TW202412752A - 固體製劑及其製造方法 - Google Patents
固體製劑及其製造方法 Download PDFInfo
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- TW202412752A TW202412752A TW112120246A TW112120246A TW202412752A TW 202412752 A TW202412752 A TW 202412752A TW 112120246 A TW112120246 A TW 112120246A TW 112120246 A TW112120246 A TW 112120246A TW 202412752 A TW202412752 A TW 202412752A
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- Prior art keywords
- solid preparation
- hydroxypropyl cellulose
- magnesium
- sodium
- loxoprofen
- Prior art date
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Classifications
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/192—Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
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- A—HUMAN NECESSITIES
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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
- A61K47/02—Inorganic compounds
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- A—HUMAN NECESSITIES
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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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- 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
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Abstract
本發明之課題為於摻合有選自由洛索洛芬及其鹽所成之群的至少一種與制酸劑的固體製劑中,提供抑制了製劑中的洛索洛芬之含量降低的安定之固體製劑,及其製造方法。依照本發明,提供一種固體製劑,其含有選自由洛索洛芬及其鹽所成之群的至少一種、含有鎂及鋁當中至少1者的化合物,與羥基丙基纖維素類。
Description
本發明係關於固體製劑及其製造方法。更詳細而言,本發明係關於含有洛索洛芬(Loxoprofen)及/或其鹽之安定的固體製劑,及其製造方法。
作為丙酸系非類固醇性解熱鎮痛消炎劑(以下稱NSAIDs)的洛索洛芬,顯示出與其他NSAIDs相同之前列腺素生合成的抑制作用,但已知具有強的解熱/鎮痛/抗發炎作用。洛索洛芬為在經口投予後維持胃黏膜刺激作用弱的未變化體的形態從消化道被吸收,並於體內成為活性體之前驅藥,因此亦已知具有相較於其他NSAIDs而言,胃黏膜損傷較少的特徴(例如參照非專利文獻1)。
作為藉由合併使用洛索洛芬及/或其鹽與其他有效成分並進行經口投予,以更抑制胃黏膜損傷之技術,揭示有於洛索洛芬中含有特定之糖類(乳糖、蔗糖、氫化麥芽糖、果糖、木糖醇或乳糖醇)之技術(參照專利文獻1)、含有制酸劑(氧化鎂)之技術(參照專利文獻2)、含有抗纖維蛋白溶酶藥之妥內散酸之技術(參照專利文獻3)等。
又,揭示洛索洛芬鈉或其水合物其吸濕性高,難以安定地進行製劑化,及成為製劑化後之保存安定性優良的製劑(專利文獻4)。
另一方面,有報導一種經口固體製劑來作為遮蔽呈現苦味之藥物的苦味之經口固體組成物,其係使用低取代度羥基丙基纖維素作為親水性高分子,並對該親水性高分子以水:親水性高分子=1~10:1之範圍來添加水,成為含水親水性高分子,將其與(A)呈現苦味之藥物混合、造粒,接著藉由乾燥至成為水分量7.5質量%以下所得到(專利文獻5)。
[先前技術文獻]
[專利文獻]
[專利文獻1] 日本專利第4585220號
[專利文獻2] 日本專利第6106727號
[專利文獻3] 日本專利第5835865號
[專利文獻4] 日本專利第6292744號
[專利文獻5] 日本專利第5527921號
[非專利文獻]
[非專利文獻1] 藥理與治療 Vol.16 No.2 1988 p.611-619
[發明所欲解決之課題]
本發明者等人著眼於製造混合存在有洛索洛芬及/或其鹽與氧化鎂等之制酸劑的固體製劑時,於保存中洛索洛芬之含量會經時地降低。本發明之課題,為於摻合有洛索洛芬及/或其鹽與制酸劑之固體製劑中,提供抑制了製劑中的洛索洛芬之含量降低的安定之固體製劑,及其製造方法。
[用以解決課題之手段]
本發明者等人為了解決上述課題而深入探討的結果,發現藉由添加羥基丙基纖維素類,即使為混合存在有洛索洛芬及/或其鹽,及氧化鎂等之制酸劑的固體製劑,亦抑制洛索洛芬之含量降低,得到優良的製劑,而完成本發明。
亦即,本發明之態樣係如以下所示。
(1) 一種固體製劑,其含有選自由洛索洛芬及其鹽所成之群的至少一種、含有鎂及鋁當中至少1者的化合物,與羥基丙基纖維素類。
(2) 如(1)之固體製劑,其中前述羥基丙基纖維素類,包含羥基丙基纖維素及低取代度羥基丙基纖維素當中至少1者。
(3) 如(2)之固體製劑,其中前述低取代度羥基丙基纖維素之粒子徑比D90/D50,為1.5~3.0。
(4) 如(2)或(3)之固體製劑,其中前述低取代度羥基丙基纖維素之平均粒子徑為30~60μm。
(5) 如(2)或(3)之固體製劑,其中前述低取代度羥基丙基纖維素中的羥基丙氧基之比例為7~16%。
(6) 如(1)至(5)中任一項之固體製劑,其中前述含有鎂及鋁當中至少1者的化合物,為選自由氧化鎂、偏矽酸鋁酸鎂,及合成水滑石所成之群的一種或二種以上。
(7) 如(1)至(6)中任一項之固體製劑,其進一步含有選自由生藥及其萃取物、咖啡因類,及鎮靜劑所成之群的一種或二種以上。
