980-12-10 | 1982-06-19 | Ajinomoto Co Inc | Oil and fat composition containing dipeptide sweetening agent |
WO1991005548A1 (en) * | 1989-10-10 | 1991-05-02 | Pitman-Moore, Inc. | Sustained release composition for macromolecular proteins |
JPH07136192A (ja) * | 1993-06-08 | 1995-05-30 | Johnson & Johnson Consumer Prod Inc | 化学療法薬の付与されたデンタルフロス |
JP2000504038A (ja) * | 1996-10-07 | 2000-04-04 | サノフィ | 経口投与のためのバルプロ酸の医薬マイクロスフェア |
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GB1541463A (en) * | 1975-10-11 | 1979-02-28 | Lion Dentifrice Co Ltd | Process for prparing a multiple emulsion having a dispersing form of water-phase/oil-phase/water-phase |
CN100584329C (zh) * | 2007-12-19 | 2010-01-27 | 姚俊华 | 茴三硫软胶囊及其制备方法 |
CN103388037A (zh) * | 2012-05-08 | 2013-11-13 | 赵霞 | 一种羊皮制品清洁养护膏 |
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2018
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2019
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JPS5799170A (en) * | 1980-12-10 | 1982-06-19 | Ajinomoto Co Inc | Oil and fat composition containing dipeptide sweetening agent |
WO1991005548A1 (en) * | 1989-10-10 | 1991-05-02 | Pitman-Moore, Inc. | Sustained release composition for macromolecular proteins |
JPH07136192A (ja) * | 1993-06-08 | 1995-05-30 | Johnson & Johnson Consumer Prod Inc | 化学療法薬の付与されたデンタルフロス |
JP2000504038A (ja) * | 1996-10-07 | 2000-04-04 | サノフィ | 経口投与のためのバルプロ酸の医薬マイクロスフェア |
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US20210378974A1 (en) | 2021-12-09 |
EP3866855A1 (fr) | 2021-08-25 |
WO2020079367A1 (fr) | 2020-04-23 |
CN112839680A (zh) | 2021-05-25 |
FR3087445A1 (fr) | 2020-04-24 |
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