DESC:with solid dosage forms of pharmaceutical substances.
BACKGROUND
It is frequently necessary to store moisture sensitive materials for relatively long periods in containers and in such cases there are challenges to prevent degradation of 10 such materials. In a particular example, certain pharmaceutical substances are supplied and/or stored in containers containing one or more unit doses of the dry substance.
During storage the presence of atmospheric moisture within the container, or the ingress of atmospheric moisture, can cause decomposition of materials. Often 15 moisture sensitive pharmaceutical substances are provided in containers together with an internal desiccant, for example a small sachet of molecular sieve or silica gel.
Many drugs are typically bottled in an atmosphere of very low humidity to avoid absorption of moisture within the container. However, each time the bottle is opened by the consumer for removal of a portion of the contents, atmospheric air is admitted 20 to the container. This results in an increase in humidity within the bottle and eventual degradation of the contents. In order to maintain a moisture-free atmosphere within the bottle after it has been opened, packagers generally place therein a pill of desiccant material or a moisture-permeable capsule containing a desiccant. However,
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the danger always exists that the consumer may inadvertently remove or even take the desiccant pill or capsule. Intake of such materials can result in discomfort or serious illness. However, this approach is less and less accepted by the health authorities, patients and consumer because of the risk of accidental swallowing.
Consequently, there have been attempts for providing desiccant material in the 5 container such that it does not come in contact with the products contained in the container.
US Patent number 5114003 discloses a container in which the desiccant canister is secured to the inside at the base of the container and the desiccant canister is punctured immediately prior to use. Desiccants have also been integrated into product 10 packaging.
Although these containers and closures ensure that the desiccant remains in the package for the entire shelf life and eliminates the potential for accidental consumption by the user, every time the package is opened, the closure device or cap with the desiccant must be held separately until the product is taken out from the 15 container. This may lead to the cap being misplaced. Further, excessive moisture is let in upon opening the package and a smaller amount of desiccant will not be sufficient for a sustained period of storage.
Another requirement of a package is that it should be user-friendly for patients/consumer. These requirements have been fulfilled by flip-top or hinged 20 closures. US Patent number 5348201 and US Patent number 5417350 disclose flip top closure devices for a dispensing opening of a container. The closure devices have a first body member with a flip top adapted to be mounted on the container and a second body member mounted on the first body member.
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US Patent number 5992659 discloses a tamper evident flip top pouring closure for use with a container having a neck with an opening. The neck also has an outer surface with a screw thread and interlocking means thereon.
The inventors have now designed an improved package for moisture-sensitive products, that includes a ring canister with a built in desiccant, which will assist in 5 overcoming the above mentioned disadvantages.
SUMMARY OF THE INVENTION
It is an object of this invention to provide a ring canister with a built in desiccant for suitable container.
It is an object of this invention to provide a container having ring canister with a built 10 in desiccant, and more particularly to container incorporating desiccant materials or odor absorbents/oxygen scavengers, particularly to containers for moisture sensitive materials or odor masking products, particularly pharmaceutical substances. Other objects and advantages of the invention will be apparent from the following description. 15
BRIEF DESCRIPTION OF DRAWINGS
FIG. 1 illustrates the top, front and isometric view of ring canister with lid of the present invention.
FIG. 2 illustrates the bottom and isometric view from bottom of ring canister without lid of the present invention. 20
FIG. 3 illustrates top and isometric view of ring canister without lid of the present invention.
FIG. 4 illustrates assembly of ring with bottle without lid and top view with lid of the present invention.
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FIG. 5 illustrates assembly of ring with bottle with lid of the present invention.
FIG. 6 illustrates section view of assembly (Front) of the present invention.
FIG. 7 illustrates section view of assembly (Isometric) of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
The present invention provides a ring canister with a built in desiccant, which can be 5 fixed in a suitable container.
In one embodiment present invention provides a container having ring canister with a built in desiccant materials which would take care of moisture permeate through body wall of container/present in headspace/ cap entering into the container while opening of the container. 10
In another embodiment present invention provides a desiccated ring canister having a component with
a. concentric circular compartment with perforation; wherein the compartment having a desiccant or an oxygen scavenger; and
b. an angular top lid. 15
In yet another embodiment present invention provides a desiccated ring canister with a desiccant which is selected from silica gel, molecular sieve or their combination.
In other embodiment present invention provides a desiccated ring canister wherein filled canister sealed by snap fit manner or by adhesive or by heat seal or by welding with an angular top lid and placing the sealed canister inside the mouth (Neck) of 20 container.
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In another embodiment present invention provides a desiccated ring canister which is made of material such as wood, plastic, or metal, preferably with a plastic material.
The present invention further provides a container for storing of any moisture sensitive materials or odor absorbents/ oxygen scavengers, including pharmaceuticals such as tablets, capsules, granules and pallets. 5 The dimension (size and shape) of the ring canister can be changed according to requirement of quantity of desiccant to be filled inside ring canister and according to neck size and shape of container.
In the description above different components of the container has been described. It is to be understood that the components/parts used in the present invention can be 10 replaced by their technical equivalence and still the invention can be performed and therefore none of the components/parts of the container should be considered as a restriction. ADVANTAGES ? Built in desiccant of the present invention would help to eliminate one 15 production operation of canister (i.e. Insertion of canister separately in container) and thereby providing easy operation with superior protection from moisture. ? Another advantage of the present invention relates to safety, the desiccant will never come in contact with the product, hence eliminating the chances of 20 brittleness in capsule formulation along with lower chances of contamination thus reducing the risk of intake of desiccant pills, sachets or canisters by consumers
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? The ring canister desiccant container of the present invention suitable or can be fitted with any type of desiccant, so it is for multipurpose use
Examples The stability studies of dabigatran tablets were carried out with or without using present invention (i.e. bottle with ring canister or without canister) and the results are 5 depicted in below Table-1. The above results clearly indicate that present invention (ring canister with desiccant) provides significant protection against degradation as compared to regular canister and no canister.
Table 1: Comparative study on Stability
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HDPE bottle with 3g Ring canister
HDPE bottle with 3g Regular canister
HDPE bottle without canister
Test Name
Related substances
Impurity-4
0.14%
0.16%
0.35%
Impurity-7
0.60%
0.66%
1.24%
Un-known impurities
0.07%
0.08%
0.26%
Total impurities
0.93%
1.03%
2.01%
Description
Observation
No lump formation or colour change observed in pellets
No lump formation or colour change observed in pellets
Colour change to off white to light brown and lump formation observed in pellets. Some pellets also stick to the capsule shell
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,CLAIMS:We Claim:
1. A ring canister for a container comprising:
A component with
a. concentric circular compartment with perforation; wherein the 5 compartment having a desiccant or an oxygen scavenger; and
b. an angular top lid.
2. The ring canister for a container according to claim 1, wherein the desiccant is selected from silica gel, molecular sieve or their combination.
3. The ring canister for a container according to claim 1, wherein filled canister 10 sealed by snap fit manner or by adhesive or by heat seal or by welding with an angular top lid and placing the sealed canister inside the mouth of container.
4. The ring canister for a container according to claim 1, wherein the ring canister component is made of material such as wood, plastic, or metal, preferably with a plastic material. 15
5. The ring canister for a container according to claim 1, wherein said container
comprises a moisture sensitive product.