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EP1077807A1 - Ameliorations apportees a un ensemble matrice avec tete destine a fa onner des unites posologiques par compression - Google Patents

Ameliorations apportees a un ensemble matrice avec tete destine a fa onner des unites posologiques par compression

Info

Publication number
EP1077807A1
EP1077807A1 EP99916398A EP99916398A EP1077807A1 EP 1077807 A1 EP1077807 A1 EP 1077807A1 EP 99916398 A EP99916398 A EP 99916398A EP 99916398 A EP99916398 A EP 99916398A EP 1077807 A1 EP1077807 A1 EP 1077807A1
Authority
EP
European Patent Office
Prior art keywords
die punch
feedstock
die
tablet
forming
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.)
Withdrawn
Application number
EP99916398A
Other languages
German (de)
English (en)
Inventor
Beuford A. Bogue
Tushar K. Misra
James H. Perkins
Jeffery W. Currington
Satish V. Kamath
Oscar A. Reyes
Kevin M. Fenton
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Biovail Technologies Ltd
Original Assignee
Biovail Technologies Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Biovail Technologies Ltd filed Critical Biovail Technologies Ltd
Publication of EP1077807A1 publication Critical patent/EP1077807A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B15/00—Details of, or accessories for, presses; Auxiliary measures in connection with pressing
    • B30B15/02—Dies; Inserts therefor; Mounting thereof; Moulds
    • B30B15/022—Moulds for compacting material in powder, granular of pasta form
    • B30B15/024—Moulds for compacting material in powder, granular of pasta form using elastic mould parts
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B30—PRESSES
    • B30B—PRESSES IN GENERAL
    • B30B15/00—Details of, or accessories for, presses; Auxiliary measures in connection with pressing
    • B30B15/06—Platens or press rams
    • B30B15/065—Press rams

