Pharmaceutical Packaging System and Method of Manufacturing Same

A pharmaceutical packaging system includes a substrate having a first surface, a first hollow cavity accessible through a first opening in the first surface, and a second hollow cavity accessible through a second opening in the first surface. The first and second hollow cavities are spaced apart and isolated from one another on the substrate. A cover is attached to at least a first portion of the first surface of the substrate surrounding the first opening and a second portion of the first surface of the substrate surrounding the second opening so as to provide a first seal for the first hollow cavity and a second seal for the second hollow cavity. At least one orally-administered medicament is contained within one of the first and second hollow cavities, and a first topically-applied medicament is contained within the other of the first and second hollow cavities.

BACKGROUND OF THE INVENTION

Embodiments of the present invention are directed to a pharmaceutical packaging system, and more particularly, to a common pharmaceutical packaging system that houses both orally-administered and topically-applied medicaments in separately sealed cavities, and a method for manufacturing the pharmaceutical packaging system.

It is found that often a health or cosmetic regimen may require a patient to take or apply multiple medicaments in order to maximize the effect of treatment. As used herein, the term “medicament” refers to a substance used for medical or cosmetic treatment, which can be, for example, a medicine, a dietary or nutritional supplement (e.g., probiotics, vitamins, nutrients, and the like), a pharmaceutical or cosmetic composition, or the like.

While it would be convenient to package orally-administered and topically-applied medicaments belonging to a single regimen together in a common package, there are stiff obstacles. Most critical is the avoidance of contamination of the orally-administered medicament by non-oral ingredients or components. In particular, the risk of contamination of the orally-administered medicament by a chemical agent from a topically-applied medicament is very serious, as ingestion of such chemical agents can be dangerous.

It is therefore desirable to provide a pharmaceutical packaging system that contains both orally-administered and topically-applied medicaments that can be used together as part of a health or cosmetic regimen. It is further desirable to provide a method and system for manufacturing such a pharmaceutical packaging system that reduces or avoids the risk of cross-contamination among the various medicaments to be contained in the pharmaceutical packaging system.

SUMMARY OF THE INVENTION

According to embodiments of the present invention, a pharmaceutical packaging system includes a substrate having a first surface, a first hollow cavity accessible through a first opening in the first surface, and a second hollow cavity accessible through a second opening in the first surface. The first and second hollow cavities may be spaced apart and isolated from one another on the substrate. A cover may be attached to at least a first portion of the first surface of the substrate surrounding the first opening and a second  portion of the first surface of the substrate surrounding the second opening so as to provide a first seal for the first hollow cavity and a second seal for the second hollow cavity. At least one orally-administered medicament may be contained within one of the first and second hollow cavities, and a first topically-applied medicament may be contained within the other of the first and second hollow cavities.

The substrate is preferably made from one or more heat moldable polymeric materials. For example, the substrate can be formed from adhered or otherwise combined layers of polyethylene terephthalate (“PET”), ethylene vinyl alcohol (“EVOH”), and polyethylene (“PE”). The first and second cavities may be created during thermoforming of the substrate material to mold depressions or the like in the material. However, the substrate can be made from any suitable material or combination of materials that is approved for contact with orally-administered and topically-applied medicaments and can provide an adequate seal. While the first and second cavities are described above as being integrally formed in the substrate material, the first and second cavities can also be separate components that are adhered or otherwise attached to the substrate by a separate process.

The first and second hollow cavities are further preferably shaped to generally conform with the nature of their respective contents. For example, if the first hollow cavity contains a solid dosage form of orally-administered medicament, the first hollow cavity may generally have a similar, although slightly larger, shape in plan view. In one embodiment, the orally-administered medicament may be an elongated capsule, in which case the first hollow cavity may also use a similar elongated shape in plan view. In the case where, for example, multiple orally-administered medicaments are contained within the first hollow cavity, the first hollow cavity may take on any shape necessary to accommodate the plurality of dosage forms, vertically and/or horizontally. In another example, if the second hollow cavity contains a topically-applied cream, lotion, or the like, the second hollow cavity is preferably sized to accommodate a user's finger to allow the user to remove the medicament for application. In some embodiments, a portion of a bottom of the second hollow cavity may be tapered for easier retrieval by the user.