(8) 如(1)至(7)中任一項之固體製劑,其進一步含有具有胺基之化合物。
(9) 一種固體製劑之製造方法,其係含有選自由洛索洛芬及其鹽所成之群的至少一種、含有鎂及鋁當中至少1者的化合物,與羥基丙基纖維素類之固體製劑之製造方法,其包含於添加選自由洛索洛芬及其鹽所成之群的至少一種,與含有鎂及鋁當中至少1者的化合物進行造粒之前,對羥基丙基纖維素類添加水來進行造粒之第1步驟。
(10) 如(9)之固體製劑之製造方法,其中於前述第1步驟中,相對於前述羥基丙基纖維素類之質量而言,前述水之質量為0.4倍以上。
[發明之效果]
依照本發明,提供即使為混合存在有洛索洛芬及/或其鹽,及氧化鎂等之制酸劑的固體製劑,亦抑制了洛索洛芬之含量降低的優良之固體製劑。
本發明之固體製劑,含有選自由洛索洛芬及其鹽所成之群的至少一種、含有鎂及鋁當中至少1者的化合物,與羥基丙基纖維素類。
本發明之固體製劑,為第十八次修正日本藥典中記載的錠劑、散劑、顆粒劑、膠囊劑或丸劑,較適宜為顆粒劑或錠劑。最佳為錠劑。又,顆粒劑中,將遵照第十八次修正日本藥典進行製劑之粒度試驗法時,全部量通過18號(850μm)篩,且殘留於30號(500μm)篩者佔全部量之10%以下者有時稱為細粒劑。
又,本發明之顆粒劑或錠劑之態樣,亦可為以水溶性之高分子等將製劑包衣而得者。亦即,可列舉膜衣顆粒、膜衣錠等。又,本發明之固體製劑亦可經糖衣包衣。
進一步地,本發明之固體製劑為錠劑時,除了如本說明書中主要示出之單層錠以外,亦可為將組成相異的粉末或顆粒重疊為2層或3層以上並經壓縮成型而得的多層錠。再者,本發明中,錠劑為多層錠時,洛索洛芬及/或其鹽、含有鎂及鋁當中至少1者的化合物,與羥基丙基纖維素類係位在同一層。
本發明之固體製劑,含有洛索洛芬及/或其鹽。
本發明中「洛索洛芬及/或其鹽」,換言之,係指「選自由洛索洛芬及其鹽所成之群的至少一種」,其係洛索洛芬及/或其鹽(包括含水鹽)(鹽較佳為藥理上容許之鹽),較適宜為洛索洛芬鈉、更適宜為洛索洛芬鈉・2水合物。
本發明所用之洛索洛芬及/或其鹽,作為洛索洛芬鈉水合物而收錄於第十八次修正日本藥典。
本發明之固體製劑中所含有的洛索洛芬及/或其鹽之含量並不限制,作為成人每1投予單位(1次投予量)之固體製劑中所含有的成分之量,以無水物換算量計較佳為10~180mg、更佳為30~120mg、又更佳為30~90mg,投予次數為1日1~3次。
本發明之固體製劑為錠劑時,錠劑中,造粒顆粒內中所含有的洛索洛芬及/或其鹽之含量,不特別限制,作為成人每1投予單位(1次投予量)之錠劑中所含有的成分之量,以無水物換算量計較佳為10~180mg、更佳為30~120mg、又更佳為30~90mg,亦可為45~90mg,此時投予次數亦為1日1~3次。
錠劑中所含有的洛索洛芬及/或其鹽不特別限定,以固體製劑全體之質量為基準,為1~80質量%,較佳為2~50質量%、更佳為5~30質量%,亦可為5~20質量%。
本發明之固體製劑,含有:含有鎂及鋁當中至少1者的化合物。
含有鎂及鋁當中至少1者的化合物,例如可列舉氧化鎂、矽酸鎂、矽酸鋁酸鎂、矽酸鎂鋁、氫氧化鎂、氫氧化鎂/硫酸鋁鉀之共沈澱生成物、碳酸鎂、合成水滑石、偏矽酸鋁酸鎂、乾燥氫氧化鋁凝膠、合成矽酸鋁、氫氧化氧化鋁鎂、氫氧化鋁凝膠、氫氧化鋁/碳酸氫鈉共沈澱生成物、氫氧化鋁/碳酸鎂混合乾燥凝膠、氫氧化鋁/碳酸鎂/碳酸鈣共沈澱生成物、皂土等。上述之中,作為含有鎂及鋁當中至少1者的化合物,尤佳為選自由氧化鎂、偏矽酸鋁酸鎂,及合成水滑石所成之群的一種或二種以上。
本發明中使用偏矽酸鋁酸鎂時,可使用第十八次修正日本藥典中收錄者、亦可使用醫藥品添加物專門字典中收錄者,可容易地獲得。
市售之偏矽酸鋁酸鎂不特別限定,例如係有富士化學工業股份有限公司製Neusilin。
本發明之固體製劑中的偏矽酸鋁酸鎂之含有比例,只要考慮固體製劑之崩解性/藥劑之溶出性與作為制酸劑之功能來選擇即可,不特別限定,以固體製劑全體之質量為基準,可為0.1~90質量%、可為1~90質量%,較佳為5~80質量%。
本發明中使用氧化鎂時,可使用第十八次修正日本藥典中收錄者、亦可使用醫藥品添加物專門字典中收錄者,可容易地獲得。
市售之氧化鎂不特別限定,例如可使用富田製藥製氧化鎂(輕質等級)、協和化學工業製氧化鎂(重質等級)等。
本發明之固體製劑中的氧化鎂之含有比例,只要考慮固體製劑之崩解性/藥劑之溶出性與作為制酸劑之功能來選擇即可,不特別限定,以固體製劑全體之質量為基準,可為0.1~90質量%、可為1~90質量%,較佳為5~80質量%。
本發明中使用合成水滑石時,可使用日本藥典外醫藥品規格2002中收錄者、亦可使用醫藥品添加物專門字典中收錄者,可容易地獲得。
市售之合成水滑石不特別限定,例如可使用協和化學工業股份有限公司製Alcamac(B等級)、協和化學工業股份有限公司製Alcamac(L等級)、協和化學工業股份有限公司製Alcamac(SH等級)協和化學工業股份有限公司製Alcamac (SN等級)等。
本發明之固體製劑中的合成水滑石之含有比例,只要考慮固體製劑之崩解性/藥劑之溶出性與作為制酸劑之功能來選擇即可,不特別限定,以固體製劑全體之質量為基準,可為0.1~90質量%、可為1~90質量%,較佳為5~80質量%。
本發明之固體製劑,含有羥基丙基纖維素類。
作為羥基丙基纖維素類,較佳使用羥基丙基纖維素及低取代度羥基丙基纖維素當中至少1者。
將羥基丙基纖維素類以利用了雷射繞射/散射的粒度分布計(例如MicrotracBEL股份有限公司製 Microtrac MT3000II系列等)進行粒子測定時,所得之粒度分布之50%累積直徑與90%累積直徑之比D90/D50,較佳為1.5~3.0。
將羥基丙基纖維素類以利用了雷射繞射/散射的粒度分布計(例如MicrotracBEL股份有限公司製 Microtrac MT3000II系列等)進行粒子測定時,其平均粒子徑(50%累積直徑),較佳為30~60μm。
將羥基丙基纖維素類以第十八次修正日本藥典解說書、低取代度羥基丙基纖維素中記載之定量法進行測定時,其羥基丙氧基之比例,較佳為7~16%。
羥基丙基纖維素及低取代度羥基丙基纖維素,可使用第十八次修正日本藥典中收錄者、亦可使用醫藥品添加物專門字典中收錄者,可容易地獲得。
市售之羥基丙基纖維素及低取代度羥基丙基纖維素不特別限定,例如可使用日本曹達股份有限公司製NISSO HPC(HPC-SL等級)、日本曹達股份有限公司製NISSO HPC (HPC-SSL等級)、日本曹達股份有限公司製NISSO HPC (HPC-L等級)、日本曹達股份有限公司製NISSO HPC(HPC-H等級)、Ashland製KLUCEL
