DESC:FIELD OF THE INVENTION:
The present invention is a snap-on cap or closure container for dispensing a liquid pharmaceutical composition intended for ophthalmic administration. The container system comprises (a) a reservoir bottle; (b) a liquid pharmaceutical composition disposed in said bottle; and (c) a closure or cap assembly unit for sealing the bottle. Particularly, disclosed is a cap or closure assembly unit comprising a cap or closure and a drop dispenser, wherein the drop dispenser is screwed into the cap, and then snap fitted onto the container.
BACKGROUND OF INVENTION:
Various liquid drug dispensers or containers having a liquid pharmaceutical composition have been in commercial use for decades. Typically, the drug delivery system (container or bottle) used commonly in ophthalmic is a plastic container closure system (primary packaging material) which comprises three components i.e., a liquid container or bottle, a dropper, and a cap, often integrated with a tamper-evident closure. Patient can self-administer the liquid drugs by squeezing the liquid container and few drops (1 to 2) will be used to achieve the desired effect.
As discussed supra, the prior art container closure system is assembled with three different stages during liquid filling and capping operations. (1) stage I: filling liquid into the container; (2) stage II: placement of dropper with the container, and (3) stage III: closure assembly with container & dropper. Sometimes, the dropper is fixed or fitted with cap and this assembly is then screwed onto the container. However, the problem associated with assembling the plastic container closure system is the uneven position and inconsistent force or torque (vertical and horizontal) applied while screwing or torquing tamper evident closure into the container. This results in either the loose or tight fitment of the components. The loose fitment of the components leads to product leakage and on the other side, the excessive fitment would create in-built physical stress and breakage in plastic components; therefore, the ultimate result is failure in package seal integrity and sterility. Further, the above stated invisible defects cannot be 100% detected during the online production process and are even difficult to encounter during offline testing of the randomly selected samples for visual inspection and leak testing as a part of in the process quality test. The inappropriate fitment of container closure system, slight inaccuracies or marks in container neck profile form a capillary and clear path for bacteria and fungi to transfer into the product. This is the most common and most difficult container defect to detect and remains hidden beneath the closure once it is applied.
Additionally, after each use, the user or patient have to screw-on the cap or closure on the container. The ophthalmic drug product is often packed in small round shape plastic containers with caps. The limited surface area available and tapering cap profiles makes it difficult to grip repeatably and across a broad spectrum of patients. This issue becomes amplified if the drug product is intended for use by elderly patients or patients with reduced dexterity and if the closure becomes too tightly closed with excessive torque on the containers.
To solve this problem, Aptar has developed a snap-on closure container where the closure fitted with drop dispenser is snap fixed on the container and patients must pull the cap instead of unscrewing it from the container in-order to expose the drop dispenser (https://www.aptar.com/products/pharmaceutical/ophthalmic-squeeze-dispenser-technology-platform/). But there are some problems with this system: (1) patients are not used to snap on caps and will find them confusing as compared to screw caps, (2) sometimes the cap becomes too loose after repeated use meaning it has ceased to seal hermetically and could come off when carried in a purse or bag, (3) due to the snap fit , hygiene of the bottle may be conceded, (4) snap on cap are less preferred when the dosage is more than 2 times a day, as it fails to ensure an integrated container closure system due to loose fitment.
The inventors of the instant invention have found a way to address the problems associated with the prior art. Inventors developed a component comprising screw cap or closure, where a drop dispenser is screwed into the cap and this component is then snap fitted on to container. With this, the problems associated with screwing the cap on container have been solved. Further, the instant arrangement is easy to use for patients who must unscrew the cap to expose the drop dispenser. The robustness of the screw cap makes patients feel more comfortable while carrying it in a bag as it feels more secure. The cap does not become loose even after repeated use as it is sealed hermetically and does not come off when carried in a purse or bag. Hygiene of the bottle is, once closed, ensured due to screw cap. Screw cap are preferable when the dosage is more than 2 times a day, as it ensures integrated container closure system.

SUMMARY OF INVENTION:
Disclosed herein is a snap-on cap or closure container for dispensing a liquid pharmaceutical composition for ophthalmic administration. Specifically, disclosed is a cap or closure assembly unit comprising a cap or closure and a drop dispenser, wherein the drop dispenser is screwed into the cap, and then snap fitted onto the container.
BRIEF SUMMARY OF FIGURES:
Figure 1: It shows the various components of snap-on cap container.
Figure 2: It shows the complete container once all the components are assembled.
Figure 3: Transverse section of snap-on cap container of figure 2.