Definitions

  • the present invention relates generally to a die punch for forming compression dosage units, more specifically, tablets from tableting feedstock. More particularly the present invention relates to an improved die punch, die punch tip assembly and a method for constructing such a die punch where the formed tablet and residual feedstock is readily released from the die punch tip.
  • Dosage units in the form of tablets are typically prepared by compressing a tableting feedstock into a tablet configuration.
  • the tableting feedstock may be a formulation containing a medicinal substance or drug and other ingredients such as excipients which are selected for properties which enhance the production and use of the tablet.
  • Direct compression usually involves use of a tableting feedstock, which is a powdered blend of active ingredients with suitable excipients.
  • Tableting processes using direct compression typically include the use of a machine which provides one or more sets of opposed upper and lower die punches and a die cavity positioned between the punches.
  • the tableting feedstock is retained within the die cavity between the upper and lower die punches and the die punches are movable towards one another, or the upper die punch is moved towards the lower die punch within the cavity to compress the tableting feedstock into a tablet between the die punches.
  • the tablet generally takes the shape and configuration defined by the opposed facing surfaces of the upper and lower die punches and the walls of the die cavity.
  • Direct compression of tableting feedstock may be used to form low density amorphous compression dosage units.
  • Such low density compression dosage units may be of the type developed by the assignee herein and marketed under the trademark
  • the surfaces of conventional die punches are typically formed of stainless steel and in conventional direct compression techniques, the compression force applied by the punches hardens the tablet to such an extent that feedstock adherence to the punch surfaces is not a problem.
  • the lack of tablet hardening may result in such adherence of feedstock to the die punch surfaces.
  • a desirable configuration for a low density tablet is that having opposed angular chamfered edges rather than edges in the form of a right cylinder so that the edges of the fragile low density tablet are not subjected to fracture, crumbling or deterioration which may adversely affect product appearance and usage. Tablets having chamfered edges have also been found to have lower incidence of friability.
  • use of these nonstick tips on the end of die punches prevents the low density tablet from being formed in such a desired configuration.
  • the present invention provides a die punch tip assembly for forming compression tablets from tableting feedstock.
  • the tip assembly includes a tip body having a generally planar element including a first surface for positioning in facing opposition to the tableting feedstock and an opposed second surface.
  • the tip body further includes a stem extending from the second surface of the planar member for securement to a die punch.
  • the feedstock contacting member formed of resiliently compressible material is formed onto the planar element of the tip body.
  • the resiliently compressible material forming the feedstock contacting member covers at least a portion of the second surface of the planar element and is formed into a tablet shaping configuration over the first surface. Due to the compressible nature of the feedstock contacting member, residual feedstock material does not remain thereon during the tablet forming process.
  • the present invention also provides a die punch for forming compression formed tablets from tableting feedstock.
  • the die punch includes a die punch body and a die punch tip removably supported to one end of the die punch body.
  • the die punch tip includes a tip body having a planar element with opposed first and second surfaces. A stem extends from the second surface for attachable insertion into a bore in the one end of the die punch body.
  • the die punch tip further includes a feedstock contacting member formed of resiliently compressible material about the planar element. Resiliently compressible material is formed into a tablet shaping configuration over the first surface.
  • the present invention provides a method of forming a compression tablet forming tip.
  • a tip body is provided having a planar element and a stem extending from one surface of the planar element.
  • a resiliently compressible material is formed over the planar element covering a least a portion of the one surface and forming a tablet shaping configuration on the other surface.
  • the generally compressible material forming the feedstock contacting member is molded directly over the planar member of the tip.
  • one surface of the planar member may include a raised central portion from which the stem extends. The raised central portion forms an annular surface about the stem. This annular surface remains free from the resiliently compressible material to provide an uncovered surface which is positionable against the one surface of the die punch body.
  • the hardness of the resiliently compressible material is selected so that depending upon the particular feedstock being employed, the feedstock contacting member will have sufficient hardness to form the particular configuration of the tablet yet bet sufficiently resiliently compressible to resilient release of the formed tablet without residual feedstock material remaining thereon.
  • Figure 1 is a schematic representation of a pair of conventional die punches supported within a die cavity used to compress tableting feedstock into a tablet.
  • Figure 2 is a schematic representation of a pair of die punches formed in accordance with the present invention supported within a die cavity used to compress tableting feedstock into a tablet.