TM(ELF Pharm等級)、Ashland製KLUCELTM(EF Pharm等級)、Ashland製KLUCELTM(LF Pharm等級)、信越化學工業股份有限公司製L-HPC®(LH-21等級)、信越化學工業股份有限公司製L-HPC®(LH-22等級)、信越化學工業股份有限公司製L-HPC®(LH-11等級)、信越化學工業股份有限公司製L-HPC®(LH-B1等級)、信越化學工業股份有限公司製L-HPC®(LH-31等級)、信越化學工業股份有限公司製L-HPC®(LH-32等級)、信越化學工業股份有限公司製L-HPC®(NBD-22等級)、信越化學工業股份有限公司製L-HPC
®(NBD-21等級) 、信越化學工業股份有限公司製L-HPC®(NBD-20等級)等。
本發明之固體製劑中的羥基丙基纖維素類之含有比例,只要考慮固體製劑之崩解性/藥劑之溶出性與作為制酸劑之功能來選擇即可,不特別限定,以固體製劑全體之質量為基準,可為1~80質量%、可為3~70質量%,較佳為5~50質量%。
本發明之固體製劑,較佳為進一步含有選自由生藥及其萃取物、咖啡因類,及鎮靜劑所成之群的一種或二種以上。
咖啡因類可列舉咖啡因水合物、無水咖啡因、苯甲酸鈉咖啡因、檸檬酸咖啡因等。
本發明之固體製劑中的咖啡因類之含有比例不特別限定,例如,以固體製劑全體之質量為基準,可為1~80質量%、可為3~80質量%、亦可為5~70質量%。
鎮靜劑例如可列舉烯丙基異丙基乙醯基脲、溴異戊醯脲等。
本發明之固體製劑中的鎮靜劑之含有比例不特別限定,例如,以固體製劑全體之質量為基準,可為1~80質量%、可為2~80質量%、亦可為2~70質量%。
使用生藥時,其種類不特別限定,例如可摻合選自麻黃、南天果實、櫻皮、遠志、甘草、桔梗、車前子、車前草、紅花石蒜(石蒜)、美遠志、貝母、茴香、黃柏、黃連、莪蒁、洋甘菊、桂皮、黃龍膽、牛黃、獸膽(包含熊膽)、沙參、生薑、蒼朮、丁香、陳皮、白朮、地龍、竹節人參、人參、野梧桐、阿仙藥、淫羊藿、延胡索、黃芩、黃精、纈草、栝蔞仁、杏仁、枸杞子、枸杞葉、荊芥、決明子、牻牛兒苗、香附子、五味子、細辛、日本花椒、紫菀、地骨皮、芍藥、麝香、辛夷、川芎、前胡、當藥、桑白皮、蘇葉、大蒜、當歸、吐根、麥門冬、半夏、番紅花、反鼻、白芷、茯苓、牡丹皮、牡蠣、鹿茸、防己等之生藥及此等之萃取物(萃取物、酊劑、乾燥萃取物等)等的1種或2種以上之成分。
本發明之固體製劑中,較佳含有甘草萃取物、芍藥萃取物、纈草萃取物當中至少1者;更佳含有甘草萃取物及纈草萃取物當中至少1者。
本發明之固體製劑中的生藥及其萃取物之含有比例不特別限定,例如各生藥為萃取物時,以固體製劑全體之質量為基準,為1~80質量%,可為1~70質量%、可為1~60質量%、亦可為1~50質量%。
本發明中所用之甘草、芍藥、纈草等之生藥,為自古以來作為單方或漢方方劑而用於藥用者,可直接使用遵照各自慣用之方法所得的生藥粉或萃取成分。生藥粉或萃取成分之形態,亦可使用通常之市售品或其加工品。生藥粉例如可作為將乾燥切細加工品進一步微細粉碎而得的粉末狀(微粉末狀)之乾燥粉末使用。又,自生藥的萃取成分之形態不特別限制,例如能夠以乾燥萃取物、萃取物粉末、軟萃取物、流體萃取物、含有乙醇或乙醇及水的酊劑等任意形態使用。較佳的生藥,包含製劑化之自由度高的萃取成分例如軟萃取物、乾燥萃取物末等。
萃取成分,能夠藉由慣用之方法例如以萃取溶劑從前述生藥中萃取具有抗菌作用之活性成分而得到。作為萃取溶劑,例如多使用水、親水性溶劑或此等之混合溶劑。前述親水性溶劑,例如可列舉甲醇、乙醇、丙醇、異丙醇、丁醇、異丁醇、s-丁醇、t-丁醇等之醇類;甲基賽珞蘇、乙基賽珞蘇等之賽珞蘇類;丙酮等之酮類;二噁烷、四氫呋喃等之醚類;吡啶、嗎啉、乙腈、N,N-二甲基甲醯胺、二甲基乙醯胺、N-甲基吡咯啶酮等之含氮溶劑等。此等之親水性溶劑可單獨,或作為二種以上之混合溶劑使用。
甘草係如以往般,可作為抗發炎劑、感冒藥、解熱鎮痛藥、鎮咳去痰藥、胃腸藥、驅蟲藥、鼻炎用內服藥、喉嚨清涼劑、健胃清涼劑、含維生素之保健劑、甘味劑、調味劑、著色劑、香味劑、香料,或賦形劑使用。
本發明中使用「甘草」時,較適宜可使用第十八次修正日本藥典中揭示之甘草、甘草粉末、甘草萃取物、甘草粗萃取物。
又,上述或上述以外之各種甘草係有市售,故可容易獲得。
作為市售之甘草,例如係有使用水或30%乙醇水溶液等作為萃取溶劑而得之萃取物,例如因應甘草萃取物、甘草乾燥萃取物、甘草軟萃取物、甘草流體萃取物等萃取物之種類,有販賣各種原生藥換算比者。又,此等之甘草之萃取物以外,亦可適當使用甘草萃取物、甘草萃取液等。不特別限定。
於固體製劑使用市售之甘草時,例如只要考慮原生藥換算比,以固體製劑中的甘草含量成為適切的方式使用甘草即可。
本發明之固體製劑中的甘草(甘草或甘草之萃取物)之含量亦無特別限制,就每1日投予量之固體製劑中所含有的成分之量而言,以原生藥換算量計,較佳為10mg~10g、更佳為150mg~5g、又更佳為500mg~3000mg,亦可為500mg~1500mg。投予次數為1日1~3次。
本發明之固體製劑中,例如使用甘草乾燥萃取物時,甘草乾燥萃取物之含有比例不特別限定,以固體製劑全體之質量為基準,可為0.1~80質量%、可為1~50質量%,較佳為5~40質量%、更佳為10~30質量%。
本發明中使用「纈草」時,「纈草」可適合使用第十八次修正日本藥典中揭示之纈草、纈草粉末。
又,上述或上述以外之纈草亦有市售,故可容易獲得。
市售之纈草,例如可使用纈草粉末或纈草萃取物(例如軟萃取物或乾燥萃取物等),不特別限定。
於固體製劑使用市售之纈草時,只要考慮原生藥換算比,以固體製劑中的纈草含量成為適切的方式使用纈草即可。
本發明中使用纈草(纈草或纈草之萃取物)時,含量不特別限定,例如,就每1日投予量之固體製劑中所含有的成分之量而言,以原生藥換算量計,可為25~6000mg,較佳為50~5000mg、更佳為100~4000mg、又更佳為200mg~3200mg,亦可為400~1600mg,投予次數為1日1~3次。
本發明之固體製劑中,例如使用纈草萃取物時,纈草萃取物之含有比例不特別限定,以固體製劑全體之質量為基準,可為1~50質量%,較佳為2~40質量%、更佳為3~20質量%。
本發明中使用「芍藥」時,「芍藥」可適合使用第十八次修正日本藥典中揭示之芍藥、芍藥粉末。
又,上述或上述以外之芍藥亦有市售,故可容易獲得。
市售之芍藥,例如可使用芍藥粉末或芍藥萃取物(例如包含乾燥萃取物或軟萃取物等),不特別限定。
於固體製劑使用市售之芍藥時,只要考慮原生藥換算比,以固體製劑中的芍藥含量成為適切的方式使用芍藥即可。
本發明中使用芍藥(芍藥或其萃取物)時,含量不特別限定,以原生藥換算計,每1日較佳投予100~ 5000mg、更佳投予150~2000mg、特佳投予200~900mg,投予次數為1日1~3次。
本發明之固體製劑中,例如使用芍藥乾燥萃取物時,芍藥乾燥萃取物之含有比例不特別限定,以固體製劑全體之質量為基準,可為1~50質量%,較佳為2~40質量%、更佳為3~20質量%。
本發明之固體製劑,較佳可進一步含有具有胺基之化合物。