The cover is preferably made from a foil material. For example, the cover can be formed from a combination of metal and polymeric films, such as a combination of PET, aluminums, and PE. However, the cover can be made from any suitable material or combination of materials that is approved for contact with orally-administered and  topically-applied medicaments, and which can be attached to the first surface of the substrate, or portions thereof, to provide a substantially fluid-tight seal for the hollow cavities. Limiting the sealing of the cover to portions of the first surface of the substrate surrounding the first and second openings, for example, simplifies manufacturing and makes it easier for the end user to remove the cover when the medicaments are to be used.

The cover is preferably attached to the substrate via heat sealing, although other similar processes may be used as well.

It is preferred that the orally-administered medicament be one of a capsule, tablet, or softgel, although other orally-administered medicament forms, such as a powder or the like, may be used as well. As an example, a single capsule may be contained within the first hollow cavity. As another example, two tablets may be contained within the first hollow cavity. The orally-administered medicament is preferably one of a probiotic, a nutricosmetic, a cosmeceutical, or a food or nutritional supplement, although any other types of orally-administered medicaments, for example, analgesics, antibiotics, anti-virals, antihistamines, and the like may be used as well. In particular, the at least one orally-administered medicament may be a nutricosmetic, a probiotic, or a combination of a nutricosmetic and a probiotic.

It is further preferred that the first topically-applied medicament be one of a serum, cream, lotion, ointment, paste, gel cream, or gel, although any other acceptable topically-applied forms may be used as well. The first topically-applied medicament is preferably a “day cream” formulated for anti-aging purposes with sun filters and specific ingredients for the skin protection, or a “night cream” formulated for hydration and anti-aging purposes, although any other types of topically-applied medicaments, for example analgesics, anti-fungals, antibiotics, topical retinoids, sunscreens, moisturizers, steroids, and the like may be used as well.

The substrate may include additional hollow cavities accessible through respective openings in the first surface, and which are each configured to receive a corresponding medicament that is sealed by the cover. For example, in some embodiments, the substrate further includes a third hollow cavity accessible through a third opening in the first surface. The third hollow cavity may be spaced apart and isolated from the first and second hollow cavities on the substrate. The third hollow cavity may be formed similar to the first and second hollow cavities. The cover may further be attached to at least a third  portion of the first surface of the substrate surrounding the third opening so as to provide a third seal for the third hollow cavity. A second topically-applied medicament is preferably contained within the third hollow cavity.

It is further preferred that the second topically-applied medicament be one of a serum, cream, lotion, ointment, paste, gel cream, or gel, although any other acceptable topically-applied forms may be used as well. The second topically-applied medicament is preferably an oily skin serum formulated for oily skin or a dry skin serum formulated for dry skin, although any other types of topically-applied medicaments, for example analgesics, anti-fungals, antibiotics, topical retinoids, sunscreens, moisturizers, steroids, and the like may be used as well. It is further preferred that the first and second topically-applied medicaments be different from one another.

According to further embodiments of the present invention, a method for manufacturing the pharmaceutical packaging system and a packaging line for performing the method are also provided. The packaging line may include a first filling cabinet, into which is provided the substrate having the first surface, the first hollow cavity accessible through the first opening in the first surface, and the second hollow cavity accessible through the second opening in the second surface. As before, the first and second hollow cavities may be spaced apart and isolated from one another on the substrate. While the substrate is in the first filling cabinet, the at least one orally-administered medicament or the first topically-applied medicament may be fed into the first hollow cavity. The cover may be provided for the first surface and may be sealed to the first surface at a portion surrounding the first hollow cavity to provide the first seal. The substrate may be moved into a second filling cabinet of the packaging line, which may have a different internal pressure than the first filling cabinet. The cover may be partially moved away from the first surface of the substrate to expose the second hollow cavity. While the substrate is in the second filling cabinet, the other of the at least one orally-administered medicament or the first topically-applied medicament may be fed into the second hollow cavity. The cover may then be sealed to the first surface at a portion surrounding the second hollow cavity to provide the second seal.

