AU2003285146A1

AU2003285146A1 - Systems and methods for forming blister packages with support members for pharmaceutical product packaging

Info

Publication number: AU2003285146A1
Application number: AU2003285146A
Authority: AU
Inventors: Stuart Bagley; Ron Rosenbaum; Todd Siegel
Original assignee: MTS Medication Technologies Inc
Current assignee: MTS Medication Technologies Inc
Priority date: 2002-11-18
Filing date: 2003-11-05
Publication date: 2004-06-15
Also published as: US20040093835A1; WO2004045957A2; WO2004045957A3; EP1565377A2; EP1565377A4; CA2494691A1

Description

WO 2004/045957 PCT/US2003/035182 SYSTEMS AND METHODS FOR FORMING BLISTER PACKAGES WITH SUPPORT MEMBERS FOR PHARMACEUTICAL PRODUCT PACKAGING Background of the Invention Field of the Invention The present invention relates generally to field of pharmaceutical product packaging systems and methods. More specifically, the present invention is directed to systems and methods for automatically forming the blister portions of a solid pharmaceutical product package and the corresponding packaging support members for an overall pharmaceutical product package. The two distinct portions are preferably formed in a single in-line process into a unitary package member. Description of the Related Art Currently in the field of pharmaceutical product packaging systems and methods, typical conventional solutions for the manufacture of the solid pharmaceutical product packaging include clear plastic sheets with blister package cavities formed into the plastic sheets. The cavities formed into the clear plastic sheets are sealed with either foil or paper or cardboard backing that is adhesively secured to the perimeter around the cavities formed in the plastic sheets. In the typical conventional manufacturing solutions for these products, the cardboard 1 WO 2004/045957 PCT/US2003/035182 backing members are produced by punching out portions of cards on in-line flexographic presses or in sheet fed die cutting machines. The process is typically initiated with 10-20 point cardboard. In a series of steps, through the use of an in-line machine, the cardboard is coated, printed and die cut. The unwanted die cut portion is then removed, glue or adhesive is applied to one side of the remaining portion of the cardboard sheets and foil or other backing material is laminated on the adhesive backed side of the punch card material. Subsequently, the products are sheeted at the end of the press into, for example, twelve by nine inch punch cards. A variety of different sizes are possible for the output depending upon the size of the original stock. In an alternate approach, more manual processing is utilized. In this more manual approach, sheet fed offset printing is applied and a separate die cutting machine is utilized. Windowing machinery is thereafter used to laminated the punch card with the foil. This processing is performed at individual distinct processing stations rather than through the use of the in-line process described above. Regardless of the type of initial processing, clear plastic sheets with blister members formed therein are later inserted into the punch cards. This is typically performed by the customer or during packaging or manufacturing when the individual blister packages are filled with solid pharmaceutical products. The punch cards advantageously have openings in the card member that correspond to each of the blister cavities formed in the sheet of clear plastic material. The card member is 2 WO 2004/045957 PCT/US2003/035182 typically utilized to provide both support and sealing of the cavity portions formed into the clear plastic sheets. In one conventional application, the blister members that are formed in the sheet of clear plastic material are subsequently inserted into the holes formed in the punch cards. The cards are produced with a portion that folds over and simultaneously seals a plurality of blister cavities. A foil material is typically utilized for sealing and also allowing easy access to the solid pharmaceutical cavity. Specifically, in one particular design twelve by nine inch punch cards are folded over such that the total package size ultimately is six by nine inches. In yet another alternate application that is known as form fill and seal, plastic sheet material is processed to form cavities from roll stock and thereafter the cavities are filled with drug product. The filled cavities are then sealed with foil. If a cardboard punch card is desired for the finished product then a previously manufactured cardboard backing is added at a later station in the form fill and seal machine or in a secondary process that occurs off-line. One significant shortcoming of the conventional systems and methods for forming these pharmaceutical product package members is that multiple machines ' Sand corresponding manufacturing processes are required in order to form each of the separate portions of the overall package. In particular, one or more machines or processing steps are required in order to form the blisters in the sheets of clear plastic material. Additionally, separate machines and processing is required in order to produce the backing material for the product package which, as noted above, is '3 WO 2004/045957 PCT/US2003/035182 typically formed from cardboard. Yet another shortcoming and deficiency is that the plastic sheets with the blister cavities formed therein consume a significant amount of space and therefore require larger storage space. Accordingly, there remains a need in the field for improved systems and methods for forming pharmaceutical product packaging members that utilize fewer machines and processing steps in order to form the overall solid pharmaceutical product package. In light of the foregoing, one object and advantage of the present invention is to provide improved systems and methods for more efficiently forming both backing and support members as well as forming the blister portions for solid pharmaceutical product