FIELD OF INVENTION
The present invention relates to a superior ergonomically designed angular dispensing pack for topical products. The dispensing pack of the present invention offers the advantages of reduced risk of contamination, reduced wastage, user-friendly, tamper evident pack as well as improved targeted delivery in comparison to conventional packing systems for topical powdered products. The said angular pack design is suitable for treatment of localized disorders such as skin infections and the like or for other applications such as cosmetic purposes.
BACKGROUND OF THE INVENTION
It has been observed that sometimes patients do not comply with their prescribed treatment regimen of administering the drug to the skin due to difficulty in measuring the precise amount and ensuring accurate dose of therapeutic drug, which is very important in order to achieve desired effect. Further, in case of topical formulations, it is important to ensure that the drug should come in contact with only the affected skin area, especially if the drug is potent or have side effects. Thus, there exists a need to provide a dermal administration that alleviates the above problems and enables the patient to conveniently administer the therapeutic drug accurately to a desired skin area without exposure to undesired skin areas.
Conventional packaging systems for dispensing of powders comprise a straight plastic container with a disk having certain holes. However, these type of packages are meant for straight direction dispensing and miss the targeted site such as disease affected areas. Also, at times those packages are not convenient to dispense at the back of body of consumer or patient and a lot of material such as powder goes wasted.
The present inventors after conducting a large number of trials involving minute adjustments in dimensions of threads and other parameters have prepared a new unique integrated pack design that is a significant improvement over conventional packaging systems. The angular pack by its innovative shape and design solves the existing consumer issues as well as commercial challenges, besides providing aesthetic value at the point of sale. The said package design involves the concept of combination of straight container with angular top attachment. This pack also provides the advantage of ease-in shop floor operation.
SUMMARY OF THE INVENTION

The present invention provides a dispensing pack comprising a container filled with a powder composition comprising clotrimazole and pharmaceutically acceptable excipients, an angular cap fitted onto the container and optionally a top cap, wherein the angular cap is designed to be fitted onto the container at an angle from 20° to 40 with horizontal axis and at an angle from 50° to 75° with vertical axis.
BRIEF DESCRIPTION OF THE DRAWINGS
Figure 1: Schematic diagram showing the angular dispensing pack; 1 represents angular cap, 2
represents container, 3 and 4 represent top cap, 5 represents sifter and 6 represents powder
composition.
Figure 2: Schematic diagram showing the angular cap; 1 represents sifter and 2 represents body of
angular cap.
Figure 3: Schematic diagram showing the container and outline of angular cap; 1 represents sifter,
2 represents chimney channels, 3 represent angular cap, 4 represent container and 5 represents
powder composition.
Figure 4: Schematic diagram showing outer view and inner view of the sifter; 1 represents outer
view of the sifter with hole, 2 represent inner view of sifter with hole, 3 represents inner view of
sifter with depressions which provides resting positions for outlets of chimneys when not in use.
Figure 5: Cross-section diagram of the angular cap and container. 1 represents one of chimneys, 2
represents neck of angular cap, 3 represents container and 4 represents angular cap.
DETAILED DESCRIPTION OF THE INVENTION
First aspect of the present invention provides a dispensing pack comprising
i) a container filled with a powder composition comprising clotrimazole and pharmaceutically
acceptable excipients; ii) an angular cap fitted onto the container; iii) optionally a top cap,
wherein the angular cap is designed to be fitted onto the container at an angle from 20° to 40° with
horizontal axis and at an angle from 50° to 75° with vertical axis.
In one particular embodiment, the dispensing pack includes a container filled with a powder composition comprising clotrimazole and pharmaceutically acceptable excipients, an angular cap comprising a sifter having chimney channels for outflow of the powder composition of

