TWI433652B - 用於壓錠之嵌入式液體潤滑劑 - Google Patents
用於壓錠之嵌入式液體潤滑劑 Download PDFInfo
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- TWI433652B TWI433652B TW097113859A TW97113859A TWI433652B TW I433652 B TWI433652 B TW I433652B TW 097113859 A TW097113859 A TW 097113859A TW 97113859 A TW97113859 A TW 97113859A TW I433652 B TWI433652 B TW I433652B
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Description
本發明係關於醫藥及營養藥錠劑。更特定言之,本發明提供用於在壓錠中進行有效潤滑之組合物及方法。
硬脂酸或硬脂酸金屬鹽、尤其硬脂酸鎂通常用作醫藥及營養藥組合物中之賦形劑以促進壓錠過程。諸如硬脂酸鎂之化合物充當潤滑劑且藉由減少錠劑形成及脫模期間錠劑-模壁界面處之摩擦及/或藉由預防黏住衝頭面及模壁來促進壓錠。
雖然在整個醫藥及營養藥工業中用作潤滑劑,但使用硬脂酸鎂作為潤滑劑具有若干缺點。硬脂酸鎂為層狀潤滑劑。作為層狀潤滑劑,硬脂酸鎂之結構為層狀薄片之堆疊。當一或多個層狀薄片自堆疊"剝離"且至少部分地包覆周圍微粒時,發生潤滑。混合促進自堆疊移除薄片且因此促進潤滑度(亦即,用層狀潤滑劑潤滑具有"混合敏感性")。
當混合包含硬脂酸鎂之組合物時,層狀薄片自硬脂酸鎂之堆疊結構剝離且包覆組合物之周圍微粒或顆粒。因此,混合時間、速度及/或混合方法影響硬脂酸鎂之潤滑功效。舉例而言,若混合過程中過多層狀薄片自硬脂酸鎂之堆疊結構剝離,則發生過度潤滑。亦即,微粒過多包覆有層狀薄片,其減少微粒間黏結,引起不良壓縮性及較低錠劑硬度,因此產生潛在加工問題及/或畸形錠劑之傾向。在一些狀況下,過度潤滑可致使錠劑具有疏水性,此可能
不合需要地延長崩解時間。
雖然混合為內含物均勻所需,但當硬脂酸鎂或其他層狀潤滑劑用作潤滑劑時,即使混合時間、速度及/或混合機制之適度變化亦會引入潤滑程度之變化,此繼而引起相關聯之壓縮性及壓錠問題。當用作潤滑劑時,硬脂酸鎂通常在壓錠之前單獨最後一步中被添加至組合物中以控制潤滑過程,且使過度潤滑或對混合過程中硬脂酸鎂結構之不當破壞的機會降至最低。
通常,液體潤滑劑尚未特別適用於意欲壓錠之營養藥及/或醫藥的粉末摻合組合物。通常,液體潤滑劑僅可少量添加至粉末摻合物中且必須緊接在壓縮之前添加,此係因為其傾向於濕潤粉末摻合物,從而使混合困難。
已提出兩種克服與使用液體潤滑劑相關之問題的方法。一種方法係藉由氫化將液體不飽和植物油潤滑劑轉變成固體飽和油潤滑劑。此方法具有以下缺點:(1)氫化植物油與增加之冠狀心臟病危險相關聯,及(2)氫化植物油作為壓錠潤滑劑遠不如普通金屬硬脂酸鹽潤滑劑有效。
用以促進將液體潤滑劑用於意欲壓錠之乾燥混合物中的第二種方法係用不溶於油之成膜物質包覆液體潤滑劑以避免濕潤問題。成膜物質集合以在油滴表面上形成一層或表皮。如美國專利3,518,343中所述之成膜物質包括水溶性膠,諸如阿拉伯膠(gum Arabic)、果膠、黃蓍膠、經改質之纖維素(諸如,羥丙基纖維素或羧甲基纖維素)、海藻酸鹽或蛋白質物質(諸如,明膠)。雖然不溶於油之膜形成劑
可在某種程度上解決濕潤問題,但此項技術中已知之經膜包覆之液體具有大大降低之潤滑功效,此係因為潤滑劑包裹在膜中
因此,需要用於改良用於壓錠之乾燥營養藥及/或醫藥組合物之潤滑的組合物及/或方法。