packages. Other objects and advantages of the present invention will be apparent in light of the following Summary and Detailed Description of the Presently Preferred Embodiments. Summary of the Invention Systems and methods are provided for more efficiently forming both backing and support members of a solid pharmaceutical product package as well as the blister cavity portions for the packages. The solid pharmaceutical product packaging solutions of the present invention utilize fewer machines and processing steps in order to form an overall solid.pharmaceutical product package. Specifically, in accordance with the preferred exemplary embodiments of the present invention, the manufacturing processing steps associated with the 4 WO 2004/045957 PCT/US2003/035182 formation of the blister members in the clear plastic sheets is integrated in-line with manufacturing of the cardboard support material. In accordance with one of the preferred exemplary embodiments, as one portion of a first side of the cardboard backing material is laminated with. foil, the other side is laminated with a thermoplastic material. Each side is preferably previously punched or die cut and the unwanted material is removed in order to form openings therein prior to the lamination step in the same in-line processing. The preferred thermoplastic material is polyethylene but other suitable plastic materials will also perform satisfactory results. In a preferred exemplary embodiment, a polyethylene coextrusion or one that. is coated or laminated with Saran material or other clear plastic may be utilized. The most preferred material is medical packaging film manufactured by Dow Chemical Corporation known as MPF 2005 or Saranex which is readily available. The lamination can be achieved either with conventional glue lamination or through the use of heat and pressure as in an alternate embodiment. In a subsequent step or stage, additional heat is applied to the plastic material in order to soften the material. Those skilled in the art will appreciate that a variety of different processing techniques and/or mechanisms may be utilize for applying heat to the material, such as, for example, passing the material through a heater or wrapping it around a hot roller. Alternatively, in yet another alternate exemplary embodiment, conventional cold forming may be utilized. The material is then preferably run through a rotary male-female matched set 5 WO 2004/045957 PCT/US2003/035182 of punches that indents each blister in line prior to sheeting into separate individual punch cards. It is believed that processing speeds of 100 feet per minute or greater can be achieved through utilization of the systems and methods of the present invention. In accordance with the systems and methods of the present invention, greater manufacturing efficiency is achieved with fewer manufacturing steps and less machinery. Accordingly, as a result, utilization of the systems and methods of the present invention provide a significant economic advantage over previous approaches to the formation of solid pharmaceutical product packaging. Those skilled in the art will appreciate that a variety of different processing techniques may be utilized in order to achieve the results of the present invention. More specifically, it should be recognized that it is not necessary to immediately form the blister or cavity portions of the package member during the in-line process. Those skilled in the art will recognize that the cavity member may also be subsequently formed when the solid pharmaceutical products are being inserted into the package. In this alternate embodiment, shipping of the package material is easier because less volume is required. In an alternate preferred exemplary embodiment, a male-female punch that is preferably of a rotary design may not be utilized in the original in-line manufacturing process. In this alternate approach, a flat bed forming station maybe used. In this exemplary embodiment, the material is routed through an accumulator after the preferably clear plastic material has been laminated to the board or backing material. Thereafter, the combined structure is passed to an intermittent forming 6 WO 2004/045957 PCT/US2003/035182 station where the material can be heated and then intermittently formed in a vacuum or pressure former. This approach is not the preferred approach due to the anticipated reduced productivity in the overall process but it should be recognized that this approach may ultimately prove easier to functionally achieve. This intermittent forming station is preferably integrated into the in-line manufacturing process. Those skilled in the art will appreciate that it is unnecessary to utilize such a machine in this manner. As an alternate approach, the plastic material may be secured to the cardboard backing with the holes formed therein. Sheets of this material can be accumulated and the formation of the actual blister may be made at a later time. In yet a further alternate exemplary embodiment, the blister portion of the package is not formed in-line. In this alternate exemplary approach, after the preferably clear plastic material has been laminated, the punch card would continue in the process through the sheeter mechanism. As a result this intermediate product has a flat sheet of preferably clear plastic material on one side and a flat sheet of foil on the other. The material is then desirably formed off-line in a secondary machine. This can be done alternately in a dedicated machine designed to thermoform material or in a packaging machine where the preferably clear plastic laminated punch card is introduced into the packaging machine as is known in the art. The card is preferably pre-heated in one station and thereafter the blisters are vacuum or pressure formed with or without male-female flat tooling. Finally the card is filled with medications, folded over and sealed in order to form finished package. 