FIELD OF INVENTION
It relates to a packaging kit comprising a light, moisture and/or oxygen sensitive drug comprising a lined carton which comprises a bottle containing the drug, wherein the liner of the lined carton is made up of impermeable material and said liner is sealed under vacuum. Also, the packaging kit comprising light, moisture and/or oxygen sensitive pharmaceutical composition containing said drug.
BACKGROUND OF THE INVENTION
There are a number of drug candidates where oxygen, light or moisture sensitivity of the drug is not recognized until drug development has progressed into late stages of development at which time a significant amount of resources have been already expended. Drug degradation often limits shelf-life or may render a drug unmarketable. In fact, drug candidates that are highly oxygen, light or moisture sensitive are often excluded from further development. At the later stages of development, reformulation can require considerably more time and money.
Therefore, there is a need for a means of reducing or eliminating oxygen, light or moisture based drug instability without involving a formulation change.
Atmospheric oxygen and moisture can diffuse into many types of containers over a lengthy storage period and lead to degradation of susceptible drug. The conventional bottle packs generally made of high density polyethylene are permeable to gases and moisture. Sometimes addition of desiccant, induction sealing closures or increasing thickness of bottle is used for protection from the ingress of moisture and gas. However, seldom the above approaches render product stable.
Glass bottles comparatively have given the best results in this respect but they are prone to breakage. Breakage is to some extent a storage and transport problem but is particularly 'use' problem as glass bottles are fragile in repeated use. Moreover, glass bottles are quite heavier that plastic bottles for same size.
Several attempts have been made in the prior art to prepare a packaging for light, moisture or oxygen sensitive drug candidates.
US 4,150,744 discloses a packaging system comprising an outer impermeable hermetically sealed envelop and an inner bottle wherein impermeable envelop is purged with inert gas or is under vacuum.
US 4,051,265 discloses a blow molded thermoplastic container containing liquid food sensitive to light and oxygen and an over wrap of polyethylene terephthalate enclosing said container.
In above prior arts, as the outer bag is in direct contact with the surrounding atmosphere, there could be chances of accidental leakage of bag leading to loss of inert atmosphere. Also, the packaging disclosed in the prior arts, lack aesthetic appeal and ease of transportation. Moreover, printing or pasting of labels would be difficult on over wrap or envelop.
We have now endeavored to develop an improved packaging kit for light, moisture and/or oxygen sensitive drugs by solving aforementioned problems.
SUMMARY OF THE INVENTION
The present invention relates to a packaging kit for light, moisture and/or oxygen sensitive drugs.
According to one of the aspect, there is provided a packaging kit for a light, moisture and/or oxygen sensitive drug comprising a lined carton which comprises a bottle containing the drug,
wherein the liner of the lined carton is made up of impermeable material and said liner is sealed under vacuum.
In another aspect, there is provided a process for the preparation of a packaging kit for light, moisture and/or oxygen sensitive drug comprising the steps of: i. Filing the drug into the bottle;
ii. Inserting the bottle of step i) within the lined carton;
Hi. Sealing impermeable liner of the lined carton of step ii) under the vacuum.
In another aspect, there is provided a packaging kit for a pharmaceutical composition of a light, moisture and/or oxygen sensitive drug comprising a lined carton which comprises a bottle containing the pharmaceutical composition, wherein the liner of the lined carton is made up of impermeable material and said liner is sealed under vacuum.
In another aspect, there is provided a process for the preparation of a packaging kit for pharmaceutical composition of a light, moisture and/or oxygen sensitive drug comprising the steps of: i. Filing the pharmaceutical composition into the bottle;
ii. Inserting the bottle of step i) within the lined carton;
iii. Sealing impermeable liner of the lined carton of step ii) under the vacuum.
BRIEF DESCRIPTION OF THE DRAWINGS FIG.1 is a schematic view of packaging process.
DESCRIPTION OF THE INVENTION
We have now developed the packaging kit which provides simplified way of vacuum packaging of bottle packs and provides a barrier to the content. Moreover, the shape and size of the bottle remains intact after vacuum packaging and is very convenient for the end users. Hence, the packaging looks elegant and attractive to the potential consumers.
Pharmaceutical compositions as used herein may include tablet, capsule, powder, granules, suspension, emulsion and the like.
"Impermeable" as used herein include completely impermeable material or a substantially impermeable material that provides high barrier property to the kit.
The term "oxygen-sensitive" or "oxygen-sensitivity" refers to the ability of a substance to react with oxygen under normal ambient conditions about 5°C to about 40°C. The reaction may involve the addition of oxygen to the substance, removal of hydrogen from the substance, or the loss or removal of one or more electrons from a molecular entity, with or without concomitant loss or removal of a proton or protons. It can also involve indirect processes where an oxidizing agent (e.g., peroxide, superoxide) is generated which oxidize the drug.