在一實施例中,本發明提供一種用於壓錠之營養增補劑組合物,其包含具有嵌入式潤滑之基質。具有嵌入式潤滑之基質包含細微地分散在不溶於油之物質中的油性液體。在一例示性實施例中,營養增補劑組合物實質上不含硬脂酸鹽。適於分散在不溶於油之物質中的油性液體包括(但不限於)維生素E(較佳呈維生素E乙酸鹽形式)、動物油、合成油、礦物油、聚乙二醇、矽油及其組合。合適之不溶於油之物質包括(但不限於)澱粉、糊精、微晶纖維素、乙基纖維素、明膠、糖、葡萄糖、麥芽糖、果糖、山梨糖醇、蔗糖、甘露糖醇、山梨糖醇、乳糖、甲基纖維素、羥丙基甲基纖維素、麥芽糊精、二氧化矽、無水磷酸二鈣及其組合。
組合物可為直接壓縮、碾壓或粒化組合物。
本發明之一實施例提供一種用於壓錠之醫藥組合物,其包含具有嵌入式潤滑之基質,其中該具有嵌入式潤滑之基質包含分散在不溶於油之基底物質中的油性液體,且其中該醫藥組合物實質上不含硬脂酸鹽。
提供一種潤滑用於壓錠之營養增補劑或醫藥組合物的方
法。該方法包含提供具有嵌入式液體潤滑劑之基質,提供營養增補劑組合物或醫藥組合物,將具有嵌入式液體潤滑劑之基質與營養增補劑或醫藥組合物混合,且形成錠劑。營養增補劑或醫藥組合物可為直接壓縮混合物、碾壓混合物或包含粒化組合物。
本發明提供一種包含具有一或多種嵌入式液體潤滑劑之基質的組合物。嵌入式液體潤滑劑用以為組合物之壓錠提供潤滑。更特定言之,本發明之具有嵌入式液體潤滑劑之基質為不溶於油之顆粒-固體基底物質,其具有分散在該基底物質中的黏油性液體潤滑劑。在一較佳實施例中,具有嵌入式液體潤滑劑之基質可用作金屬硬脂酸鹽潤滑劑(諸如,硬脂酸鎂)之替代物,作為營養藥或醫藥組合物之壓錠潤滑劑。或者,具有嵌入式潤滑劑之基質可用作硬脂酸鹽潤滑劑或其他壓錠潤滑劑之部分代替物。具有嵌入式潤滑劑之基質為用於壓錠乾燥營養及/或醫藥組合物(諸如,維生素及/或礦物質組合物)之有用潤滑劑。具有嵌入式潤滑劑之基質尤其可用於在壓錠過程中經受直接壓縮之組合物。在一例示性實施例中,發現細微地分散在澱粉/糊精基質中之液體維生素E乙酸鹽有效潤滑用於直接壓縮之綜合維生素及礦物質調配物。
除為壓錠提供潤滑外,尤其如與傳統金屬硬脂酸鹽潤滑劑相比,本發明之組合物一般可提供一或多個以下優點:(1)消除硬脂酸鎂過度潤滑對壓縮性之不良影響;
(2)藉由消除單獨的潤滑劑添加及摻合(例如,混合)階段使製造過程更有效率;(3)較少之潤滑劑誘發之對錠劑硬度的軟化作用;(4)錠劑之較低脆碎性;(5)低濃度時減少之崩解時間延長;及/或(6)與其他成份之優良相容性。
將維生素E作為嵌入基質中之潤滑劑的實施例可提供抗氧化性及/或營養增補維生素E之額外益處。
本發明進一步包括一種潤滑用於壓錠之營養或醫藥組合物之方法,其藉由提供具有嵌入式液體潤滑劑之基質及營養增補劑或醫藥組合物,且將具有嵌入式液體潤滑劑之基質與營養增補劑或醫藥組合物在壓錠之前混合。
不希望束縛於理論,本發明者咸信將液體潤滑劑嵌入基質中允許液體潤滑劑均勻分布在基質中而不濕潤基質。在壓縮後,液體潤滑劑可自基質壓出且為壓錠提供潤滑,從而消除使用硬脂酸及金屬硬脂酸鹽時所見之過度潤滑問題。因為基質中之液體潤滑劑不具有混合相關之過度潤滑問題,所以其可在單一步驟中與用於混合之其他組份一起被添加。因此,可避免習知之緊接在壓錠之前作為單獨步驟添加潤滑劑的步驟。
如本文所用之術語"具有嵌入式液體潤滑劑之基質"意謂一種包含至少一種細微地分散在不溶於油之物質中之油性液體的組合物,其中該基質看似乾燥且肉眼看不見油或油性外觀,且基質自由流動。將小油微粒併入不溶於油之物
質體中(例如,散布在不溶於油之物質之空隙空間中)。藉由壓錠過程之壓力,可將潤滑劑自基質移出。不溶於油之物質可為單一組份或組份混合物。通常,不溶於油之物質呈乾燥微粒形式。類似地,油性液體可為單一實體或油性液體之混合物。組成具有嵌入式液體潤滑劑之基質的各物質應為哺乳動物可消化之物質。
