WO1995009615A1 - Process i - Google Patents
Process i Download PDFInfo
- Publication number
- WO1995009615A1 WO1995009615A1 PCT/SE1994/000896 SE9400896W WO9509615A1 WO 1995009615 A1 WO1995009615 A1 WO 1995009615A1 SE 9400896 W SE9400896 W SE 9400896W WO 9509615 A1 WO9509615 A1 WO 9509615A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- agglomerates
- characterisedin
- screws
- screw feeder
- finely divided
- Prior art date
Links
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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/007—Pulmonary tract; Aromatherapy
- A61K9/0073—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy
- A61K9/0075—Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
- B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
- B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
- B01J2/20—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by expressing the material, e.g. through sieves and fragmenting the extruded length
Definitions
- the method of agglomeration is applicable in principle to all materials, including mixtures of various powders. Any powder, provided it is fine enough, can be granulated or pelletized without a binder by systematic agitation or rolling of the particulate material.
- the method according to the invention provides a process for facilitating the technical handling and significantly increase the medical value of the substance. It has been found that this method produces agglomerates having excellent handling properties, which have sufficient strength to withstand packaging and storage, but which are sufficiently soft so that they will break down into primary particles when they are expelled from an inhalator during inhalation therapy.
- an apparatus for performing the method of treatment of a finely divided powdered medicament having a particle size smaller than 10 ⁇ m and poor flowing properties to form, in a controlled manner, agglomerates or pellets which are free flowing and which are capable of breaking down to provide the finely divided medicament wherein the apparatus comprises a screw feeder with at least two co-operating screws which are rotating, a spheronizing device for spheronizing the resulting agglomerates and a sizing device for sizing the agglomerates to obtain a uniform size of the final product.
- the outer diameter of the screws is 20 mm and the inner diameter of the screws is between 10 - 19 mm, preferably between 15 - 19 mm. It is also important for the characteristics of the obtained agglomerates that the housing 9 around the screws in the screw feeder fits around the screws in a tight manner leaving only a minimal groove between the walls of the housing and the screws, see fig. 2b. If there is a distance between the wall and the screws finely divided powdered medicament will be compacted in this area during the rotation of the screws and the agglomeration procedure will result in a less uniform product.
- the granulating container is made of a material which is inert and do not contaminate the powder, such as for example metal, plastic or any other suitable material. In order to avoid electrostatic forces to build up during the spheronization process the container could be grounded.
- the most efficient manner to carry out the agglomeration process according to this invention is to incorporate two further steps of sieving and one further step of spheronization.
- a further sieving step is hereby incorporated into the process directly after the agglomeration process in the screw feeder. After this sieving the agglomerates are spheronized in the granulating container and a second further sieving step is carried out after this spheronization.
- the agglomeration process described in the present invention gives a high yield of the total operation and acceptable batch to batch variations to the final product.
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Organic Chemistry (AREA)
- Pulmonology (AREA)
- Otolaryngology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
