JP6231385B2 - 医薬組成物 - Google Patents
医薬組成物 Download PDFInfo
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- JP6231385B2 JP6231385B2 JP2013529316A JP2013529316A JP6231385B2 JP 6231385 B2 JP6231385 B2 JP 6231385B2 JP 2013529316 A JP2013529316 A JP 2013529316A JP 2013529316 A JP2013529316 A JP 2013529316A JP 6231385 B2 JP6231385 B2 JP 6231385B2
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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
- A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/12—Antivirals
- A61P31/14—Antivirals for RNA viruses
- A61P31/18—Antivirals for RNA viruses for HIV
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Oncology (AREA)
- Virology (AREA)
- Communicable Diseases (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Tropical Medicine & Parasitology (AREA)
- AIDS & HIV (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
Description
(a)HIV感染症の長期間の治療、又はHIVに感染する危険性がある個人におけるHIV感染症の予防用の、有効量の式(I)の化合物又はその医薬として許容される塩を含む非経口医薬組成物であって、少なくとも1週間の時間間隔で断続的に投与される組成物。
[発明の効果]
式(I)の化合物、マンニトール、ポリソルベート20、PEG 3350、及び注射用水を配合し、湿式ビーズミルを使用して粉砕した。得られた懸濁液を、3mLのUSPタイプIガラスバイアルに充填容量1.5mLで充填し、各バイアルに栓をして封止し、次いで、ガンマ線照射により最終滅菌する。
粒径
実施例1に記載のプロセスにより調製した式(I)の化合物の注射用の懸濁液の試料を29.9〜31.5kGy線量のガンマ線照射で照射した。粉砕時間は5時間であった。レーザー回折技術により求めた粒径は、以下の通りである:
X10=75nm
X50=157nm
X90=646nm
200nm未満のX50が達成された。
ガンマ線照射
実施例1に記載のプロセスにより調製した式(I)の化合物の注射用の懸濁液の試料を29.9〜31.5kGy線量のガンマ線照射で照射した。HPLCによりガンマ線照射前及びガンマ線照射後の試料を薬物関連不純物に関して試験した。
ガンマ線照射前 0.19
ガンマ線照射後 0.16
この配合物は、ガンマ線照射をしても安定である。
式(I)の化合物、マンニトール、ポリソルベート20、PEG 3350、及び注射用水を配合し、マイクロ流動化装置M-110Pを使用してマイクロ流動化した。最小内部寸法が87μmの相互作用チャンバ(G10Z)に懸濁液を通し、50回通した後に、以下に列挙している粒径を得た:
X10=82nm
X50=221nm
X90=726nm
[実施例5]
ラット薬物動態
雄及び雌のラット(10/性別/群)に0(ビヒクル)、5、30、若しくは100mg/kgで皮下(SC)注射により、又は0(ビヒクル)、2.5、10、若しくは75mg/kgで筋肉内(IM)注射により、式(I)の化合物を1回与えた。投薬後、ラットを75〜76日間(SC、最初の5匹の対照ラット/性別を包含)又は84〜85日間(IM、残りの5匹の対照ラット/性別;IM)の無治療期間に保持した。ビヒクル対照ラットには、SC及びIM注射の両方を与えた。図1〜4は、投与経路及び性別による血漿中濃度-時間プロファイルを示している。
Claims (13)
- 医薬懸濁液が皮下投与用である、請求項1に記載の医薬懸濁液の製造方法。
- 医薬懸濁液が筋肉内投与用である、請求項1に記載の医薬懸濁液の製造方法。
- 医薬懸濁液が1カ月当たり1回の投与用である、請求項1から3のいずれかに記載の医薬懸濁液の製造方法。
- 医薬懸濁液が2カ月毎に1回の投与用である、請求項1から3のいずれかに記載の医薬懸濁液の製造方法。
- 医薬懸濁液が3カ月毎に1回の投与用である、請求項1から3のいずれかに記載の医薬懸濁液の製造方法。
- 医薬懸濁液が30日間〜365日間の任意の間隔で投与するためのものである、請求項1から3のいずれかに記載の医薬懸濁液の製造方法。
- 式(I)の化合物の量が、剤形1ml当たり10mg〜500mgである、請求項1から7のいずれかに記載の医薬懸濁液の製造方法。
- 医薬懸濁液における式(I)の化合物の体積メディアン径(x50)が200nm以下である、請求項1から8のいずれかに記載の医薬懸濁液の製造方法。
- 医薬懸濁液における式(I)の化合物の体積平均粒径が0.1〜0.5μmの範囲である、請求項1から8のいずれかに記載の医薬懸濁液の製造方法。
- ガンマ線照射が、滅菌用のガンマ線照射である、請求項1から10のいずれかに記載の医薬懸濁液の製造方法。
- 医薬懸濁液が、ヒトにおけるHIV感染症の治療用医薬懸濁液である請求項1から11のいずれかに記載の医薬懸濁液の製造方法。
- 医薬懸濁液が、ヒトにおけるHIV感染症の予防用医薬懸濁液である請求項1から11のいずれかに記載の医薬懸濁液の製造方法。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US38354110P | 2010-09-16 | 2010-09-16 | |
US61/383,541 | 2010-09-16 | ||
PCT/US2011/051713 WO2012037320A2 (en) | 2010-09-16 | 2011-09-15 | Pharmaceutical compositions |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2014500849A JP2014500849A (ja) | 2014-01-16 |
JP6231385B2 true JP6231385B2 (ja) | 2017-11-15 |