如本文所用之術語"油"意謂實質上不溶於水(如默克索引(Merck Index)、CRC手冊或MSDS資料表所指定)且在周圍溫度下為液體的物質。"嵌入式液體潤滑劑"包括油以及在周圍溫度下為液體、具有潤滑性且不與不溶於油之物質反應或不溶解不溶於油之物質的其他物質。
嵌入式液體潤滑劑與覆膜之潤滑劑的不同之處在於不存在引起不溶於油之物質在油滴表面上組成一層之化學或物理過程。適於形成基質之不溶於油之物質的簡單清單與膜形成聚合物之清單可能重疊;然而僅僅化學一致性並不具有決定性。組合方法、所用比例、其他反應性實體之存在、水分量及溫度為可決定形成覆膜之油還是形成具有嵌入式潤滑劑之基質的例示性因子。
如本文所用之術語"硬脂酸鹽"包括硬脂酸及硬脂酸金屬鹽。硬脂酸鎂為例示性硬脂酸金屬鹽。實質上,不含硬脂酸鹽意謂組合物包含少於0.01 wt%之硬脂酸鹽。
術語"綜合維生素及礦物質"或"綜合維生素及綜合礦物質"增補劑包括包含至少一種維生素及至少一種礦物質及視情況一或多種相關營養劑之組合物。術語"綜合維生素
及礦物質"或"綜合維生素及綜合礦物質"應以本文中其在術語"增補劑"、"錠劑"或"組合物"前時之類似方式予以解釋。此外,綜合維生素及礦物質增補劑為營養增補劑及/或營養藥之實例。
如本文所用之"營養劑"包括除維生素及礦物質外之已知對健康具有益處之物質。營養劑包括(但不限於)類胡蘿蔔素(諸如,葉黃素、番茄紅素、玉米黃素、蝦青素及相關花黃素)、纖維、植物固醇、糖苷、多酚、B複合相關化合物(諸如,膽鹼及肌醇)、ω-3脂肪酸、益生菌、葡糖胺、草藥、胺基酸及肽。
如本文所用之短語"崩解時間"意謂醫藥組合物或營養增補劑之錠劑劑量單位在受控實驗室條件下崩解所花費之時間量。一般技術者熟悉用於測定崩解時間之方法及程序。
術語"乾燥醫藥組合物"係指以乾燥物質形式呈現之用於壓縮成錠劑劑型之組合物。雖然組合物在壓縮成錠劑時為乾燥,但並不排除涉及水分之加工步驟,只要該物質在呈現用於壓錠時不明顯濕潤即可。
應認為如本文所用之術語"醫藥活性之劑"、"活性之劑"、"活性劑"、"治療劑"、"藥物"係等效術語,且意謂用於預防、診斷、減緩、治療或治癒疾病或醫學病況之物質。
本發明之組合物可包含任何營養或醫藥組合物,其可形成錠劑型。具有複數個營養組份及/或醫藥活性劑的組合物亦在本發明之範疇內。舉例而言,對於營養組合物實施例而言,組合物可包含單一營養組份、精選之組份組(諸
如,針對骨健康之營養素組)或廣效性營養組份(諸如,維生素及礦物質)及視情況一或多種營養劑(諸如,市售綜合維生素及礦物質錠劑或具有一或多種添加營養劑之綜合維生素及礦物質錠劑)。
可包括在本發明之組合物中的合適維生素及相關實體包括(但不限於)維生素C、維生素E、硫胺素(維生素B1
)、核黃素(維生素B2
)、菸鹼酸(維生素B3
)、吡哆醇(維生素B6
)、葉酸、鈷胺素(維生素B12
)、泛酸(維生素B5
)、生物素、維生素A(及維生素A前驅體)、維生素D、維生素K及其他B複合維生素與其混合物。
可包括在本發明之組合物中的合適礦物質包括(但不限於)鐵、碘、鎂、鋅、硒、銅、鈣、錳、矽、鉬、釩、硼、鎳、錫、磷、鉻、鈷、氯化物、鉀及其組合。綜合維生素-綜合礦物質錠劑之礦物質組份通常以鹽形式提供。所用鹽形式應為醫藥學上可接受之鹽形式。
維生素及礦物質與可包括在營養增補劑中之相關劑及劑量之列表闡述於制定之參考指南中,諸如the United States Pharmacopeia National Formulary Official Compendium of Standards(亦即,the U.S.P.N.F.Official Compendium of Standards)或包括修正內容的European Directive 90/496/EC,將該等以引用的方式併入本文中。維生素及礦物質之量可在特定實施例中變化,但通常應落在U.S.P.N.F.Official Compendium of Standards或European Union Directive中所述之劑量內。
