Vented bottle pack for Co-amoxiclav formulations
Field of the Invention
The present invention relates to a vented bottle pack for storage of Co-amoxiclav formulations. The bottle pack comprises of a pressure-sensitive valve to relieve excess internal bottle pressure caused due to gases developed inside the bottle.
Background of the Invention
Certain products have a tendency of releasing or emitting gas after they have been placed within a sealed package, container or vessel. For example, in the food industry, roasted coffee beans release significant quantity of carbon-dioxide following the roasting process, which is often released more after placing coffee in a sealed container. If such products are packaged in a container or package devoid of any mechanism to vent the built up steam/gas pressure, the walls of the container may expand or bulge outwards or even rupture. Such a bulge or expansion of the container wall not only makes it unattractive but also is a potential cause of product degradation in case of unstable products.
Traditionally, several approaches have been used to remove carbon dioxide gas from the inside of a package. In one approach, micro perforated films are used. These films allow the gaseous exchange of carbon dioxide and oxygen between the inside and outside of the package thus allowing it to respire. However, these micro perforated films are expensive and can not be used for products which are sensitive to the effects of oxygen and moisture.
In another approach, the carbon dioxide inside the package is reduced by sachets containing a scavenger material, such as alkaline earth metal oxide or hydroxide that can selectively react with the carbon dioxide in the package. The sachets add an extra step to the filling process, and pose potential risks such as accidental grinding, rupture and ingestion.

US4552767 discloses a combination of calcium hydroxide and sodium or potassium hydroxide to be used as a carbon dioxide scavenger in coffee packaging.
US6451423 is directed to a composite carbon dioxide absorbent or filler material dispersed into a polymeric matrix for use as the interior layer of a package or container containing coffee, fresh produce and the like.
Yet another approach is the use of valves, which has long been known in the food industry. Vented packs are also used in microwaveable sealed packs to relieve the pack of steam generated while heating the food. A variety of designs and mechanisms for the operation of valves in containers and closures are known in the prior art.
US6663284 describes a pressure sensitive one-way valve to control the release of pressurized gas from a sealed container wherein the sealed container has a venting aperture therein.
US5829884 relates to flexible bag-like packages, and more particularly to a flexible reclosable bag package including a sealing arrangement for a profile strip fastener assembly mounted on a front wall of the body of the bag, and a venting arrangement for gas evolved within the bag.
WO9210110 describes a vented container for storing and cleaning an element and, more specifically, to a vented container for the chemical disinfection of contact lenses which allows the pressure developed during the chemical disinfection process to vent while preventing leakage of the cleaning solution.
US3966071 discloses a pressure relieving bottle closure. The opening is sized to permit excessively pressurized gas, which has already permeated the top seal, to bulge the sealing liner outwardly into the opening to permit the gas to pass through the side seal between the sealing liner and the side finish of the bottle at the location of the opening. The relieved fluid then escapes between the closure threads and the bottle threads.
In industrial facilities or research laboratories, the stored chemicals may produce gases if the chemicals have a tendency to vaporize naturally or if they unexpectedly react with

another reagent. Release of gas build-up in chemical storage vessels is necessary for the safe storage of chemicals and to prevent explosion.
WO2004078351 describes a vent cap for releasing gas from containers, while preventing spillage of the contents therein.
Similarly certain pharmaceutical products are also unstable and prone to degradation. The resulting by-product may directly trigger further degradation or act as a catalyst and accelerate the degradation process. One such example is Co-amoxiclav.
Co-amoxiclav is the combination antibiotic containing amoxicillin trihydrate (a 3-lactam antibiotic) with clavulanate potassium (a ß-lactamase inhibitor). This combination results in an antibiotic with an increased spectrum of action and restored efficacy against p-lactamase producing amoxicillin-resistant bacteria. Currently, the commercially available formulations of Co-amoxiclav are packaged in blister packs, strip packs or HDPE bottles. It has been observed that this combination product, upon storage releases carbon dioxide due to degradation, leading to a pressure build-up on the walls of the bottle or blister. The bulge or expansion of the package makes it unattractive from the perspective of the consumer, and also presents difficulty for the retailer who attempts to maximize the retail shelf space. It is therefore required to provide a pressure relieving mechanism in the form of a valve in the product package to address the problems due to carbon dioxide build-up within the container.
Thus the present invention provides a novel way of packaging formulations of Co-amoxiclav. The packaging comprises a bottle pack with a pressure sensitive valve being introduced to the mouth of the bottle to permit the release of built-up gaseous byproducts generated as a result of degradation of Co-amoxiclav from within the sealed container while at the same time preventing the ingress of air through the valve into the container.

