DESC:The following specification particularly describes and ascertains the nature of this invention and the manner in which it is to be performed:
DUAL COMPARTMENT CONTAINER FOR PHARMACEUTICAL DOSAGE FORMS

FIELD OF THE INVENTION
The present invention relates generally to containers having a plurality of compartments for containing a variety of dissimilar substances. More particularly, the present invention relates to a dual compartment container for retaining separate ingredients of a pharmaceutical dosage form and facilitating their mixture just before use.

BACKGROUND OF THE INVENTION
Dual compartment containers have been used in the past to ship and store products having component substances which must be kept separated until immediately prior to use.
One example of a dual compartment container is shown in U.S. Pat. No. 3,443,726 (“the ‘726 patent”). The ‘726 patent describes a multiple element mixing and dispensing container in which a first can unit, which includes a bottle-receiving threaded collar may be filled with contents and sealed, after which a second element, such as a bottle which includes a threaded neck and a separate dispenser spout, is screwed or locked in a fixed position in the collar so as to seal the bottle, and in which a combination can cap and frangible plug is provided which seals the contents of the two containers from contact with each other until container units are further rotated, whereupon a neck extension or nose on the bottle unit fractures the plug, thereby allowing the contents of the two containers to mix with each other. After the contents are mixed, they are dispensed from the bottle unit, as by squeezing the bottle unit so as to force the liquid through the dispenser valve or spout. The frangible seal is designed to break as a single piece in a knock out pattern and the seal is mixed with the product upon breaking, which is not desirable for pharmaceutical purposes as there is a risk of product being contaminated.
Another example of a dual compartment container for mixing two liquids is shown in U.S. Pat. No. 4,465,183 (“the ‘183 patent”). The ‘183 patent describes a two-part liquid container with a breakable partition which has a first half container sealing a sheet at a neck portion thereof for containing a first liquid; an intermediate cylindrical member for connecting a cylindrical sealing piece through a collapsible piece at a lower end thereof spirally engaging the lower half end thereof with the outer periphery of the neck portion of the first half container; a second half container sealing a sheet at the bottom opening thereof and having a cutting blade depending toward the vicinity of the bottom therein for engaging the lower part thereof impossible to turn with the upper half part of the intermediate member; and a sealing member for sealing the upper opening of the second half container.
There are several disadvantages associated with the container described in the ‘183 patent. For example, the knife member is integral with the top container and, therefore, requires fairly complex and costly molding operations. The lateral motion of the knife member relative to the membrane during the cutting action creates the possibility of tearing the membrane and, therefore, interfering with the mixing of the contents, especially if the component substances are somewhat viscous liquids. The container described in the ‘183 patent also utilizes a separate piece (the breakable partition) which performs no other function than to maintain the containers separated during shipment and prior to use, thus also adding to the cost. Additionally, the container described in the ‘183 patent requires a three-step operation prior to use: (1) the user must remove the partition, (2) screw the containers together, and then (3) remove the cap sealing the spout. This container requires two separate membrane seals, one for each separate compartment. Furthermore, the intermediate member which is used to hold and screw the containers together as they are being threaded toward each other is also an extra piece which adds to the complexity and cost of the device. The container described in the ‘183 patent also requires that the membranes sealing each of the containers be completely cut, thus possibly enabling the membranes to clog the spout of the container during use.
Another example of a dual compartment container is shown in U.S. Pat. No. 4,247,001 (“the ‘001 patent”). The 001 patent describes a container whose shell consists of two cup-shaped parts bounding respective compartments of the shell cavity separated from each other by a frangible membrane. A piercing assembly in the compartment of one part includes a blade member extending in a closed loop contiguously adjacent the circumferential wall of the one part and spacers interposed between the blade member and the bottom wall which is resiliently movable inward of the shell cavity for engagement with the spacers whereupon the blade member cuts the membrane. One of the compartments in this container has a flexible bottom wall and includes a cutting frame within its interior. Pressing the bottom wall in a given direction causes the cutting frame to press against a sealing membrane to cut it with a piercing action.
There are several disadvantages associated with the container described in the ‘001 patent. For example, the bottom wall must be protected during shipment to avoid premature piercing of the membrane. Additionally, the container requires a separate cap or seal for the spout. Furthermore, the operation of the container described in the ‘001 patent requires three steps: (1) the protective feature preventing premature motion of the flexible wall must be removed, (2) the flexible wall must be depressed to cut the membrane and (3) then the spout must be opened. In addition to the foregoing disadvantages, the container described in the ‘001 patent is not suitable for mixing viscous fluids. The presence of the knife frame within the container creates an impediment to material flow which interferes with complete mixing of such substances.
Another example of a dual compartment container is shown in U.S. Pat. No. 4,682,689 (“the 689 patent”). The 689 patent describes a dual-compartment container for use with two substances which must be separated prior to use and which may be combined by the single step of removing the cap from the container. A top container containing one substance is sealed along its bottom end by a membrane and is rotatably seated within a bottom container containing another substance. A container cap seals the top container prior to use and is threaded onto the bottom container. The cap is provided with a ratchet means which causes common rotation of the cap and the top container while the cap is being unthreaded from the bottom container. An annular knife member is interposed between the two containers and keyed to the top container for common rotation therewith as the cap is removed. Cam means are provided to translate rotary motion of the knife member relative to the bottom container into longitudinal motion of the knife member relative to the top container in order to pierce the sealing membrane.
There are several disadvantages associated with the container described in the ‘689 patent. For example, the container described in the ‘001 patent requires an annular internal knife member for piercing a sealing membrane. Additionally, the sealing membrane is pierced as the cap of the container is removed.
To overcome the disadvantages associated with the prior art, the dual compartment container should be capable of storing two components which have to be mixed prior to use and further, does not affect the safety and quality of the product. The container should also be able to store formulations which are not stable for storage for a long time, but must be formed immediately before use, for example, powder with a diluent; as in the case of amoxicillin oral suspension, separation of the powder and diluent is necessary to extend the shelf life of the product because the powder may begin to degrade in a short time after it has been mixed with diluent. Further, a seal separating the compartments needs to be inert, compatible with the pharmaceutical product and should not drop into the product once broken, thus the seal should not contaminate the product.

