CN102413815A - 形成用于人使用的口腔崩解片剂的方法 - Google Patents
形成用于人使用的口腔崩解片剂的方法 Download PDFInfo
- Publication number
- CN102413815A CN102413815A CN2010800187268A CN201080018726A CN102413815A CN 102413815 A CN102413815 A CN 102413815A CN 2010800187268 A CN2010800187268 A CN 2010800187268A CN 201080018726 A CN201080018726 A CN 201080018726A CN 102413815 A CN102413815 A CN 102413815A
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- CN
- China
- Prior art keywords
- tablet
- cavity
- pill
- preparation
- medicine
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
- A61J3/10—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of compressed tablets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J7/00—Devices for administering medicines orally, e.g. spoons; Pill counting devices; Arrangements for time indication or reminder for taking medicine
- A61J7/0007—Pill breaking or crushing devices
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Zoology (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
Description
阶段 | 时间[h:m] | 温度[℃] | 真空[毫巴] |
冷冻 | 00:30 | -35 | 1000 |
预备 | 00:20 | -35 | 1000 |
初始升华 | 00:10 | -35 | 0.370 |
升华1 | 03:00 | 40 | 0.370 |
升华2 | 16:00 | 40 | 0.370 |
关闭步骤 | 00:01 | 4 | 0.021 |
阶段 | 时间[h:m] | 温度[℃] | 真空[毫巴] |
冷冻 | 00:30 | -35 | 1000 |
预备 | 00:30 | -35 | 1000 |
初始升华,部分1 | 00:10 | -35 | 0.310 |
初始升华,部分2 | 05:00 | -15 | 0.310 |
升华1 | 07:00 | 10 | 0.310 |
升华2 | 24:00 | 35 | 0.310 |
关闭步骤 | 00:01 | 35 | 0.310 |
批次 | 明胶(w%) | 甘露糖醇(w%) | 水适量 |
Sol P1 | 4 | 3 | 93 |
Sol P2 | 4 | 6 | 90 |
Sol P3 | 4 | 9 | 87 |
Sol P4 | 8 | 3 | 89 |
Sol P5 | 8 | 6 | 86 |
Sol P6 | 8 | 9 | 83 |
Sol P7 | 12 | 3 | 85 |
Sol P8 | 12 | 6 | 82 |
Sol P9 | 12 | 9 | 79 |
制剂 | 平均破碎强度(N) |
Sol P1 | 0.71 |
Sol P2 | 1.81 |
Sol P3 | 2.39 |
Sol P4 | 4.11 |
Sol P5 | 2.68 |
Sol P6 | 4.39 |
Sol P7 | 5.89 |
Sol P8 | 4.45 |
Sol P9 | 4.19 |
批次 | 明胶(w%) | 甘露糖醇(w%) | 蔗糖(w%) | TRA(w%) |
K | 8 | 9 | 2 | - |
L | 8 | 9 | 4 | - |
M | 8 | 12 | 2 | - |
N | 8 | 12 | 4 | - |
O | 8 | 9 | 2 | 8 |
P | 8 | 12 | 2 | 8 |
Claims (17)
Applications Claiming Priority (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US17363409P | 2009-04-29 | 2009-04-29 | |
EP09159050 | 2009-04-29 | ||
US61/173,634 | 2009-04-29 | ||
EP09159050.5 | 2009-04-29 | ||
EP091590505 | 2009-04-29 | ||
PCT/EP2010/055682 WO2010125087A1 (en) | 2009-04-29 | 2010-04-28 | Process to form an orally disintegrating tablet for human use |
Publications (2)
Publication Number | Publication Date |
---|---|
CN102413815A true CN102413815A (zh) | 2012-04-11 |
CN102413815B CN102413815B (zh) | 2013-10-23 |
Family
ID=40908570
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN2010800187268A Active CN102413815B (zh) | 2009-04-29 | 2010-04-28 | 形成用于人使用的口腔崩解片剂的方法 |
Country Status (10)
Country | Link |
---|---|
US (2) | US9119794B2 (zh) |
EP (1) | EP2424496B1 (zh) |
JP (1) | JP5620977B2 (zh) |
CN (1) | CN102413815B (zh) |
AR (1) | AR076465A1 (zh) |
BR (1) | BRPI1013690B8 (zh) |
ES (1) | ES2663073T3 (zh) |
RU (1) | RU2554757C2 (zh) |