The substrate may be provided as part of a web that contains a plurality of substrates. For example, the web may be a continuous roll of material used for the substrates, from which the substrates may be later cut, punched-out, or otherwise severed to  create each individual pharmaceutical packaging system. The first and second hollow cavities for each substrate may be pre-formed on the roll, or may be formed while the web is traversing the packaging line prior to entering the first filling cabinet. The web may traverse the packaging line while supported on a conveyor belt, on individual rollers, combinations thereof, or the like.

The first filling cabinet preferably has a negative internal pressure therein. Such negative internal pressure can be provided by a vacuum or other air flow ventilation system designed to extract more air from the first filling cabinet than can enter, as is conventionally known. The internal pressure is preferably a minimum of 0.5 Pa. While the negative internal pressure is preferred, other internal pressures may be used, with the concept that the internal pressure within the first filling cabinet should be different from at least some of the other cabinets along the packaging line, in particular the second filling cabinet. In this way, air exchange between the first and second filling cabinets, where the various medicaments will be exposed, can be prevented.

Depending on the nature of the medicament to be dispensed, the first filling cabinet may include the necessary dispensing equipment. For example, in one embodiment, the first filling cabinet may feed the at least one orally-administered medicament into the first hollow cavity. Where the orally-administered medicament is a solid dosage form, for example, the first filling cabinet may include a hopper and one or more feeding tubes in communication with the hopper for leading one or more tablets, capsules, or the like into the first hollow cavity in the substrate. For increasing manufacturing capability, multiple feeding tubes are preferred so that multiple substrates can be fed generally simultaneously.

In another embodiment, for example, the first filling cabinet may feed the first topically-applied medicament into the first hollow cavity. Where the first topically-applied medicament is a cream, lotion, gel, or the like, the first filling cabinet may include one or more feeding tubes, each having a nozzle at an end thereof, for dispensing the first topically-applied medicament, which may be supplied from a chamber or an external feeding assembly. As with the orally-administered medicament, it may be beneficial to having multiple feeding tubes to feed multiple substrates generally simultaneously.

The cover may be provided as a continuous sheet that is applied to the substrate web. For example, a continuous sheet of foil may be provided on a roll that is led to the  web via a conveyor belt, a series of rollers, combinations thereof, or the like. The cover sheet is preferably first brought into contact with the web at a location external to the first filling cabinet, which may be inside a first sealing cabinet, which may be provided between the first and second filling cabinets. However, the cover sheet may be brought into contact with the web inside the first filling cabinet downstream from where the first hollow cavity is filled. After the cover sheet meets the web, a first sealing head may create the first seal. As with the filling procedure, it may be advantageous if the first sealing head can create first seals on a plurality of substrates generally simultaneously.

Where the cover is provided as part of a sheet, it may be advantageous to at least partially sever the sheet after the first seal has been created. A partial severance ensures that each substrate can be associated with a “flap” containing a portion of its corresponding cover, which can be moved away from the substrate to expose the second hollow cavity. While the final cover may be trimmed away from the sheet at this stage, it may be complex and time consuming to achieve the final cover shape, and so it can be more beneficial to make a single cut in the sheet adjacent to a substrate in the packaging line in order to keep the line moving. The extent of severing of the cover from the sheet can also be dependent on the procedure for exposing the second hollow cavity downstream. The first sealing cabinet may be provided with a first cutting tool to accomplish the severing task. As with previously described procedures, it may be advantageous if the first cutting tool can create multiple cuts in the sheet generally simultaneously.