可包括在本發明之組合物中的營養劑包括(但不限於)類胡蘿蔔素(諸如,葉黃素、番茄紅素、玉米黃素、蝦青素及相關花黃素)、B複合相關化合物(諸如,膽鹼及肌醇)、(例如)纖維、植物固醇、益生菌、糖苷、多酚、膽鹼、ω-3脂肪酸、葡糖胺、草藥、胺基酸及肽。
本發明之組合物進一步包含具有嵌入式液體潤滑劑之基質。該基質包含基底物質部分及油性液體。基底物質部分為不溶於油之物質。適於基底物質部分之不溶於油之物質包括(但不限於)澱粉、糊精、微晶纖維素、乙基纖維素、明膠、糖、葡萄糖、麥芽糖、果糖、山梨糖醇、蔗糖、甘露糖醇、山梨糖醇、乳糖、甲基纖維素、羥丙基甲基纖維素、麥芽糊精、二氧化矽、無水磷酸二鈣及其組合。合適之油性液體包括(但不限於)維生素E(較佳呈維生素E乙酸鹽形式)、動物油、合成油、礦物油、具有潤滑功能之有機液體、聚乙二醇、矽油及其組合。視情況,為達成加工之目的,可能需要包括一種加工助劑,諸如二氧化矽。基底物質在基質中應處於實質上微粒狀態,以便可獲得微粒間之空間(或空隙空間)以容納潤滑劑之小微粒或微滴。
為避免濕潤且提供油性液體均勻嵌入基底物質,將油性液體細微地分散在基底物質中。油性液體在基底物質中之分散應使得基質看似乾燥且以肉眼看不見任何油或油性外觀,且基質自由流動。分散在基底物質中之油性液體之量通常將高達約70% wt/wt(油/油加上基底物質)。通常約10%至約55% wt/wt(油/油加上基底物質)便於維持基質性質且
提供針對壓錠組合物中所用之每一量之基質的最佳量之潤滑劑。此等量具有代表性且其他量可同樣合適,其中特定量視基底物質及所用油性液體之性質、流動性質及/或所需潤滑度而定。
舉例而言,維生素E乙酸鹽在壓縮下自澱粉麥芽糊精基底物質之釋放與維生素E乙酸鹽在壓縮下自澱粉明膠基底物質之釋放不同。而調整油對基質基底之比率及/或添加加工助劑(諸如,二氧化矽)為可用以調節流動性質之例示性方法。
若基質將用於意欲直接壓縮之組合物,則較佳至少70%之基質將具有在約20目(850微米)至約200目(75微米)之範圍內的粒徑(如藉由美國標準篩所量測)。此外,對於直接壓縮而言,具有嵌入式潤滑劑之基質將較佳具有約5至約21之卡氏壓縮指數(Carr compressibility Index)值。
所用基質之量將視所需潤滑之量而定,而潤滑之量為組合物中活性劑(activity)及賦形劑之化學及物理性質的函數。在包含實質性部分之研磨礦物質的綜合維生素及礦物質增補劑之一例示性實施例中,例如低至基質(其為50 wt%之潤滑劑)之約0.1%至約1.5% wt/wt的潤滑劑之量可提供充分潤滑。
油性液體在基底物質中之分散可用混合來實現。基底物質粒徑、混合速度及混合機制為可經改變以達成所需分散的例示性參數。舉例而言,小的基底物質粒徑及高剪切混合可用以產生其中肉眼看不見油之細微分散。例如其他方
法(諸如,噴霧法)可同樣適於將油性液體細微地分散在基底物質中。若基底物質包含一或多種可在一定條件下反應或集合以形成膜之物質,則選擇用於製備具有嵌入式潤滑劑之基質的方法應避免將引起膜形成之加工步驟及/或物質添加。
如上所述,大量潤滑物質可適於分散/嵌入具有嵌入式潤滑劑之基質中。然而,維生素E可具有一些勝於其他傳統潤滑油之優點。大部分傳統潤滑油含有反式脂肪酸(trans fat),其與增加之冠狀心臟病危險相關聯。相反,已提出維生素E亦有助於心臟及血管健康。此外,維生素E被廣泛公認為強抗氧化劑。維生素E用作增補劑以預防自由基在人體中之破壞性影響。維生素E亦廣泛用作各種消費品中之防腐劑以維持品質及/或預防不需之反應且延長存放期。可以游離形式或衍生化形式(諸如,維生素E乙酸鹽)使用維生素E。