  • Figures 3 and 4 show successive steps of a die punch supported within a die cavity used in accordance with the present invention.
  • Figures 5, 6 and 7 show, respectively, successive steps employed in forming a die punch of a preferred embodiment of the present invention.
  • Figure 8 is a further embodiment of an improved die punch of the present invention.
  • Figure 9 is an apparatus used to form an improved die punch of the present invention.
  • Figure 10 is a front plan view of a plurality of die punches and cavities for manufacturing tablets from feedstock in accordance with the present invention.
  • Figure 11 is a side elevational showing of a die punch tip body employed in combination with an improved die punch tip assembly of the present invention.
  • Figure 12 shows a vertical section of the die punch tip assembly of the present invention including the die punch tip body of Figure 11, having formed thereover a resiliently compressible feedstock contacting member.
  • Figure 12A is an enlarged sectional showing of an alternate embodiment of the die punch tip assembly of Figure 12.
  • Figure 13 is a top plan view of the die punch tip assembly of Figure 12.
  • Figure 14 is a side elevational showing of a die punch which may be used in combination with the die punch tip assembly of Figure 12.
  • Figure 15 shows the lower end of the die punch of Figure 16 for removable attachment with the die punch tip assembly of Figure 12.
  • the present invention provides a unique method and apparatus for preparing compression dosage units, such as tablets, in a die cavity and for releasing the formed tablets from die punches which form the tablet.
  • the present invention is especially useful for forming rapidly dissolving tablets.
  • tablette is used herein to mean a unit having two sides, sometimes referred to as a top and a bottom, and a continuous edge which joins the top and the bottom. The entire mass of the material throughout the tablet is the "volume" of the tablet.
  • the mass of the units prepared in accordance with the present invention is continuous in the sense that the feedstock material used to prepare the units (“tableting feedstock") is prepared in a single compression chamber (“die"), but which may have two different densities.
  • the die cavity can support a pair of opposed compressors, sometimes referred to as "die punches".
  • a first volume is associated with the edge in that it circumscribes the unit and includes the edge surface.
  • a second volume which is referred to as the "non-edge" portion, is within the edge portion.
  • the tableting feedstock is compressed and formed within the die cavity in such a manner that it is readily released after formation without residual feedstock remaining on the die punches.
  • the method and apparatus of this invention are especially useful in making low density tablets, such as for example rapid dissolving tablets containing saccharides which undergo further curing or processing to form a rigid structure.
  • low density is used herein to denote tablets wherein at least 60% and preferably 80% of the volume of the tablet has a density of less than 1.2 grams per cubic centimeter and preferably less than 0.8 grams per cubic centimeter.
  • the apparatus and process of the present invention are used to make high porosity tablets which have a porosity of 0.20 to 0.50 and preferably 0.3 to 0.5.
  • Porosity as used herein is defines as: l-(bulk density ⁇ actual density).
  • the method and apparatus of this invention is also useful in making "rapidly dissolving" tablets or other tablets where the feedstock material may "stick” or “cling” to the tablet die punch tip.
  • the non-edge portion of units prepared in accordance with the invention may have a lower density, mass per unit volume, than the edge portion.
  • the non-edge volume density can be less than about 1.2 grams per cubic centimeter, preferably less than 0.8 grams per cubic centimeter, and most preferably not greater than 0.6 grams per cubic centimeter.
  • the edge portion of tablets prepared according to the invention can have a higher density than the non-edge portion.
  • the edge portion has a density which is at least about 10% greater than the density of the non-edge portion, preferably about 15% greater, and most preferably about 20% greater.
  • the density of the edge portion is preferably about 0.64 grams per cubic centimeter, preferably about 0.69 grams per cubic centimeter, and most preferably about 0.72 grams per cubic centimeter.
  • the extent of the edge portion is that amount of volume and surface sufficient to increase the "strength" of the unit for handling by processing machinery and personnel without deterioration of the unit, "Strength” includes both resistance to unit fracture and surface crumbling, i.e., friability.
  • Tableting feedstock materials that will particularly benefit from the present invention are those which are used to form rapidly disintegrating, or dissolving tablets.
  • these tableting feedstock materials comprise multiparticulate formulations with one or more disintegrating, dissolving or solubilizing excipients.
  • excipients have a tendency to adhere to the tableting presses after a short amount of time, creating a costly problem for manufacturers.
  • Examples of such disintegrating tableting feedstock materials can be found in commonly assigned U.S. Patent Nos. 4,855,326; 5,622,719, 5,840,334; 5,464,632; 5,576,014; 3,725,556; 4,517,179 and 5,055,306.
  • tableting feedstock materials for rapidly disintegrating tablets may also comprise particulate materials which may also be coated.
  • the particulates can be crystalline, spherical and microparticulate in character. Such microparticulates may also be crystalline or spherical, and coated or uncoated.
  • any tableting feedstock materials that comprise materials that have a tendency to stick, clump, or adhere to the tableting die punches should benefit from the resiliently compressible material tipped feedstock contacting members of the present invention.