To partially move the cover away from the first surface of the substrate, a vacuum suction head may be provided. The vacuum suction head may be configured to lower onto the cover, attach thereto using suction, and lift away from the substrate, taking the cover with it, leaving a space between the cover and the portion of the substrate surface having the second opening leading to the second hollow cavity. Alternatively, the vacuum suction head may be positioned sufficiently close to the cover such that the vacuum force is sufficient to attract the cover material thereto from a fixed position. In the case described above, where the cover is supplied as a continuous sheet and a cut is made in the sheet to create a “flap” of material, the vacuum suction head may lift the flap, which may expose multiple substrates at once. A remaining portion of the cover may be held in place during this procedure by virtue of the first seal. In conjunction with the vacuum suction head, a cam rail may also be provided, which is preferably capable of maintaining exposure of the  second hollow cavity (and any additional relevant hollow cavities) until after the second hollow cavity (and any other relevant hollow cavities) has been filled. In essence, the cam rail may take over for the vacuum suction head as the substrate moves downstream within the packaging line. The cam rail may not only maintain exposure of the second hollow cavity, but may further manipulate the cover to increase access to the second hollow cavity or the like by, for example, folding the cover away from the second opening in the substrate. The vacuum head may move laterally with the web toward the cam rail, whereupon suction may be released after the cover is transferred over to the cam rail. The vacuum suction head may then reverse direction and return to its starting position to attach with another cover. Alternatively, the vacuum suction head may be positioned sufficiently close to the cam rail that the raised “flap” can engage the cam rail during continued travel of the sheet without requiring movement of the vacuum suction head.

While the cover is described above as being partially moved away from the substrate by use of a vacuum suction head and cam rail assembly, other techniques may be used as well in keeping with the invention. Moreover, the cover may be individually supplied for each substrate, rather than as part of a sheet, and each individual cover would then be partially moved away from the substrate surface in a manner similar to that described above.

It is further preferred that the vacuum suction head and cam rail, or other components performing similar functionality, be located within the second filling cabinet. However, such components can also be located outside of the second filling cabinet, or may have portions located both inside and outside of the second filling cabinet.

The second filling cabinet preferably has a positive internal pressure therein. Such positive internal pressure can be provided by a blower or air flow ventilation system designed to force more air into the second filling cabinet than can enter, as is conventionally known. The internal pressure is preferably a minimum of +0.5 Pa. While the positive internal pressure is preferred, other internal pressures may be used, with the concept that the internal pressure within the second filling cabinet should be different from at least some of the other cabinets along the packaging line, in particular the first filling cabinet.

The second filling cabinet may include the necessary dispensing equipment for feeding the other of the at least one orally-administered medicament or the first topically-applied  medicament into the second hollow cavity. Such equipment has been described above for both orally-administered and topically-applied medicaments. For increasing manufacturing capability, multiple feeding tubes are preferred so that multiple substrates can be fed generally simultaneously.

Following the filling of the second hollow cavity, the cover may be allowed to return to its position in contact with the substrate surface. This may occur either inside of the second filling cabinet or externally thereto, such as, for example, within a second sealing cabinet located downstream of the second filling cabinet. The second sealing cabinet may be provided with a second sealing head, similar to the first sealing head, which completes the second seal by attaching the cover to the portion of the substrate surface surrounding the second opening to the second hollow cavity. As with the previous procedures, it may be advantageous if the second sealing head can create second seals on a plurality of substrates generally simultaneously.

The second sealing cabinet may further include a second cutting tool that may pre-cut the substrate so that various portions thereof can be easily detached by the user. For example, portions of the substrate having the first and second hollow cavities may be separable from one another if the user so chooses. The second sealing cabinet may also include a third cutting tool that may be responsible for final separation of the substrate from the web and/or the cover from the continuous sheet.