SUMMARY OF THE DESCRIBED EMBODIMENTS
The present invention overcomes the deficiencies of prior art containers by providing a dual compartment container for retaining separate ingredients of a pharmaceutical dosage form and facilitating their mixture just before use, said dual compartment container comprising:
(a) a first compartment comprising a continuous side wall, a closed bottom, and a top portion, wherein said top portion comprises an opening;
(b) a second compartment comprising a continuous side wall, a bottom portion, and a top portion, wherein said bottom portion and said top portion comprise an opening;
(c) a passageway for connecting the opening in the top of the first compartment with the opening in the bottom of the second compartment;
(d) atleast one frangible seal sealing the passageway between the first compartment and the second compartment, wherein said frangible seal is of sufficient strength to remain intact and retain an ingredient in the first compartment separate from an ingredient in the second compartment until relative rotation of the first compartment and the second compartment breaches the frangible seal allowing mixing of the ingredients in the first compartment and the second compartment; and
(e) a closure cap mounted on top of the second compartment.
In another embodiment of the invention, there is described a dual compartment container for retaining separate ingredients of a pharmaceutical dosage form and facilitating their mixture just before use, said dual compartment container comprising:
(a) a first compartment comprising a continuous side wall, a closed bottom, and a top portion, wherein said top portion comprises an opening;
(b) a second compartment comprising a continuous side wall, a bottom portion, and a top portion, wherein said bottom portion and said top portion comprise an opening;
(c) a passageway for connecting the opening in the top of the first compartment with the opening in the bottom of the second compartment;
(d) atleast one frangible seal sealing the passageway between the first compartment and the second compartment, wherein said frangible seal is of sufficient strength to remain intact and retain an ingredient in the first compartment separate from an ingredient in the second compartment until relative rotation of the first compartment and the second compartment breaches the frangible seal allowing mixing of the ingredients in the first compartment and the second compartment;
(e) a closure cap releasably mounted on top of the second compartment; and
(f) a cup releasably mounted on the closure cap.
In another embodiment of the invention, there is described a method of preparing
a pharmaceutical dosage form, said method comprising:
(A) providing a dual compartment for retaining separate ingredients of a pharmaceutical dosage form and facilitating their mixture just before use, said dual compartment container comprising:
(a) a first compartment comprising a continuous side wall, a closed bottom, and a top portion, wherein said top portion comprises an opening;
(b) a second compartment comprising a continuous side wall, a bottom portion, and a top portion, wherein said bottom portion and said top portion comprise an opening;
(c) a passageway for connecting the opening in the top of the first compartment with the opening in the bottom of the second compartment;
(d) atleast one frangible seal sealing the passageway between the first compartment and the second compartment, wherein said frangible seal is of sufficient strength to remain intact and retain an ingredient in the first compartment separate from an ingredient in the second compartment until relative rotation of the first compartment and the second compartment breaches the frangible seal allowing mixing of the ingredients in the first compartment and the second compartment; and
(e) a closure cap mounted on top of the second compartment;
(B) rotating at least one of the first compartment or the second compartment relative to the other compartment to breach the frangible seal allowing mixing of the contents in the first compartment and the second compartment to form a pharmaceutical dosage form.
In another embodiment of the invention, there is described a method of preparing
a pharmaceutical dosage form, said method comprising:
(A) providing a dual compartment for retaining separate ingredients of a pharmaceutical dosage form and facilitating their mixture just before use, said dual compartment container comprising:
(a) a first compartment comprising a continuous side wall, a closed bottom, and a top portion, wherein said top portion comprises an opening;
(b) a second compartment comprising a continuous side wall, a bottom portion, and a top portion, wherein said bottom portion and said top portion comprise an opening;
(c) a passageway for connecting the opening in the top of the first compartment with the opening in the bottom of the second compartment;
(d) atleast one frangible seal sealing the passageway between the first compartment and the second compartment, wherein said frangible seal is of sufficient strength to remain intact and retain an ingredient in the first compartment separate from an ingredient in the second compartment until relative rotation of the first compartment and the second compartment breaches the frangible seal allowing mixing of the ingredients in the first compartment and the second compartment;
(e) a closure cap releasably mounted on top of the second compartment; and
(f) a cup releasably mounted on the closure cap;
(B) rotating at least one of the first compartment or the second compartment relative to the other compartment to breach the frangible seal allowing mixing of the contents in the first and second compartments to form a pharmaceutical dosage form;
(C) dispensing the pharmaceutical dosage form from the dual compartment container into the cup; and
(D) administering the pharmaceutical dosage form.
In one embodiment of the invention, the second compartment has an angular mouth for easy and drip-free dispensing of the pharmaceutical dosage form after mixing.
In one embodiment of the invention, the second compartment has a round mouth for dispensing of the pharmaceutical dosage form after mixing.
In an embodiment of the invention, the container is suitable for oral, topical and parenteral dosage forms.
In one embodiment of the invention, the cup component of the dual compartment container is a measuring cup for accurate measurement of the pharmaceutical dosage form.
In an embodiment of the invention, the frangible seal of the dual compartment container is attached to the first compartment.
In another embodiment of the invention, the frangible seal of the dual compartment container is attached to the second compartment.
In an embodiment of the invention, the frangible seal of the dual compartment container is attached to the first compartment and to the second compartment.
The first and second compartments of the dual compartment container according to the invention may contain any combination of ingredients in the form of solids, liquids, and or semisolids to form the pharmaceutical dosage forms according to the invention. It is within the scope of the invention that the first compartment and second compartment independently contain a liquid, solid, or a combination of liquid and solid ingredients used to form the pharmaceutical dosage form upon mixing the ingredients in the first and second compartments. In a preferred embodiment, a dry powder is packaged in the first compartment and a liquid for reconstitution is packaged in the second compartment.
Advantages of the dual compartment container for mixing and dispensing pharmaceutical dosage forms according to the invention include at least the following: (1) breaking of the frangible seal which separates the compartments of the dual compartment container does not result in fragments of the seal being deposited into the pharmaceutical dosage form; (2) the dual compartment container is capable of storing two components which have to be mixed prior to use and does not affect the safety and quality of the pharmaceutical product or does not block the flow of the pharmaceutical product; (3) the dual compartment container readily assists consumers’ efforts to follow prescribed dosing schedules involving dosage forms that need to be mixed prior to administering; and (4) the dual compartment container is simple and inexpensive to manufacture.
These and other objects of the invention, as well as many of the intended advantages thereof, will become more readily apparent when reference is made to the following description taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be readily understood by the following detailed description in conjunction with the accompanying drawings, wherein like reference numerals designate like structural elements, and in which:

FIG. 1 is an exploded elevation view of the dual compartment container for containing and isolating two separate ingredients of an pharmaceutical dosage form and facilitating their mixture just before use, according to the invention.

FIG. 2 is a fully assembled view of the dual compartment container for containing and isolating two separate ingredients of an pharmaceutical dosage form and facilitating their mixture just before use, according to the invention.

FIG. 3 is a cross-section view of a dual compartment container for containing and isolating two separate ingredients of an pharmaceutical dosage form and facilitating their mixture just before use, according to the invention.

FIG. 4 is a top view of the seal with the weakened sections piercing and the solid lines which prevent them from falling into the composition after the piercing action.

Other aspects and advantages of the invention will become apparent from the following detailed description taken in conjunction with the accompanying drawings which illustrate, by way of example, the principles of the described embodiments.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Reference will now be made in detail to representative embodiments illustrated in the accompanying drawings. It should be understood that the following descriptions are not intended to limit the embodiments to one preferred embodiment. To the contrary, it is intended to cover alternatives, modifications, and equivalents as can be included within the spirit and scope of the described embodiments as defined by the appended claims.
Referring now to the drawings, wherein like reference numerals represent like elements, FIG. 1 shows an exploded elevation view of one embodiment of a dual compartment container 10 for retaining separate ingredients of an pharmaceutical dosage form and facilitating their mixture just before use. The dual compartment container 10 comprises a first compartment 20, a second compartment 40, a closure cap 80, a pouring spout 74 and optionally a cup 90.
With reference to the drawings, FIG. 2 shows one embodiment of the fully assembled dual compartment container 10 having a first compartment 20, a second compartment 40, a closure cap 80, and a cup 90.
Fig 3 shows a detailed view wherein the first compartment 20 comprises a continuous side wall 22, a closed bottom 24, and a top portion 26. The top portion 26 of the first compartment 20 comprises a shoulder 28 and an opening 30 having a neck portion 32. The neck portion 32 comprises a continuous side wall 34 which extends upwardly radially around the opening 30. The side wall 34 comprises a lip 36 at the terminal end of the side wall 34 and a groove member 38 extending along the inner perimeter of the side wall 34. The diameter of the opening 30 in the first compartment 20 is not critical, however it must be large enough to allow passage there through of the pharmaceutical dosage form from the first compartment 20 into the second compartment 40. The lip 36 at the terminal end of the side wall 34 provides a planar surface for bonding a frangible seal completely enclosing and sealing the opening 48.
The second compartment 40 comprises a continuous side wall 42, a bottom portion 44, and a top portion 60. The bottom portion 44 of the second compartment 40 comprises a shoulder 46 and an opening 48 having a neck portion 50. The neck portion 50 comprises a continuous side wall 52 which extends downwardly radially around the opening 48. The side wall 52 comprises a lip 54 at the terminal end of the side wall 52 and a thread member 56 extending along the outer perimeter of the side wall 52. The lip 54 at the terminal end of the side wall 52 provides a planar surface for bonding a frangible seal 100 completely enclosing and sealing the opening 48.
The frangible seal 100 serves to seal the ingredients of the pharmaceutical dosage form contained in the first compartment 20 from contacting or mixing with the ingredients contained in the second compartment 40 until rotation of the first compartment 20 relative to the second compartment 40 breaches the frangible seal 100 resulting in mixing of the ingredients in the compartments to form the pharmaceutical dosage form. As used herein, “breach” or “breached” means that at least a portion of the frangible seal 100 is broken, allowing contacting or mixing of the ingredients in the first compartment 20 and the second compartment 40 of the dual compartment container. The frangible seal 100, therefore, is sufficiently strong to remain intact from the pressure created from a filling operation of ingredient(s) in the second compartment 40 and subsequent shipping and handling of the dual compartment container 10. Moreover, the frangible seal 100 prevents the transfer of moisture from a liquid containing compartment to the other compartment containing water sensitive contents. At the same time, the frangible seal 100 is frangible enough to breach upon rotation of the first compartment 20 relative to the second compartment 40. After breaching, the frangible seal 100 is prevented from mixing with the pharmaceutical dosage form by being at least partially attached to the planar surface of the lip 54 at the terminal end of the side wall 52 or to the planar surface of the lip 36 at the terminal end of the side wall 34.