7 WO 2004/045957 PCT/US2003/035182 Those skilled in the art will readily appreciate that the punch card does not have to be of a fold-over style and the foil backing can be produced separately and subsequently added to the clear plastic laminated member after it has been filled with medication. Although the preferred embodiment has been described with reference to utilization of the thermoplastic or other heat formable material, it should be readily recognized that any formable plastic or similar material may be formed with the application of heat as described above in order to achieve the desired product. Those skilled in the art should also appreciate that cold.forming materials may also be utilized. Brief Description of the Drawings Figure 1 illustrates a top plan view of the finished blister pack formed in accordance with an exemplary embodiment of the present invention; Figure 2 illustrates a side view of the finished blister pack formed in accordance with an exemplary embodiment of the present invention; Figure 3 illustrates an alternate view of the finished blister pack formed in accordance with an exemplary embodiment of the present invention; Figure 4 is an exploded illustration of the separate portions of a solid pharmaceutical package formed in accordance with an exemplary embodiment of the present invention; Figure 5 illustrates the placement of the sheet of clear plastic material on a cardboard member in accordance with an exemplary embodiment of the present invention; . Figure 6 illustrates step in the manufacturing process in accordance with an exemplary intermittent embodiment of the present invention; Figure 7 illustrates step in the manufacturing process in accordance with an exemplary intermittent embodiment of the present invention; 8 WO 2004/045957 PCT/US2003/035182 Figure 8 illustrates further step in the manufacturing process in accordance with an exemplary embodiment of the present invention; Figure 9 illustrates further step in the manufacturing process in accordance with an exemplary embodiment of the present invention; Figure 10 illustrates further step in the manufacturing process in accordance with an exemplary embodiment of the present invention; Figure 11 illustrates further step in the manufacturing process in accordance with an exemplary embodiment of the present invention; and Figure 12 illustrates an alternate exemplary embodiment. Detailed Description of the Presently Preferred Embodiments Figure 1 illustrates a top plan view of the finished blister pack formed in accordance with an exemplary embodiment of the present invention that is shown generally at 10. The overall package is comprised of a support member 12 that incorporates a plurality of openings -14 for receiving individual doses of solid pharmaceutical products 16. The solid pharmaceutical products are secured via a clear plastic material 18. This material is preferably thermoplastic material such as polyethylene but other suitable plastic materials will also perform satisfactory results. In a preferred exemplary embodiment, polyethylene co-extruded with saran or other clear plastic material may be utilized. The most preferred material is medical packaging film manufactured by Dow Chemical Corporation known as MPF 2005 or Saranex which is readily available. The product displayed in Figures 1 and 2 represents the overall finished product that is formed in the manufacturing process described below. Figure 2 is a side view that illustrates the finished blister pack of Figure 1 formed in accordance 9 WO 2004/045957 PCT/US2003/035182 with an exemplary embodiment of the present invention. Figure 3 is a perspective view that illustrates the finished blister pack formed in accordance with an exemplary embodiment of the present invention. Figures 2 and 3 more clearly illustrates the fact that the support member is actually comprised of an upper portion 21 and a backing or lower portion 22 between which the plastic material 18 is secured. Figure 4 is an exploded illustration of the separate portions of a solid pharmaceutical package formed in accordance with an exemplary embodiment of the present invention. In particular, Figure 4 more clearly illustrates the fact that both the upper and lower portion 21, 22 of the support member 12 includes openings 14 for receiving one or more individual solid pharmaceutical medications. Additionally, the illustration of Figure 4 clearly shows the preferably clear plastic material 18 placed adjacent the upper member and the sheet of foil backing material 24 secured to the lower backing or support member 22. The backing material 24 may be formed from either foil or thin paper or any other suitable product which may be easily punctured or torn in order to provide access to the cavity. During the filling process, medications are located between the sheet of preferably clear plastic material 18 and the foil or paper backing 24 in registration with the corresponding holes in the respective sides of the backing or support member. Figure 5 illustrates an intermediate stage in the manufacturing process wherein preferably clear plastic material sheet 18 and the backing foil or paper sheet 24 have been laminated to the respective sides of the support members 21, 22. 10 WO 2004/045957 PCT/US2003/035182 Figures 6 and 7 illustrate the formation of the blister protrusion in the preferably clear plastic material sheet 18. This stage in the processing can actually be performed at an intermittent stage wherein roll fed material is temporarily accumulated in order to allow the use of an intermittent process in the formation of the cavities. Prior to this stage in the process, the preferably clear plastic material has been heated. Plug assist vacuum forming is preferably utilized although those skilled in the art will appreciate the other alternate approaches may be utilized as well. For example, pressure and vacuum forming without the use of male plugs may be used as an alternate solution. Heating is preferred in order to increase the ease with which the material can be stretched. As shown in Figure 6, male blister forming members 32 are located in registration above female blister forming members 33. The male and female members are in registration with the corresponding openings in the sheet of material that has not been shown in this illustration for the sake of convenience. The male blister forming members. 