作為具有胺基之化合物,只要係具有胺基之化合物則不特別限定,例如可摻合選自如異白胺酸、白胺酸、離胺酸、甲硫胺酸、苯基丙胺酸、蘇胺酸(蘇胺酸)、色胺酸、纈胺酸、組胺酸、酪胺酸、半胱胺酸、天門冬胺酸、天門冬醯胺、絲胺酸、麩胺酸、麩醯胺、脯胺酸、甘胺酸、丙胺酸、精胺酸之胺基酸、羧甲基半胱胺酸(carbocysteine)、妥內散酸或其鹽等的1種或2種以上之成分。
固體製劑中所含有的具有胺基之化合物不特別限定,以固體製劑全體之質量為基準,可為1~90質量%、可為2~80質量%、亦可為5~60質量%。
具有胺基之化合物於組成物中之摻合量,例如,就每1日投予量之固體製劑中所含有的成分之量而言,可為每1次100~1000mg、可為每1次200~700mg,投予次數為1日1~3次。
又,本發明之固體製劑中,亦可含有「橙皮苷類」。
本發明中使用橙皮苷類時,可列舉橙皮苷,及糖苷基(glycosyl)橙皮苷等之橙皮苷衍生物。橙皮苷亦稱為維生素P,收錄於日本藥典外醫藥規格2002等中。
本發明之固體製劑中的橙皮苷之含有比例不特別限定,以固體製劑全體之質量為基準,可為0~30質量%、亦可為0.1~15質量%。
具有橙皮苷之化合物於組成物中之摻合量,例如,就每1日投予量之固體製劑中所含有的成分之量而言,可為每1次10~500mg、可為每1次20~300mg,投予次數為1日1~3次。
本發明之固體製劑,可遵照常規方法而製劑化。
本發明中,例如可製造含有洛索洛芬及/或其鹽、含有鎂及鋁當中至少1者的化合物,與羥基丙基纖維素類之造粒顆粒,並對所得之造粒顆粒添加其後追加之成分使形成造粒顆粒外部,且進行打錠,藉以製造錠劑。
亦即,錠劑例如可藉由製造含有洛索洛芬及/或其鹽、含有鎂及鋁當中至少1者的化合物,與羥基丙基纖維素類之造粒顆粒(至少1者的造粒顆粒)的步驟;及混合前述造粒顆粒,與所期望之添加劑(其後追加之成分)並進行打錠藉以製造錠劑之步驟來製造。又,配置於顆粒外部之成分,可任意成為顆粒狀。
本發明中的其後追加之成分(造粒顆粒外部),為於錠劑中構成造粒顆粒之外部的部位,例如,可為錠劑中以被覆1個造粒顆粒的方式所構成之部位、亦可為以被覆複數個造粒顆粒的方式所構成之部位。又,可為錠劑中被覆至少1個造粒顆粒的部位並且其係構成錠劑之外側面的部位。錠劑係於錠劑中具有造粒顆粒,於前述造粒顆粒中亦可含有洛索洛芬及/或其鹽、含有鎂及鋁當中至少1者的化合物,與羥基丙基纖維素類當中至少1者。
本發明之含有洛索洛芬及/或其鹽、含有鎂及鋁當中至少1者的化合物與羥基丙基纖維素類的固體製劑之製造方法中,可包含將水與羥基丙基纖維素類造粒之步驟(第1步驟)。
第1步驟中,所添加之水之質量,相對於羥基丙基纖維素類之質量,只要多於0.4倍即可,亦可為0.5倍以上、0.6倍以上、0.7倍以上、0.8倍以上或1.0倍以上。相對於水之質量而言,羥基丙基纖維素類之質量的上限不特別限定,一般而言為3倍以下。
將水與羥基丙基纖維素類造粒後,藉由將洛索洛芬及/或其鹽,與含有鎂及鋁當中至少1者的化合物進行造粒,於羥基丙基纖維素類(特別是低取代度羥基丙基纖維素)中併入洛索洛芬及/或其鹽與含有鎂及鋁當中至少1者的化合物,容易達成安定化。
作為一例,係對低取代度羥基丙基纖維素添加水進行造粒後,添加洛索洛芬及/或其鹽,與含有鎂及鋁當中至少1者的化合物進行造粒後,依需要添加水追加進行造粒。上述造粒之後,可藉由添加其他添加物(例如生藥萃取物、交聯羧甲基纖維素鈉、羥基丙基纖維素等),並依需要添加水進行造粒,來製造造粒顆粒。對造粒顆粒混合其後追加之成分之後,可藉由以打錠機打錠來製造錠劑。
作為別的例子,係對低取代度羥基丙基纖維素添加分散於水的生藥萃取物並進行造粒後,添加輕質矽酸酐,並添加水進行造粒。上述造粒之後,添加洛索洛芬及/或其鹽、含有鎂及鋁當中至少1者的化合物,與依期望之其他添加物(例如生藥萃取物、赤藻糖醇、部分α化澱粉、羥基丙基纖維素等)進行造粒後,依需要添加水追加進行造粒,藉此可製造造粒顆粒。對造粒顆粒混合其後追加之成分後,可藉由以打錠機打錠來製造錠劑。
製劑化時,可適當使用公知之方法與添加劑來進行製劑化。添加劑可在不損及本發明之效果的範圍內適當添加。
添加劑可列舉藥學上容許之乘載體例如賦形劑、結合劑、崩解劑、崩解輔助劑、潤滑劑、流動化劑、光澤化劑、發泡劑、防濕劑、界面活性劑、安定化劑、乳化劑、抗氧化劑、填充劑、保存劑、甘味劑、調味劑、清涼化劑、香料、芳香劑、著色劑、基材、包衣劑、糖衣劑、可塑劑、分散劑,及消泡劑等,可依上述目的使用可用於以往公知之固體製劑的製劑添加劑。
賦形劑例如可列舉糖漿粉、阿拉伯膠、阿拉伯膠粉末、可可脂、焦糖、羧基甲基澱粉鈉、含水二氧化矽、無水無晶形氧化矽、木糖醇、矽酸鋁酸鎂、矽酸鈣、矽酸鎂、輕質矽酸酐、無水磷酸氫鈣、無水磷酸氫鈣造粒物、磷酸一氫鈣、磷酸氫鈣水合物、磷酸氫鈣造粒物、磷酸氫鈉水合物、磷酸二氫鈣水合物、磷酸二氫鈉水合物、磷酸二氫鉀、結晶纖維素、結晶纖維素/羧甲基纖維素鈉、結晶纖維素(微粒子)、結晶纖維素(粒)、粉末纖維素、合成矽酸鋁、合成矽酸鋁/羥基丙基澱粉/結晶纖維素、小麥澱粉、米粉、米澱粉、重質矽酸酐、精製白糖、精製白糖球狀顆粒、明膠、D-山梨醇、碳酸鈣、碳酸鎂、沈降碳酸鈣、糊精、玉米澱粉、玉米澱粉造粒物、海藻糖、二氧化矽、乳糖水合物、乳糖造粒物、白糖、馬鈴薯澱粉、羥基丙基澱粉、部分α化澱粉、粉糖、粉末飴、粉末還原麥芽糖水飴、粉末纖維素、果膠、聚氧乙烯硬化蓖麻油、聚氧乙烯硬化蓖麻油60、氫化麥芽糖、D-甘露醇、硫酸鈣、赤藻糖醇、葡萄糖、果糖等。
作為結合劑例如可摻合選自阿拉伯膠、阿拉伯膠粉末、寒梅粉、明膠、蟲膠、羥基丙基澱粉、羥丙基甲基纖維素(hypromellose)、聚三葡萄糖、聚維酮、聚乙烯醇(完全皂化物)、聚乙烯醇(部分皂化物)、甲基丙烯酸共聚物L、甲基丙烯酸共聚物LD、甲基丙烯酸共聚物S、甲基丙烯酸丁酯/甲基丙烯酸甲酯共聚物、甲基纖維素、聚乙烯醇/丙烯酸/甲基丙烯酸甲酯共聚物等的1種或2種以上之成分。
崩解劑例如可列舉羧基甲基澱粉鈉、羧甲基纖維素、羧甲基纖維素鈣、交聯羧甲基纖維素鈉、交聯聚維酮(crosspovidone)、羥基丙基澱粉、部分α化澱粉等。
崩解輔助劑例如可列舉羧基甲基澱粉鈉、羧甲基纖維素、羧甲基纖維素鈣、交聯羧甲基纖維素鈉、輕質矽酸酐、結晶纖維素、碳酸氫鈉、沈降碳酸鈣、乳糖水合物、羥基丙基澱粉、聚山梨醇酯40、聚山梨醇酯60、聚山梨醇酯80、聚乙烯二醇(macrogol)1500、聚乙烯二醇4000等。
潤滑劑例如可列舉硬脂酸鎂、硬脂酸鈣、滑石、蔗糖脂肪酸酯、甘油脂肪酸酯、聚乙二醇、硬化油、硬脂醯富馬酸鈉(sodium stearyl fumarate)等。
作為流動化劑,例如可摻合選自含水二氧化矽、輕質矽酸酐、合成矽酸鋁、重質矽酸酐、氫氧化氧化鋁鎂、硬脂酸、硬脂酸鈣、硬脂酸鎂、磷酸三鈣、滑石、磷酸氫鈣造粒物等的1種或2種以上之成分。
