TW201808274A - 具高活性成分含量之ω-3脂肪酸胺基酸鹽的錠劑 - Google Patents
具高活性成分含量之ω-3脂肪酸胺基酸鹽的錠劑 Download PDFInfo
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- TW201808274A TW201808274A TW106117438A TW106117438A TW201808274A TW 201808274 A TW201808274 A TW 201808274A TW 106117438 A TW106117438 A TW 106117438A TW 106117438 A TW106117438 A TW 106117438A TW 201808274 A TW201808274 A TW 201808274A
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- omega
- fatty acid
- amino acid
- lozenge
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Classifications
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Abstract
本發明關於包含一或多種ω-3脂肪酸胺基酸鹽之錠劑、製備根據本發明之錠劑的方法及根據本發明之錠劑作為食物補充品或藥品的用途。
Description
本發明係關於包含一或多種ω-3脂肪酸胺基酸鹽之錠劑、製備根據本發明之錠劑的方法及根據本發明之錠劑作為食物補充品或藥品的用途。
ω-3脂肪酸,特別是二十碳五烯酸(EPA)及二十二碳六烯酸(DHA),與對心血管系統、對發炎性疾患、對大腦發展和機能、對中樞神經系統崩潰及對其他範圍之許多正面健康影響有關(C.H.S.Ruxton,S.C.Reed,M.J.A.Simpson,K.J.Millington,J.Hum.Nutr.Dietet 2004,17,449)。因此,ω-3脂肪酸之攝取係由監管機構的聲明獲得支持。例如,EFSA(European Food Safety Authority)建議成人250mg之EPA+DHA的日攝取量(daily intake)(EFSA Panel on Dietetic Products,Nutrition and Allergies,EFSA Journal 2010,8(3),1461)。AHA(American Heart Association)建議無心血管疾患病史的人每周攝取至少兩餐多脂之魚,有心血管疾患病史的人每日從魚或食物補充品攝取約1g之EPA+DHA,且每日攝取2至4g之EPA+DHA以治療高血脂值(P.M.Kris-Etherton,W.S.Harris,L.J.Appel,Circulation 2002,106,2747)。再者,當局明確地認可以臨床研究為基礎所決定關於ω-3脂肪酸之健康需求(EU Register on Nutrition and Health Claims;也能參見:EFSA Journal 2011,9(4),2078)。因此,ω-3脂肪酸,尤其是來自魚油還有其他植物或微生物來源,越來越常被用作食物補充品、食品添加物及藥劑。
依照標準命名,視雙鍵之數目和位置而將多元不飽和脂肪酸(polyunsaturated fatty acid)分類。有兩個系列或家族,取決於最接近該脂肪酸之甲基末端的雙鍵位置。ω-3系列包含於第三個碳原子處之雙鍵,而ω-6系列直到第6個碳原子為止皆沒有雙鍵。因此,二十二碳六烯酸(DHA)具有22個碳原子之鏈長及自該甲基算起第3個碳原子開始有6個雙鍵,且被稱作"22:6 n-3"(全順式-4,7,10,13,16,19-二十二碳六烯酸)。另一種重要之ω-3脂肪酸是二十碳五烯酸(EPA),其被稱作"20:5 n-3"(全順式-5,8,11,14,17-二十碳五烯酸)。
