US20070042143A1 - Sachet for a pharmaceutical composition - Google Patents
Sachet for a pharmaceutical composition Download PDFInfo
- Publication number
- US20070042143A1 US20070042143A1 US10/553,630 US55363004A US2007042143A1 US 20070042143 A1 US20070042143 A1 US 20070042143A1 US 55363004 A US55363004 A US 55363004A US 2007042143 A1 US2007042143 A1 US 2007042143A1
- Authority
- US
- United States
- Prior art keywords
- sachet
- sachet according
- per unit
- unit area
- weight per
- Prior art date
- 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.)
- Abandoned
Links
- 239000008194 pharmaceutical composition Substances 0.000 title claims abstract description 12
- 238000007789 sealing Methods 0.000 claims abstract description 10
- 230000004888 barrier function Effects 0.000 claims abstract description 8
- 239000008187 granular material Substances 0.000 claims description 18
- KBOPZPXVLCULAV-UHFFFAOYSA-N mesalamine Chemical compound NC1=CC=C(O)C(C(O)=O)=C1 KBOPZPXVLCULAV-UHFFFAOYSA-N 0.000 claims description 12
- 229960004963 mesalazine Drugs 0.000 claims description 12
- 239000004698 Polyethylene Substances 0.000 claims description 6
- -1 polyethylene Polymers 0.000 claims description 6
- 229920000573 polyethylene Polymers 0.000 claims description 4
- 150000003839 salts Chemical class 0.000 claims description 4
- 229920001684 low density polyethylene Polymers 0.000 claims description 3
- 239000004702 low-density polyethylene Substances 0.000 claims description 3
- 239000008203 oral pharmaceutical composition Substances 0.000 claims description 2
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical group [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 claims 1
- 229910052782 aluminium Inorganic materials 0.000 claims 1
- 239000011888 foil Substances 0.000 claims 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 7
- 230000005611 electricity Effects 0.000 description 6
- 230000003068 static effect Effects 0.000 description 6
- 238000004519 manufacturing process Methods 0.000 description 5
- 239000000463 material Substances 0.000 description 4
- 239000000203 mixture Substances 0.000 description 4
- 239000004480 active ingredient Substances 0.000 description 3
- 239000002245 particle Substances 0.000 description 3
- 239000005030 aluminium foil Substances 0.000 description 2
- 230000001419 dependent effect Effects 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 1
- 239000008186 active pharmaceutical agent Substances 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 229960004168 balsalazide Drugs 0.000 description 1
- IPOKCKJONYRRHP-FMQUCBEESA-N balsalazide Chemical compound C1=CC(C(=O)NCCC(=O)O)=CC=C1\N=N\C1=CC=C(O)C(C(O)=O)=C1 IPOKCKJONYRRHP-FMQUCBEESA-N 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 150000001875 compounds Chemical class 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 239000007884 disintegrant Substances 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 238000010438 heat treatment Methods 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 239000011236 particulate material Substances 0.000 description 1
- 239000008188 pellet Substances 0.000 description 1
- 230000035699 permeability Effects 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 229940069328 povidone Drugs 0.000 description 1
- 239000000651 prodrug Substances 0.000 description 1
- 229940002612 prodrug Drugs 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B15/00—Layered products comprising a layer of metal
- B32B15/04—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material
- B32B15/12—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material of paper or cardboard
-
- 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
- A61K31/60—Salicylic acid; Derivatives thereof
-
- 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
- A61K31/60—Salicylic acid; Derivatives thereof
- A61K31/606—Salicylic acid; Derivatives thereof having amino groups
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- 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
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—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
- A61K9/14—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
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
- A61K9/5047—Cellulose ethers containing no ester groups, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/06—Anti-spasmodics, e.g. drugs for colics, esophagic dyskinesia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B15/00—Layered products comprising a layer of metal
- B32B15/04—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material
- B32B15/08—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
- B32B15/085—Layered products comprising a layer of metal comprising metal as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin comprising polyolefins
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B15/00—Layered products comprising a layer of metal