In embodiments where the substrate includes additional hollow cavities configured to receive various medicaments, the packaging line described above may be modified to include additional equipment, cabinets, or the like to accommodate the additional processing steps needed. For example, in the embodiment where the substrate includes the third hollow cavity for receiving the second topically-applied medicament, the filling cabinet responsible for feeding the first topically-applied medicament to the substrate can be modified to include a second set of feeding tubes and nozzles for dispensing the second topically-applied medicament. In embodiments where the first and second topically-applied medicaments are dispensed in the second filling cabinet, when the cover is partially moved away from the substrate, the third hollow cavity is preferably also exposed as a result. Preferably, the first and second topically-applied medicaments can be fed generally simultaneously. Similarly, the first or second sealing head may be used to create the third seal, as necessary, depending on which filling cabinet is responsible for feeding of the  second topically-applied medicament. Alternatively, the second topically-applied medicament can have its own separate filling and/or sealing cabinets.

The packaging line according to embodiments of the present invention is not limited to the configurations described above. For example, the first and second filling cabinets can include more or fewer components, perform additional operations, and may or may not be joined by a common conveyor. As another example, the sealing heads may be utilized within the respective filling cabinets as opposed to having separate sealing cabinets. Cutting tools may also have their own cabinets, be external to any cabinets on a packaging line, or be located within filling cabinets. As another example, one or more cabinets may include machine vision cameras to observe proper placement of medicaments in their respective hollow cavities.

DETAILED DESCRIPTION OF THE INVENTION

Certain terminology is used in the following description for convenience only and is not limiting. The words “right,” “left,” “lower” and “upper” designate directions in the drawings to which the reference is made. The words “inwardly” and “outwardly” refer to directions toward and away from, respectively, the geometric center of the apparatus and designated parts thereof. The terminology includes the words above specifically mentioned, derivatives thereof and words of similar import.

Referring toFIGS. 1 and 2, there is shown an example of a pharmaceutical packaging system10in accordance with a preferred embodiment of the present invention. The pharmaceutical packaging system10includes a substrate12having a first surface12a. A first hollow cavity14is formed in the substrate12and is accessible through a first opening16in the first surface12a.A second hollow cavity18is formed in the substrate12and is accessible through a second opening20in the first surface12a.A third hollow cavity22is formed in the substrate12and is accessible through a third opening24in the first surface12a.

A cover26is placed on the first surface12aof the substrate12. The cover26is at least adhered to first, second, and third portions27a,27b,27cof the first surface12a.InFIG. 2, the cover26is removed, and the first, second, and third portions27a,27b,27cof the first surface12aare respectively delimited by dashed lines around each of the first, second, and third openings16,20, and24. Connection of the cover26to the first, second, and third portions27a,27b,27cthereby provides first, second, and third seals to prevent the ingress or egress of air with respect to the first, second, and third hollow cavities14,18,22.

In the example ofFIG. 2, the first hollow cavity14contains a capsule28of a nutricosmetic. The second hollow cavity18contains an anti-aging day cream30. The third hollow cavity22contains an oily or dry skin serum32.

FIG. 3shows an alternative embodiment of a pharmaceutical packaging system10′, having a substrate12′ with first, second, and third hollow cavities14′,18′, and22′. In this embodiment, the first hollow cavity14′ is sized and shaped to accommodate two tablets of a nutricosmetic (not shown) stored side-by-side. The second hollow cavity18′ contains a hydrating and anti-aging night cream (not shown). The third hollow cavity22′ contains an oily or dry skin serum (not shown).

Referring toFIG. 5, there is shown a packaging line100for manufacturing the pharmaceutical packaging system10in accordance with a preferred embodiment of the present invention. The packaging line100includes, in a downstream order, a first filling cabinet102, a first sealing cabinet104, a second filling cabinet106, and a second sealing cabinet108. Substrates12are provided as part of a web101(FIG. 4) from a roll110, which is moved between the various cabinets102,104,106,108by a conveyor belt112. As seen inFIG. 4, the web101includes a plurality of substrates12arranged in two rows extending in the travel direction of the web101.