clotrimazole and pharmaceutical^ acceptable excipients. The sifter at its bottom surface includes depressions which coincide with the position for channels of chimneys when not in use and therefore acts like the locking mean.
In one specific embodiment, the angular cap is fitted to the container in a detachable manner and in other embodiments it is fixedly fitted into the container. According to one embodiment, the angular cap is having chimneys for outflow of the powder from the container wherein the chimney is a vertical channel like structure connecting the interior of the container with the exterior environment. In a preferred embodiment, dispensing pack comprises at least three chimneys for outflow of the powder from the container wherein the each chimney is designed to be fitted in the angular pack at an angle from 20°to 40° with horizontal axis and from 50° to 75° with vertical axis. In one specific embodiment, the angular cap is having at least three chimneys with channels for outflow of the powder from the container. In one yet another specific embodiment, inner diameter of each chimney ranges from 0.5 mm to 10 mm, preferably 1 mm to 10 mm and the height of the each chimney channel ranges from 2 mm to 20 mm. In another embodiment, the angular cap comprises four chimneys, wherein the inner diameter of each chimney channel ranges from 1 mm to 2 mm. In another embodiment, the angular cap comprises of five chimneys, wherein the inner diameter of each chimney ranges from 0.5 mm to 2 mm. In one of the embodiments, the height of each chimney ranges from 2 mm to 20 mm. According to yet another embodiment, the dispensing pack comprises five chimneys, the distance between each chimney ranges from 6 mm to 10 mm. it may be noted that the angular cap is made through complex molding process involving minute measurements for appropriate fitment. The complex molding process helps to build up integrated anti-counterfeiting mechanism in a cost effective manner.
In another aspect of the present invention, the outflow of powder composition from the chimney channel is controlled with the help of sifter snap-fitted on to the mouth of chimney well or also refened to as a channel. This sifter controls the dispensing by sliding it in clockwise and anti-clockwise direction. The design of the neck of the angular cap allows the sifter to fit easily and does not permit it to detach easily. Platform and threads help in smooth functioning of the sifter and snap fitting it on the angular cap as well as during dispensing of the powder. In one of the embodiments, the dispensing pack comprises a sifter comprising three holes, wherein the diameter of each hole ranges from 2 mm to 3 mm. In another embodiment, the dispensing pack comprises a sifter comprising four holes, wherein the diameter of each hole ranges from 1 mm to 3 mm. In yet another embodiment, the dispensing pack comprises a sifter comprising five holes, wherein the diameter of each hole ranges from 1 mm to 2 mm. In the one specific embodiment of the present

invention, the dispensing pack comprises a sifter, wherein the bottom side of the sifter comprises small protrusions which coincide with the chimneys of the angular cap. In this manner, the pack is activated when the sifter is rotated to unlock the chimneys at the time of dispensing the powder. It acts as an opening and closing gate for dispensing of the powdered product. The sifter is kept in a closed position during transit or when not in use by the user. According to one of the embodiments of the above aspect, the dispensing pack comprises a sifter comprising three holes, the distance between each hole ranges from 10 mm to 12 mm. According to another embodiment of the above aspect, the dispensing pack comprises a sifter comprising four holes, the distance between each hole ranges from 8 mm to 12 mm. According to yet another embodiment of the above aspect, the dispensing pack comprises a sifter comprising five holes, the distance between each hole ranges from 6 mm to 10 mm. According to one of the embodiments, the sifter can be made tamper-evident with a break-away ring attached to the skirt of the sifter.
It is possible to have a roll-on ball or a sponge fitted onto the chimneys of the angular cap according to one specific embodiment. The triangular cap is designed suitably, which is to be snap fitted on to the angular cap. The cap comprises hollow triangular cylindrical body and a round concentric central shaft which fits the dispensing orifice. The Inner portion of the longer corner side of the cap contain two ribs which are guided and slidable within the groove provided on the angular cap. There is a rib at the bottom portion of the skirt of the top cap comfortably tuck fitted in the profiled canal on the angular cap.
As per one embodiment of the present invention, the container is triangular in shape with rounded neck and orifice having appropriate mechanism to snap fit the angular top. The upper part of container is sized to form a conical rim having a dispensing orifice. In a preferred embodiment, the diameter of orifice of the container is in the range of 10 mm to 50 mm. According to one embodiment of above aspect, the triangular container of the package contains a blunt depression on a side that arrests the movement of angular cap which is difficult to detach during transportation or usage by customer or patient. This blunt depression acts as a guide to snap fit the cap after powder filling operation. The proper alignment of declined portion of the angular cap and blunt depression of the container is required for perfect capping. According to another embodiment of above aspect, the container comprises at least two platforms on the outer diameter.
According to one embodiment, the container has a capacity of 30g to 500g. The dispensing orifice of the container fits into the concentric central shaft of angular cap and provides passage for dispensing of powdered product through chimney to holes of sifter. The bottom of the triangular container of the package has peripheral protrusions forming a triangular ridge which provides ease-