- B32B15/20—Layered products comprising a layer of metal comprising aluminium or copper
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
- B32B27/10—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of paper or cardboard
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B27/00—Layered products comprising a layer of synthetic resin
- B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B7/00—Layered products characterised by the relation between layers; Layered products characterised by the relative orientation of features between layers, or by the relative values of a measurable parameter between layers, i.e. products comprising layers having different physical, chemical or physicochemical properties; Layered products characterised by the interconnection of layers
- B32B7/04—Interconnection of layers
- B32B7/12—Interconnection of layers using interposed adhesives or interposed materials with bonding properties
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2307/00—Properties of the layers or laminate
- B32B2307/20—Properties of the layers or laminate having particular electrical or magnetic properties, e.g. piezoelectric
- B32B2307/21—Anti-static
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2307/00—Properties of the layers or laminate
- B32B2307/70—Other properties
- B32B2307/72—Density
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2307/00—Properties of the layers or laminate
- B32B2307/70—Other properties
- B32B2307/724—Permeability to gases, adsorption
- B32B2307/7242—Non-permeable
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2307/00—Properties of the layers or laminate
- B32B2307/70—Other properties
- B32B2307/724—Permeability to gases, adsorption
- B32B2307/7242—Non-permeable
- B32B2307/7246—Water vapor barrier
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2307/00—Properties of the layers or laminate
- B32B2307/70—Other properties
- B32B2307/726—Permeability to liquids, absorption
- B32B2307/7265—Non-permeable
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2323/00—Polyalkenes
- B32B2323/04—Polyethylene
- B32B2323/046—LDPE, i.e. low density polyethylene
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2439/00—Containers; Receptacles
- B32B2439/40—Closed containers
- B32B2439/46—Bags
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2439/00—Containers; Receptacles
- B32B2439/80—Medical packaging
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1303—Paper containing [e.g., paperboard, cardboard, fiberboard, etc.]
Definitions
- the present invention concerns a sachet for a pharmaceutical composition.
- Oral pharmaceutical formulations comprising mesalazine are known, which are either tablets or granulate.
- Granulate may be packed in sachets.
- a “sachet” will refer to an envelope or bag for a granulate, while “granulate” refers to particles, granulate or spheronised particles.
- sachets tend to suffer from the draw back of complicated manufacturing methods or high production costs.
- a sachet should preferably be easy to open without the use of scissors.
- Static electricity may build up between certain granulate types and sachets. This is dependent of the type of granulate as well as the type of sachet. If static electricity is present, it tends to be difficult to pour granulate from the sachet.
- granulate in a sachet may be sensitive to degradation by light, humidity and/or air. This is also dependent of the type of sachet as well as the type of granulate.
- mealazine also encompasses pharmaceutically acceptable salts and esters thereof, such as those mentioned in WO 97/23199 p. 15, l. 17- p. 6, l. 12, as well as prodrugs, such as balsalazide.
- the formulation to be stored in a sachet according to the invention, is preferably in the form of a particulate material, e.g. granulate, spheres, pellets, particles, preferably granulate.
- the present sachet may be used for any pharmaceutical formulation, but is especially suitable for storing pharmaceuticals comprising sensitive compounds such as mesalazine.
- the present invention concerns a sachet, comprising the layers:
- bonding layer preferably an adhesive such as polyethylene
- barrier layer preferably aluminium foil
- sealing layer preferably low density polyethylene.
- a sachet for a product containing mesalazine should therefore preferably provide a barrier to humidity, atmospheric air and light.
- the sachet should also be easy to open for a patient, preferably without the use of additional tools, such as scissors. It has been a problem to provide a sachet with the necessary barrier properties without sacrificing the possibility of tearing open the sachet with human fingers. Further, existing sachets tend to suffer from the build up of static electricity.
- a sachet should be easy to manufacture, easy to fill, easy to empty, and have an appealing look to improve patient compliance.