TW (1) | TWI471127B (zh) |
WO (1) | WO2010125087A1 (zh) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN115176118A (zh) * | 2019-12-16 | 2022-10-11 | 西北大学 | 冻干的试剂 |
Families Citing this family (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
TWI436789B (zh) * | 2008-01-21 | 2014-05-11 | Intervet Int Bv | 含有藥學化合物的顆粒之冷凍乾燥方法及含有此顆粒的藥學包 |
US8192659B1 (en) | 2011-09-12 | 2012-06-05 | On Demand Therapeutics, Inc. | Methods of making microtablets for drug delivery |
JP2014533240A (ja) | 2011-10-31 | 2014-12-11 | メルク・シャープ・アンド・ドーム・コーポレーションMerck Sharp & Dohme Corp. | 生物材料の凍結乾燥球形ペレットを調製する方法 |
US20140017318A1 (en) | 2012-07-10 | 2014-01-16 | Kevin O'Connell | Method to produce a medicinal product comprising a biologically active protein and the resulting product |
US9314519B2 (en) | 2012-08-21 | 2016-04-19 | Intervet Inc. | Liquid stable virus vaccines |
WO2014090386A1 (en) | 2012-12-11 | 2014-06-19 | Alfred E. Tiefenbacher (Gmbh & Co. Kg) | Orally disintegrating tablet containing asenapine |
US9393298B2 (en) | 2013-03-15 | 2016-07-19 | Intervet Inc. | Liquid stable bovine virus vaccines |
US9480739B2 (en) | 2013-03-15 | 2016-11-01 | Intervet Inc. | Bovine virus vaccines that are liquid stable |
AR097762A1 (es) | 2013-09-27 | 2016-04-13 | Intervet Int Bv | Formulaciones secas de vacunas que son estables a temperatura ambiente |
CA2927431C (en) * | 2013-10-16 | 2023-10-03 | Merck Sharp & Dohme Corp. | Method of microwave vacuum drying spherical-shaped pellets of biological materials |
AR099470A1 (es) | 2014-02-17 | 2016-07-27 | Intervet Int Bv | Vacunas de virus de aves de corral líquidas |
TWI670085B (zh) | 2014-02-19 | 2019-09-01 | 荷蘭商英特威國際公司 | 液體穩定之豬病毒疫苗 |
CZ306556B6 (cs) * | 2015-06-23 | 2017-03-08 | České Vysoké Učení Technické V Praze, Fakulta Strojní, Ústav Materiálového Inženýrství | Indentační hlavice, instrumentovaný měřící systém a způsob stanovení mechanických vlastností materiálů indentační metodou |
US10617650B2 (en) | 2015-10-16 | 2020-04-14 | Merck Sharp & Dohme Corp. | Process for preparing formulations for gastrointestinal-targeted therapies |
AU2017384392B2 (en) | 2016-12-20 | 2023-05-25 | Lts Lohmann Therapie-Systeme Ag | Transdermal therapeutic system containing asenapine and polysiloxane or polyisobutylene |
PL3338768T3 (pl) | 2016-12-20 | 2020-05-18 | Lts Lohmann Therapie-Systeme Ag | Transdermalny system terapeutyczny zawierający asenapinę |
JP2020525545A (ja) | 2017-06-26 | 2020-08-27 | エルテーエス ローマン テラピー−ジステーメ アーゲー | アセナピンおよびシリコーンアクリルハイブリッドポリマーを含有する経皮治療システム |
CN108906188A (zh) * | 2018-06-04 | 2018-11-30 | 邓帅 | 一种重症监护室用药片粉碎冲剂装置 |
MX2020014286A (es) | 2018-06-20 | 2021-03-25 | Lts Lohmann Therapie Systeme Ag | Sistema terapeutico transdermico que contiene asenapina. |
KR102281776B1 (ko) * | 2019-09-10 | 2021-07-27 | 주식회사 제네웰 | 동결건조용 몰드 및 이를 사용하는 수용성 고분자 구의 제조방법 |
US11672761B2 (en) | 2020-11-16 | 2023-06-13 | Orcosa Inc. | Rapidly infusing platform and compositions for therapeutic treatment in humans |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0450141A1 (en) * | 1989-08-14 | 1991-10-09 | Janssen Pharmaceutica Inc. | Carrier material for administration of drugs |