In an embodiment of the invention, the frangible seal of the dual compartment container is attached to the first compartment 20.
In another embodiment of the invention, the frangible seal 100 of the dual compartment container is attached to the second compartment 40.
In an embodiment of the invention, the frangible seal 100 of the dual compartment container is attached to the first compartment 20 and to the second compartment 40.
As shown in Fig.4, the frangible seal has weakened sections 104 to allow for easy piercing without tearing it completely off into contents of the container. The solid lines 106 prevent the seal from falling off into the container.
The seal may be prepared from frangible and non-frangible sheet materials. Additionally, a layer of non-frangible sheet material may also be used provided it has a cut out void configuration. In one embodiment, the cut out void configuration includes one or more uncut portions that connect one or more broken open center flaps of the frangible seal to the annular portion 102 of the frangible seal remaining bonded to the planer surface of the lip 54 around the interior opening of the neck portion 50 or to the planar surface of the lip 36 at the terminal end of the side wall 34, thereby preventing one or more broken open center flaps from tearing from the peripheral surface area when the frangible seal breaks open.
The force required to breach the frangible seal 100 when bonded over the planar surface of the lip 54 at the terminal end of the side wall 52 or to the planar surface of the lip 36 at the terminal end of the side wall 34 can be adjusted by the following methods: (i) increasing or decreasing the thickness of the frangible sheet material; (ii) the choice of frangible sheet material; (iii) the use of an adhesive layer in addition to a layer of frangible sheet material; (iv) the choice and/or amount of adhesive used to bond the frangible sheet material to the planar surface of the lip 54 or to the lip 36; (v) the dimensions or the configuration of a breaking pattern used in the frangible sheet material; and (vi) combinations of one or more of these methods. Preferably, the force required to break the frangible seal 100 is at least about 10 newtons. In addition, the material used to prepare the frangible seal 100 (a) must not be reactive with the ingredient(s) stored in either the first compartment 20 or the second compartment 40; (b) must not impart odor/taste to the pharmaceutical dosage form; and (c) must be non-toxic.
The frangible seal 100 may be prepared from any suitable frangible sheet material. Preferred the frangible sheet material is made up of one or more layers selected from the group consisting of medicine grade foil, fine silicon cap, metal foil, polymers, plastic, paper, vinyl, and combinations thereof. In a preferred embodiment, the frangible sheet material is made up of medicine grade foil, fine silicon cap. Suitable plastic materials include polyethylene, polypropylene, polyvinylchloride, mylar, cellophane, and vinyl. It is within the scope of the invention to prepare the frangible seal 100 as a laminate. An example of a laminate includes, but is not limited to, one or more layers of frangible sheet material and one or more layers of adhesive. The frangible seal is fixed either with adhesive or fused onto the edges of the compartment to prevent them from falling into the composition after the piercing action.
In an embodiment, there exists a tearing mechanism for the frangible seal 100. The tearing mechanism may be in the form of atleast one spike.
The term “spike”, “knife” or “tearing mechanism” as described herein can be synonymously used.
The frangible seal may be breached with the help of spikes located either on the first compartment 20 or on the second compartment 40. The spike may be located at multiple positions including the centre and/or it may be peripherally located. The position of the spike is critical in determining the pattern in which the seal is designed to break. It is also an embodiment of the invention wherein multiple spikes are present.
In one embodiment, the frangible seal is located on the second compartment 40 and atleast one spike is located on the first compartment 20. In such an embodiment, the mode of operation is as: Rotation of the first compartment 20 relative to the second compartment 40 causes the thread member 56 extending along the outer perimeter of the side wall 52 in the neck portion 50 of the second compartment 40 to rotate downward into the groove member 38 located on the inner side wall of the neck portion 32 on the top portion 26 of the first compartment 20. This downward movement of the second compartment 40 results in upward motion of the spikes towards the frangible seal 100 and eventually breaks it, thus, creating a passageway between the first compartment 20 and the second compartment 40 allowing the contents in each compartment to contact or mix with each other.