- This aspect provides a sachet giving long storage stability for a pharmaceutical composition contained therein, e.g. where the active pharmaceutical ingredient is mesalazine. Further, the sachet is easy to tear and static electricity is eliminated, providing for a sachet which may be emptied completely for its contents.
- the combination of the sachet and the oral formulation according to the present invention provides for little build up of static electricity.
- the outer paper i) has in a preferred embodiment a weight per unit area of 10-100 g/m 2 , preferably 30-70 g/m 2 , more preferred 40-60 g/m 2 , most preferred 50 g/m 2 .
- Paper having a weight per unit area outside the range of 10-100 g/m 2 are hardly suitable in industrial manufacturing of sachets. Paper having a weight per unit area below about 30-40 g/cm 2 tend to break in manufacturing equipment for sachets. For paper having a weight per unit area above about 60-70 g/cm 2 it is difficult to shape the material to sachets. Optimal results have been achieved with a weight per unit area above of about 50 g/cm 2 .
- the bonding layer ii) preferably has a weight per unit area of 6-20 g/m 2 , preferably 9-18 g/m 2 , more preferred 12-15 g/m 2 . If a very thin layer is used, it usually necessitate the use of expensive special polymers to achieve an appropriate coverage. If a thick layer is applied, it inherently more expensive and hard to avoid an uneven layer.
- the barrier layer iii) preferably has a thickness of 6-30 ⁇ m, more preferred 7-25 ⁇ m, preferably 9-25 ⁇ m, more preferred 8-20 ⁇ m, preferably 9-15 ⁇ m, more preferred 12 ⁇ m.
- sealing layer iv) has a thickness of 15-50 ⁇ m. If a very thin layer is applied, it has a tendency not to cover the surface completely. If a very thick layer is applied, it is hard to weld through, and any heating applied may not warm evenly.
- the sealing layer iv) preferably has a weight per unit area of 10-100 g/m 2 , more preferred 15-75 g/m 2 , preferably 20-50 g/m 2 , more preferably 30-40 g/m 2 , most preferred 35 g/m 2 .
- the present invention concerns the use of the sachet for a pharmaceutical composition according to the invention.
- the sachet has proven suitable for storing the pharmaceutical compositions according to the invention.
- the present invention concerns the use of the sachet for medical purposes.
- a sachet according to the present sachet is especially suitable for a pharmaceutical formulation comprising mesalazine or a pharmaceutically acceptable salt thereof.
- the present sachet has a remarkably low tendency to build up static electricity. This has formerly especially been a problem with mesalazine granulate.
- mesalazine product may be mentioned granulate obtainable according to the patent application
- mesalazine as the active ingredient in granulate in the present sachet, but also relates to other active ingredients, such as the ingredients mentioned in WO 00/44353, p. 12-16.
- excipients may be comprised in the composition according to the invention, such as fillers, disintegrants, pH adjusters, or surfactants.
- excipients are well known from the literature, see e.g. WO 00/44353, p. 16-20, for a number of suitable excipients.
- excipients are hygroscopic. As an example of such excipient povidone may be mentioned. If an active ingredient is to be formulated with a hygroscopic excipient, the need for a suitable sachet is emphasized. The present sachet is suitable for being used for pharmaceuticals comprising at least one hygroscopic excipient.
- the material of a sachet had the following composition: Paper, claycoated 50 g/m 2 Polyethylene, low density 12 g/m 2 Aluminium foil 12 ⁇ m Polyethylene, low density 35 g/m 2
- g/m 2 PE corresponds to 13 ⁇ m
- 35 g/m 2 PE corresponds to 38 ⁇ m.
- the material had a grammage of 129 g/m 2 .
- the permeability to water vapour was ⁇ 0.05 g/m 2 , 24 h, 25° C., 75% RH, and to O 2 ⁇ 0.05 ml/m 2 , 24 h, atm, 23° C., 75% RH.