32 are moved toward the corresponding female members 33 and push through the sheet of preferably clear plastic material in order to form the blister members 35 as shown in Figure 7. Those skilled in the art will appreciate that vacuum forming with plug assist is preferably utilized in the formation of the blister portions. However, it should be recognized that this is not necessary. Figure 7 illustrates a stage in the process wherein the upper male blister forming members have been moved away from the female members and the product package, thus leaving the blisters 35 in the packaging material. In accordance with 11 WO 2004/045957 PCT/US2003/035182 the preferred exemplary embodiment, the male blister forming members are preferably located on a rotary member in order to provide continuous processing of the overall package. This preferred process is in contrast to the intermittent processing shown in Figures 6 and 7. This arrangement provides for the greatest degree of output. As noted above, it is anticipated that manufacturing speeds in excess of 100 linear feet per minute can be achieved. Additionally, as also noted in the summary, it is possible to have rows of male and female members or plates with multiple rows that stamp the blisters during the manufacturing process as shown in Figures 6 and 7. The preferred embodiment is, however, a rotary mechanism. Figure 8 illustrates the filling process for placement of one or more individual solid pharmaceutical products into each of the respective blister openings in the overall package. As shown in Figure 8, the medications are located in package templates 42 and one or more sliding plates allows an opening in at least one of the plates to drop the medications into the desired blister package openings at the appropriate time. This is a conventional processing step and is not necessary for utilization of the present invention during the in-line process. This step actually preferably takes place at a later point in time and even at a different location than the Original manufacturing process. Figure 9 illustrates the completed package with individual solid pharmaceutical members located within the blister portions of the overall package. The individual solid pharmaceutical products can be accessed by pushing on the blister portions against the solid pharmaceutical products to push the solid 12 WO 2004/045957 PCT/US2003/035182 pharmaceutical products through the backing material for access. This is the typical way of the solid pharmaceutical products are accessed through similar packaging materials. The advantages to utilization of the system methods of the present invention are primarily achieved in the overall efficiencies provided in the manufacturing process. Yet another additional advantage inherent in the systems and methods of the present invention is that the material that is used preferably shrinks around the pharmaceutical product thereby allowing more efficient storage of the product packaging material. Figure 12 illustrates the portions of the manufacturing process of the preferred exemplary embodiment directed to the formation of blister members and the lamination of the preferably clear plastic material to the cardboard backing. As shown in Figure 12, the lamination portion of the process entails matching the preferably clear plastic material 18 to the cardboard member over the corresponding holes in the cardboard. Heated rollers 42, 44 are utilized in order to raise the temperature of the preferably clear plastic material 18 to a desired temperature. Heating is preferable because it enables the material to be more easily formed. Male and female rollers 46, 48 rotate such that rows of male members engage . corresponding rows of female members to simultaneously form a plurality of blister portions. This facilitates more rapid processing in an in-line or continuous roll fed machine. This approach eliminates the need for temporary accumulation of the roll fed materials which would be necessary if an intermittent forming station is used as detailed above. 13 WO 2004/045957 PCT/US2003/035182 The finished product 48 passes from the rows of male and female members located on the rollers 46, 48 to further processing stations were about material is subsequently cut to the desired size. Additionally, as recognized above, the rollers 46, 48 could be replaced with stamp members that incorporate rows of male and female members that are engaged for the purpose of forming the blister portions intermittently. Those skilled in the art will appreciate that the preferred exemplary embodiment has been described with respect to the formation of support members wherein one side of the cardboard material has holes which are covered by the formable plastic material and the other side has holes covered by foil. It should be recognized that in an alternate embodiment, a single sheet of cardboard material may be formed with the process according to the invention wherein a single sheet has holes formed therein and a formable plastic material is applied thereto. Subsequent to, or simultaneously with this processing, the blister members may be formed into the formable plastic material and a backing may be applied. Preferably this backing may be foil material. A solid pharmaceutical or other similar product is inserted into the blister cavity. Those skilled in the art will appreciate that the Backing material may be applied directly to the cardboard support member upon which the plastic material has been applied and within which the blisters have been formed. This alternate approach would eliminate the need for a further cardboard support portion. 14