In another embodiment, the frangible seal is located on the first compartment 20 and atleast one spike is located on the second compartment 40. In such an embodiment, the mode of operation is as: Rotation of the first compartment 20 relative to the second compartment 40 causes the thread member 56 extending along the outer perimeter of the side wall 52 in the neck portion 50 of the second compartment 40 to rotate downward into the groove member 38 located on the inner side wall of the neck portion 32 on the top portion 26 of the first compartment 20. This downward movement of the second compartment 40 results in downward motion of the spikes towards the frangible seal 100 and eventually breaks it, thus, creating a passageway between the first compartment 20 and the second compartment 40 allowing the contents in each compartment to contact or mix with each other.
In one embodiment, the frangible seal is located on both the first compartment 20 and the second compartment 40 and atleast one spike is located on one of the compartments or both or between the gap between the two compartments. In such an embodiment, the mode of operation is as: Rotation of the first compartment 20 relative to the second compartment 40 causes the thread member 56 extending along the outer perimeter of the side wall 52 in the neck portion 50 of the second compartment 40 to rotate downward into the groove member 38 located on the inner side wall of the neck portion 32 on the top portion 26 of the first compartment 20. The spike on first compartment/second compartment would respectively travel in an upward/downward motion to break the respective seals of the other compartment, thus, creating a passageway between the first compartment 20 and the second compartment 40 allowing the contents in each compartment to contact or mix with each other.
Optionally, the dual compartment container 10 is inverted one or more times to facilitate effective mixing of the pharmaceutical dosage form. In a preferred embodiment, a shaking/vibrating motion may assist in further mixing of the ingredients in the first compartment 20 and second compartment 40 to form the pharmaceutical dosage form.
The second compartment 40 is to be screw attached to the first compartment 20 of the dual compartment container 10. The diameter of the side wall 52 and the positioning and size of the thread member 56 on the neck portion 50 of the second compartment 40 is such to allow the thread member 56 to mate with the groove 38 extending along the inner perimeter of the side wall 34 on the neck portion 32 of the first compartment 20. The thread member 56 on the neck portion 50 of the second compartment 40 when inserted into the neck portion 32 of the first compartment 20 is prevented from stripping by the presence of the shoulder 28 on the top portion 26 of the first compartment 20.
The top portion 60 of the second compartment 40 comprises a shoulder 62 and an opening 64 having a neck portion 66. The neck portion 66 comprises a continuous side wall 68 which extends upwardly radially around the opening 64. The side wall 68 comprises a lip 70 at the terminal end and a thread member 72 extending along the outer perimeter of the side wall 68.
The combination of the neck portion 66, continuous side wall 68, and lip 70 create a pouring spout 74 on the top portion 60 of the second compartment 40. The pouring spout 74 is alternatively termed as angular mouth. The pouring spout 74 may have any shape provided it allows an pharmaceutical dosage form to be discharged therefrom. Preferably, the pouring spout 74 has a shape that facilitates pouring of the pharmaceutical dosage form. Preferably, the lip 70 on the pouring spout 74 has a “v” shape when viewed in one hemisphere.
In one embodiment of the invention, the second compartment has an round mouth for dispensing of the pharmaceutical dosage form after mixing.
The closure cap 80 comprises a top portion 82 having an outer end 84 with a cylindrical skirt portion 86 extending downwardly from the outer end 64. In a preferred embodiment, the top portion 82 of the closure cap 80 has a slidable channel, and the skirt portion 86 of the closure cap 80 has an outwardly extending tab 85 for ease of gripping by a user. The closure cap 80 when screwed in place on the neck portion 66 on top portion 60 of the second compartment 40 prevents any substantial evaporation or leakage of the pharmaceutical dosage form or ingredients from the opening 64 on top portion 60 of the second compartment 40. In a preferred embodiment of the closure cap 80, the interior of the skirt portion 86 comprises groove member 88 set up to receive thread member 72 on the exterior of the neck portion 66 on the top portion 60 of the second compartment 40. The groove member 88 on the interior of the skirt portion 86 of the closure cap 80 when mated with the thread member 72 on the neck portion 66 of the second compartment 60 is prevented from stripping by the presence of the shoulder 62 on the top portion 60 of the second compartment 40.