輸入市場之ω-3脂肪酸產品大都以油的形式供應,從含量約30% ω-3脂肪酸之魚油開始到高達超過90%含量的EPA或DHA或這兩種ω-3脂肪酸之混合物的濃縮物。使用之配方主要是軟質明膠膠囊。此外,許多其他產 品形式皆已經有人描述過,如微膠囊或粉末製劑(C.J.Barrow,B.Wang,B.Adhikari,H.Liu,Spray drying and encapsulation of omega-3 oils,in:Food enrichment with omega-3 fatty acids(編輯:C.Jacobsen,N.S.Nielsen,A.Frisenfeldt Horn,A.-D.Moltke Soerensen),pp.194-225,Woodhead Publishing Ltd.,Cambridge 2013,ISBN 978-0-85709-428-5;T.-L.Torgersen,J.Klaveness,A.H.Myrset,US 2012/0156296 A1)。在化學上,這些通常是含有不同濃度之ω-3脂肪酸的三酸甘油酯或脂肪酸乙酯,同時磷脂,例如磷蝦油、游離脂肪酸(T.J.Maines,B.N.M.Machielse,B.M.Mehta,G.L.Wisler,M.H.Davidson,P.R.Wood,US 2013/0209556 A1;M.H.Davidson,G.H.Wisler,US 2013/0095179 A1;N.J.Duragkar,US 2014/0018558 A1;N.J.Duragkar,US 2014/0051877 A1)及不同脂肪酸鹽亦屬已知,例如與鉀、鈉、銨(H.J.Hsu,S.Trusovs,T.Popova,US 8203013 B2)、鈣和鎂的鹽(J.A.Kralovec,H.S.Ewart,J.H.D.Wright,L.V.Watson,D.Dennis,C.J.Barrow,J.Functional Foods 2009,1,217;G.K.Strohmaier,N.D.Luchini,M.A.Varcho,E.D.Frederiksen,US 7,098,352 B2),其中這些鹽不是水溶性,胺基醇(P.Rongved,J.Klaveness,US 2007/0213298 A1)、胺化合物如六氫吡嗪(B.L.Mylari,F.C.Sciavolino,US 2014/0011814 A1)及胍化合物如二甲雙胍(metformin)(M.Manku,J.Rowe,US 2012/0093922 A1;B.L.Mylari,F.C. Sciavolino,US 2012/0178813 A1;B.L.Mylari,F.C.Sciavolino,US 2013/0281535 A1;B.L.Mylari,F.C.Sciavolino,WO 2014/011895 A2)。對人體而言不同ω-3衍生物之生物利用率(bioavailability)差異很大。既然如同游離脂肪酸之ω-3脂肪酸與單醯基甘油酯一起被小腸吸收,游離ω-3脂肪酸之生物利用率比三酸甘油酯或乙酯之生物利用率更好,因為這些三酸甘油酯或乙酯必須先在消化道中分裂成游離脂肪酸(J.P.Schuchhardt,A.Hahn,Prostaglandins Leukotrienes Essent.Fatty Acids 2013,89,1)。不同ω-3衍生物間之氧化安定性也極為不同。游離ω-3脂肪酸被描述成對氧化非常敏感(J.P.Schuchhardt,A.Hahn,Prostaglandins Leukotrienes Essent.Fatty Acids 2013,89,1)。關於固態ω-3形式之運用,假設其與液態產物相比安定性提高了(J.A.Kralovec,H.S.Ewart,J.H.D.Wright,L.V.Watson,D.Dennis,C.J.Barrow,J.Functional Foods 2009,1,217)。