Family
ID=45832235
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2013529316A Active JP6231385B2 (ja) | 2010-09-16 | 2011-09-15 | 医薬組成物 |
Country Status (28)
Country | Link |
---|---|
US (3) | US20130171214A1 (ja) |
EP (1) | EP2616076B1 (ja) |
JP (1) | JP6231385B2 (ja) |
KR (1) | KR101938662B1 (ja) |
CN (1) | CN103547266B (ja) |
AU (1) | AU2011302030B2 (ja) |
BR (1) | BR112013005907B1 (ja) |
CA (1) | CA2810524C (ja) |
CL (1) | CL2013000715A1 (ja) |
CY (1) | CY1118279T1 (ja) |
DK (1) | DK2616076T3 (ja) |
EA (1) | EA024924B1 (ja) |
ES (1) | ES2594557T3 (ja) |
HR (1) | HRP20161280T1 (ja) |
HU (1) | HUE031336T2 (ja) |
IL (1) | IL225028A (ja) |
LT (1) | LT2616076T (ja) |
ME (1) | ME02520B (ja) |
MX (1) | MX346193B (ja) |
PL (1) | PL2616076T3 (ja) |
PT (1) | PT2616076T (ja) |
RS (1) | RS55222B1 (ja) |
SI (1) | SI2616076T1 (ja) |
SM (1) | SMT201600350B (ja) |
TW (1) | TWI577377B (ja) |
UA (1) | UA108250C2 (ja) |
WO (1) | WO2012037320A2 (ja) |
ZA (1) | ZA201301766B (ja) |
Families Citing this family (22)
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JO3387B1 (ar) | 2011-12-16 | 2019-03-13 | Glaxosmithkline Llc | مشتقات بيتولين |
CA2893959A1 (en) * | 2012-12-14 | 2014-06-19 | Shenshen Cai | Pharmaceutical compositions |
US9808428B2 (en) | 2014-01-14 | 2017-11-07 | Board Of Regents Of The University Of Nebraska | Compositions and methods for the delivery of therapeutics |
US20170165271A1 (en) * | 2014-02-24 | 2017-06-15 | The Board Of Regents Of The University Of Nebraska | Compositions and Methods for the Delivery of Therapeutics |
AU2015323321A1 (en) * | 2014-09-26 | 2017-04-13 | Glaxosmithkline Intellectual Property (No.2) Limited | Long acting pharmaceutical compositions |
EP3203995A4 (en) | 2014-10-09 | 2019-05-15 | Board of Regents of the University of Nebraska | COMPOSITIONS AND METHODS FOR DELIVERY OF THERAPEUTIC AGENTS |
MX2017008264A (es) * | 2014-12-20 | 2017-10-02 | Troikaa Pharmaceuticals Ltd | Formulaciones inyectables de paracetamol. |
JP7160466B2 (ja) * | 2016-06-23 | 2022-10-25 | ヴィーブ ヘルスケア カンパニー | 治療薬の送達のための組成物及び方法 |
US11077050B2 (en) | 2017-03-24 | 2021-08-03 | Merck Sharp & Dohme Corp. | Formulation for parenteral administration |
EP3655106A4 (en) * | 2017-07-18 | 2021-04-21 | VIIV Healthcare Company | COMBINED INGREDIENTS THERAPY |
EP3737359A4 (en) | 2018-01-12 | 2021-11-03 | Board of Regents of the University of Nebraska | ANTIVIRAL PRODRUGS AND THEIR FORMULATIONS |
US11458136B2 (en) | 2018-04-09 | 2022-10-04 | Board Of Regents Of The University Of Nebraska | Antiviral prodrugs and formulations thereof |
WO2020086555A1 (en) | 2018-10-22 | 2020-04-30 | Board Of Regents Of The University Of Nebraska | Antiviral prodrugs and nanoformulations thereof |
CN109646440B (zh) * | 2019-01-11 | 2021-04-20 | 山东省农业科学院奶牛研究中心 | Cabotegravir在制备抗牛传染性鼻气管炎药物中的应用 |
PL3938047T3 (pl) | 2019-03-22 | 2022-11-07 | Gilead Sciences, Inc. | Zmostkowane tricykliczne związki karbamoilopirydonowe i ich zastosowanie farmaceutyczne |
