BR112015029038A2 - comprimido engolível, e, processo para preparação de um comprimido engolível - Google Patents
comprimido engolível, e, processo para preparação de um comprimido engolívelInfo
- Publication number
- BR112015029038A2 BR112015029038A2 BR112015029038A BR112015029038A BR112015029038A2 BR 112015029038 A2 BR112015029038 A2 BR 112015029038A2 BR 112015029038 A BR112015029038 A BR 112015029038A BR 112015029038 A BR112015029038 A BR 112015029038A BR 112015029038 A2 BR112015029038 A2 BR 112015029038A2
- Authority
- BR
- Brazil
- Prior art keywords
- swallowable
- preparing
- swallowable tablet
- tablets
- tablet
- Prior art date
Links
- 238000004519 manufacturing process Methods 0.000 title abstract 2
- 239000000546 pharmaceutical excipient Substances 0.000 abstract 2
- NINIDFKCEFEMDL-UHFFFAOYSA-N Sulfur Chemical compound [S] NINIDFKCEFEMDL-UHFFFAOYSA-N 0.000 abstract 1
- 239000004480 active ingredient Substances 0.000 abstract 1
- 238000007906 compression Methods 0.000 abstract 1
- 230000006835 compression Effects 0.000 abstract 1
- 238000001035 drying Methods 0.000 abstract 1
- 239000008187 granular material Substances 0.000 abstract 1
- 238000005469 granulation Methods 0.000 abstract 1
- 230000003179 granulation Effects 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 229910052717 sulfur Inorganic materials 0.000 abstract 1
- 239000011593 sulfur Substances 0.000 abstract 1
Classifications
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
- A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- 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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/08—Bronchodilators
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
- A61P11/12—Mucolytics
-
- 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
- A61K9/1682—Processes
- A61K9/1688—Processes resulting in pure drug agglomerate optionally containing up to 5% of excipient
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pulmonology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
1 / 1 resumo âcomprimido engolãvel, e, processo para preparaãão de um comprimido engolãvelâ esta invenã§ã£o refere-se aos comprimidos engolãveis contendo pelo menos 80% em peso de n-acetilcisteãna (nac) e pelo menos um excipiente farmaceuticamente aceitã¡vel, em particular comprimidos nos quais o odor de enxofre estã¡ ausente, em que os ditos comprimidos sã£o montados usando um granulado preparado por meio de um processo de granulaã§ã£o seca do ingrediente ativo sozinho, com o qual os excipientes sã£o misturados antes da compressã£o.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
IT000874A ITMI20130874A1 (it) | 2013-05-29 | 2013-05-29 | Compresse deglutibili di n-acetilcisteina |
ITMI2013A000874 | 2013-05-29 | ||
PCT/EP2014/060950 WO2014191410A1 (en) | 2013-05-29 | 2014-05-27 | Swallowable n-acetylcysteine tablets |
Publications (2)
Publication Number | Publication Date |
---|---|
BR112015029038A2 true BR112015029038A2 (pt) | 2017-07-25 |
BR112015029038B1 BR112015029038B1 (pt) | 2022-12-06 |
Family
ID=48748383
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
BR112015029038-8A BR112015029038B1 (pt) | 2013-05-29 | 2014-05-27 | Comprimido engolível, e, processo para preparação de um comprimido engolível |
Country Status (29)
Country | Link |
---|---|
US (1) | US9808427B2 (pt) |
EP (1) | EP3003278B1 (pt) |
JP (1) | JP6438013B2 (pt) |
CN (1) | CN105228595B (pt) |
AU (1) | AU2014273148B2 (pt) |
BR (1) | BR112015029038B1 (pt) |
CA (1) | CA2911474C (pt) |
CY (1) | CY1122114T1 (pt) |
DK (1) | DK3003278T3 (pt) |
EA (1) | EA031856B1 (pt) |
ES (1) | ES2721649T3 (pt) |
HR (1) | HRP20190687T1 (pt) |
HU (1) | HUE044880T2 (pt) |
IL (1) | IL242439B (pt) |
IT (1) | ITMI20130874A1 (pt) |
LT (1) | LT3003278T (pt) |
MX (1) | MX366917B (pt) |
MY (1) | MY174005A (pt) |
PE (1) | PE20160184A1 (pt) |
PH (1) | PH12015502608B1 (pt) |
PL (1) | PL3003278T3 (pt) |
PT (1) | PT3003278T (pt) |
RS (1) | RS58653B1 (pt) |
SG (2) | SG10201709861YA (pt) |
SI (1) | SI3003278T1 (pt) |
TR (1) | TR201906101T4 (pt) |
UA (1) | UA117829C2 (pt) |
WO (1) | WO2014191410A1 (pt) |
ZA (1) | ZA201508411B (pt) |
Families Citing this family (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DK3554491T3 (en) * | 2016-12-15 | 2023-05-15 | Zambon Spa | N-acetylcystein til anvendelse som antibakterielt middel |
IT201700109080A1 (it) * | 2017-09-28 | 2019-03-28 | Neilos S R L | Composizione per la prevenzione e/o il trattamento delle affezioni delle vie respiratorie |