再者,據悉ω-3脂肪酸與不同胺基酸(如離胺酸及精胺酸)之製劑,呈混合物(P.Literati Nagy,M.Boros,J.Szilbereky,I.Racz,G.Soos,M.Koller,A.Pinter,G.Nemeth,DE 3907649 A1)或呈鹽(B.L.Mylari,F.C.Sciavolino,WO 2014/011895 A1;T.Bruzzese,EP 0699437 A1;T.Bruzzese,EP0734373 B1;T.Bruzzese,US 5750572,J.Torras等人,Nephron 1994,67,66;J.Torras等人,Nephron 1995,69,318;J.Torras等人, Transplantation Proc.1992,24(6),2583;S.El Boustani等人,Lipids 1987,22(10),711;H.Shibuya,US 2003/0100610 A1)。藉由噴乾製備ω-3胺基醇也曾被提及(P.Rongved,J.Klaveness,US 2007/0213298 A1)。依一般形式,DHA胺基酸鹽之製備係藉由在高真空低溫下蒸乾或冷凍乾燥描述(T.Bruzzese,EP0734373 B1 und US 5750572)。所得產物被形容成非常稠之透明油狀物,其於低溫轉化成蠟質外觀和稠度之固體。
最終,原則上已知將ω-3胺基酸製劑加工成錠劑。由於該製劑中存有胺基酸且另使用助劑如黏結劑、釋離劑及結構形成物質,根據實施例中提及之配方,於錠劑成品中之ω-3脂肪酸濃度於ω-3胺基酸鹽之案例中為至多38%(T.Bruzzese,EP0734373 B1及US 5750572,實施例15),或於ω-3脂肪酸胺基酸混合物之案例中為至多34.6%(P.Literati Nagy,M.Boros,J.Szilbereky,I.Racz,G.Soos,M.Koller,A.Pinter,G.Nemeth,DE 3907649 A1)。
然而,儘管有詳盡之先前技藝,但是所有已知之產物形式皆具有一或多個缺點以致於需要進一步改良。例如,最常見之ω-3三酸甘油酯及乙酯油類本來就比游離ω-3脂肪酸更不易被生物利用。這些反而對氧化特別敏感。做成軟明膠膠囊之現成配方比單純固體製錠更複雜、更貴且更易產生缺陷。此外,許多消費者考量宗教或其他立場而反對消費動物源明膠。迄今所述之固體ω-3配 方,無論呈微膠囊化或結合之油(bound oil)、呈與胺基酸之混合物或呈鹽,皆具有其他嚴重缺點。例如,鹼金屬鹽在水溶液中為強鹼性,而鹼土金屬鹽實際上為非水溶性,這限制了生物利用率。儘管與胺基酸之混合物或鹽為水溶性且因此應該易被生物利用,但是所述之錠劑卻仍舊具有較低ω-3脂肪酸含量,關於ω-3脂肪酸和胺基酸的鹽為至多38%及關於ω-3脂肪酸和胺基酸的混合物至多34.6%。這有賴於用於製備安定錠劑之大量添加助劑如釋離劑和黏結劑及結構形成物質。但是低ω-3脂肪酸含量導致下列事實:消費者必須頻繁且較大量地攝取相應產品以達到建議之日攝取量,其可能隨著國家和健康狀況為數百毫克至高達數公克。
基於所述缺點,需要ω-3脂肪酸製劑,其可輕易且有成本效益地配製成錠劑之固體,其具有比標準液體配方佳之生物利用率且此外也更安定,及此外其儘可能使ω-3脂肪酸高度濃縮以維持儘可能低的日攝取量。
頃發現,令人驚訝的是,可獲得包含一或多種ω-3脂肪酸胺基酸鹽之錠劑,其中選自由聚乙烯吡咯烷酮(PVP)、澱粉、乳糖、微晶型纖維素、硫酸鈣、甘露醇、磷酸鈣及其混合物所組成之群組的黏結劑及結構形成物質(structuring-forming substance)之含量以該錠劑之總重量為基準計為總共40重量%或更少。
本發明之第一態樣因此關於包含一或多種ω-3脂肪酸胺基酸鹽之錠劑,其特徵為選自由聚乙烯吡咯烷酮(PVP)、澱粉、乳糖、微晶型纖維素、硫酸鈣、甘露醇、磷酸鈣及其混合物所組成之群組的黏結劑及結構形成物質之含量以該錠劑之總重量為基準計為總共40重量%或更少。