DETAILED DESCRIPTION:
Disclosed herein is a snap-on cap or closure container for dispensing a liquid pharmaceutical composition for ophthalmic administration. Specifically, disclosed is a cap or closure assembly unit comprising a cap or closure and a drop dispenser, wherein the drop dispenser is screwed into the cap, and then snap fitted onto the container. With this, the problems associated with screwing the cap on container have been solved. Further, the instant arrangement is easy to use for patients who must unscrew the cap to expose the drop dispenser. The robustness of screw cap makes patient feel more comfortable while carrying it in a bag as it feels more secure. The cap does not become loose even after repeated use as it is sealed hermetically and does not come off when carried in a purse or bag. Hygiene of the bottle is, once closed, ensured due to screw cap. Screw cap are preferable when the dosage is more than 2 times a day, as it ensures an integrated container closure system.
In a first embodiment of the invention, disclosed is a kit for dispensing a liquid pharmaceutical composition for ophthalmic administration comprising a container system. The container system comprises (a) a reservoir bottle which can be squeezed, (b) a liquid pharmaceutical composition is disposed within the reservoir bottle; and (c) a closure or cap assembly unit for sealing the container.
The closure or cap assembly unit comprises the closure or cap and a dispensing dropper. The dispensing dropper is fitted into the closure or cap. In further embodiment, the built-in drop dispenser is fitted into the cap or closure by means of screws. The built-in drop dispenser comprises a nozzle with nozzle orifice at the proximal side and this part fits into cap or closure. The built-in drop dispenser is having threads or screw around the circumference which fit into grooves formed inside the cap. In further embodiment, the closure or cap assembly unit is formed separately where built-in drop dispenser is fitted or fixed inside the closure or cap using screw formed onto drop dispenser. This assembly unit is then ready to snap fitted onto container bottle having reservoir.
In another embodiment of the invention, disclosed is a kit for dispensing a liquid pharmaceutical composition for an ophthalmic administration comprising a container system. The container system comprises of (a) reservoir bottle which can be squeezed, (b) the liquid pharmaceutical composition is disposed within the reservoir bottle, (c) closure or cap assembly unit for sealing the container comprising closure or cap and dispensing dropper.
In yet another embodiment, disclosed is a container system comprising of (a) reservoir bottle which can be squeezed, (b) the liquid pharmaceutical composition is disposed within the reservoir bottle, (c) closure or cap assembly unit for sealing the container comprising closure or cap and dispensing dropper.
In yet another embodiment, disclosed is a container system comprising a reservoir bottle having a specific volume. The capacity of reservoir bottle (fill volume) varies from 5 ml up to 15 ml. The reservoir bottle has a neck with an open end (end where dispensing dropper fits). Further the neck has a collar which is formed circumferentially which helps in snap fitting of cap or closure. The reservoir can be made from different materials such as plastic or glass and it may be either transparent or opaque depending on the property of the liquid pharmaceutical composition.
In yet another embodiment, disclosed is a container system which comprises a dropper dispenser. The dropper dispenser has a dispenser base which snap-fits onto the neck of the reservoir bottle. The circular portion above the dispenser base has screws or threads. The screws or threads are either single or double or multiple circular threads. The proximal part of the dropper dispenser is having nozzle for dispensing the liquid pharmaceutical composition. The nozzle has decreased diameter toward a tip opening. The tip of nozzle has smooth surface and aids in formation of a droplet size are between about 10 µl and about 50 µl. In one embodiment, the dropper delivers the desired drop size ranging from 30 to 70 µl.
In still another embodiment, disclosed is a container system which comprises closure or cap. Generally, the function of a cap is to protect or seal the container from exposure to external environment. The cap comprises grooves inside the inner circumference which matches with the threads or screws on the dispensing dropper so that dispensing dropper can screw fit in, and patient can access the nozzle by unscrewing it. In one embodiment, the cap comprises a bottom surface which has a protrusion in the center which fits into the aperture formed in the built-in drop dispenser nozzle. The function of this protrusion is to form a seal so that microbial contamination of the pharmaceutical composition is prevented during the usage of the container. In one embodiment, the diameter of the protrusion is lesser than the diameter of the aperture formed in the built-in drop dispenser nozzle.
More specifically, the invention is a two-component system, wherein component one comprises cap or closure screw fitted with built-in drop dispenser and the component two comprises of reservoir bottle, where the built-in drop dispenser of component one is snap fitted with reservoir bottle, and wherein this way of preparing container system for ophthalmic administration prevents breaking of cap or closure while assembling and hence very economical way of making such containers.
Figure 1 discloses exploded view of container system comprising of reservoir bottle 1 which can be squeezed, the liquid pharmaceutical composition is disposed within the reservoir bottle, and closure or cap assembly unit for sealing the container comprising closure or cap 2 and dispensing dropper 3. The reservoir bottle has a neck 7 with an open end at the proximal end (end where dispensing dropper fits). Further the neck has a circumferentially formed collar 6 which helps in snap fitting of cap or closure.
The dispensing dropper 3 is fitted into the closure or cap 2. In further embodiment, the built-in drop dispenser is fitted into the cap or closure by means of screws 5. The built-in drop dispenser comprises nozzle 4 with nozzle orifice 11 at the proximal side and this part fits into cap or closure protrusion 9. The built-in drop dispenser is having threads or screw 5 around the circumference which fits into grooves formed inside the cap. In further embodiment, the closure or cap assembly unit is formed separately where built-in drop dispenser is fitted or fixed inside the closure or cap using screw formed onto drop dispenser. This assembly unit is then ready to snap fitted onto container bottle having reservoir.