具有嵌入式維生素E之基質可廣泛用作壓錠潤滑劑。該基質相當適用於直接壓縮組合物中。舉例而言,具有嵌入式維生素E之基質可有效潤滑含有高含量研磨金屬鹽之直接壓縮綜合維生素/礦物質調配物。咸信諸如金屬鹽之研磨物質使潤滑困難。具有嵌入式維生素E之基質可為綜合維生素/礦物質調配物之有效唯一潤滑劑,或具有嵌入式維生素E之基質可與另一潤滑劑結合用於各種可壓錠調配物中。雖然相當適用於直接壓縮組合物,但具有嵌入式維生素E之基質亦適用於具有較少研磨物質之壓縮摻合物、
經受碾壓之組合物或經受壓錠之粒化組合物中。
本發明之組合物意欲用於壓錠以製備用於經口投與之固體形式(亦即,錠劑)。因此,為形成固體劑型,組合物可進一步包含除維生素及礦物質外之賦形劑及/或加工助劑。例示性賦形劑及加工助劑包括(但不限於)吸收劑、稀釋劑、調味劑、著色劑、穩定劑、填充劑、結合劑、崩解劑、助流劑、抗黏著劑、糖或塗膜劑、防腐劑、緩衝劑、人工甜味劑、天然甜味劑、分散劑、增稠劑、增溶劑及其類似物或其一些組合。在一較佳實施例中,不包括硬脂酸及/或金屬硬脂酸鹽潤滑劑作為賦形劑。
可藉由將具有嵌入式潤滑劑之基質與意欲包括在錠劑劑型中之維生素及/或礦物質及/或營養劑及壓錠賦形劑組合來製備本發明之營養組合物。因為具有嵌入式潤滑劑之基質不具有混合敏感性,所以添加具有嵌入式潤滑劑之基質的時機及/或方式並非關鍵。因此,無需用於添加潤滑劑之特定添加步驟及/或潤滑劑之特定混合規定。
一旦將具有嵌入式潤滑劑之基質與壓錠混合物之其他組份組合,如此製備之組合物即可饋入壓錠機中且形成錠劑。壓錠機之壓力足以將潤滑劑自基質壓出以允許潤滑。
具有嵌入式潤滑劑之基質相當適用於直接壓縮摻合物(例如,針對直接壓縮而製備之組合物)。然而,具有嵌入式潤滑劑之基質同樣可用於意欲用於壓錠之粒化摻合物或藉由碾壓製備之組合物的潤滑,此係因為潤滑功能在組合物被壓成錠劑時達成。
利用具有嵌入式潤滑劑之基質作為壓錠潤滑劑的用於壓錠之醫藥活性劑的組合物可如上文針對營養組合物所述來製備。
在一例示性實施例中,具有嵌入式潤滑劑之基質為維生素E乙酸鹽,其分散在等份的經改質之食用澱粉及麥芽糊精之基底物質中。維生素E對基底物質之比率為以重量計約50/50。在基質中可包括二氧化矽作為加工助劑。通常,加工用二氧化矽加工助劑係以約0.2至2.5%之量包括於基質中。維生素E、澱粉、麥芽糊精及加工助劑(若使用)應經混合使得油黏性維生素E細微地分散在澱粉麥芽糊精基底物質中,且以肉眼看不見任何液體或黏性物質。混合可使用高剪切混合器或噴霧系統來實現。混合方法應產生呈自由流動粉末形式之基質。一旦製備時,具有嵌入式潤滑劑之基質接著可與待壓錠之物質組合。此組合物代表在本發明之範疇內的許多基質組合物,且以達成例示性目的而提供。
本發明之一例示性實施例之營養增補劑組合物的一實例提供於表1中。此組合物代表在本發明之範疇內的許多組合物,且以達成例示性目的而提供。表1之例示性組合物為綜合維生素及礦物質增補劑。對於表1,具有嵌入式潤滑劑之基質為細微地分散在澱粉麥芽糊精基底(50% w/w)中之維生素E,以二氧化矽作為加工助劑,如實例1中所
述。對於營養增補劑組合物之個別樣本而言,具有嵌入式潤滑劑之基質之量係在0.3%至8.8%之間變化,且因此表列為表1中之一系列量。具有嵌入式潤滑劑之基質為組合物中之唯一潤滑劑(例如,不添加硬脂酸鎂或其他壓錠潤滑劑)。表1中所提供之調配組成物係以每片錠劑之每種組份重量(mg)來說明。