- Control Of Multiple Motors (AREA)
- Saccharide Compounds (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines Containing Plant Substances (AREA)
- Stereophonic System (AREA)
- Control Of Motors That Do Not Use Commutators (AREA)
- Exchange Systems With Centralized Control (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- General Preparation And Processing Of Foods (AREA)
- Physical Or Chemical Processes And Apparatus (AREA)
- Electrical Discharge Machining, Electrochemical Machining, And Combined Machining (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Mixers Of The Rotary Stirring Type (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
Abstract
Description
Claims
Priority Applications (17)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SK391-96A SK283569B6 (en) | 1993-10-01 | 1994-09-29 | Method of treatment of a finely divided powdered medicament, device for performing this method and agglomerates produced by this method |
AT94929076T ATE209903T1 (en) | 1993-10-01 | 1994-09-29 | PROCEDURE I |
DK94929076T DK0721331T3 (en) | 1993-10-01 | 1994-09-29 | Course of action |
CA002172053A CA2172053C (en) | 1993-10-01 | 1994-09-29 | Process (i) for the preparation of powdered medicament |
DE69429357T DE69429357T2 (en) | 1993-10-01 | 1994-09-29 | PROCEDURE I |
AU78261/94A AU679789B2 (en) | 1993-10-01 | 1994-09-29 | Process I |
UA96031189A UA41373C2 (en) | 1993-10-01 | 1994-09-29 | Method for treating finely dispersed powdered drug composition, device for its realization, and agglomerates |
NZ274277A NZ274277A (en) | 1993-10-01 | 1994-09-29 | Making spheroidal granules of an inhalable medicament powder by agglomerating, spheronising, then sizing |
PL94313765A PL175564B1 (en) | 1993-10-01 | 1994-09-29 | Process i |
BR9407686A BR9407686A (en) | 1993-10-01 | 1994-09-29 | Process and apparatus for the treatment of a finely divided powder medicine using the apparatus and agglomerates |
EP94929076A EP0721331B1 (en) | 1993-10-01 | 1994-09-29 | Process i |
KR1019960701674A KR100347496B1 (en) | 1993-10-01 | 1994-09-29 | Method and apparatus for producing aggregates |
HU9600821A HU222355B1 (en) | 1993-10-01 | 1994-09-29 | Process and apparatus for treatment of finely divided powdered medicament |
JP51074895A JP3732508B2 (en) | 1993-10-01 | 1994-09-29 | Method for producing powdered drug |
US08/317,033 US5551489A (en) | 1993-10-01 | 1994-10-03 | Agglomeration of finely divided powders |
NO19961290A NO314836B1 (en) | 1993-10-01 | 1996-03-29 | Method and apparatus for treating a finely divided powdered drug, use of the apparatus and agglomerates |
FI961430A FI116364B (en) | 1993-10-01 | 1996-03-29 | Process I |
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
SE9303214-2 | 1993-10-01 | ||
SE9303214A SE9303214D0 (en) | 1993-10-01 | 1993-10-01 | Process I |
SE9304271-1 | 1993-12-22 | ||
SE9304271A SE9304271D0 (en) | 1993-12-22 | 1993-12-22 | Process I |
US08/317,033 US5551489A (en) | 1993-10-01 | 1994-10-03 | Agglomeration of finely divided powders |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1995009615A1 true WO1995009615A1 (en) | 1995-04-13 |
Family
ID=27355730
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/SE1994/000896 WO1995009615A1 (en) | 1993-10-01 | 1994-09-29 | Process i |
Country Status (23)
Country | Link |
---|---|
US (1) | US5551489A (en) |
EP (1) | EP0721331B1 (en) |
JP (1) | JP3732508B2 (en) |
CN (1) | CN1110300C (en) |
AT (1) | ATE209903T1 (en) |
AU (1) | AU679789B2 (en) |
BR (1) | BR9407686A (en) |
CZ (1) | CZ289214B6 (en) |
DE (1) | DE69429357T2 (en) |
DK (1) | DK0721331T3 (en) |
EG (1) | EG20677A (en) |
ES (1) | ES2166786T3 (en) |
FI (1) | FI116364B (en) |
HU (1) | HU222355B1 (en) |
IL (1) | IL111080A (en) |
NO (1) | NO314836B1 (en) |
NZ (1) | NZ274277A (en) |
PL (1) | PL175564B1 (en) |
PT (1) | PT721331E (en) |
RU (1) | RU2170082C2 (en) |
SG (1) | SG48049A1 (en) |
SK (1) | SK283569B6 (en) |
WO (1) | WO1995009615A1 (en) |
Cited By (23)
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DE19522899C1 (en) * | 1995-06-23 | 1996-12-19 | Hexal Pharmaforschung Gmbh | Process for the continuous sintering of a granulate |