Optionally, a cup 90 is mounted on either the top portion 60 of the second compartment 40 or is mounted on the top portion 82 of the closure cap 80. In a preferred embodiment, the cup 90 is mounted to the top portion 82 of the closure cap 80 by means of the slidable channel located on the top portion 82 of the closure cap 80. The cup 90 comprises a base 92, a continuous side wall 94, and a rim 96. In a preferred embodiment, the cup 90 is a transparent measuring cup having a series of scale marks 98 at different heights on the outer perimeter of the continuous side wall 94. The scale marks 98 assist in administering a specific amount of the pharmaceutical dosage form according to the invention. In a preferred embodiment, the cup 90 has an inner radius 99 large enough for a finger bottom at the intersection where the bottom and sidewall planes meet. The inner radius 99 is preferably smooth to provide easy cleaning after administration of the pharmaceutical dosage form according to the invention. In a preferred embodiment, the continuous sidewall 94 of the measuring cup 90 has an outwardly extending tab 95 for ease of gripping by a user. More preferably, in a closed position, the outwardly extending tab 95 on the cup 90 is in alignment with the outwardly extending tab 85 on the closure cap 80.
The first compartment 20 and the second compartment 40 of the dual compartment container 10 according to the invention may contain any combination of ingredients in the form of solids, liquids, and or semisolids to form the pharmaceutical dosage forms according to the invention. It is within the scope of the invention that the first compartment 20 and the second compartment 40 independently contain a liquid, solid, or a combination of liquid and solid ingredients used to form the pharmaceutical dosage form upon mixing the ingredients in the first compartment 20 and the second compartment 40. In a preferred embodiment, a dry powder is packaged in the first compartment 20 and a liquid for reconstitution is packaged in the second compartment 40 of the dual compartment container 10.
The components of the dual compartment container 10 according to the invention may be prepared from any material provided the material is safe for use, adequately protects the pharmaceutical dosage form, and is compatible with the pharmaceutical dosage form. From a chemical perspective, the material used to prepare the container should be such that the ingredients of the pharmaceutical dosage form are not adsorbed onto the surface of the material, are not absorbed into the body of the material, and do not migrate through the material (compatibility). Further, the material used to prepare the dual compartment container 10 should not release substances that can accumulate in the pharmaceutical dosage form in quantities sufficient to affect its stability (which addresses compatibility) or to present a risk of toxicity (which addresses safety). Preferably, components of the dual compartment container 10 are prepared using a polymer selected from polyethylene, polypropylene, acetal, acrylic, polyamide, polyvinyl chloride, polystyrene, polycarbonate, acrylonitrile butadiene styrene, polyethylene terephthalate, and the like. Most preferably, the components of the dual compartment container closure system are prepared from high density polyethylene (“HDPE”) which is noted for its strong moisture barrier properties. In addition to the polymer used to prepare components of the dual compartment container 10, other additives may be used in the manufacture of such components such as plasticizers, fillers, antioxidants, etc. Preferably, components of the dual compartment container 10 are prepared by co-extrusion or injection molding.
The material of the closure cap may be prepared from any material provided the material is safe for use, adequately protects the pharmaceutical dosage form, and is compatible with the pharmaceutical dosage form. In case of injectable products, the closure cap may be prepared from a material having a capability of resealing itself and maintaining the sterility of the contents.
The foregoing description, for purposes of explanation, used specific nomenclature to provide a thorough understanding of the described embodiments. However, it will be apparent to one skilled in the art that the specific details are not required in order to practice the described embodiments. Thus, the foregoing descriptions of the specific embodiments described herein are presented for purposes of illustration and description. They are not target to be exhaustive or to limit the embodiments to the precise forms disclosed. It will be apparent to one of ordinary skill in the art that many modifications and variations are possible in view of the above teachings.
The advantages of the embodiments described are numerous. Different aspects, embodiments or implementations can yield one or more of the aforementioned advantages. Many features and advantages of the present embodiments are apparent from the written description and, thus, it is intended by the appended claims to cover all such features and advantages of the invention. Further, since numerous modifications and changes will readily occur to those skilled in the art, the embodiments should not be limited to the exact construction and operation as illustrated and described. Hence, all suitable modifications and equivalents can be resorted to as falling within the scope of the invention.