作為光澤化劑,例如可摻合選自卡瑙巴蠟、白蜜蠟、精製蟲膠、聚乙烯二醇400、聚乙烯二醇1500、聚乙烯二醇4000、聚乙烯二醇6000、聚乙烯二醇6000NF、蜜蠟等的1種或2種以上之成分。
作為發泡劑,例如可摻合選自乾燥碳酸鈉、酒石酸、酒石酸氫鉀、碳酸氫鈉、檸檬酸酐等的1種或2種以上之成分。
作為防濕劑,例如可摻合選自乙基纖維素、橄欖油、乾燥氫氧化鋁凝膠、甘油、矽酸鎂、輕質矽酸酐、硬化油、合成矽酸鋁、蔗糖脂肪酸酯、硬脂酸、硬脂酸鎂、精製蟲膠、精製白糖、滑石、中性無水硫酸鈉、沈降碳酸鈣、富馬酸/硬脂酸/聚乙烯基縮醛二乙基胺基乙酸酯/羥基丙基甲基纖維素2910混合物、聚乙烯基縮醛二乙基胺基乙酸酯等的1種或2種以上之成分。
作為界面活性劑,例如可摻合選自蔗糖脂肪酸酯、聚氧乙烯硬化蓖麻油20、聚氧乙烯硬化蓖麻油60、聚氧乙烯硬脂基醚、聚氧乙烯鯨蠟基醚、聚氧乙烯山梨醇酐單月桂酯、聚氧乙烯山梨醇蜜蠟、聚氧乙烯壬基苯基醚、聚氧乙烯(20)聚氧丙烯(20)二醇、聚氧乙烯(105)聚氧丙烯(5)二醇、聚氧乙烯(120)聚氧丙烯(40)二醇、聚氧乙烯(160)聚氧丙烯(30)二醇、聚氧乙烯(10)聚氧丙烯(4)鯨蠟基醚、聚山梨醇酯20、聚山梨醇酯60、聚山梨醇酯80、聚乙烯二醇400、單油酸山梨醇酐、單硬脂酸甘油、單硬脂酸山梨醇酐、單月桂酸山梨醇酐、月桂基硫酸鈉等的1種或2種以上之成分。
作為安定化劑,例如可摻合選自己二酸、L-天門冬胺酸、L-天門冬胺酸鈉、DL-丙胺酸、L-丙胺酸、L-精胺酸、L-精胺酸鹽酸鹽、海藻酸鈉、海藻酸丙二醇酯、苯甲酸、苯甲酸鈉、乙二胺、乙二胺四乙酸鈣二鈉、乙二胺四乙酸鈉、乙二胺四乙酸四鈉、乙二胺四乙酸四鈉四水合物、氯化鋅、氯化銨、氯化鈣水合物、氯化鯨蠟基吡啶鎓、氯化鐵(III)、氯化鈉、氯化鎂、鹽酸半胱胺酸、L-鹽酸組胺酸、可可脂、羧基乙烯基聚合物、羧甲基纖維素鈣、羧甲基纖維素鈉、含水二氧化矽、乾燥碳酸鈉、甘胺酸、甘油、甘油脂肪酸酯、葡萄糖酸鈣水合物、葡萄糖酸鈉、葡萄糖酸鎂、L-麩胺酸鉀、L-麩胺酸鈉、L-麩胺酸L-離胺酸、輕質矽酸酐、結晶磷酸二氫鈉、軟骨素硫酸鈉、氧化鋅、L-胱胺酸、L-半胱胺酸、酒石酸、蔗糖脂肪酸酯、硬脂酸、精製明膠、精製大豆卵磷脂、明膠、明膠水解物、山梨醇酐脂肪酸酯、牛磺酸、滑石、碳酸鈣、碳酸氫鉀、碳酸氫鈉、碳酸鈉水合物、碳酸鎂、天然維生素E、生育酚、生育酚乙酸酯、乳糖、濃甘油、聚維酮、聚氧乙烯硬化蓖麻油60、聚氧乙烯硬脂基醚、聚氧乙烯鯨蠟基醚、聚氧乙烯壬基苯基醚、聚氧乙烯硬化蓖麻油、聚氧乙烯(42)聚氧丙烯(67)二醇、聚氧乙烯(54)聚氧丙烯(39)二醇、聚氧乙烯(160)聚氧丙烯(30)二醇、聚氧乙烯(196)聚氧丙烯(67)二醇、聚氧乙烯椰子油脂脂肪甘油酯(7E.O.)、聚山梨醇酯20、聚山梨醇酯60、聚山梨醇酯80、聚乙烯醇(部分皂化物)、聚乙烯二醇300、聚乙烯二醇400、聚乙烯二醇4000、檸檬酸酐、無水檸檬酸鈉、無水磷酸一氫鈉、無水磷酸二氫鈉、甲基纖維素、l-薄荷腦、單硬脂酸甘油、藥用碳、硫酸鎂水合物、DL-蘋果酸、磷酸氫鈉水合物、磷酸二氫鉀、磷酸二氫鈣水合物、L-白胺酸、聚乙烯醇/丙烯酸/甲基丙烯酸甲酯共聚物等的1種或2種以上之成分。
乳化劑例如可列舉甘油脂肪酸酯、丙二醇脂肪酸酯、聚氧乙烯甘油脂肪酸酯、聚甘油脂肪酸酯、蔗糖脂肪酸酯、山梨醇酐脂肪酸酯、聚氧乙烯山梨醇酐脂肪酸酯、聚氧乙烯山梨醇脂肪酸酯、聚乙二醇脂肪酸酯、氫化大豆磷脂質等。
抗氧化劑例如可列舉抗壞血酸、L-抗壞血酸硬脂酸酯、檸檬酸水合物、大豆卵磷脂、天然維生素E、天然維生素E、生育酚、生育酚乙酸酯、棕櫚酸抗壞血酸、焦亞硫酸鈉等。
填充劑例如可列舉RSS No.1生橡膠、丙烯酸澱粉1000、含水二氧化矽、氧化鈦、二氧化矽、磷酸一氫鈣等。
保存劑例如可列舉苯甲酸、苯甲酸鈉、對羥苯甲酸乙酯、對羥苯甲酸丙酯、對羥苯甲酸甲酯、去氫乙酸、去氫乙酸鈉、山梨酸、苯氧基乙醇等。
作為甘味劑,例如可摻合選自阿斯巴甜、乙醯磺胺酸鉀(acesulfame potassium)、甜茶、甜茶粉末、還原麥芽糖水飴、甘草、甘草萃取物、甘草粉末、木糖醇、甘草苷酸二鉀、甘草苷酸二鈉、糖精(saccharin)、糖精鈉水合物、蔗糖素、甜菊萃取物、甜菊萃取精製物、精製白糖、果糖、白糖、氫化麥芽糖、D-甘露醇、赤藻糖醇等的1種或2種以上之成分。
作為調味劑,例如可摻合選自氯化鈉、柑橘、柑橘油、可可粉、果糖、焦糖、木糖醇、檸檬酸鈣、檸檬酸水合物、檸檬酸鈉水合物、L-麩胺酸、L-麩胺酸鈉、葡萄柚萃取物、黑砂糖、糖精、糖精鈉水合物、酒石酸、D-酒石酸、酒石酸氫鉀、DL-酒石酸鈉、蔗糖素、甜菊萃取物、甜菊萃取精製物、當藥、D-山梨醇、單寧酸、海藻糖水合物、果寡糖、粉糖、薄荷粉、D-甘露醇、dl-薄荷腦、l-薄荷腦、薄荷腦粉、綠茶粉末、DL-蘋果酸、DL-蘋果酸鈉、檸檬油、玫瑰油等的1種或2種以上之成分。
清涼化劑例如可列舉茴香油、d-樟腦、dl-樟腦、桂皮油、薄荷水、薄荷油、l-薄荷腦等。
作為香料,例如可摻合選自柑橘香料、瓜拿納萃取物、甜橙、草莓、黑糖香料、草莓香料、櫻桃香料、香蕉粉末香料、桃子香精、水果香精、薄荷、哈密瓜粉末香料、l-薄荷腦、薄荷油等的1種或2種以上之成分。
芳香劑例如可列舉茴香粉末、茴香油、乙基香草精、d-樟腦、dl-樟腦、綠薄荷油、松脂油、鳳梨粉末香料51357、鳳梨粉末香料59492、薄荷水、薄荷油、香草粉末香料54286、香草精、佛手柑油、d-冰片、dl-冰片、dl-薄荷腦、l-薄荷腦、尤加利油、玫瑰水、玫瑰油等。
作為著色劑,例如可摻合選自黃色氧化鐵、黃色三氧化二鐵、柑橘香精、褐色氧化鐵、碳黑、焦糖、β-胡蘿蔔素、金箔、黑色氧化鐵、氧化鈦、三氧化二鐵、重氮黃、食用藍色1號、食用黃色4號、食用黃色5號、食用藍色2號鋁色澱、食用黃色4號鋁色澱、食用紅色2號、食用紅色3號、食用紅色102號、三氧化二鐵/甘油懸浮液、銅葉綠素鈉、銅葉綠素、酚紅、孔雀石綠、亞甲藍、藥用碳、核黃素、核黃素丁酸酯、核黃素磷酸酯鈉、綠茶末、玫瑰油等的1種或2種以上之成分。
作為基劑,可摻合選自阿拉伯膠粉末、α化澱粉、乙基纖維素、可可脂、卡瑙巴蠟、羧基乙烯基聚合物、羧甲基纖維素、羧甲基纖維素鈉、還原麥芽糖水飴、含水二氧化矽、乾燥氫氧化鋁凝膠、洋菜、洋菜粉末、三仙膠、甘胺酸、甘油、甘油脂肪酸酯、輕質矽酸酐、結晶纖維素、硬化油、合成矽酸鋁、合成矽酸鎂鈉、氧化鈦、酒石酸、蔗糖脂肪酸酯、矽油、硬脂酸、硬脂酸鎂、明膠、D-山梨醇、滑石、碳酸鈣、玉米澱粉、乳酸、乳酸乙酯、乳酸鈣水合物、乳酸/甘醇酸共聚物、濃甘油、馬鈴薯澱粉、羥丙基甲基纖維素、聚三葡萄糖、果膠、聚維酮、聚山梨醇酯60、聚山梨醇酯80、聚乙烯醇(部分皂化物)、微晶蠟、聚乙烯二醇200、聚乙烯二醇300、聚乙烯二醇400、聚乙烯二醇1000、聚乙烯二醇1500、聚乙烯二醇1540、聚乙烯二醇4000、聚乙烯二醇6000、聚乙烯二醇6000NF、聚乙烯二醇20000、D-甘露醇、單硬脂酸甘油、單硬脂酸山梨醇酐、單硬脂酸鯊魚肝油酯、單硬脂酸丙二醇、單硬脂酸聚乙二醇、月桂基硫酸鈉、聚乙烯醇/丙烯酸/甲基丙烯酸甲酯共聚物等的1種或2種以上之成分。
