TW200904456A - Organic compounds - Google Patents

Organic compounds Download PDF

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TW200904456A
TW200904456A TW097110250A TW97110250A TW200904456A TW 200904456 A TW200904456 A TW 200904456A TW 097110250 A TW097110250 A TW 097110250A TW 97110250 A TW97110250 A TW 97110250A TW 200904456 A TW200904456 A TW 200904456A
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copper
coated
copper salt
coating
composition
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TW097110250A
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Georg Ludwig Kis
Jacques Vandermander
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Novartis Ag
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Priority claimed from EP07104792A external-priority patent/EP1974733A1/en
Application filed by Novartis Ag filed Critical Novartis Ag
Publication of TW200904456A publication Critical patent/TW200904456A/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/34—Copper; Compounds thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • 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
    • A23L33/105—Plant extracts, their artificial duplicates or their derivatives
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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
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    • A23L33/15—Vitamins
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    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • 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
    • A23L33/16—Inorganic salts, minerals or trace elements
    • 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
    • A23P20/00—Coating of foodstuffs; Coatings therefor; Making laminated, multi-layered, stuffed or hollow foodstuffs
    • A23P20/10—Coating with edible coatings, e.g. with oils or fats
    • 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
    • A61K31/28—Compounds containing heavy metals
    • A61K31/30—Copper compounds
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
    • A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline 
    • A61K31/353—3,4-Dihydrobenzopyrans, e.g. chroman, catechin
    • A61K31/355—Tocopherols, e.g. vitamin E
    • 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
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
    • A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
    • A61K47/6951—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
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    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
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    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816—Wall or shell material
    • A61K9/4825—Proteins, e.g. gelatin
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    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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Description