  • the present invention is directed to improved die punches where the tableting feedstock may be compressed into a tablet and upon disengagement of the die punches from the tableted material residual tableting feedstock is not retained or collected on surfaces of the die punches which contact the feedstock.
  • the die punches may be used in an automated repetitive process over a longer time period without need for costly down time due to maintenance and cleaning.
  • FIG 1 a schematic representation of a typical die assembly 10 used to form a tablet 13 (Fig. 4) from tableting feedstock 11 (Fig. 3) is shown.
  • a cylindrical die cavity 12 is formed by a cavity wall 14.
  • the cavity wall 14 defines opposed open upper and lower ends 16 and 18 which permit insertable accommodation of an upper die punch 20 and a lower die punch 22 respectively.
  • Each die punch 20, 22 may be formed of stainless steel and includes a generally cylindrical body, and defines opposed tablet shaping end surfaces 24, 26 which are positioned in facing opposition. Die punches 20, 22 are operatively movable toward and away from one another so as to compress tableting feedstock 11 contained with die cavity 12 into a shaped dosage unit such as tablet 13. One or both of the die punches 20 and 22 are subsequently removed from die cavity 12 to permit removal of the formed tablet.
  • the tablet shaping end surfaces 24 and 26 are designed so as to form a particular tablet configuration such as chamfered opposed edges. Such configuration reduces tablet deterioration and friability and results in an aesthetically pleasing tablet shape, in the present embodiment, tablet shaping end surfaces 24, 26 include a perimetrical rim 24a, 26a and a central depression 24b, 26b.
  • Die assembly 10 may be to used to form a low density tablet by applying low compressive forces to the tableting feedstock by opposed die punches 20 and 22. While such low compressive forces are sufficient to shape the tableting feedstock into a low density tablet, it has been found that upon withdrawal of one or more of the punches 20 and 22 from die cavity 16, a certain amount of residual of tableting feedstock is retained on the tablet shaping end surfaces 24 and 26. Such residue is a result of the low compressive forces used to form the low density tablet as well as the amorphous nature of the feedstock material.
  • preferred materials used to form the feedstock may include sugars or sugar derivatives.
  • Improved die assembly 30 includes a cylindrical die cavity 32 formed by a cavity wall 34.
  • the cavity wall 34 defines opposed upper and lower open ends 36 and 38 which permit insertable accommodation of improved die punches 40 and 42.
  • Die punches 40 and 42 include opposed tablet shaping end surfaces 44 and 46 respectively which are configured as shown in Figure 1 to provide a tablet with opposed chamfered edges. Each tablet shaping end surface 44 and 46 supports an elastomeric feedstock contacting member 50.
  • feedstock contacting member 50 is formed of resiliently compressible elastomeric material.
  • the material forming feedstock contacting member 50 as well as its selected thickness permits the feedstock contacting member to compress upon contact with the feedstock material contained in die cavity 32 even under low compression forces.
  • die punch 40 towards the lower die punch will compress feedstock 11 into a tablet configuration with the tablet configuration being defined by the shape of tablet shaping end surface 44 of die punch 40 and the elastomeric feedstock contacting member 50 which is shaped in conformance therewith.
  • die punch 40 is retracted from die cavity 32 through upper end 34 so as to permit removal of the formed low density tablet 13.
  • 11 low density tablet 13 will have the general configuration of tablet shaping end surface 44 as further defined by feedstock contacting member 50.
  • the feedstock contacting member 50 Upon the retraction of die punch 40 from the tablet forming position, the feedstock contacting member 50 will resiliently return to its original uncompressed configuration and, due to this elastic return or rebound, will dislodge any feedstock material remaining in contact with the surface thereof.
  • This resilient rebound effect of the resiliently compressible feedstock contacting member prevents retention or buildup of residual feedstock material thereon. Therefore, upon subsequent cycling of the die punch 40 to form additional tablets 13, feedstock contacting member 50 will present a clean, non-residue bearing surface in position to form the next successive tablet.
  • the present invention takes advantage of the ability of the compressible feedstock contacting member to resiliently return to its uncompressed condition after compression of the feedstock 11 into a tablet 13 so as to discharge or expel any residual uncompressed feedstock material thereon.
  • Feedstock material for tablet formation may contain particulates of active agents which may or may not be coated with protective, enteric or taste-making coatings. These particulates may take the form of crystalline particulates or microparticulates, microparticles, and microspheres. No matter what the form of particulates utilized in the tableting feedstock, it is important that the integrity of the particulates, especially coated particulates, be maintained in the finished tablet.
  • the resiliently compressible material forming the feedstock contacting member of the present invention due to its resilient compressibility, helps prevent damage to the particulates.
  • any resiliently compressible elastomeric material may be employed as a feedstock contacting member. Such materials should be of sufficient thickness as applied to the tablet shaping end surfaces of the die
  • the present invention contemplates use of resilient elastomeric materials such as vulcanized rubber (VULCALONTM), latex, polyurethane, polyethylene, polyethyleneketone (PEEK) or any other suitable elastomer.