使以上成份通過20號(美國標準篩)手工篩,且使用V摻合機在單一步驟中摻合在一起。20號美國標準篩之篩孔為約0.033吋(0.84 mm)。將所有樣品同等混合,其中例外為所添加之具有嵌入式潤滑劑之基質的量。將具有各種濃度之具有嵌入式潤滑劑之基質(維生素E)的所得壓縮混合物槳式饋入用於壓縮之使用Manesty β壓力機及經改進之橢圓形壓錠工具的模具中。壓力定在30、40及50 kN,其中預壓力為約8 kN及壓製速度為85 rpm。錠劑為0.330吋寬、0.745吋長及約0.280吋厚(其中由於所用之具有嵌入式潤滑劑之基質的量的變化,所以尺寸略有變化)。Manesty β壓力機經裝備儀器以監測壓力及脫模力,且使用MCC軟體記錄結果。藉由硬度測定器(Dr.Schleuniger Pharmatron,模型6D-500N)評估錠劑之硬度,藉由Vanderkamp脆碎性測定器(Van-Kel Industry,模型10809)評估錠劑之脆碎性,藉由分析天平評估錠劑之重量且藉由測徑規評估錠劑之厚度。維生素E基質作為唯一潤滑劑表現良好,對錠劑硬度、脆碎性及崩解時間(DT)具有最小影響。
發現使用最少0.3%(以重量計)之具有嵌入式維生素E之基質(或0.15%維生素E)可使壓縮混合物充分潤滑以進行壓縮及隨後自模具中脫模,且使用最少1.2%之具有嵌入式維生素E之基質(或0.6%維生素E)使表面平滑及外觀精美。0.3%之具有嵌入式維生素E之基質足以提供與可比較之維生素及礦物質增補劑(其中0.3%硬脂酸鎂用作潤滑劑)同等之脫模力。
添加具有嵌入式維生素E之基質一般隨著在三個固定壓力(30、40及50 kN)中之任一者下濃度增加而降低錠劑硬度。在所測試之壓力下硬度之減少不如在相同壓力範圍上使用硬脂酸鎂作為潤滑劑之可比較維生素及礦物質組合物的硬度改變大(例如,在所測試之壓力範圍上,與0.3%之具有嵌入式維生素E之基質對錠劑硬度無顯著降低影響相比,0.3%硬脂酸鎂之存在降低錠劑硬度5 kP)。如與僅在使用硬脂酸鎂作為壓錠潤滑劑上不同之可比較錠劑組合物相比,發現在所測試之所有濃度(0.3-8.8%)下具有嵌入式維生素E之基質降低脆碎性約50%。具有嵌入式維生素E之基質以低濃度(0-1.2%)的存在未顯示對崩解時間之顯著影響,然而,在較高濃度(2.4%及4.6%)下崩解時間自0.9 min增加至2 min及4 min。此項技術中熟知對於維生素及礦物質組合物而言,即使以低濃度(約0.3%)添加硬脂酸鎂亦通常增加崩解時間,此係因為其賦予壓縮摻合物疏水性。
亦發現具有嵌入式維生素E之基質與維生素及礦物質錠劑中之其他成份相容。在壓成錠劑後,基於加速穩定性研究,維生素E可完全回收且穩定。未觀測到具有嵌入式維生素E之基質對維生素及礦物質錠劑中之其他成份的穩定性具有顯著影響。
在市售的高速雙面輪轉壓力機上,具有4.6%之具有嵌入式維生素E之基質的維生素及礦物質組合物之壓縮按比例增大至高達每分鐘5500錠劑之商業速率。各衝頭及模具組每分鐘產生約90錠劑。發現錠劑表面平滑且外表精美。具
有嵌入式維生素E之基質似乎有效潤滑用於以正常商業生產速率壓縮之壓縮摻合物。
研究了過度混合對使用具有嵌入式維生素E之基質作為潤滑劑的綜合維生素及礦物質組合物之壓縮性的可能影響。過度混合實驗在8 L Littleford粒化機中以400 rpm執行。不同於V摻合機之滾動混合機制,此裝置使用以高rpm之刮板。製備使用4.6%之具有嵌入式維生素E之基質的綜合維生素及礦物質組合物的樣本且將其在Littleford中混合0、2、4、10及20分鐘後加以壓縮。混合程度對錠劑硬度及脆碎性無顯著影響,但略微減小經具有嵌入式維生素E之基質潤滑之組合物錠劑的脫模力。為進行比較,亦製備使用0.3%硬脂酸鎂代替具有嵌入式維生素E之基質但所有其他方面均相同的維生素及礦物質組合物,且將其在Littleford中混合0、2、4、10及20分鐘後加以壓縮。對於使用0.3%硬脂酸鎂作為潤滑劑之錠劑而言,增加混合時間顯著減小錠劑硬度,略微減小脫模力,且顯著增加脆碎性。表2顯示在混合0、2、4、10及20分鐘後在40 kN下壓縮之錠劑的錠劑硬度之例示性資料。