於本發明之一較佳組態中,選自由聚乙烯吡咯烷酮(PVP)、澱粉、乳糖、微晶型纖維素、硫酸鈣、甘露醇、磷酸鈣及其混合物所組成之群組的黏結劑及結構形成物質之含量以該錠劑之總重量為基準計為總共20重量%或更少,更佳地10重量%或更少,特佳地1重量%或更少。於本發明之另一個較佳組態中,根據本發明之錠劑不含選自由聚乙烯吡咯烷酮(PVP)、澱粉、乳糖、微晶型纖維素、硫酸鈣、甘露醇、磷酸鈣及其混合物所組成之群組的黏結劑及結構形成物質。
特別令人驚訝的是發現到僅添加少許助劑之ω-3脂肪酸胺基酸鹽,特別是於沒添加黏結劑或結構形成物質係特別有益的案例中,能被壓實而得到錠劑。最終,藉由直接壓實製備錠劑一般僅描述用於一些物質如硫酸鈣、磷酸氫鈣、(微晶型)纖維素、乳糖或其他糖及糖衍生物,而非用於ω-3脂肪酸或其衍生物(Pharmazeutische Hilfsstoffe[Pharmaceutical Auxiliaries],Peter C.Schmidt,Siegfried Lang,p.131f.,GOVI-Verlag,ISBN 978-3-7741-1222-3)。
ω-3脂肪酸(其可能個別或依任何較佳組合存於根據本發明之錠劑中)包含例如二十碳三烯酸(ETE)20:3(n-3)(全順式-11,14,17-二十碳三烯酸)、二十碳四烯酸(ETA)20:4(n-3)(全順式-8,11,14,17-二十碳四烯酸)、二十一碳五烯酸(HPA)21:5(n-3)(全順式-6,9,12,15,18-二十一碳五烯酸)、二十二碳五烯酸(鰶魚酸)(DPA)22:5(n-3)(全順式-7,10,13,16,19-二十二碳五烯酸、二十四碳五烯酸24:5(n-3)(全順式-9,12,15,18,21-二十四碳五烯酸)、二十四碳六烯酸(鯡酸)24:6(n-3)(全順式-6,9,12,15,18,21-二十四碳六烯酸)。
ω-3脂肪酸可自任何適合起始材料獲得,此外該起始材料可藉任何適合方法加工。典型起始材料包括魚屠體、蔬菜及其他植物的所有部份,還有由微生物發酵或藻類發酵所得之材料。此起始材料之典型加工方法係,尤其,粗製油萃取之步驟(如該起始材料之萃取和分離)還有精煉粗製油之步驟(如沉積和脫膠、脫酸、漂白及脫臭(參照例如"EFSA Scientific Opinion on Fish Oil for Human Consumption")。其他加工方法包括,尤其是,將ω-3脂肪酸酯至少部分轉化成對應之游離ω-3脂肪酸或其無機鹽的步驟。
ω-3脂肪酸也可藉由也可藉由使該ω-3脂肪酸酯分裂且於其後自基本上由ω-3脂肪酸酯所組成之組成物移除先前作為酯之部分接附之醇而獲得。該酯分裂較佳於鹼性條件之下進行。酯分裂方法從先前技藝眾所周知。
根據本發明之錠劑的安定性不是取決於該脂肪酸組分是否為,例如,EPA或DHA濃縮物的水解產物、EPA/DHA半濃縮物(semi-concentrate)的水解產物或甚至魚油之水解產物。
於本發明之一有益組態中,ω-3脂肪酸係選自二十碳五烯酸(EPA)、二十二碳六烯酸(DHA)及其混合物。
於本發明之另一個有益組態中,胺基酸係選自鹼性胺基酸,較佳選自離胺酸、精胺酸、鳥胺酸及其混合物。
當使用已經由充分高濃縮之EPA或DHA起始材料或EPA/DHA混合物所製備的ω-3脂肪酸胺基酸鹽時,所得錠劑可具有總共超過40%之ω-3脂肪酸含量。在此高ω-3脂肪酸含量之案例中,為了達到ω-3脂肪酸之建議日攝取量,僅攝取幾個錠劑便足夠,有可能只要每日單一錠。
因此,於本發明之一有益組態中,ω-3脂肪酸之含量以該錠劑之總重量為基準計為總共40重量%或更多,特佳地50重量%或更多。
ω-3脂肪酸與胺基酸之鹽係溶於消化道,其中釋出適於被身體直接吸收之游離ω-3脂肪酸,且不再需要先前化學或酵素分裂,如魚油中之ω-3三酸甘油酯或由彼所製備之ω-3脂肪酸乙酯的情況中所需者。