  • VULCALONTM vulcanized rubber
  • PEEK polyethyleneketone
  • the present invention is designed to form pharmaceutical tablets, it is also desirable to provide a suitable elastomer which is approved for pharmaceutical usage.
  • the feedstock contacting member may be formed from a sheet of medical grade latex material.
  • Such latex material is commonly employed in making latex gloves used in medical applications.
  • An extent 52 of such latex material is shown in Figure 5.
  • one surface 54 thereof typically has a rough surface while the opposed surface 56 has a relatively smooth surface.
  • a segment of latex extent 58 is cut therefrom. Segment 58 is cut to have the general expanse of die punch 40 (Fig. 7) and is slightly larger than the expanse of the tablet shaping end surface, or punch tip 44.
  • the tablet shaping end surface 44 of die punch 40 is cleaned with isopropyl alcohol to remove any debris or impurities.
  • a suitable adhesive 59 is applied to tablet shaping end surface 44 and to the rough surface 54 of segment 58.
  • the segment 58 is then applied to tablet shaping end surface 44 with the smooth surface 56 facing outwardly therefrom.
  • Pressure is applied to the segment 58 against tablet shaping end surface 44 and held there for an appropriate period of time to allow for the adhesive to set. Due to the flexible nature of the latex material forming segment 58, it can be conformed to the particular configuration of tablet shaping end surface 44. As the segment 58 is applied and conformed, any air trapped between the segment and the tablet shaping end surface can be expelled. After the segment 58 has been adhered to tablet shaping end surface 44 to form feedstock
  • any suitable adhesive may be used to adhere segment 58 to tablet shaping end surface 44 a particular adhesive which has been found to be preferable is an adhesive manufactured and sold by Loctite Corporation under the trade designation SUPER BONDER 495. It is also desirable for the adhesive to be of medical grade for use in pharmaceutical applications.
  • One particular approved medical grade adhesive which may be employed includes Loctite Corporation SUPER BONDER 416.
  • the present invention provides a feedstock contacting member 50 which is positionable over a tablet shaping end surface 44 to yield a tablet having the desired shape characteristics. As described above, such characteristics include opposed upper and lower edges having a chamfered surface.
  • This embodiment of the present invention achieves this by providing a flexible feedstock contacting member which is applied and conforms to the predetermined shape of the tablet shaping end surface 44 of die punch 40. It is further contemplated that feedstock contacting member may itself be formed into a shape which yields the desired shaped tablet.
  • a die punch 60 may be employed which is an elongate generally cylindrical member having a lower end 62 which is positioned for insertion into the die cavity (not shown). Lower end 62 has a conventional flat surface which is generally undesirable for forming shaped tablets.
  • a feedstock contacting member or tip 65 may be separately formed and applied to lower end 62 of die punch 60.
  • Tip 65 may be formed by a wide variety of processes including various molding techniques. Numerous compressible elastomeric materials may be so formed to yield a tip of desired configuration.
  • a particular material that is suitable for such molding includes polyurethane. Polyurethane is a material which may be readily molded and has characteristics which are beneficial for use in the present invention. These characteristics include good load bearing properties, high temperature resistance, high temperature properties, moisture resistance and low
  • Tip 65 can be molded into the shape shown in Figure 8 in a conventional molding process and then applied to lower end 62 of die punch 60 using adhesive securement as above described. Tip 65 thus includes a tablet shaping end surface 66, which is similar to tablet shaping end surface 44 of the die punch 40 and yields a tablet having desired shape characteristics.
  • tip 65 can be molded and formed directly onto the lower end of die punch 60 in a single operation.
  • a tip-forming mold 61 could be constructed where the mold employs die punch 60 as one of the mold parts.
  • a mold plug 63 having a general configuration of tablet forming end 66 of tip 65 could be constructed so as to mold the polyurethane material between die punch 60 and the mold plug 63.
  • polyurethane material may be injected into a cavity 61a in mold 61 between punch 60 and plug 63.
  • the tip 65 formed by the injected polyurethane material will take the shape of plug 63 and will be formed directly onto the lower end 62 of die punch 60.
  • the polyurethane tip 65 could be formed with an embossment (not shown) at depths of between .008 inches and .020 inches.
  • the embossment would be an image (such as indicia) of a desired identification to be placed on the tablet.
  • the resulting embossed tip 65 would have formed thereon the reverse image of the indicia.
  • the tablet would include a raised image of the indicia thereon. This allows the tablet to be formed with product markings directly thereon.
  • a die assembly 70 includes a die housing 72 which supports a plurality of die cavities 74. Upper and lower bases 76 and 78 support a plurality of die punches 80. Each die punch 80 may include a tablet shaping end surface 82 and a feedstock contacting member 86 which may be
  • the feedstock contacting member 86 is shown being provided on punches 80 attached to upper base 76. It may be appreciated however that the feedstock contacting members 86 are typically applied both to the upper and lower die punches.
  • Use of die assembly 70 allows multiple tablets 13 to be formed from tableting feedstock in a single operation.