包衣劑例如可列舉丙烯酸乙酯/甲基丙烯酸甲酯共聚物分散液、甲基丙烯酸胺基烷酯共聚物E、甲基丙烯酸胺基烷酯共聚物RS、阿拉伯膠、阿拉伯膠粉末、乙基纖維素、乙基纖維素水分散液、卡瑙巴蠟、羧基乙烯基聚合物、金箔、銀箔、檸檬酸三乙酯、甘油、甘油脂肪酸酯、硬化油、氧化鈦、蔗糖脂肪酸酯、硬脂醇、硬脂酸、硬脂酸鎂、精製明膠、精製蟲膠、明膠、D-山梨醇、滑石、碳酸鈣、碳酸鎂、中金箔、沈降碳酸鈣、濃甘油、白色蟲膠、羥基丙基甲基纖維素乙酸酯琥珀酸酯、羥基丙基甲基纖維素2910/氧化鈦/聚乙烯二醇400混合物、羥丙基甲基纖維素、富馬酸/硬脂酸/聚乙烯基縮醛二乙基胺基乙酸酯/羥基丙基甲基纖維素2910混合物、聚三葡萄糖、聚山梨醇酯80、聚乙烯基縮醛二乙基胺基乙酸酯、聚維酮、聚乙烯醇(部分皂化物)、聚乙烯二醇300、聚乙烯二醇400、聚乙烯二醇600、聚乙烯二醇1500、聚乙烯二醇1540、聚乙烯二醇4000、聚乙烯二醇6000、聚乙烯二醇6000NF、聚乙烯二醇20000、聚乙烯二醇35000、甲基丙烯酸共聚物L、甲基丙烯酸共聚物LD、甲基丙烯酸共聚物S、丙烯酸甲酯/甲基丙烯酸/甲基丙烯酸甲酯共聚物、甲基纖維素、2-甲基-5-乙烯基吡啶丙烯酸甲酯/甲基丙烯酸共聚物、單硬脂酸鋁、單硬脂酸甘油、單硬脂酸山梨醇酐、單月桂酸山梨醇酐、硫酸鈣、聚乙烯醇/丙烯酸/甲基丙烯酸甲酯共聚物等。
作為糖衣劑,例如可摻合選自阿拉伯膠、阿拉伯膠粉末、乙基纖維素、卡瑙巴蠟、羧甲基纖維素鈉、氧化鈦、硬脂酸、硬脂酸聚乙烯二醇40(polyoxyl 40 stearate)、精製明膠、精製蟲膠、精製白糖、明膠、蟲膠、滑石、沈降碳酸鈣、白色蟲膠、白糖、羥丙基甲基纖維素、聚三葡萄糖、聚維酮、聚乙烯醇(部分皂化物)、聚乙烯二醇1500、聚乙烯二醇4000、聚乙烯二醇6000、聚乙烯二醇6000NF、磷酸氫鈣水合物、磷酸二氫鈣水合物、聚乙烯醇/丙烯酸/甲基丙烯酸甲酯共聚物等的1種或2種以上之成分。
作為可塑劑,例如可摻合選自檸檬酸三乙酯、甘油、甘油脂肪酸酯、D-山梨醇、中鏈脂肪酸三甘油酯、甘油三乙酸酯、濃甘油、蓖麻油、聚氧乙烯硬化蓖麻油60、丙二醇、聚氧乙烯(105)聚氧丙烯(5)二醇、聚山梨醇酯80、聚乙烯二醇400、聚乙烯二醇600、聚乙烯二醇1500、聚乙烯二醇4000、聚乙烯二醇6000、聚乙烯二醇6000NF、單硬脂酸甘油、亞麻油酸異丙酯、流動石蠟等的1種或2種以上之成分。
作為分散劑,可摻合選自甲基丙烯酸胺基烷酯聚合物RS、阿拉伯膠、阿拉伯膠粉末、羧基乙烯基聚合物、羧基甲基澱粉鈉、洋菜粉末、檸檬酸水合物、檸檬酸鈉水合物、甘油、甘油脂肪酸酯、矽酸鎂、輕質氧化鋁、輕質矽酸酐、結晶纖維素、氧化鈦、蔗糖脂肪酸酯、硬脂酸、硬脂酸鎂、D-山梨醇、大豆卵磷脂、糊精、玉米澱粉、乳糖水合物、濃甘油、馬鈴薯澱粉、羥基乙基纖維素、羥基丙基澱粉、羥丙基甲基纖維素、聚維酮、聚氧乙烯硬化蓖麻油、聚氧乙烯硬化蓖麻油40、聚氧乙烯硬化蓖麻油50、聚氧乙烯硬化蓖麻油60、聚山梨醇酯20、聚山梨醇酯60、聚山梨醇酯80、微晶蠟、聚乙烯二醇300、聚乙烯二醇4000、聚乙烯二醇6000、聚乙烯二醇6000NF、無水檸檬酸鈉、甲基纖維素、單油酸甘油、單油酸山梨醇酐、單硬脂酸鋁、單硬脂酸甘油、單硬脂酸山梨醇酐、單棕櫚酸山梨醇酐、單月桂酸山梨醇酐、月桂基硫酸鈉等的1種或2種以上之成分。
作為消泡劑,可摻合選自乙醇、甘油脂肪酸酯、二甲基聚矽氧烷(內服用)、二甲基聚矽氧烷/二氧化矽混合物、蔗糖脂肪酸酯、矽消泡劑、矽油、山梨醇酐脂肪酸酯、聚山梨醇酯80等的1種或2種以上之成分。
此等添加物不限定於上述所列舉者,又,可使用此等當中1種、亦可組合2種以上使用。
本發明之固體製劑,較適合能夠以抑制發燒、疼痛、發炎為目的使用。由於有效成分之洛索洛芬及/或其鹽具有解熱鎮痛抗發炎作用,故可作為解熱鎮痛藥,特別適合使用於頭痛、月經痛(生理痛)、牙痛、拔牙後之疼痛、咽喉痛、腰痛、關節痛、肌肉痛、肩膀僵硬痛、耳痛、挫傷痛、骨折痛、扭傷痛、外傷痛等之鎮痛、惡寒/發燒時之解熱,又,可作為感冒治療劑,以緩解感冒之各種症狀(鼻水、鼻塞、咳嗽、痰、喉嚨痛、發燒、惡寒、頭痛、打噴嚏、關節痛、肌肉痛)為目的而適合地使用。
本發明之固體製劑,例如可採取經口投予之製劑(包含錠劑、口腔內崩解錠、咀嚼錠、發泡錠、分散錠、溶解錠等)、施用於口腔內之製劑(包含口腔用錠劑、片劑(troche)、舌下錠、口含錠(buccal tablet)、附著錠、膠質劑等)等之第十八次修正日本藥典 製劑總則等中記載的劑型。
此等之組成物中,亦可進一步依需要,在不損及本發明的範圍內適當摻合其他有效成分例如解熱鎮痛劑、鎮咳/去痰劑、抗組織胺劑、抗發炎劑、抗膽鹼劑、其他維生素類、黃嘌呤衍生物,該等若有摻合禁忌,則只要適當進行顆粒分離等來製劑化即可。
作為解熱鎮痛劑,可摻合選自阿斯匹靈、阿斯匹靈鋁、乙醯胺酚、鄰乙氧苯甲醯胺(Ethenzamide)、Sasapyrine、水楊醯胺、乳芬寧、布洛芬、異丙基安替比林、Pranoprofen、二克氯吩鈉、甲芬那酸、吲哚美辛法尼西爾(Indometacin Farnesil)、阿西美辛(Acemetacin)、艾特多雷克(Etodolac)、那普洛辛、美洛西卡、希樂可舒貝、水楊酸鈉及Tiaramide鹽酸鹽等的1種或2種以上之成分。
作為鎮咳/去痰劑,例如可列舉可待因、可待因磷酸鹽水合物、二氫可待因、二氫可待因磷酸鹽、地布酸鈉(sodium dibunate)、二甲啡烷(Dimemorfan)磷酸鹽、替被匹定檸檬酸鹽、替被匹定海苯酸鹽、右旋美沙芬(Dextromethorphan)、右旋美沙芬氫溴酸鹽水合物、右旋美沙芬酚酞鹽、Alloclamide鹽酸鹽、氯哌斯汀鹽酸鹽、氯哌斯汀聯苯醯苯酸鹽(Cloperastine Fendizoate)、噴托維林(Pentoxyverine)檸檬酸鹽、諾司卡賓、諾司卡賓鹽酸鹽、曲托喹諾(Trimetoquinol)鹽酸鹽、去甲羥麻黃鹼鹽酸鹽、假麻黃鹼鹽酸鹽、假麻黃鹼硫酸鹽、l-甲基麻黃鹼鹽酸鹽、dl-甲基麻黃鹼鹽酸鹽、dl-甲基麻黃鹼糖精鹽、呱芬那辛(Guaifenesin)、癒創木酚磺酸鉀、甲酚磺酸鉀、L-羧甲基半胱胺酸、胺溴索鹽酸鹽、溴克辛鹽酸鹽、L-乙基半胱胺酸鹽酸鹽等。