200904456 九、發明說明： 【發明所屬之技術領域】 本發明係有關一種保護銅敏感性化合物及/或組合物使 其免於分解之方法。 【先前技術】 ω-3脂肪酸和許多維生素以及其他製藥學上有效之化合 物或組合物在與銅鹽接觸時很容易分解。在儲存該等化合 物及/或組合物的時候，該分解是一個主要問題，特別是
田有水存在的情況下。即使最少量水，例如本身濕度、組 合物或化合物中一個組份的水、或來自環境濕度的水亦會 出現同樣問題。 現存夕種化合物及/或組合物含有重要並且因此通常作 為必要成份的銅鹽。在該等條件下，銅鹽和銅敏感性化合 物及/或組合物的交互作用由下_段落提供之方法（群）來控 制亦即，實貝上制止或典型地預防銅敏感性化合物及/ 或組合物之分解。 【發明内容】 解決該問題之方法係提供具有適當覆層或 ::的鋼鹽。該覆層或包衣典型地抑制與該等銅敏感性化 δ物及/或組合物 被明心 互作用。該銅鹽，舉例來說， 如 一者覆羞或包覆或囊封，如，例 文^、有包衣的銅蹿憂私士 πη &囊封在明膠中。現有其他保護銅鹽 的方法，例如將其使 ^ 如.從 、 次甘油酯和二酸甘油酯囊封，例 .攸市％上可購得之產σ 度°σ Desc〇te®即為一實例。銅鹽可 I29268.doc 200904456 合物形繼絡合物’其典型地在稍 物受到腸力 鋼鹽，例如當必要時，例如：當絡合 覆銅睡，发酵素分解時。可能使用具有兩性離子的磷脂包 匕1，其包括但不限於：磷脂醯膽鹼、磷脂醯絲胺酸、 礙月曰酿乙醇胺、勒髓碟脂及其他神經酿胺，以及多種其他 的兩性離子性磷脂。 【實施方式】
在囊封的例子中，許多銅敏感性化合物可能因沒有適當 覆蓋或包覆銅，而使該等銅敏感性化合物分解。 感性成分可例如包含： 該等銅敏 實例1 成份 數量 來源 維生素C 500 mg 抗壞血酸鈣二水合物， USP 維生素Ε 400 IU α醋酸生育酚，USP 鋅 40 mg 氧化鋅 銅 1 mg 驗式碳酸銅，依據]VIerck公司目錄 ω-3脂肪酸總和 350 mg ω-3脂肪酸三酸甘油|旨Ph.Eur. 120mg (DHA : ΕΡΑ 比率變化1 : 4, 1 : ' 1 : 2, 1:1，2 :1 3 : 1 或者 4 : 1) 葉黃素 10 mg FloraGlo 20%天然來源 玉米黃質 2 mg 來自葉黃素 實例2 在另一實驗中 ，該銅 ，例如鹼式碳酸銅，係併入膠囊殼 内，其含有以下成分· 明確言之，用於製造該外殼的賦形劑為例如： 129268.doc 200904456 明膠 牛明膠束強度175(175bl〇〇mb〇vine)
甘油 99%，USP 大豆油薄片（氫化），NF 大豆油 USP，和 著色劑（如果需要）、有機及/或無機，例如二氧化鈦usp， 黑色氧化鐵E17 2及/或紅色氧化鐵e 17 2 在沒有覆蓋該銅之設計中，及以外殼覆蓋，且因此不直 接接觸銅敏感性成分之該銅之條件下探討上述組合物的穩 疋性。所說明覆蓋/包覆法的穩定性與此等銅敏感性化合 物及/或組合物的分解度具相關性。 實例3 標記160 mg ω-3脂肪酸 標記 130 mg DHA 標記11 mg 標記60 mg維生素C 標記20 mg維生素E 標記10 mg葉黃素 標記10 mg鋅 標記0.25 mg銅 含70% DHA之240 mg魚油 廿二碳六烯酸（DHA) 作為魚油中一部分的二十 碳五烯酸（EPA) 91.5 mg抗壞血酸鈣 3 1.343 mg d，l a-醋酸生育酚 中55 mg葉黃素占紅花油2〇〇/。 12.447 mg氧化鋅 0.45 mg鹼式碳酸銅 作為葉黃素一部分之玉米黃質標記〇_8 mg 上述組合物可能包含其他用於生產目標蓋倫試劑調配物 (galenic formulation),例如，用於製造膠囊外殼或類似物 之賦形劑。 129268.doc 200904456 實例4 ω·3脂肪酸在軟膠膠囊中於8〇°C下儲存2日後之穩定性（環 境濕度，即相對濕度50%-70°/〇) (ω-3脂肪酸的組份含量變化） 依據歐洲藥典5.4中所描述之標準方法，進行氣相色譜 法，分析儲存後ΕΡΑ和DHA之重量百分比。 ω-3脂肪酸 組份 未覆蓋銅之調配 物 有覆蓋銅之調配物 實例3中揭示之調 配物：（使用鹼式 碳酸銅）。該外殼 與實例21揭示之 外殼相同，但其 中不包含任何鋼 實例3中揭示之調配物，其 中驗式碳酸銅改用2.250毫 克DESCOTE®替代(有包衣 之葡糖酸銅），相當於0.25 毫克銅。該外殼與實例2中 所揭示但不包含任何銅之 外殼相同 實例3中揭示之調 配物，然而該調 配物中省略銅。 然而，外殼中含 有銅，即0.45 mg 的鹼式碳酸銅(相 當於0.25 mg銅)如 實例2所揭示 ΕΡΑ重量 百分數 h 下降5.0 % 下降1.7 % ------------ 無變化(未降低） DHA重量 百分數 -----— 無可檢測之變化 ^~---- 無可檢測之變化 無變化(未降低） EPA和DHA以 外之ω-3脂肪酸 ^的重量 百分數 下降1.9 % 下降0.4 % 無變化(未降低） *其他〇〇3脂肪酸表示α_亞麻酸、十 八碳四稀酸 f (SA) 和〇 慣用名詞： 129268.doc 200904456 如本文使用’銅或銅鹽可交換地使用並且以cu2+較佳， 但同樣也可能包括Cu+。銅鹽較佳包括醫藥上可以接受的 陰離子’例如氣離子、氧離子1氧根、葡糖酸根、碳酸 根、硫酸根，等等。 如本文使用，ω-3_脂肪酸主要（但不限於）是二十碳五稀 酸（ΕΡΑ)和二十二碳六稀酸（dha)。
如本文使用’術$覆蓋、包覆或囊封鋼或銅鹽係指該鋼 鹽和覆層、包衣或囊封試劑可有效地預防該銅鹽與該銅敏 感性化合物及/或組合物直接交互作用。 如本文使用，可消化膠囊材料是例如：上述實例2中描 述的外殼材料，但通常可以是醫藥/膳食/保健食品用膠囊 之相關技藝中使用的任何膠囊或膠囊殼或外殼材料，其典 型地是有機聚合性組合物，並且典型地在藥物學上相容 (無毒、可生物-降解、在腸或胃内可消化者方被認為合 適）。 如本文使用，術語醫藥組合物典型地係指食品補充劑組 合物及/或保健食品組合物，而反之亦然。 本發明之另一態樣係有關一種以有覆層或包衣的銅鹽在 醫藥組合物中，於治療能夠由銅鹽治療的疾病，例如與年 齡有關的黃斑變性（AMD)或糖尿病性視網膜病（DR)上之用 途0 本發明更進一步係有關一種以有覆層或包衣之銅鹽於穩 定醫藥組合物上之用途。 本發明更進一步係有關一種可穩定儲存之醫藥組合物， 129268.doc -10· 200904456 其包括co-3-脂肪酸和有包衣或覆層之銅鹽^ 本發明更進一步係有關一種以有覆層或包衣之銅鹽於穩 定食品補充劑及/或保健食品組合物免於發生與銅鹽相關 之分解之方法上之用途。 該發明s進一步係冑關一種以有覆層《包衣之銅鹽於穩 定醫藥組合物免於發生與銅鹽相關之分解之方法上之用 途。
該發明更進-步係有關-種藥物傳送系统，其包括可消 化膠囊材料、或外殼或外殼材料，一種或多種銅敏性組成 刀，如維生素E、葉黃素、或ω_3脂肪酸和銅鹽，其特徵為 該等銅鹽係置於該藥物傳送系統的外殼材料之内。 ， 該發明更進一步係有關： 一種可消化膠囊材料’特別是胃腸道可消化膠囊材料， 其包含有覆層或包衣之銅鹽，較佳地係硫酸銅、碳酸銅及/ 或葡糖酸銅，其特徵在於該膠囊材料代表用於該銅鹽之該 覆層及/或包衣材料； 在前述段落中界定之可消化膠囊，其中該銅鹽已經包覆 包衣，並且該包衣可能與該膠囊材料相同或者是另一種覆 層材料； 引述2個奴落中界定之消化性膠囊材料在填料中包括 下列成分·包括抗壞血酸鈣或實質上由其組成之維生素 :;包括^醋酸生育齡或實質上由其組成之維生素Ε;包 括氧化鋅或實質上由並 匕 山 ，、、.且珉之鋅，包括氧化銅、硫酸銅、 叙酸銅或葡糖酸銅或實質上由其組成之銅；包 129268.doc 200904456 酸甘油酯Ph.Eur或實質上由其組成之ω_3脂肪酸。 有覆層或包衣之銅鹽所使用之該覆層係根據上述描述獲 得，特別是如上述之消化性膠囊材料形式，係用在營養素 中或在食物補充劑中、特別用在以上描述之目的中，並且 視隋况與AMD冶療法結合，例如使用Lucentis⑧或 Visudyne®治療。 根據上述之描述，使用有覆層或包衣之銅鹽作爲營養素 組0物或作爲食物補充劑組合物’用於防止/治療AMD及/ 或DR。 為有此需要之個體治療及/或預防AMD及/或DR的方法包 括杈與有效量之包含依據上述說明之有覆層或包衣之銅鹽 的營養素組合物，或食物補充劑組合物。 129268.doc 12