  • use of resilient elastomeric feedstock contacting members 86 permits the die punches to be withdrawn from the die cavity without residual tableting feedstock remaining thereon. This allows the die assembly 70 to be used in a repetitive process over a long period of time without unnecessary down time for cleaning and the like.
  • FIG. 11-13 A more preferred embodiment of the present invention is shown with respect to Figures 11-13.
  • the present invention provides for direct molding of the resiliently compressible tablet forming member directly onto the end of a die punch. While such an assembly serves adequately for its intended purposes, over time there is a tendency for the tablet forming member to wear or erode requiring replacement. In those situations where the tablet forming member is molded directly onto the tip of the die punch, it may be necessary to discard the existing die punch tip and replace it with a new die punch tip. It may be appreciated that complete replacement of the tip of the die punch adds an additional cost to the tablet forming operation.
  • a die punch tip may be constructed where a tablet forming member is formed directly onto a die punch tip body so that when the tablet forming member exhibits undesirable wear characteristics, the tablet forming member may be replaced. The used tablet forming member may then be readily removed from the tip body and a new tablet forming member may be formed directly on the tip body for re-use.
  • a die punch tip assembly 100 shown in Figures 12 and 13 includes a die punch tip body 102 ( Figure 11) and a resiliently compressible elastomeric tablet forming
  • die punch tip body 102 is an elongate member having a planar element 106 at one end thereof.
  • Planar element is generally in a configuration of a disk having opposed upper and lower surfaces 108 and 110 respectively.
  • the shape of planar element 106 is such that it is readily received within a die cavity (not shown) for forming a tablet in conjunction with a second die punch tip (not shown) used in facing opposition thereto.
  • the tableting feedstock would be positioned within the die cavity between two opposed die tips and under low compression, the two die tips form a tablet therebetween from the tableting feedstock.
  • Planar element 106 includes a central raised region 112 located above upper surface 108. Raised region 112 is also disk like in shape.
  • the die tip body Extending from raised central region 112, the die tip body includes an elongate generally cylindrical stem 114.
  • Stem 114 extends centrally from raised region 112 so as to define an annular upper surface 116 of raised region 112 about stem 114.
  • Raised region 112 also defines a depending annular shoulder 118 thereabout.
  • the die punch tip body may be formed of a suitably rigid material.
  • the die punch tip is formed of stainless steel.
  • the die punch tip body may be formed of a suitably rigid polymer such as, for example, a glass filled polycarbonate. As will be described in further detail hereinbelow, forming the die punch tip body of a moldable polymer may result in manufacturing efficiencies when combined with the elastomeric tablet forming member 104.
  • Die punch tip assembly 100 includes tablet forming member 104 formed at the lower end of stem 114 about planar member 106.
  • Tablet forming member 104 is formed from a resiliently compressible elastomeric material of the type described above.
  • the resiliently compressible material employed is polyurethane.
  • the tablet forming member 104 has generally a disk like configuration defining a lower tablet shaping surface 120 which is designed to compress the tableting feedstock into a desired tablet configuration.
  • tablet forming member 104 is formed onto planar element 106 in a manner where the body 122 of tablet forming member 104 covers the lower surface 110 of planar element 106 and also at least partially covers the upper surface 108 thereof.
  • the resiliently compressible material is formed over planar element 106 so that the material extends to annular shoulder 118 leaving annular surface 116 of raised region 112 free from elastomeric material.
  • annular surface 116 of the rigid die punch tip body remains exposed for engagement with the die punch as will be described in further detail hereinbelow.
  • the tablet forming member 104 being formed of resiliently compressible elastomeric material, exhibits the desired characteristics described above in that when it is used in a die cavity it will provide for compression of the tableting feedstock into a low density tablet. Upon compaction of the feedstock into a tablet configuration, the resiliently compressible material forming the tablet forming member compresses to a small extent. Once the die punch tip assembly is retracted from the die cavity upon formation of the tablet, the tablet forming member will resiliently return to its original configuration. As described above, this resilient return or rebound serves to dislodge the tablet and any residual feedstock material from the tablet shaping surface 120 of the tablet forming member 104. Also as mentioned above, the resiliently compressible material is non-destructive to the tableting feedstock which is a significant consideration where the tablet feedstock includes drug filled microspheres.
  • the resiliently compressible material forming the tablet forming member is selected to have desired hardness as measured on the Shore hardness scale.
  • the hardness of the material is selected so that when functioning as a tablet shaping member, the material has sufficient hardness to compact the tableting feedstock into a particular configuration under low compression forces.
  • the material should be sufficiently resiliently compressible so as to have the required elasticity to dislodge the tablet and any residual feedstock from the tablet shaping surface once the tablet is formed.
  • the precise hardness of the material is selected depending upon various factors present in