如表2之資料顯示混合時間對使用具有嵌入式維生素E之基質來潤滑之錠劑的硬度幾乎無影響,但具有0.3%硬脂酸鎂之錠劑的硬度對混合時間非常敏感。
雖然已相當詳細地藉助於說明及實例來描述以上發明以達成清楚瞭解之目的,但顯然的是在隨附申請專利範圍之範疇內可實施某些改變及修改。熟習此項技術者顯而易見之對實施本發明之上述模式的修改意欲包括在以下申請專利範圍之範疇內。
Claims (23)
- 一種用於壓錠之組合物,其包含嵌入式潤滑基質,其中該嵌入式潤滑基質係由細微地分散在不溶於油之物質中的油構成或係由細微地分散在不溶於油之物質中的油及加工助劑構成,其中該嵌入式潤滑基質係該組合物的0.3%至8.8%,且其中該組合物實質上不含硬脂酸鹽。
- 如請求項1之組合物,其中該油係選自由以下各物組成之群:維生素E、動物油、合成油、礦物油、聚乙二醇、矽油及其組合。
- 如請求項2之組合物,其中該油為維生素E乙酸鹽。
- 2或3之組合物,其中該不溶於油之物質係選自由以下各物組成之群:澱粉、糊精、微晶纖維素、乙基纖維素、明膠、糖、葡萄糖、麥芽糖、果糖、山梨糖醇、蔗糖、甘露糖醇、乳糖、甲基纖維素、羥丙基甲基纖維素、麥芽糊精、二氧化矽、無水磷酸二鈣及其組合。
- 2或3之組合物,其中該組合物進一步包含至少一種礦物質。
- 2或3之組合物,其中該組合物進一步包含至少一種維生素。
- 2或3之組合物,其中該組合物進一步包含至少一種營養劑。
- 如請求項7之組合物,其中該至少一種營養劑係選自由以下各物組成之群:類胡蘿蔔素、纖維、植物固醇、糖 苷、多酚、B複合相關化合物、ω-3脂肪酸、益生菌、葡糖胺、草藥、胺基酸、肽及其組合。
- 2或3之組合物,其中該組合物為直接壓縮組合物。
- 2或3之組合物,其中該組合物包含粒化組合物。
- 2或3之組合物,其中該組合物為用於進行碾壓之組合物。
- 一種製造錠劑組合物之方法,其包含提供由細微地分散在不溶於油之物質中的油構成之嵌入式潤滑基質,提供組合物,混合該嵌入式潤滑基質與該組合物,且形成錠劑組合物,其中該嵌入式潤滑基質係該組合物的0.3%至8.8%,其中該錠劑組合物實質上不含硬脂酸鹽。
- 如請求項12之方法,其中該組合物包含至少一種礦物質。
- 如請求項12或13之方法,其中該組合物包含至少一種維生素。
- 如請求項12或13之方法,其中該組合物包含至少一種營養劑。
- 如請求項15之方法,其中至少一種該營養劑係選自由以下各物組成之群:類胡蘿蔔素、纖維、植物固醇、糖苷、多酚、B複合相關化合物、ω-3脂肪酸、益生菌、葡糖胺、草藥、胺基酸及肽。
- 如請求項12或13之方法,其中該油係選自由以下各物組 成之群:維生素E、動物油、合成油、礦物油、聚乙二醇、矽油及其組合。
- 如請求項17之方法,其中該油為維生素E乙酸鹽。
- 如請求項12或13之方法,其中該不溶於油之物質係選自由以下各物組成之群:澱粉、糊精、微晶纖維素、乙基纖維素、明膠、糖、葡萄糖、麥芽糖、果糖、山梨糖醇、蔗糖、甘露糖醇、乳糖、甲基纖維素、羥丙基甲基纖維素、麥芽糊精、二氧化矽、無水磷酸二鈣及其組合。
- 如請求項12或13之方法,其中該錠劑組合物為直接壓縮混合物。
- 如請求項12或13之方法,其中該錠劑組合物包含粒化組合物。
- 如請求項12或13之方法,其中該錠劑組合物為用於進行碾壓之組合物。
- 一種錠劑,其係藉由壓錠如請求項1至11中任一項之組合物而製得。
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US11/787,381 US20080254119A1 (en) | 2007-04-16 | 2007-04-16 | Imbedded liquid lubricants for tableting |