in shop floor operation. The container is made up of metal or glass or plastic and can be of various shapes such as triangular, cylindrical, rectangular, oval, round, oblong and tapered. In one of the embodiments, the plastic materials used in the preparation of container can be selected from the group consisting of high-density polyethylene (HDPE), low-density polyethylene (LDPE), polyethylene terephthalate (PET) or metal. The plastic container can be squeezable such that material can be removed easily without the need to invert it. The container can be affixed with different type of labels such as primary labels, shrink labels, pressure-sensitive labels, reseal labels, tamper-evident labels, roll-fed labels and the like. The container further contains two platforms on the outer diameter of the container to rest the outer path of the angular cap and avoid slippage. The dimensions of the dispensing system are designed in a way to deliver the composition with a targeted delivery to the desired skin areas.
The top cap or dust cap of the packaging system is to shield the contents of the container from the outside environment and for closing the dispensing unit which is triangular in shape. The dust cap can be made of any suitable material such as plastic or metal. According to one embodiment, the top cap is snap-fitted or screw-fitted onto the angular cap. In one of the embodiments, the top cap comprises one side longer than the other two sides of the cap, wherein the longer side is inclined inward at an angle ranging from 55° to 60 .
The powder composition filled into the dispensing pack of the present invention comprises clotrimazole as an active ingredient. Clotrimazole is prescribed to treat athlete's foot, ringworm and jock itch. Clotrimazole may cause side effects like redness, irritation, itching and burning sensation to the patients. The improved dispensing pack of the present invention allows dusting of the powder composition of clotrimazole onto the affected skin areas only and not on the unwanted healthy skin. The dispensing pack enables to dust the medicament conveniently, allows localized application and thereby reduces the wastage. It may be important to note that the dispensing pack of the present invention minimizes the puffing out the powder through neck of the container by creating a path towards chimney. This provides the advantage of smooth passage for the product to flow out from chimney and the container orifice. The components of the dispensing system used in the present invention are made of materials which are compatible for moulding process and as required for proper fitment. The components used in the pack are compatible with the composition. It was found to have no degradation of the powder composition of clotrimazole.

According to another embodiment, it is possible to include another powder medicament along with clotrimazole. In one specific embodiment, the powder composition comprises clotrimazole l%w/w, starch, talc, sodium starch glycollate and perfume.
The term "topical," as used herein, refers to a composition meant for application to the skin, scalp,
nail, or mucosal tissue.
The term "stable", as used herein, refers to chemical stability, wherein not more than 5% of total
related substances are formed on storage at 40°C and 75% relative humidity (R.H.) or at 25°C and
60% R.H. for a period of at least three months.
Various experiments on the package of present invention are performed such as stability test,
bloom effect (dispensing pattern) and dispensing capacity.
Bloom Effect (Dispensing Pattern Comparison) Experiment:
The bloom effect i.e. dispensing pattern comparison is revealed by an experiment wherein powder composition from dispensing pack is sprayed on a black paper. The spray pattern of present angular dispensing package is compared with conventional powder dispensing pack. The results obtained have indicated that dispensing from package of the present invention is quite consistent and non-messy in comparison to conventional pack. The dispensing pattern comparison is revealed by images (side and top dispensing) as shown in Figure 5. It has been observed from the comparison of the two spray patterns that the angular pack system of the present invention provides a focused and targeted delivery and thus reduces the wastage of powdered material.

claim:
1. A dispensing pack comprising
i) a container filled with a powder composition comprising clotrimazole and pharmaceutically acceptable excipients;
ii) an angular cap fitted onto the container;
iii) optionally, a top cap. wherein the angular cap is designed to be fitted onto the container at an angle from 20° to 40° with horizontal axis and at an angle from 50° to 75° with vertical axis.
2. A dispensing pack as claimed in claim 1 wherein the angular cap is having at least three chimneys for outflow of the powder from the container.
3. A dispensing pack as claimed in claim 1 wherein the inner diameter of each chimney ranges from 0.5 mm to 2 mm.
4. A dispensing pack as claimed in claim 1 wherein the height of the each chimney ranges from 2 mm to 20 mm.
5. A dispensing pack as claimed in claim 1 wherein the each chimney is designed to be fitted in the angular cap at an angle from 20° to 40° with horizontal axis and at an angle from 50° to 75° with vertical axis.
6. A dispensing pack as claimed in claim 1 wherein the top cap has a sifter that has holes coinciding with the chimneys when the pack is activated for dispensing the powder.
7. A dispensing pack as claimed in claim 6, wherein sifter comprises three, four or five holes, and distance between the holes ranges from 10 mm to 12 mm, 8 mm to 12 mm, and 6 mm to 10 mm respectively.
8. A dispensing pack according to claim 1, wherein container is triangular with rounded neck and orifice to snap fit the angular top.
9. A dispensing pack according to claim 1, wherein the container has a capacity of 30g to 500g.