Figure 2 discloses fully assembled container system 15 comprising of reservoir bottle 1 which can be squeezed, the liquid pharmaceutical composition is disposed within the reservoir bottle, closure, or cap assembly unit for sealing the container comprising closure or cap 2 and dispensing dropper 3.
Figure 3 discloses transverse section of fully assembled container system 15 of figure 2 comprising a reservoir bottle 14 having a specific volume. The capacity of reservoir bottle (fill volume) varies from 5 ml up to 15 ml. The reservoir bottle has a neck 12 with an open end at the proximal end (end where dispensing dropper fits). Further the neck has a circumferentially formed collar 13 which helps in snap fitting of cap or closure. The reservoir can be made from different materials such as plastic or glass and it may be either transparent or opaque depending on the property of the liquid pharmaceutical composition. The dropper dispenser 3 has a dispenser base which snap-fits onto the neck 12 of the reservoir bottle. The circular portion above the dispenser base has screws or threads 5. The screws or threads are either single or double or multiple circular threads. The proximal part of the dropper dispenser is having nozzle 11 for dispensing the liquid pharmaceutical composition. The nozzle has decreased diameter toward a tip opening. The tip of nozzle is smooth surface and aids in formation of a droplet size is between about 10 µl and about 50 µl. In one embodiment, the dropper delivers the desired drop size ranging from 30 to 70 µl. The cap 8 comprises grooves 10 inside the inner circumference which matches with the threads or screws 5 on the dispensing dropper so that dispensing dropper can screw fit in, and patient can access the nozzle by unscrewing it. In one embodiment, the cap comprises a bottom surface 16 which has a protrusion 9 in the center which fits into the aperture 17 formed in the built-in drop dispenser nozzle 11. The function of this protrusion is to form a seal so that microbial contamination of the pharmaceutical composition is prevented during the usage of the container. In one embodiment, the diameter of the protrusion is lesser than the diameter of the aperture formed in the dispenser nozzle.
In another embodiment, disclosed are the processes of preparing container system of the invention. The container, according to figure1 will have a round tab while integrated dropper or closure (cap) will have a round cavity of approximately same diameter. The cap with integrated dropper can be snapped on to the container with forces of 40-200N. The cap portion of the integrated cap or dropper will be able to screw on and off, to facilitate patient use. On the inside of the cap, there will a be conical or cylindrical protrusion, that matches the profile of the dropper orifice. In yet another embodiment, cap with an inbuilt dropper may have an O-ring (molded or otherwise) to ensure a tight seal once assembled with container. On a fully assembled drug delivery device, the cap can be removed by unscrewing action. After use, the same cap can be placed back upon the dropper portion of assembled device. In one embodiment, there will be a nub or hump along the screw thread profile that matches the optimal travel distance of the cap onto the dropper (i.e., optimal insertion of internal protrusion in cap in dropper orifice, to seal the container). As the user crosses over this nub or hump, user will get tactile feedback that cap is optimally placed, and closure integrity is achieved. This will prevent misuses (over or under torquing of cap). In another embodiment, there will be round tab or step along the length of dropper surface. The cap will have to slide or snapped over it for each removal and placement back. The step diameters and design will ensure tactile confirmation to user and sufficient resistance to accidental removal.
In yet another embodiment, depending on the filling assembly line that is automatic or manual, the design may vary. The assembly force from dispenser on bottle is dependent on assembly speed; approximately assembly load is 270-330 N. Further, to verify the correct capping process the leak test in accordance with product specification can be performed to evaluate the sealing between container and closure. It involves “two -step” operations of filling & capping containers with press fit mechanism. There is no need for assembly torque and vertical force for capping containers. It also eliminates the additional process of dropper assembly. Further, the process is less time-consuming by assembling the packaging components, thus increasing the production output. Also, there is minimum handling of sterile components (plastic container and closure with inbuilt dropper) in the production line. The closure is a tamper evident ring; it is difficult to separate it out from container without destruction. It provides better seal integrity as closure locks the container in 360 degrees of perimeter. The said invention reduces the number of packaging components that optimize the cost and inventory of the material.
The invention is disclosed using below specific but not limiting, embodiments.
In an embodiment, disclosed is a kit for dispensing a liquid pharmaceutical composition for ophthalmic administration comprising a container system; wherein the container system comprises: (a) a reservoir bottle which can be squeezed, (b) the liquid pharmaceutical composition disposed within the reservoir bottle; and (c) a closure or cap assembly unit for sealing the container.
The kit according to the above embodiment, wherein the reservoir bottle has a neck, and the neck has a collar which is formed circumferentially which helps in snap fitting of the cap or closure assembly unit.
The kit according to the above embodiment, wherein the closure or cap assembly unit comprises (a) a built-in drop dispenser and (b) a closure or cap.
The kit according to the above embodiment, wherein the built-in drop dispenser is fitted inside the cap or closure and said drop dispenser having a dispenser base which snap-fits onto the neck of the reservoir bottle; wherein the drop dispenser delivers a desired drop size ranging from 30 to 70 µl.
The kit according to the above embodiment, wherein the built-in drop dispenser has a screw or threads on some portion of the dispenser base towards a nozzle.
The kit according to the above embodiment, wherein the closure or cap comprises grooves and said grooves are formed inside the inner circumference of the closure or cap, and wherein the grooves of closure or cap screw fits onto the threads or screws on the drop dispenser.
The kit according to the above embodiment, wherein the closure or cap has a bottom surface having a protrusion that fits into an aperture of the nozzle of drop dispenser.

