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  Sachet for a pharmaceutical compositionUSPTO Application #: 20070042143Title: Sachet for a pharmaceutical composition Abstract: The present invention is directed to a sachet for a pharmaceutical composition, comprising the layers: paper; bonding layer; barrier layer; and sealing layer. (end of abstract)
Agent: Foley And Lardner LLP Suite 500 - Washington, DC, US Inventor: Carin Widerstrom USPTO Applicaton #: 20070042143 - Class: 428034200 (USPTO) Related Patent Categories: Stock Material Or Miscellaneous Articles, Hollow Or Container Type Article (e.g., Tube, Vase, Etc.), Paper Containing (e.g., Paperboard, Cardboard, Fiberboard, Etc.) The Patent Description & Claims data below is from USPTO Patent Application 20070042143. Brief Patent Description - Full Patent Description - Patent Application Claims
[0001] The present writ claims priority from the Danish patent application PA 2003 00612, The European patent application EP 03388023, and the U.S. provisional patent application 60/464,649. FIELD OF THE INVENTION [0002] The present invention concerns a sachet for a pharmaceutical composition. TECHNICAL BACKGROUND [0003] Oral pharmaceutical formulations comprising mesalazine are known, which are either tablets or granulate. Granulate may be packed in sachets. For the purposes of the present invention a "sachet" will refer to an envelope or bag for a granulate, while "granulate" refers to particles, granulate or spheronised particles. [0004] Known sachets tend to suffer from the draw back of complicated manufacturing methods or high production costs. In order to being accepted by consumers, a sachet should preferably be easy to open without the use of scissors. Upon pouring granulate from a sachet preferably as little material as possible should be lost. 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. Finally, 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. DISCLOSURE OF THE INVENTION [0005] These problems and others mentioned below are addressed by aspects of the invention. [0006] For the purposes of the present invention the term "mesalazine" 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. [0007] 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. [0008] The present sachet may be used for any pharmaceutical formulation, but is especially suitable for storing pharmaceuticals comprising sensitive compounds such as mesalazine. [0009] According to an aspect, the present invention concerns a sachet, comprising the layers: i) paper; ii) bonding layer, preferably an adhesive such as polyethylene; iii) barrier layer, preferably aluminium foil; and iv) sealing layer, preferably low density polyethylene. [0010] Mesalazine is sensitive to humidity, atmospheric air and/or light. 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. Preferably, a sachet should be easy to manufacture, easy to fill, easy to empty, and have an appealing look to improve patient compliance. [0011] 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. [0012] The outer paper i) has in a preferred embodiment a weight per unit area of 10-100 g/m.sup.2, preferably 30-70 g/m.sup.2, more preferred 40-60 g/m.sup.2, most preferred 50 g/m.sup.2. [0013] Paper having a weight per unit area outside the range of 10-100 g/m.sup.2 are hardly suitable in industrial manufacturing of sachets. Paper having a weight per unit area below about 30-40 g/cm.sup.2 tend to break in manufacturing equipment for sachets. For paper having a weight per unit area above about 60-70 g/cm.sup.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.sup.2. [0014] According to an aspect, the bonding layer ii) preferably has a weight per unit area of 6-20 g/m.sup.2, preferably 9-18 g/m.sup.2, more preferred 12-15 g/m.sup.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. [0015] According to an aspect, the barrier layer iii) preferably has a thickness of 6-30 .mu.m, more preferred 7-25 .mu.m, preferably 9-25 .mu.m, more preferred 8-20 .mu.m, preferably 9-15 .mu.m, more preferred 12 .mu.m. [0016] Sachet according to any of the preceding claims, wherein said sealing layer iv) has a thickness of 15-50 .mu.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. [0017] According to an aspect, the sealing layer iv) preferably has a weight per unit area of 10-100 g/m.sup.2, more preferred 15-75 g/m.sup.2, preferably 20-50 g/m.sup.2, more preferably 30-40 g/m.sup.2, most preferred 35 g/m.sup.2. Continue reading... Full patent description for Sachet for a pharmaceutical composition Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Sachet for a pharmaceutical composition patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. Start now! - Receive info on patent apps like Sachet for a pharmaceutical composition or other areas of interest. ### Previous Patent Application: Labeled containers, methods and devices for making same Next Patent Application: Plastic multi-layer structure Industry Class: Stock material or miscellaneous articles ### FreshPatents.com Support Thank you for viewing the Sachet for a pharmaceutical composition patent info. 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