The first filling cabinet102is shown in greater detail inFIG. 7. The first filling cabinet102is kept at a negative internal pressure by an air flow ventilation system (not shown). In the present embodiment shown, the first filling cabinet102is responsible for feeding the orally-administered medicament28into the first hollow cavity14of the substrate12. Accordingly, the first filling cabinet102includes a hopper120in which  capsules, tablets, or the like28may be placed in bulk for alignment and disbursement. A feeding tube122is connected to the hopper120for receiving the capsules, tablets, or the like and transporting them to the first hollow cavity14of each substrate12.

After receiving the orally-administered medicament28, the substrate12exits the first filling cabinet102and proceeds to the first sealing cabinet104, shown in greater detail inFIG. 8. The first sealing cabinet104supplies the cover26as a continuous sheet103on a roll130. The sheet103is brought into contact with the web101just prior to the web101being subjected to a first sealing head132. In the embodiment shown, the first sealing head132is configured to create the first seal on four substrates12at a time, i.e., two adjacent substrates12in one row and two correspondingly adjacent substrates12in the second row of the web101. Downstream of the first sealing head132is a first cutting tool134configured to partially sever the sheet103and the web101at the cut locations109shown inFIG. 4. In particular, a partial cut is made from an edge of the web101between every two substrates12in each row.

Upon exiting the first sealing cabinet104, the substrate12enters the second filling cabinet106, which is shown in greater detail inFIG. 6. The second filling cabinet106is kept at a positive internal pressure by an air ventilation system (not shown), thereby preventing air exchange between the first and second filling cabinets102,106. Near the entrance to the second filling cabinet106there is a vacuum suction head140. The vacuum suction head140adheres to the cover sheet103near opposing edges thereof, to lift the edges of the cover sheet103away from the web101. The locations of the cuts109(FIG. 4) ensures that only a portion of the cover sheet103overlying four adjacent substrates12on the web101is lifted at a time by the vacuum suction head140. The action of raising the edges of the cover sheet103allows “flaps”139to engage opposing cam rails142, each of which initially angle toward a center of the web101, further lifting the cover sheet103away from the substrates12so as to expose the second and third hollow cavities18,22, thereof.

In the present embodiment shown, the second filling cabinet106is responsible for feeding the first and second topically-applied medicaments30,32respectively into the second and third hollow cavities18,22of the substrate12. Accordingly, the second filling cabinet106includes a plurality of feeding tubes144a,144b,each having a nozzle146. One set of the feeding tubes144asupplies the first topically-applied medicament30while a  second set of the feeding tubes144bsupplies the second topically-applied medicament32. Preferably, each set includes four feeding tubes144a,144b,so that four substrates12can be filled generally simultaneously. The feeding tubes144a,144bare connected to one or more chambers148to supply the first and second topically-applied medicaments30,32. The cam rail142extends behind the nozzles146to allow access to the second and third hollow cavities18,22. After the second and third hollow cavities18,22have been filled, each cam rail142angles back towards an edge of the web101, allowing the “flap”139to lower and the cover sheet103to come back into contact with the web101as the substrate12exits the second filling cabinet106.

Downstream of the second filling cabinet106, the substrate12enters the second sealing cabinet108. Much like the first sealing cabinet104, the second sealing cabinet108includes a second sealing head150, which is used to create the second and third seals on four substrates12at a time. A second cutting tool152is also provided, which applies pre-cuts107(FIG. 4) to the substrates12, to allow later separation by an end user of individual portions of the substrate12. A third cutting tool154, near a downstream exit of the second sealing cabinet108, performs final separation of the substrate12from the web101and cover26from the sheet103into the final triangular shape shown inFIGS. 1 and 2.