EP0831782A1 (en) * | 1995-06-07 | 1998-04-01 | Inhale Therapeutic Systems | Methods and system for processing dispersible fine powders |
US5826633A (en) * | 1996-04-26 | 1998-10-27 | Inhale Therapeutic Systems | Powder filling systems, apparatus and methods |
ES2148059A1 (en) * | 1997-01-20 | 2000-10-01 | Astra Ab | New formulation for inhalation having a poured bulk density of from 0.28 to 0.38 g/ml, comprising budesonide |
ES2149082A1 (en) * | 1997-01-20 | 2000-10-16 | Astra Ab | New formulation for inhalation having a poured bulk density of from 0.28 to 0.38 g/ml, comprising formoterol |
ES2149083A1 (en) * | 1997-01-20 | 2000-10-16 | Astra Ab | New formulation for inhalation having a poured bulk density of from 0.28 to 0.38 g/ml, comprising terbutaline sulphate, a process for preparing the formulation and the use thereof |
US6182712B1 (en) | 1997-07-21 | 2001-02-06 | Inhale Therapeutic Systems | Power filling apparatus and methods for their use |
JP2001508793A (en) * | 1997-01-20 | 2001-07-03 | アストラ・アクチエボラーグ | Novel formulation for inhalation having a flowing bulk density of 0.28 to 0.38 G / ML, method for preparing the formulation and use thereof |
US6495167B2 (en) | 1997-03-20 | 2002-12-17 | Schering Corporation | Preparation of powder agglomerates |
US6503537B2 (en) | 1997-03-20 | 2003-01-07 | Schering Corporation | Preparation of powder agglomerates |
EP1417958A1 (en) * | 2002-11-08 | 2004-05-12 | Pari GmbH | Wet granulation process |
US7199148B2 (en) | 2002-08-14 | 2007-04-03 | Tibotec Pharmaceuticals Ltd | Broadspectrum substituted oxindole sulfonamide HIV protease inhibitors |
US7244752B2 (en) | 2001-04-09 | 2007-07-17 | Tibotec Pharmaceuticals Ltd. | Broadspectrum 2-(substituted-amino)-benzoxazole sulfonamide HIV protease inhibitors |
US7462636B2 (en) | 2002-05-17 | 2008-12-09 | Tibotec Pharmaceuticals Ltd | Broadspectrum substituted benzisoxazole sulfonamide HIV protease inhibitors |
DE102007049931A1 (en) | 2007-10-18 | 2009-04-23 | Pharmatech Gmbh | Apparatus and method for the continuous production of spherical powder agglomerates |
US7552655B2 (en) | 1999-12-17 | 2009-06-30 | Novartis Pharma Ag | Systems and methods for non-destructive mass sensing |
WO2010124203A2 (en) * | 2009-04-24 | 2010-10-28 | Schering Corporation | Agglomerate formulations including active pharmaceutical agents with targeted particle sizes |
JP2010275316A (en) * | 1997-03-20 | 2010-12-09 | Schering Corp | Preparation of powder agglomerates |
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US10023602B2 (en) | 2014-07-08 | 2018-07-17 | Universiteit Gent | Hamamelitannin analogues and uses thereof |
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- 1994-09-29 JP JP51074895A patent/JP3732508B2/en not_active Expired - Lifetime
- 1994-09-29 IL IL11108094A patent/IL111080A/en not_active IP Right Cessation
- 1994-09-29 NZ NZ274277A patent/NZ274277A/en not_active IP Right Cessation
- 1994-09-29 SK SK391-96A patent/SK283569B6/en not_active IP Right Cessation
- 1994-09-29 RU RU96108803/14A patent/RU2170082C2/en active
- 1994-09-29 BR BR9407686A patent/BR9407686A/en not_active IP Right Cessation
- 1994-09-29 AT AT94929076T patent/ATE209903T1/en active
- 1994-09-29 ES ES94929076T patent/ES2166786T3/en not_active Expired - Lifetime
- 1994-09-29 PL PL94313765A patent/PL175564B1/en unknown
- 1994-09-29 EP EP94929076A patent/EP0721331B1/en not_active Expired - Lifetime
- 1994-09-29 EG EG60594A patent/EG20677A/en active
- 1994-09-29 HU HU9600821A patent/HU222355B1/en active IP Right Grant
- 1994-09-29 AU AU78261/94A patent/AU679789B2/en not_active Expired
- 1994-09-29 CN CN94193634A patent/CN1110300C/en not_active Expired - Lifetime
- 1994-09-29 PT PT94929076T patent/PT721331E/en unknown
- 1994-09-29 SG SG1996006659A patent/SG48049A1/en unknown
- 1994-09-29 DK DK94929076T patent/DK0721331T3/en active
- 1994-09-29 CZ CZ1996942A patent/CZ289214B6/en not_active IP Right Cessation
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