於另一個態樣中,本發明關於一種製備根據本發明之錠劑的方法,其特徵為該ω-3脂肪酸胺基酸鹽係 隨意與一或多種黏結劑及/或一或多種結構形成物質一起壓製。
於一較佳組態中,根據本發明之方法的特徵為該ω-3脂肪酸胺基酸鹽係於該壓製(compression)以前壓實(compacted)。該壓實(compaction)能,例如,使用配備25mm雙面衝頭(biplanar punch)之Exzenter壓片機於15至20kN(30.5至40.7MPa)之壓縮力完成。所得產物能於其後再藉由1mm篩網弄碎。
於另一個較佳方案中,根據本發明之方法的特徵為該ω-3脂肪酸胺基酸鹽較佳為於該壓製以前及隨意地於該壓實以前利用溶劑(例如水或乙醇)或利用溶劑混合物(例如水/乙醇混合物)製成粒狀。
原則上已知ω-3脂肪酸胺基酸鹽。如一開始所述,這些可藉由自含水性或水性醇系媒介沉澱或藉由噴乾而呈微細之實質上無色的粉末獲得,其與迄今所述的這些物質之蠟質稠度不同,有其益處。
於一較佳方案中,根據本發明之方法的特徵為該ω-3脂肪酸胺基酸鹽係藉由自水溶液或醇系水溶液沉澱獲得。
於另一個較佳方案中,根據本發明之方法的特徵為該ω-3脂肪酸胺基酸鹽係藉由水溶液或醇系水溶液之噴乾獲得。
於另一個態樣中,本發明關於根據本發明之錠劑的用途,該錠劑係用作食物補充品或藥品。
於本發明之上下文中,藥品可包含,除了在此所述之ω-3脂肪酸以外,醫藥上可接受之助劑及藥學活性成分如施德丁(statin)、抗高血壓藥劑、抗糖尿劑、抗痴呆劑、抗抑鬱劑、抗肥胖劑、食慾抑制劑及改善記憶及/或認知機能之藥劑。
該配方可利用21×9mm長橢圓形衝頭於5kN壓縮力壓製成50N硬錠劑。所用之ω-3脂肪酸離胺酸鹽具有48重量%之ω-3脂肪酸(EPA+DHA之總和)含量。這造成41重量%之錠劑成品的ω-3脂肪酸含量。
此配方也可被直接壓製成錠劑。所用之ω-3脂肪酸離胺酸鹽具有65重量%之ω-3脂肪酸(EPA)含量。這造成56.1重量%之錠劑成品的ω-3脂肪酸含量。
Claims (12)
- 一種包含一或多種ω-3脂肪酸胺基酸鹽之錠劑,其特徵為選自由聚乙烯吡咯烷酮(PVP)、澱粉、乳糖、微晶型纖維素、硫酸鈣、甘露醇、磷酸鈣或其混合物所組成之群組的黏結劑及結構形成物質(structuring-forming substance)之含量以該錠劑之總重量為基準計為總共40重量%或更少。
- 如申請專利範圍第1項之錠劑,其中該黏結劑及結構形成物質之含量總共20重量%或更少,較佳地10重量%或更少,特佳地1重量%或更少。
- 如申請專利範圍第1或2項之錠劑,其中該ω-3脂肪酸係選自二十碳五烯酸(EPA)、二十二碳六烯酸(DHA)及其混合物。
- 如申請專利範圍第1至3項中任一項之錠劑,其中該胺基酸係選自鹼性胺基酸。
- 如申請專利範圍第1至4項中任一項之錠劑,其中該胺基酸係選自離胺酸、精胺酸、鳥胺酸及其混合物。
- 如申請專利範圍第1至5項中任一項之錠劑,其中該ω- 3脂肪酸之含量以該錠劑之總重量為基準計為總共40重量%或更多,較佳地50重量%或更多。
- 一種製備如申請專利範圍第1至6項中任一項之錠劑之方法,其特徵為該ω-3脂肪酸胺基酸鹽係隨意與一或多種黏結劑及/或一或多種結構形成物質一起壓製。
- 如申請專利範圍第7項之方法,其中該ω-3脂肪酸胺基酸鹽係於該壓製(compression)以前壓實(compacted)。
- 如申請專利範圍第7或8項之方法,其中該ω-3脂肪酸胺基酸鹽係於該壓製以前及隨意於該壓實(compaction)以前以溶劑或溶劑混合物造粒。
- 如申請專利範圍第7至9項中任一項之方法,其中該ω-3脂肪酸胺基酸鹽係藉由水溶液或醇系水溶液之沉澱獲得。
- 如申請專利範圍第7至9項中任一項之方法,其中該ω-3脂肪酸胺基酸鹽係藉由水溶液或醇系水溶液之噴乾獲得。
- 一種如申請專利範圍第1至6項中任一項之錠劑之用途,其中該錠劑係用作食物補充品或藥品。
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