UY38982A (es) * | 2019-12-09 | 2021-06-30 | Viiv Healthcare Co | Composiciones farmacéuticas |
WO2021173522A1 (en) | 2020-02-24 | 2021-09-02 | Gilead Sciences, Inc. | Tetracyclic compounds for treating hiv infection |
CA3184868A1 (en) * | 2020-07-09 | 2022-01-13 | Rene Holm | Long-acting formulations |
US20230321089A1 (en) * | 2020-09-01 | 2023-10-12 | Viiv Healthcare Company | Combination of cabotegravir and levonorgestrel |
WO2022079739A1 (en) | 2020-10-14 | 2022-04-21 | Cipla Limited | Fixed dose compositions of cabotegravir and rilpivirine |
PT4196479T (pt) | 2021-01-19 | 2024-01-03 | Gilead Sciences Inc | Compostos de piridotriazinas substituídos e suas utilizações |
CN118121552A (zh) * | 2022-12-01 | 2024-06-04 | 浙江萃泽医药科技有限公司 | 一种可注射的药物组合物及其制备方法与应用 |
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2011
- 2011-09-14 TW TW100133064A patent/TWI577377B/zh active
- 2011-09-15 CA CA2810524A patent/CA2810524C/en active Active
- 2011-09-15 EA EA201390233A patent/EA024924B1/ru unknown
- 2011-09-15 KR KR1020137009569A patent/KR101938662B1/ko active IP Right Grant
- 2011-09-15 PT PT118259209T patent/PT2616076T/pt unknown
- 2011-09-15 JP JP2013529316A patent/JP6231385B2/ja active Active
- 2011-09-15 EP EP11825920.9A patent/EP2616076B1/en active Active
- 2011-09-15 RS RS20160826A patent/RS55222B1/sr unknown
- 2011-09-15 BR BR112013005907-9A patent/BR112013005907B1/pt active IP Right Grant
- 2011-09-15 US US13/823,316 patent/US20130171214A1/en not_active Abandoned
- 2011-09-15 AU AU2011302030A patent/AU2011302030B2/en active Active
- 2011-09-15 SI SI201130966A patent/SI2616076T1/sl unknown
- 2011-09-15 ME MEP-2016-192A patent/ME02520B/me unknown
- 2011-09-15 DK DK11825920.9T patent/DK2616076T3/en active
- 2011-09-15 UA UAA201303057A patent/UA108250C2/ru unknown
- 2011-09-15 HU HUE11825920A patent/HUE031336T2/hu unknown
- 2011-09-15 PL PL11825920T patent/PL2616076T3/pl unknown
- 2011-09-15 WO PCT/US2011/051713 patent/WO2012037320A2/en active Application Filing
- 2011-09-15 LT LTEP11825920.9T patent/LT2616076T/lt unknown
- 2011-09-15 ES ES11825920.9T patent/ES2594557T3/es active Active
- 2011-09-15 MX MX2013003037A patent/MX346193B/es active IP Right Grant
- 2011-09-15 CN CN201180044588.5A patent/CN103547266B/zh active Active
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2013
- 2013-03-03 IL IL225028A patent/IL225028A/en active IP Right Grant
- 2013-03-07 ZA ZA2013/01766A patent/ZA201301766B/en unknown
- 2013-03-15 CL CL2013000715A patent/CL2013000715A1/es unknown
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2016
- 2016-10-04 CY CY20161100985T patent/CY1118279T1/el unknown
- 2016-10-04 SM SM201600350T patent/SMT201600350B/it unknown
- 2016-10-05 HR HRP20161280TT patent/HRP20161280T1/hr unknown
- 2016-10-13 US US15/292,394 patent/US11224597B2/en active Active
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2021
- 2021-12-10 US US17/547,682 patent/US20220096469A1/en active Pending
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