,CLAIMS:WE CLAIM:

1. A dual compartment container comprising:
(a) a first compartment comprising a continuous side wall, a closed bottom, and a top portion, wherein said top portion comprises an opening;
(b) a second compartment comprising a continuous side wall, a bottom portion, and a top portion, wherein said bottom portion and said top portion comprise an opening;
(c) a passageway for connecting the opening in the top of the first compartment with the opening in the bottom of the second compartment;
(d) atleast one frangible seal sealing the passageway between the first compartment and the second compartment, and
(e) a closure cap mounted on top of the second compartment.
f) optionally a cup releasably mounted on the closure cap.
2. A method of preparing a pharmaceutical dosage form suitable for administration, said method comprising:
(A) providing a dual compartment container for retaining separate ingredients of a pharmaceutical dosage form and facilitating their mixture just before use, said dual compartment container comprising:
(a) a first compartment comprising a continuous side wall, a closed bottom, and a top portion, wherein said top portion comprises an opening;
(b) a second compartment comprising a continuous side wall, a bottom portion, and a top portion, wherein said bottom portion and said top portion comprise an opening;
(c) a passageway for connecting the opening in the top of the first compartment with the opening in the bottom of the second compartment;
(d) atleast one frangible seal sealing the passageway between the first compartment and the second compartment, and
(e) a closure cap mounted on top of the second compartment;
f) optionally a cup releasably mounted on the closure cap.
(B) rotating at least one of the first compartment or the second compartment relative to the other compartment to breach the frangible seal allowing mixing of the contents in the first compartment and the second compartment to form a pharmaceutical dosage form.