  • a particularly desirable material for the formation of tablet forming member 104 is a thermoplastic polyurethane sold by Bayer Corporation under the trademark TEXTN.
  • the particular thermoplastic polyurethane employed has a hardness value on the Shore hardness scale of from about 75 A to about 90A. More preferably, it has been found that a suitable tablet is formed where the hardness of the thermoplastic polyurethane is selected to have a Shore hardness value of from about 80A to about 85 A. Specifically, 85 A has been found to be most preferable.
  • Thermoplastic polyurethane of this hardness value shows sufficient resilient elastomeric properties so as to allow the tablet and any residual feedstock material to be released from the tablet shaping surface 120 of tablet forming member 104 yet retain sufficient rigid shape characteristics to form the low compression tablet of desired configuration.
  • the tablet forming member 104 is formed directly about the planar element 106 of die punch tip body 102.
  • Such prefe ⁇ ed method of forming the tablet forming member is by injection molding the resiliently compressible polyurethane material thereon.
  • Suitable die molds may be provided having the desired shaped characteristics and the die punch tip body 102 may be inserted between the molds in a manner known in the art as insert molding.
  • the thermoplastic polyurethane may be injected into the cavity formed by the die molds and the die tip body to injection mold the material about planar element 106 in the configuration shown in Figure 14.
  • Injection molding is a prefe ⁇ ed method, as it is an efficient technique for forming the tablet forming member about the die punch tip body and also allows the tablet shaping surface 120 to be precisely formed.
  • injection molding is described as a prefe ⁇ ed method of forming the tablet forming
  • die punch tip body is preferably formed from stainless steel it is contemplated that the die punch tip body may be formed of any suitably rigid material. In fact, it is contemplated that the die punch tip body may be formed from a molded polymer. One such molded polymer which may be employed is glass filled polycarbonate. The die tip punch tip body 102 may be formed in a separate molding operation and subsequently tablet forming member 104 may be molded about planar element 106.
  • the die punch tip body 102 as well as the tablet forming member 104 may be formed in a single molding operation.
  • the die punch tip body and the tablet forming member may be formed in a single overmolding process.
  • overmolding allows the co-molding of two different polymers into a single component. Overmolding provides a low cost technique for forming a die punch tip assembly. This cost effective manufacturing method could render the entire die punch tip disposable.
  • the planar element 106 of die punch tip body may be modified to include one or more through apertures 125 extending between opposed upper and lower surfaces 108 and 110.
  • the through apertures 125 provide for the accommodation of the resiliently compressible material forming tablet forming member 104 during formation thereof so as to securely position and lock the tablet forming member 104 to the planar member 106 of die punch tip body 102.
  • die punch 130 is typically formed of stainless steel and includes an elongate generally cylindrical die punch body 132.
  • One end of die punch body 132 includes an extending die punch projection 134 which tapers to generally reduced elongate cylindrical configuration.
  • the die punch projection 134 provides for the removable securement of die punch tip assembly 100.
  • the distal end 136 includes an elongate central bore 138 formed therein.
  • the bore 138 is cylindrical in shape having a diameter which provides for the insertion of stem 114 of die punch tip body 102.
  • Die punch projection 134 includes an upper lateral aperture 133 in transverse communication with bore 138. Upper lateral aperture 133 provides a venting passageway to bore 138 to permit the insertion of die punch tip assembly 100 therein as will be described below.
  • the die punch projection 134 also includes a lower lateral aperture 140 in transverse communication with bore 138.
  • Aperture 140 accommodates a set screw 142 which is inserted thereinto to secure die punch tip body 102 within die punch projection 134 in a manner which is well known in the art.
  • the die punch may be used in a manner described above in combination with a die cavity and an opposed similarly formed die punch to form a low density tablet from tableting feedstock.
  • the resiliently compressible nature of the tablet forming member 104 allows for release of the formed tablet and any residual feedstock therefrom so that the die punch tip assembly may be repetitively used without need for cleaning and costly down time.
  • the die tip assembly 100 may be removed from the die punch and a replacement die punch tip assembly may be reinserted for subsequent use.
  • the present invention provides manufacturing efficiencies in that the worn die tip assembly need not be completely discarded.
  • the tablet forming member 104 may be stripped from the die punch body 102 and the die punch body may be reused so that a new tablet forming member may be molded thereover.
  • the reusability of the die punch tip body results in a significant cost savings as the tip body is not discarded. This is especially beneficial where the tip body is formed of metal such as stainless steel, where replacement parts may be costly.
  • the present invention also contemplates that the entire die punch tip assembly may be discarded where the die punch tip body is formed from a rigid molded polymer such as glass filled polycarbonate. In this instance, it may be more cost efficient to discard the entire die punch tip assembly and replace it, as the cost of manufacturing a subsequent polymer part may be less than the cost of replacing the tablet forming member thereon.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