Claims

1. A method of forming a product package comprising steps of: forming holes in first and second portions of support board; applying a sheet of plastic material to the cover the holes formed in the first portion of the support board; applying a temporary covering material to holes formed in the second portion of the support board; and further wherein all the steps occur in a continuous process

2. The method of claim 1, wherein the support board is formed of cardboard.

3. The method of claim 1, further comprising a step of forming cavity members in the sheet of plastic material covering the holes in the first portion of the support board in the same in-line manufacturing process.

4. The method of claim. 1, wherein the support board is formed of . plastic.

5. The method of claim 1, wherein the temporary cover material is formed of foil. 15 WO 2004/045957 PCT/US2003/035182

6. An in-line manufacturing machine for forming a product package comprising: means for forming holes in first and second portions of support board; means for applying a sheet of plastic material to cover the holes formed in the first portion of the support board; and means for applying a temporary covering material to holes formed in the second portion of the support board.

7. The machine of claim 6, wherein the support board is formed of cardboard.

8. The machine of claim 6, further comprising a means for forming cavity members in the sheet ofplastic material covering the holes in the first portion of the support board in the same in-linemachine.

9. The machine of claim 6, wherein the support board is formed of plastic.

10. The machine of claim 6, wherein the temporary cover material is formed of foil.

11. A method of forming a product package comprising steps of: forming holes in first a support board; 16 WO 2004/045957 PCT/US2003/035182 applying a sheet of plastic material to the cover the holes formed in the support board; and further wherein all the steps occur in a continuous process.

12. The method of claim 11, further comprising a step of forming blister cavities in the plastic material at the locations of the holes.

13. The method of claim 12, further comprising a step of filling the blister cavities with a product.

14. The method of claim 13, further comprising a step of applying a backing material to seal the cavities.

15. The method of claim 14, wherein the backing material is a foil material.

16. The method of claim 14, wherein the backing material is a foil material that is secured to a cardboard support with holes formed therein.

17. The method of claim 12, wherein the step of forming the blister cavities is performed at a forming station that is separated from a manufacturing machine which performs any preceding manufacturing steps. 17