CLAIMS:

1. A kit for dispensing a liquid pharmaceutical composition for ophthalmic administration comprising a container system; wherein the container system comprises: (a) a reservoir bottle which can be squeezed, (b) the liquid pharmaceutical composition disposed within the reservoir bottle; and (c) a closure or cap assembly unit for sealing the container.

2. The kit according to claim 1, wherein the reservoir bottle has a neck, and the neck has a collar which is formed circumferentially which helps in snap fitting of the cap or closure assembly unit.

3. The kit according to claim 2, wherein the closure or cap assembly unit comprises (a) a built-in drop dispenser and (b) a closure or cap.

4. The kit according to claim 3, wherein the built-in drop dispenser is fitted inside the cap or closure and said drop dispenser having a dispenser base which snap-fits onto the neck of the reservoir bottle; wherein the drop dispenser delivers a desired drop size ranging from 30 to 70 µl.

5. The kit according to claim 4, wherein the built-in drop dispenser has a screw or threads on some portion of the dispenser base towards a nozzle.

6. The kit according to claim 3, wherein the closure or cap comprises grooves and said grooves are formed inside the inner circumference of the closure or cap, and wherein the grooves of closure or cap screw fits onto the threads or screws on the drop dispenser.

7. The kit according to claim 6, wherein the closure or cap has a bottom surface having a protrusion that fits into an aperture of the nozzle of drop dispenser.