抗組織胺劑例如可列舉氮卓斯汀(Azelastine)鹽酸鹽、阿利米嗪(Alimemazine)酒石酸鹽、依巴斯汀(Ebastine)、依匹斯汀(Epinastine)鹽酸鹽、依美斯汀(Emedastine)富馬酸鹽、奧沙米特(Oxatomide)、奧洛他定(Olopatadine)鹽酸鹽、卡比諾沙明、可利汀富馬酸鹽、二苯基二磺酸鹽、卡比諾沙明馬來酸鹽、d-氯菲安明馬來酸鹽、dl-氯菲安明馬來酸鹽、可多替芬(Ketotifen)富馬酸鹽、二苯基吡啉鹽酸鹽、二苯基吡啉茶氯酸鹽(Diphenylpyraline Teoclate)、二苯胺明鹽酸鹽(Diphenhydramine Hydrochloride)、二苯胺明水楊酸鹽、二苯胺明單寧酸鹽、屈普利汀鹽酸鹽、Tripelennamine鹽酸鹽、Thonzylamine鹽酸鹽、非索非那定、Fenethazine鹽酸鹽、普敏太定鹽酸鹽(Promethazine Hydrochloride)、普敏太定、Mequitazine、Methdilazine鹽酸鹽、羅拉他定、鹽酸異戊酯、二啡特羅鹽酸鹽(Difeterol Hydrochloride)、Methdilazine鹽酸鹽、甲苄氫咔啉萘二磺酸鹽(Mebhydrolin Napadisilate)、普敏太定亞甲基二水楊酸鹽、二啡特羅磷酸鹽等。
抗發炎劑可列舉甘草苷酸及其衍生物以及該等之鹽類(例如甘草苷酸二鉀、甘草苷酸單銨等)、妥內散酸等。
抗膽鹼劑可列舉莨菪鹼氫溴酸鹽、曼陀羅萃取物、甲基莨菪鹼溴化物、甲基-l-莨菪鹼溴化物、哌侖西平(Pirenzepine)鹽酸鹽、丁基莨菪鹼溴化物、顛茄生物鹼(belladonna alkaloid)、顛茄萃取物、顛茄總生物鹼、碘化異丙醯胺、碘化二苯基哌啶基甲基二氧雜環戊烷、東莨菪萃取物、東莨菪根、東莨菪根總生物鹼檸檬酸鹽等。
維生素類可列舉維生素A、維生素C、維生素B1、維生素B2、維生素B5、維生素B6、維生素B12、維生素P、維生素E、橙皮苷、菸鹼酸、菸鹼醯胺、泛醇、泛酸鈣、泛酸鈉、生物素、天門冬胺酸鉀/鎂等等量混合物、六菸鹼酸肌醇、熊去氧膽酸(ursodeoxycholic acid)、L-半胱胺酸、L-鹽酸半胱胺酸、乳清酸、伽瑪-米糠醇、甘油磷酸鈣、葡萄糖酸鈣、葡萄糖醛酸內酯、葡萄糖醛酸醯胺、軟骨素硫酸鈉、人參、薏苡仁、碘酸。
上述之咖啡因以外之黃嘌呤衍生物(其他黃嘌呤衍生物),例如可列舉茶鹼、可可鹼。
此等添加物不限定於上述所列舉者,又,可使用此等當中1種、亦可組合2種以上使用。
可將本發明之固體製劑,藉由SP包裝、PTP包裝、袋狀包裝、棒狀包裝、瓶包裝等而一時包裝來氣密保存。進一步地,可將該等予以枕狀包裝、亦可將該等容納於箱盒等中。
換言之,本發明之一實施形態之醫藥品,亦可具備固體製劑,與包裝前述固體製劑之包裝材。
SP包裝、PTP包裝、棒狀包裝、枕狀包裝所用之材料不特別限定,例如可使用聚氯乙烯薄膜、聚偏二氯乙烯薄膜、聚丙烯薄膜、聚對苯二甲酸乙二酯薄膜、聚乙烯薄膜等之單層之樹脂薄膜或組合此等樹脂薄膜而得的複層之薄膜或於此等樹脂薄膜附著有鋁箔者。又,本發明之一實施形態之醫藥品,亦可使用顧慮到環境(對環境之負荷少)的環境對應容器作為包裝材,可於包裝材之至少一部分使用利用了顧慮到環境(對環境之負荷少)的素材(例如再生塑膠、生質塑膠、生分解性塑膠)等之材料。
又,發明之一實施形態之醫藥品,可於包裝材之至少一部分使用玻璃紙或蒸鍍薄膜。
本發明之固體製劑之包裝材料,例如,較佳為不易受到水分影響之材質的包裝(藉由防濕材料及氣體障壁性材料當中至少1者所形成之包裝)。
例如,作為水分影響低的材質之包裝(防濕材料),亦可為PTP(聚丙烯)+聚乙烯鋁枕狀包裝(PTP與聚乙烯鋁枕之組合包裝)。又,考慮到抑制固體製劑中的水分值上昇、固體製劑之保存安定性、開封後之固體製劑之安定性等,作為不易受到水分影響的材質之包裝(防濕材料),亦可使用於兩面使用了鋁的PTP包裝(Al-Al包裝)。
再者,顧慮到吸濕性時,亦可將乾燥劑等於瓶包裝內或枕狀包裝內同時保存。
作為氣體障壁性材料可使用公知者,不特別限定,例如可為具有功能性障壁層的積層薄膜等,亦可兼具上述防濕材料之角色或與上述防濕材料一併使用。
[實施例]
為了更詳細說明本發明,以下記載比較例及實施例,但本發明不限定於此等。
試驗例1:含有洛索洛芬鈉水合物、制酸劑之錠劑之保存安定性試驗
1.錠劑之製造
藉由以下方法製造試驗所用的比較例1、實施例1~5之製劑(錠劑)。又,比較例1、實施例1~5之處方(每6錠)示於表1、2。表1及以下之表中所出現的%,未特別提及時意指質量%。
(比較例1)
將遵照表1之比率所秤量之洛索洛芬鈉・2水合物(KOLON LIFE SCIENCE,INC.製)、氧化鎂(協和化學股份有限公司製)、甘草乾燥萃取物(阿爾卑斯藥品工業股份有限公司製)、部分α化澱粉(旭化成股份有限公司製,PCS PC-10)、交聯羧甲基纖維素鈉(FMC International製,AcDiSol Croscarmellose Sodium),與羥基丙基纖維素(日本曹達股份有限公司製,HPC-SL)以高速攪拌造粒機(型式:FM-VG05、廠商:Powrex股份有限公司)混合後,添加純水藉以造粒,作為造粒顆粒。
對於造粒顆粒,作為其後追加之成分,遵照表1於塑膠袋混合硬脂醯富馬酸鈉(木村產業製,PRUV)後,以打錠機(型式:VIRGO、菊水製作所股份有限公司製)打錠而得到錠劑。
(實施例1)
將遵照表1之比率秤量的低取代度羥基丙基纖維素(信越化學工業股份有限公司製,L-HPC NBD-022)投入高速攪拌造粒機(型式:FM-VG05、廠商:Powrex股份有限公司),添加純水進行造粒1後,添加洛索洛芬鈉・2水合物(KOLON LIFE SCIENCE,INC.製),與氧化鎂(協和化學股份有限公司製),依需要添加純水進行造粒2。造粒2之後,添加甘草乾燥萃取物(阿爾卑斯藥品工業股份有限公司製)、交聯羧甲基纖維素鈉(FMC International製,AcDiSol Croscarmellose Sodium),與羥基丙基纖維素(日本曹達股份有限公司製,HPC-SL),依需要添加純水進行造粒,藉以作為造粒顆粒。
對於造粒顆粒,作為其後追加之成分,將遵照表1之比率秤量的硬脂醯富馬酸鈉(木村產業製,PRUV)於塑膠袋混合後,以打錠機(型式:VIRGO、菊水製作所股份有限公司製)進行打錠而得到錠劑。
實施例2~5,除了將組成變更為表1、2所示之組成以外,係以與實施例1相同之方法得到錠劑。惟,就實施例4、5而言,係於其後追加添加D-甘露醇(Freund產業股份有限公司製,Granutol R)來製造錠劑。
2.試驗方法
將比較例1及實施例1~5之錠劑填充至玻璃瓶(3k規格瓶),以金屬蓋(藥用Nо.3)上蓋後,於60℃之條件放置1個月。於保管後藉由HPLC法測定洛索洛芬鈉含量,算出自保管前之殘存率。
3.試驗結果
洛索洛芬鈉殘存率係得到如表1及表2所示之結果。再者,表1~表4中之「-」意指錠劑中不含所該當之物質。
又,本試驗中洛索洛芬鈉殘存率之指標,係由以下所示之基準進行評價。
A(優):洛索洛芬鈉殘存率為95%以上
B(可):洛索洛芬鈉殘存率為未達95%