Claims (1)

  1. 200904456 . 十、申請專利範圍： 1. 一種以有覆層或包衣之銅鹽於用於治療及/或預防可由銅 鹽治療及/或預防的疾病之醫藥組合物上之用途。 2. 如請求項1之用途，其中該疾病係與年齡有關之黃斑變 性或糖尿病性視網膜病。 3· 一種以有覆層或包衣之銅鹽於穩定醫藥組合物使免於發 ‘ 生與銅鹽相關之分解之用途。 4.如請求項1至3中任一項之用途，其中該醫藥組合物包括 f 一或多種銅敏感性化合物，如：ω- 3脂肪酸、維生素c、 維生素Ε、葉黃素及/或玉米黃質。 5 ·如請求項1至3中任一項之用途’其中該銅係以明膠、脂 質體或單酸甘油|旨和二酸甘油g旨包覆。 6.如請求項丨至3中任一項之用途’其中該銅係葡糖酸銅、 氧化銅、碳酸銅或氣化銅。 7，如請求項1至3中任一項之用途，其中該包衣是兩性離子 性碟脂，其包括但不限於：磷脂醯膽鹼、磷脂醯絲胺 I， 酸、磷脂醯乙醇胺、鞘髓磷脂及其他神經醯胺，以及多 種其他的兩性離子性鱗脂。 ， 8.如巧求項1至3中任一項之用途，其中該銅係銅環糊精絡 合物。 9.種可消化膠囊材料，特別是胃腸道可消化膠囊材料， 〃包3有覆層或包衣之銅鹽，其特徵在於該膠囊材料代 表用於該銅鹽之該覆層及/或包衣材料。 10·如請求項9之可消化膠囊材料，其中該銅鹽已經包覆包 129268.doc 200904456 衣，並且該包衣可能與該膠囊材料相同或者是另 層材料。 裡覆 η.如請求項9或1()之可消化膠囊材料，其在填料中包括以 下成份：包括抗壞血酸鈣或實質上由其組成之維生= c;包括d’ia醋酸生育酚或實質上由其組成之維生素 包括氧化鋅或實質上由其組成之辞；包括酸三酸甘 油酯Ph.Eur或實質上由其組成之ω_3脂肪酸。 12. 一種呈如請求項9至"中任一項之可消化膠囊形式之有 覆層或包衣之銅鹽於營養素或食物補充劑中之用途。 13. —種呈如請求項9至丨丨中任一項之可消化膠囊形式之有 覆層或包衣之銅鹽於製造營養素組合物或作為食物補充 劑組合物上之用途，該組合物係用於預防及/或治療與年 齡有關之育斑變性或糖尿病性視網膜病。 14. 一種包含呈如請求項9至u中任一項之可消化膠囊形式 之有覆層或包衣之銅鹽的營養素組合物或食物補充劑組 合物於製造藥劑上之用途，該藥劑係用於為有此需要之 個體治療及/或預防AMD及/或DR。 129268.doc 200904456 七、 指定代表圖： (一) 本案指定代表圖為：（無） (二) 本代表圖之元件符號簡單說明： 八、 本案若有化學式時，請揭示最能顯示發明特徵的化學式： (無） 129268.doc
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