3. The frangible seal as claimed in preceding claims wherein said frangible seal is attached to the first compartment or second compartment.

4. The frangible seal as claimed in claim 3 wherein said frangible seal comprises weakened sections for easy piercing.

5. The frangible seal as claimed in claim 4 wherein said frangible seal is breached in a definite pattern without falling into the dual compartment container.

6. The frangible seal as claimed in preceding claims wherein said frangible seal is of sufficient strength to remain intact and retain an ingredient in the first compartment separate from an ingredient in the second compartment until relative rotation of the first compartment and the second compartment breaches the frangible seal allowing mixing of the ingredients in the first compartment and the second compartment.

7. The dual compartment container as claimed in preceding claims wherein first or second compartment further comprises atleast one tearing mechanism for breaching the frangible seal.

8. The dual compartment as claimed in preceding claims wherein the second compartment comprises an angular mouth for easy and drip-free dispensing of the pharmaceutical dosage form after mixing.

9. The dual compartment container as claimed in claim 1 or claim 2 wherein the first compartment and the second compartment are prepared using a polymer selected from low density polyethylene, high density polyethylene, polypropylene, acetal, acrylic, polyamide, polyvinyl chloride, polystyrene, polycarbonate, acrylonitrile butadiene styrene, polyethylene terephthalate, and combinations thereof.

10. The dual compartment container as claimed in claim 9 wherein the first compartment and the second compartment are prepared using high density polyethylene.