如比較例1所示,將洛索洛芬鈉水合物與氧化鎂混合時,洛索洛芬鈉之殘存率降低,但可知藉由如實施例1所示般於添加過純水的低取代度羥基丙基纖維素造粒物中添加洛索洛芬鈉水合物與氧化鎂進行造粒後,添加其他成分進行造粒,可抑制洛索洛芬鈉之含量降低。
如實施例2所示般,去掉甘草乾燥萃取物的情況,亦得到相同之結果。
又,如實施例3及實施例5所示般,將氧化鎂取代為偏矽酸鋁酸鎂或合成水滑石等之制酸劑的情況,亦可得到相同之結果。
進一步地,如實施例4所示般,可知變更低取代度羥基丙基纖維素之等級的情況,亦可抑制洛索洛芬鈉之含量降低。
<實施例6~9>
實施例6~9之處方(每6錠)示於表3。
(實施例6)
將遵照表3之比率秤量的低取代度羥基丙基纖維素(信越化學工業股份有限公司製,L-HPC NBD-022)投入高速攪拌造粒機(型式:FM-VG-25、廠商:Powrex股份有限公司),添加分散於純水的纈草萃取物進行造粒1後,添加輕質矽酸酐(日本AEROSIL股份有限公司製,AEROSIL 200),並添加純水進行造粒2。造粒2之後添加洛索洛芬鈉・2水合物(KOLON LIFE SCIENCE,INC.製)、氧化鎂(協和化學股份有限公司製)、甘草乾燥萃取物(阿爾卑斯藥品工業股份有限公司製)、赤藻糖醇(物產Food Science股份有限公司製)、部分α化澱粉(旭化成股份有限公司製,PCS PC-10),與羥基丙基纖維素(日本曹達股份有限公司製,HPC-SL微粉)進行造粒,藉以作為造粒顆粒。
對於造粒顆粒,作為其後追加之成分,將遵照表3之比率秤量的輕質矽酸酐(日本AEROSIL股份有限公司製,AEROSIL 200),與硬脂醯富馬酸鈉(木村產業製,PRUV)以混合機(型式:TM-30S、廠商:昭和化學機械工作所股份有限公司)混合後,以打錠機(型式:Collect 19HUK、廠商:菊水製作所股份有限公司)打錠而得到錠劑。
將遵照表3所製作的錠劑(未著衣錠)給入膜衣機(型式:HCT-MINI、廠商:Freund產業股份有限公司),進一步將聚乙烯醇(三菱化學股份有限公司製,Gohsenol EG-05P)、羥丙基甲基纖維素(信越化學工業股份有限公司製,TC-5R)、氧化鈦(Freund產業股份有限公司製,氧化鈦FG)、蔗糖脂肪酸酯(Surfhope SE PHARMA J-2203F)、聚乙二醇(日油股份有限公司製,聚乙烯二醇6000P)、三氧化二鐵(癸巳化成股份有限公司製),與黃色三氧化二鐵(癸巳化成股份有限公司製)與純水混合而調製膜衣液。接著,將所得之包衣液使用膜衣機於錠劑(未著衣錠)上塗佈目標量,之後添加卡瑙巴蠟(Freund產業股份有限公司製,卡瑙巴蠟 105)使產生光澤藉以製作膜衣錠。
實施例7~9,除了變更組成為如表3所示之組成以外,可藉由與實施例6相同之手法製作膜衣錠。
<實施例10>
實施例10之處方(每6錠)示於表4。
將遵照表4之比率秤量的低取代度羥基丙基纖維素(信越化學工業股份有限公司製,L-HPC NBD-022)投入高速攪拌造粒機(型式:FM-VG-400P、廠商:Powrex股份有限公司),添加分散於純水的纈草萃取物進行捏合1後,添加輕質矽酸酐(日本AEROSIL股份有限公司製,AEROSIL 200),並添加純水進行捏合2。捏合2之後添加洛索洛芬鈉・2水合物(KOLON LIFE SCIENCE,INC.製)、氧化鎂(協和化學股份有限公司製)、甘草乾燥萃取物(阿爾卑斯藥品工業股份有限公司製)、赤藻糖醇(物產Food Science股份有限公司製)、部分α化澱粉(旭化成股份有限公司製,PCS PC-10),與羥基丙基纖維素(日本曹達股份有限公司製,HPC-SL微粉)進行造粒,藉以作為造粒顆粒。
對於造粒顆粒,作為其後追加之成分,將遵照表10之比率秤量的輕質矽酸酐(日本AEROSIL股份有限公司製,AEROSIL 200),與硬脂醯富馬酸鈉(木村產業製,PRUV)以混合機(型式:TM-1000S、廠商:昭和化學機械工作所股份有限公司)混合後,以打錠機(型式:AQUARIUS、廠商:菊水製作所股份有限公司)打錠而得到錠劑。
實施例10,除了變更組成為如表4所示之組成以外,可藉由與實施例6相同之手法來製作膜衣錠。
將實施例10之錠劑進行PTP(聚丙烯)填充,進一步進行聚乙烯鋁枕狀包裝(PTP與聚乙烯鋁枕之組合包裝),於60℃之條件放置1個月。保管後藉由HPLC法測定洛索洛芬鈉含量,算出自保管前之殘存率。
其結果,如實施例10(表4)所示般,即使將錠劑予以PTP(聚丙烯)填充,且以聚乙烯鋁枕狀包裝保管的情況,亦可確認到良好的結果。
<製劑例1~60>
製劑例1~60之處方(每6錠)示於表5~12。
製劑例1~60,除了將組成變更為表5~12所示之組成以外,可藉由與實施例1相同之手法製作錠劑。
以上,說明了本發明之較佳實施形態及實施例,但本發明不限定於此等。在不脫離本發明之要旨的範圍內,可進行構成之附加、省略、取代及其他變更。
[產業上之可利用性]
本發明之固體製劑,作為解熱鎮痛藥,特別適合使用於頭痛、月經痛(生理痛)、牙痛、拔牙後之疼痛、咽喉痛、腰痛、關節痛、肌肉痛、肩膀僵硬痛、耳痛、挫傷痛、骨折痛、扭傷痛、外傷痛等之鎮痛、惡寒/發燒時之解熱,又,作為感冒治療劑,適合使用於緩解感冒之各種症狀(鼻水、鼻塞、咳嗽、痰、喉嚨痛、發燒、惡寒、頭痛、打噴嚏、關節痛、肌肉痛)。
Claims (10)
- 一種固體製劑,其含有選自由洛索洛芬及其鹽所成之群的至少一種、含有鎂及鋁當中至少1者的化合物,與羥基丙基纖維素類。
- 如請求項1之固體製劑,其中前述羥基丙基纖維素類,包含羥基丙基纖維素及低取代度羥基丙基纖維素當中至少1者。
- 如請求項2之固體製劑,其中前述低取代度羥基丙基纖維素之粒子徑比D90/D50,為1.5~3.0。
- 如請求項2或3之固體製劑,其中前述低取代度羥基丙基纖維素之平均粒子徑為30~60μm。
- 如請求項2或3之固體製劑,其中前述低取代度羥基丙基纖維素中的羥基丙氧基之比例為7~16%。
- 如請求項2或3之固體製劑,其中前述含有鎂及鋁當中至少1者的化合物,為選自由氧化鎂、偏矽酸鋁酸鎂,及合成水滑石所成之群的一種或二種以上。
- 如請求項2或3之固體製劑,其進一步含有選自由生藥及其萃取物、咖啡因類,及鎮靜劑所成之群的一種或二種以上。
- 如請求項2或3之固體製劑,其進一步含有具有胺基之化合物。
- 一種固體製劑之製造方法,其係含有選自由洛索洛芬及其鹽所成之群的至少一種、含有鎂及鋁當中至少1者的化合物,與羥基丙基纖維素類的固體製劑之製造方法,其包含於添加選自由洛索洛芬及其鹽所成之群的至少一種,與含有鎂及鋁當中至少1者的化合物進行造粒之前,對羥基丙基纖維素類添加水來進行造粒之第1步驟。
- 如請求項9之固體製劑之製造方法,其中於前述第1步驟中,相對於前述羥基丙基纖維素類之質量而言,前述水之質量為0.4倍以上。
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