- the sachets were folded around the filling tube of a filling/sealing station, such that the paper was on the outside of the sachet, and then sealed lengthwise, with a low density polyethylene as a sealing layer. After forming the cross seal at the bottom the sachet is filled with granulates, and then sealed again at the top and finally cut.
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Inorganic Chemistry (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
- Laminated Bodies (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Macromolecular Compounds Obtained By Forming Nitrogen-Containing Linkages In General (AREA)
- Wrappers (AREA)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US10/553,630 US20070042143A1 (en) | 2003-04-23 | 2004-04-22 | Sachet for a pharmaceutical composition |
Applications Claiming Priority (7)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US46464903P | 2003-04-23 | 2003-04-23 | |
| EP20030388023 EP1470819A1 (en) | 2003-04-23 | 2003-04-23 | High drug load mesalazine sachet |
| DKPA200300612 | 2003-04-23 | ||
| DKPA200300612 | 2003-04-23 | ||
| EP03388023.8 | 2003-04-23 | ||
| PCT/EP2004/004280 WO2004093883A2 (en) | 2003-04-23 | 2004-04-22 | Sachet for a pharmaceutical composition |
| US10/553,630 US20070042143A1 (en) | 2003-04-23 | 2004-04-22 | Sachet for a pharmaceutical composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| US20070042143A1 true US20070042143A1 (en) | 2007-02-22 |
Family
ID=36655488
Family Applications (3)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| US10/553,630 Abandoned US20070042143A1 (en) | 2003-04-23 | 2004-04-22 | Sachet for a pharmaceutical composition |
| US10/553,629 Active 2027-01-06 US8858992B2 (en) | 2003-04-23 | 2004-04-23 | High drug load mesalazine sachet |
| US14/483,695 Expired - Lifetime US9402815B2 (en) | 2003-04-23 | 2014-09-11 | High drug load mesalazine sachet |
Family Applications After (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| US10/553,629 Active 2027-01-06 US8858992B2 (en) | 2003-04-23 | 2004-04-23 | High drug load mesalazine sachet |
| US14/483,695 Expired - Lifetime US9402815B2 (en) | 2003-04-23 | 2014-09-11 | High drug load mesalazine sachet |
Country Status (20)
| Country | Link |
|---|---|
| US (3) | US20070042143A1 (da) |
| EP (3) | EP1615619A2 (da) |
| JP (4) | JP2007523664A (da) |
| KR (1) | KR100849966B1 (da) |
| CN (1) | CN1777430B (da) |
| AU (1) | AU2004231316B2 (da) |
| CA (2) | CA2520197A1 (da) |
| CY (1) | CY1115560T1 (da) |
| DK (1) | DK1615648T3 (da) |
| ES (1) | ES2486245T3 (da) |
| HK (1) | HK1198917A1 (da) |
| IL (1) | IL170978A (da) |
| MX (1) | MXPA05011308A (da) |
| NO (1) | NO335375B1 (da) |
| NZ (1) | NZ542591A (da) |
| PL (1) | PL1615648T3 (da) |
| PT (1) | PT1615648E (da) |
| RU (2) | RU2005131492A (da) |
| SI (1) | SI1615648T1 (da) |
| WO (2) | WO2004093883A2 (da) |
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| US6537680B1 (en) * | 1998-09-03 | 2003-03-25 | Stora Kopparbergs Bergslags Aktiebolag (Publ) | Paper or paperboard laminate and method to produce such a laminate |
| US6773720B1 (en) * | 1999-06-14 | 2004-08-10 | Cosmo S.P.A. | Mesalazine controlled release oral pharmaceutical compositions |
| US6199698B1 (en) * | 1999-12-03 | 2001-03-13 | Alusuisse Technology & Management, Ltd. | Pharmaceutical packaging with separation means |
| US20020034541A1 (en) * | 2000-07-14 | 2002-03-21 | Roberto Valducci | Oral solid pharmaceutical formulations with pH-dependent multiphasic release |
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