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TWI433652B true TWI433652B (zh) | 2014-04-11 |
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US (3) | US20080254119A1 (zh) |
EP (2) | EP2136653B1 (zh) |
JP (2) | JP5615170B2 (zh) |
KR (2) | KR20100016514A (zh) |
CN (2) | CN105360879B (zh) |
AU (1) | AU2008242256B2 (zh) |
BR (1) | BRPI0810017A2 (zh) |
CA (1) | CA2682551C (zh) |
CO (1) | CO6220919A2 (zh) |
DK (2) | DK2599394T3 (zh) |
EC (1) | ECSP099676A (zh) |
ES (2) | ES2655552T3 (zh) |
HK (1) | HK1216227A1 (zh) |
HU (2) | HUE035179T2 (zh) |
IL (1) | IL201495A (zh) |
MX (1) | MX340643B (zh) |
MY (1) | MY146906A (zh) |
NO (1) | NO2136653T3 (zh) |
NZ (1) | NZ580136A (zh) |
PH (1) | PH12009501979A1 (zh) |
PL (2) | PL2599394T3 (zh) |
PT (2) | PT2136653T (zh) |
RU (2) | RU2615823C9 (zh) |
TW (1) | TWI433652B (zh) |
WO (1) | WO2008130883A1 (zh) |
ZA (1) | ZA200907217B (zh) |
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CN103261404B (zh) * | 2010-12-16 | 2017-06-09 | 默克专利有限公司 | 干的颗粒状细胞培养基 |
DE102011010437A1 (de) * | 2011-02-04 | 2012-08-09 | J. Rettenmaier & Söhne Gmbh + Co. Kg | Tablettierhilfsmittel |
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US11419350B2 (en) | 2016-07-01 | 2022-08-23 | Corbion Biotech, Inc. | Feed ingredients comprising lysed microbial cells |
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KR20220114618A (ko) * | 2019-12-17 | 2022-08-17 | 9286-3620 퀘벡 인크. | 단백질/폴리사카라이드 코아세르베이트의 인시츄 형성에 기반한 경구 전달 시스템 |
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2007
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