Ce dispositif matrice permet de façonner par compression des comprimés à partir d'une matière première de fabrication de comprimés. Ce dispositif comporte une partie matrice et une partie tête amovible. La partie tête est constituée d'un corps sur lequel est formé un élément entrant en contact avec la matière première. Cet élément de contact (50) est fait d'un matériau compressible élastiquement entrant en contact de manière élastique avec la matière première (11) au moment du compactage de celle-ci (11) sous forme de comprimé. Ce type de contact élastique permet à la matière première de se séparer de l'élément de contact (50).
EP99916398A 1998-05-12 1999-04-06 Ameliorations apportees a un ensemble matrice avec tete destine a fa onner des unites posologiques par compression Withdrawn EP1077807A1 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US221502 1980-12-30
US7641698A 1998-05-12 1998-05-12
US76416 1998-05-12
US22150298A 1998-12-28 1998-12-28
PCT/US1999/007496 WO1999058320A1 (fr) 1998-05-12 1999-04-06 Ameliorations apportees a un ensemble matrice avec tete destine a façonner des unites posologiques par compression

Publications (1)

Publication Number Publication Date
EP1077807A1 true EP1077807A1 (fr) 2001-02-28

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EP99916398A Withdrawn EP1077807A1 (fr) 1998-05-12 1999-04-06 Ameliorations apportees a un ensemble matrice avec tete destine a fa onner des unites posologiques par compression

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Country Link
EP (1) EP1077807A1 (fr)
AU (1) AU3472899A (fr)
CA (1) CA2331665A1 (fr)
MX (1) MXPA00011043A (fr)
WO (1) WO1999058320A1 (fr)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10013449B4 (de) * 2000-03-17 2007-03-01 Henkel Kgaa Verfahren und Vorrichtung sowie Verwendung der Vorrichtung zur Herstellung von Muldenformkörpern
WO2001098068A1 (fr) * 2000-06-21 2001-12-27 Goericke Peter Moule a compression et son procede de production
WO2005018921A1 (fr) * 2003-08-25 2005-03-03 Alpex Pharma Sa Tablet punches and method for tableting
DE102004051006B4 (de) * 2004-10-20 2009-07-02 Fette Gmbh Rundlaufpresse
EP4253026A1 (fr) * 2022-03-29 2023-10-04 Korsch AG Dispositif de fabrication de pièces pressées sans bord
DE102024105853A1 (de) * 2024-02-29 2025-09-04 Ritter Pharma-Technik Gmbh Pressstempel zum Verpressen von pulver- oder granulatförmigen Stoffen sowie eine Pressstempelanordnung und eine Rundläuferpresse

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL81600C (fr) *
US3408436A (en) * 1963-03-26 1968-10-29 Colgate Palmolive Co Method for making composite die
FR1595194A (fr) * 1968-12-17 1970-06-08
GB1355521A (en) * 1971-01-15 1974-06-05 British Ceramic Res Ass Die assemblies for pressing ceramic material
US4061453A (en) * 1975-10-06 1977-12-06 Wolverine Aluminum Corporation Tooling for a powder compacting press
GB2276345A (en) * 1993-03-24 1994-09-28 Unilever Plc Process for making shaped articles
US5648033A (en) * 1993-09-10 1997-07-15 Fuisz Technologies Ltd. Method and apparatus for retaining a formed compression dosage unit within a die cavity
DE9409108U1 (de) * 1994-06-03 1994-08-04 Wilhelm Fette Gmbh, 21493 Schwarzenbek Preßstempel für eine Tablettiermaschine

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9958320A1 *

Also Published As

Publication number Publication date
CA2331665A1 (fr) 1999-11-18
MXPA00011043A (es) 2003-09-10
WO1999058320A1 (fr) 1999-11-18
AU3472899A (en) 1999-11-29

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