BR112020008653A2 (pt) * | 2017-11-02 | 2020-10-27 | Zambon S.P.A. | composições farmacêuticas compreendendo safinamida |
US10288629B1 (en) * | 2017-12-19 | 2019-05-14 | Aeterna Zentaris, Inc. | Method of assessing growth hormone deficiency in humans by a macimorelin containing composition |
EP3806828A1 (en) * | 2018-06-14 | 2021-04-21 | Poxel | Film-coated tablet comprising a triazine derivative for use in the treatment of diabetes |
IT201800007928A1 (it) * | 2018-08-07 | 2020-02-07 | Sofar Spa | Composizione contenente un agente mucolitico per il trattamento di ipersecrezione di muco e dispositivo per il suo dosaggio |
CN112843008A (zh) * | 2021-02-07 | 2021-05-28 | 广东赛康制药厂有限公司 | 一种乙酰半胱氨酸片及其制备方法 |
CN114886860B (zh) * | 2022-06-28 | 2023-04-25 | 山东达因海洋生物制药股份有限公司 | 一种乙酰半胱氨酸药物组合物及其制剂和制备工艺 |
Family Cites Families (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0481294B2 (de) * | 1990-10-19 | 2001-04-11 | Spirig Ag Pharmazeutische Präparate | Feste, schnell-lösliche Arzneimittelzubereitung enthaltend N-Acetylcystein |
GB9305058D0 (en) * | 1993-03-12 | 1993-04-28 | Penn Pharm Ltd | Pharmaceutical compositions |
IT1311907B1 (it) * | 1999-04-06 | 2002-03-20 | Zambon Spa | Compresse deglutibili ad alto contenuto di n-acetilcisteina. |
US6623754B2 (en) * | 2001-05-21 | 2003-09-23 | Noveon Ip Holdings Corp. | Dosage form of N-acetyl cysteine |
JP2003155232A (ja) * | 2001-09-07 | 2003-05-27 | Takeda Chem Ind Ltd | 不快な臭いが低減されたl−システイン配合固形製剤およびその製造方法 |
US20080139654A1 (en) * | 2006-12-09 | 2008-06-12 | Eric Mott Soderling | Acetaminophen compositions having minimized side effects including reduced hepatotoxicity |
IT1399492B1 (it) * | 2010-04-13 | 2013-04-19 | Alpex Pharma Sa | Composizioni farmaceutiche effervescenti contenenti n-acetilcisteina. |
EP2574333B1 (en) * | 2011-09-27 | 2017-01-11 | Friulchem SpA | N-acetylcysteine effervescent tablet and its therapeutical applications |
-
2013
- 2013-05-29 IT IT000874A patent/ITMI20130874A1/it unknown
-
2014
- 2014-05-27 DK DK14728495.4T patent/DK3003278T3/da active
- 2014-05-27 HU HUE14728495 patent/HUE044880T2/hu unknown
- 2014-05-27 JP JP2016516129A patent/JP6438013B2/ja active Active
- 2014-05-27 MY MYPI2015704193A patent/MY174005A/en unknown
- 2014-05-27 PE PE2015002421A patent/PE20160184A1/es active IP Right Grant
- 2014-05-27 WO PCT/EP2014/060950 patent/WO2014191410A1/en active Application Filing
- 2014-05-27 SI SI201431172T patent/SI3003278T1/sl unknown
- 2014-05-27 SG SG10201709861YA patent/SG10201709861YA/en unknown
- 2014-05-27 CA CA2911474A patent/CA2911474C/en active Active
- 2014-05-27 PL PL14728495T patent/PL3003278T3/pl unknown
- 2014-05-27 PT PT14728495T patent/PT3003278T/pt unknown
- 2014-05-27 TR TR2019/06101T patent/TR201906101T4/tr unknown
- 2014-05-27 AU AU2014273148A patent/AU2014273148B2/en active Active
- 2014-05-27 US US14/893,100 patent/US9808427B2/en active Active
- 2014-05-27 LT LTEP14728495.4T patent/LT3003278T/lt unknown
- 2014-05-27 ES ES14728495T patent/ES2721649T3/es active Active
- 2014-05-27 MX MX2015016130A patent/MX366917B/es active IP Right Grant
- 2014-05-27 UA UAA201512351A patent/UA117829C2/uk unknown
- 2014-05-27 EP EP14728495.4A patent/EP3003278B1/en active Active
- 2014-05-27 BR BR112015029038-8A patent/BR112015029038B1/pt active IP Right Grant
- 2014-05-27 CN CN201480029563.1A patent/CN105228595B/zh active Active
- 2014-05-27 RS RS20190507A patent/RS58653B1/sr unknown
- 2014-05-27 EA EA201592172A patent/EA031856B1/ru unknown
- 2014-05-27 SG SG11201509177VA patent/SG11201509177VA/en unknown
-
2015
- 2015-11-04 IL IL242439A patent/IL242439B/en active IP Right Grant
- 2015-11-13 ZA ZA2015/08411A patent/ZA201508411B/en unknown
- 2015-11-23 PH PH12015502608A patent/PH12015502608B1/en unknown
-
2019
- 2019-04-11 HR HRP20190687TT patent/HRP20190687T1/hr unknown
- 2019-04-11 CY CY20191100404T patent/CY1122114T1/el unknown
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
B06F | Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette] | ||
B07D | Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette] | ||
B07E | Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette] | ||
B06U | Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette] | ||
B350 | Update of information on the portal [chapter 15.35 patent gazette] | ||
B09A | Decision: intention to grant [chapter 9.1 patent gazette] | ||
B16A | Patent or certificate of addition of invention granted [chapter 16.1 patent gazette] |
Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 27/05/2014, OBSERVADAS AS CONDICOES LEGAIS |