Summary of the Invention
According to one embodiment there is provided a vented bottle pack for storage of Co-amoxiclav formulation, the bottle pack comprising:
(a) a bottle having a side wall, a bottom wall, an open top and containing a Co-amoxiclav formulation therein;
(b) a closure removably attached to said bottle and disposed upon the open top; and
(c) a pressure-sensitive valve seated on the open top of the bottle and below the inside top of the closure, wherein the pressure-sensitive valve is adapted to open upon a predetermined increase in pressure within the bottle to release the gases through the valve and out of the closure.
According to another embodiment there is provided a vented bottle pack for storage of Co-amoxiclav formulation, the bottle pack comprising:
(a) a bottle having a side wall, a bottom wall, an open top and containing a Co-amoxiclav formulation therein;
(b) a closure removably attached to said bottle and disposed upon the open top; and
(c) a pressure-sensitive valve, which is part of an induction sealing liner interposed between the inside top of the closure and the open top of the bottle, wherein the pressure-sensitive valve is adapted to open upon a predetermined increase in pressure within the bottle to release the gases through the valve and out of the closure.
Brief Description of the Drawings
Fig. 1(a) shows the front view of the vented bottle pack with the valve seated on the open top of the bottle and below the inside top of the closure.
Fig. 1(b) depicts the passage for gas exit through the vented bottle pack.
Fig. 1(c) shows the enlarged view of the valve assembly placed on the open top of the bottle. The base of the valve assembly shows the gas exit passage from the pressurized bottle through the valve.

Fig. 2(a) shows the vented bottle pack containing the pressure-sensitive valve as part of the induction seal liner.
Fig. 2(b) shows enlarged view of the fitment of the valve as part of the induction seal liner and the passage of gas exit through a selectively permeable membrane.
Detailed Description of the Invention
The term 'Co-amoxiclav' as used herein refers to a combination antibiotic containing amoxicillin (a ß-lactam antibiotic) with clavulanic acid (a ßlactamase inhibitor) and pharmaceutically acceptable salts, and solvates/hydrates thereof. For example, the combination antibiotic may contain amoxicillin trihydrate and potassium clavulanate.
The 'formulation (s)' of Co-amoxiclav may be in the form of tablets, capsules, powder or granules.
In the present invention, Co-amoxiclav formulation may be put in a bottle. The bottle has a side wall, a bottom wall and an open top. A closure is provided which is removably attached to said bottle and disposed upon the open top. A pressure-sensitive valve is seated on the open top of the bottle. The size of the valve is such that the same sits snuggly on the mouth of the bottle thereby creating an air tight seal. Details of the making of the valve are excluded from the scope of this patent.
Various valve arrangements which respond to specific pressures are available commercially. The built-up gases within the bottle, generated as a result of interaction of amoxicillin and clavulanic acid and their degradation, are released by the opening of the valve, and are let out into the atmosphere through the valve and out of the closure. When the product gives out the gas and a sufficient pressure is built up, this activates the valve. Upon activation this valve opens and lets the gases out of the bottle. The pressure sensitive valve is preferably a one-way valve, so that it doesn't allow the other gases to enter the bottle. Once the pressure is relieved, the valve closes automatically, thereby creating a seal. The gases coming out of the valve are then relieved into the atmosphere.

Another method for the fitment of the valve may be as part of the induction seal liner. As most bottles in the pharmaceutical industry are sealed, the valve may be a part of the induction seal liner and is sealed along with the liner on the bottle to create a seal.
The material of construction of the bottle may be glass, plastic or metal. The plastic may be chosen from high density polyethylene (HDPE), low density polyethylene (LDPE), polyethylene terephthalate (PET), cyclic olefin copolymer (COC), polycarbonate (PC) or others including multi-layered bottles.

WE CLAIM:
1. A vented bottle pack for storage of Co-amoxiclav formulation, the bottle pack
comprising:
(a) a bottle having a side wall, a bottom wall, an open top and containing a Co-amoxiclav formulation therein;
(b) a closure removably attached to said bottle and disposed upon the open top; and
(c) a pressure-sensitive valve seated on the open top of the bottle and below the inside top of the closure, wherein the pressure-sensitive valve is adapted to open upon a predetermined increase in pressure within the bottle to release the gases through the valve and out of the closure.

2. A vented bottle pack according to Claim 1, wherein the pressure-sensitive valve is part of an induction sealing liner interposed between the inside top of the closure and the open top of the bottle.
3. A vented bottle pack according to any of Claims 1 or 2, wherein the pressure-sensitive valve is a one-way valve.
4. A vented bottle pack according to any of the preceding claims, wherein the material of construction of the bottle is selected from glass, plastic or metal.
5. A vented bottle pack according to Claim 4, wherein the plastic used for the construction of the bottle is chosen from high density polyethylene (HDPE), low density polyethylene (LDPE), polyethylene terephthalate (PET), cyclic olefin copolymer (COC) and polycarbonate (PC).
6. A vented bottle pack according to Claim 1, wherein the Co-amoxiclav formulation is in the form of tablets, capsules, powder or granules.
7. A vented bottle pack for storage of Co-amoxiclav formulation substantially described and exemplified herein.