WO1993012770A1 (en) * | 1991-12-20 | 1993-07-08 | Pfizer Inc. | Porous shaped delivery devices and method of producing thereof |
US5382437A (en) * | 1993-10-25 | 1995-01-17 | Hunter Research Corporation | Frozen liquified gas composition and method for oral administration of drugs, biologicals, nutrients and foodstuffs |
WO1997048383A1 (en) * | 1996-06-17 | 1997-12-24 | Janssen Pharmaceutica N.V. | Biconvex rapidly disintegrating dosage forms |
US20060057207A1 (en) * | 2001-11-30 | 2006-03-16 | Pfizer Inc | Fast-disintegrating dosage forms of 5,8,14-triazatetracyclo[10.3.1.02,11.04,9]-hexadeca-2(11),3,5,7,9-pentaene |
Family Cites Families (12)
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US2552027A (en) | 1948-01-17 | 1951-05-08 | American Cyanamid Co | Casting gelatin tablets |
FR2634376B1 (fr) | 1988-07-21 | 1992-04-17 | Farmalyoc | Nouvelle forme unitaire, solide et poreuse comprenant des microparticules et/ou des nanoparticules, ainsi que sa preparation |
CA2000666C (en) * | 1988-10-14 | 1996-07-09 | Jeffrey Lawrence Finnan | Method of making a free-flowing, spray-dried edible powder comprising an oil |
US6177104B1 (en) * | 1994-01-27 | 2001-01-23 | The Board Of Regents Of The University Of Oklahoma | Particulate support matrix for making a rapidly dissolving dosage form |
GB9908014D0 (en) | 1999-04-08 | 1999-06-02 | Scherer Corp R P | Pharmaceutical compositions |
NL1012549C2 (nl) | 1999-07-09 | 2001-01-10 | Ocu Technologies B V | Inktsamenstelling voor een smeltbare inkt en een werkwijze voor het bedrukken van een substraat met een dergelijke inktsamenstelling. |
US7122143B2 (en) | 2001-09-28 | 2006-10-17 | Mcneil-Ppc, Inc. | Methods for manufacturing dosage forms |
JP3981569B2 (ja) * | 2002-02-26 | 2007-09-26 | 天野実業株式会社 | 乾燥装置 |
WO2003094886A2 (en) | 2002-05-07 | 2003-11-20 | Ferring Bv | Desmopressin in an orodispersible dosage form |
FR2868520B1 (fr) | 2004-04-06 | 2006-07-07 | Millennium Energy Sa | Installation de deshydratation par zeolithes |
TWI398272B (zh) | 2005-03-08 | 2013-06-11 | Intervet Int Bv | 化學定義的安定劑 |
CN101583483B (zh) * | 2006-11-15 | 2012-12-12 | 新东工业株式会社 | 一种压片成型方法及其使用的辊压式成型装置 |
-
2010
- 2010-04-26 TW TW99113079A patent/TWI471127B/zh active
- 2010-04-27 AR ARP100101408A patent/AR076465A1/es active IP Right Grant
- 2010-04-28 US US13/266,510 patent/US9119794B2/en active Active
- 2010-04-28 JP JP2012507725A patent/JP5620977B2/ja active Active
- 2010-04-28 CN CN2010800187268A patent/CN102413815B/zh active Active
- 2010-04-28 WO PCT/EP2010/055682 patent/WO2010125087A1/en active Application Filing
- 2010-04-28 US US13/266,511 patent/US9095516B2/en active Active
- 2010-04-28 RU RU2011148342/15A patent/RU2554757C2/ru active
- 2010-04-28 EP EP10716339.6A patent/EP2424496B1/en active Active
- 2010-04-28 ES ES10716339.6T patent/ES2663073T3/es active Active
- 2010-04-28 BR BRPI1013690A patent/BRPI1013690B8/pt active IP Right Grant
