WO2004045957A2

WO2004045957A2 - Systems and methods for forming blister packages with support members for pharmaceutical product packaging

Info

Publication number: WO2004045957A2
Application number: PCT/US2003/035182
Authority: WO
Inventors: Todd Siegel; Ron Rosenbaum; Stuart Bagley
Original assignee: Medical Technology Systems, Inc.; BAGLEY, Ann
Priority date: 2002-11-18
Filing date: 2003-11-05
Publication date: 2004-06-03
Also published as: EP1565377A4; WO2004045957A3; EP1565377A2; CA2494691A1; AU2003285146A1; US20040093835A1

Abstract

Systems and methods are provided for forming both backing and support members of a solid pharmaceutical product package as well as the blister portions for the packages. The disclosed solid pharmaceutical product packaging solutions utilize fewer machines and processing steps in order to form an overall solid pharmaceutical product package. In accordance with the preferred exemplary embodiments of the present invention, the manufacturing processing steps associated with the formation of the blister members in the clear plastic sheets is integrated in line with manufacturing of the backing material.

Description

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 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 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 J and 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 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 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 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 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. 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; 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 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. 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 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 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. 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.

Claims

We claim:

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.

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 of plastic material covering the holes in the first portion of the support board in the same in-line machine.

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; 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.