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0450141A1 (en) * | 1989-08-14 | 1991-10-09 | Janssen Pharmaceutica Inc. | Carrier material for administration of drugs |
WO1993012770A1 (en) * | 1991-12-20 | 1993-07-08 | Pfizer Inc. | Porous shaped delivery devices and method of producing thereof |
US5382437A (en) * | 1993-10-25 | 1995-01-17 | Hunter Research Corporation | Frozen liquified gas composition and method for oral administration of drugs, biologicals, nutrients and foodstuffs |
WO1997048383A1 (en) * | 1996-06-17 | 1997-12-24 | Janssen Pharmaceutica N.V. | Biconvex rapidly disintegrating dosage forms |
US20060057207A1 (en) * | 2001-11-30 | 2006-03-16 | Pfizer Inc | Fast-disintegrating dosage forms of 5,8,14-triazatetracyclo[10.3.1.02,11.04,9]-hexadeca-2(11),3,5,7,9-pentaene |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN115176118A (zh) * | 2019-12-16 | 2022-10-11 | 西北大学 | 冻干的试剂 |
Also Published As
Publication number | Publication date |
---|---|
EP2424496A1 (en) | 2012-03-07 |
US9095516B2 (en) | 2015-08-04 |
RU2554757C2 (ru) | 2015-06-27 |
AR076465A1 (es) | 2011-06-15 |
TW201103525A (en) | 2011-02-01 |
CN102413815B (zh) | 2013-10-23 |
RU2011148342A (ru) | 2013-06-10 |
BRPI1013690A2 (pt) | 2016-04-26 |
US20120049412A1 (en) | 2012-03-01 |
BRPI1013690B8 (pt) | 2020-12-08 |
EP2424496B1 (en) | 2018-02-21 |
JP5620977B2 (ja) | 2014-11-05 |
ES2663073T3 (es) | 2018-04-11 |
TWI471127B (zh) | 2015-02-01 |
BRPI1013690B1 (pt) | 2020-02-11 |
WO2010125087A1 (en) | 2010-11-04 |
JP2012525177A (ja) | 2012-10-22 |
US20120048764A1 (en) | 2012-03-01 |
US9119794B2 (en) | 2015-09-01 |
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SE01 | Entry into force of request for substantive examination | ||
C14 | Grant of patent or utility model | ||
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Owner name: ORGANON BIOLOGICAL NETHERLANDS CO., LTD. Free format text: FORMER OWNER: MSD OUSI CO., LTD. Effective date: 20131015 Owner name: MERCK SHARP + DOHME CORP. Free format text: FORMER OWNER: ORGANON BIOLOGICAL NETHERLANDS CO., LTD. Effective date: 20131015 |
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Address after: Holland box Mel Patentee after: INTERVET INTERNATIONAL B.V. Patentee after: N.V. Organon Address before: Holland box Mel Patentee before: INTERVET INTERNATIONAL B.V. Patentee before: N.V. ORGANON |
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Effective date of registration: 20131015 Address after: Holland box Mel Patentee after: INTERVET INTERNATIONAL B.V. Patentee after: MERCK SHARP & DOHME B.V. Address before: Holland box Mel Patentee before: INTERVET INTERNATIONAL B.V. Patentee before: Organon biological science Holland Co.,Ltd. Effective date of registration: 20131015 Address after: Holland box Mel Patentee after: INTERVET INTERNATIONAL B.V. Patentee after: Organon biological science Holland Co.,Ltd. Address before: Holland box Mel Patentee before: INTERVET INTERNATIONAL B.V. Patentee before: N.V. Organon |