The term "moisture-sensitivity" or "light-sensitivity" refers to the ability of a substance to get degraded in presence of moisture or light under normal ambient conditions about 5°C to about 40°C.
Example of oxygen-sensitive/moisture sensitive/light sensitive drugs as used herein include atorvastatin, azithromycin, pseudoephedrine, tiagabine, acitretin, rescinnamine, lovastatin, tretinoin, isotretinoin, simvastatin, ivermectin, verapamil, oxybutynin, hydroxyurea, selegiline, esterified estrogens, tranylcypromine, carbamazepine, ticlopidine, methyldopahydro, chlorothiazide, methyldopa, naproxen, acetominophen, erythromycin, bupropion, rifapentine, penicillamine, mexiletine, verapamil, diltiazem, ibuprofen, cyclosporine, saquinavir, morphine, sertraline, cetirizine, N-[[2-methoxy-5-(1-methyl)phenyl]methyl]-2-(diphenylmethyl)-1-azabicylco[2.2.2]octan-3-amine, adrenaline, amiodarone hydrochloride, atropine sulphate, diazepam, ephedrine, frusemide, haloperidol, lignocaine, metoclopramide, noradrenaline, omeprazole, ondansetron, phenytoin, vercuronium, acyclovir, amoxicillin, cefotaxime, cefotetan, metronidazole, cefuroxime, flucloxacillin and bupivacaine.
Carton as used herein provides aesthetic appeal, ease of transportation, ease of labeling and protection from the rupture of vacuum packaging. The carton may be made of paper board or coated paper board or polymeric material and the like. It may have any shape and size suitable to accommodate the bottle inside.
Lined carton as used herein means a carton containing a liner. Liner is made up of material which is impermeable to light, oxygen and/or moisture such as aluminium foil or a laminate comprising laminate structure along with aluminium foil. Aluminium foil acts as a complete barrier to light, moisture and/or oxygen.
The liner may also be made of impermeable polymeric film or laminate which also provides complete barrier to light, moisture and/or oxygen. Polymeric film may further be metal deposited (deposition of aluminium on film through metallization process). Polymeric film includes polymer selected from the group consisting of PET (polyethylene terpthalate), EVA (Ethylene Vinyl Acetate), EVOH (Ethylene Vinyl Alcohol), PVC (polyvinyl chloride) & the like.
All these properties render the drug which is susceptible to degradation, to be more stable on storage and eventually increase its shelf life.
Other materials that can be used in laminate along with impermeable material include polyethylene (PE), bi-axially oriented polypropylene (BOPP), PET (polyethylene terpthalate) or oriented polyamide (OPA).
The liner is fixed within the carton with a glue having low bond strength. Specific examples of glue includes solvent based adhesive or hot melt adhesive wherein solvent based adhesives principally consist of polymers such as natural rubber, polychloroprene etc. dissolved in aliphatic or aromatic solvents and hot melt adhesives are solvent-free adhesives. The hot melt adhesive consist polymers such as ethylene vinyl acetate (EVA) copolymers, styrene-isoprene-styrene (SIS) copolymers, styrene-butadiene-styrene (SBS) copolymers, ethylene ethyl acrylate copolymers (EEA), polyurethane reactive (PUR) and the like.
Bottle may be made of thermoplastic polymers such as polyethylene particularly HOPE or LDPE, polypropylene, polyvinylchloride, polycarbonate, polyamide, polystyrene, polytetrafluroethylene and the like.
The packaging may further comprise an oxygen absorber or moisture absorber. These absorbers may be present in the bottle along with drug or are present in between the liner and the bottle.
Suitable oxygen-absorbers include metal-based absorbers such as particulate-type iron (e.g., hydrogen reduced iron, electrolytically reduced iron, atomized iron, and milled pulverized iron powders), copper powder, zinc powder and the like. The oxygen absorber may also contain polymer based oxygen absorbing agent. These oxygen absorbers may be provided in a sachet, pouch, cartridge or canisters.
Examples of suitable moisture-absorber include silica gel, clay, molecular sieve, magnesium sulfate, ammonium chloride, calcium oxide, calcium oxide, magnesium oxide, barium oxide, barium hydroxide, strontium oxide, aluminum oxide and the like. These moisture absorbers may be provided in a sachet, pouch, or canister.
The lined carton may be custom made or taken as ready made carton from the vendor.
According to one of the embodiment, packaging kit is prepared by a process comprising the steps of:
i. Fixing of a liner within a carton to obtain lined carton;
ii. closing the lined carton of step i) from the bottom;
iii. filing the drug or the pharmaceutical composition into the bottle;
iv. inserting the bottle of step iii) within the lined carton of step ii);
iv. sealing impermeable liner of the lined carton of step ii) under the vacuum,
wherein during application of vacuum, upper portion of pouch gets detached from the inner surface of the carton and acquires the shape of the bottle.
According to another embodiment, packaging kit is prepared by a process comprising the steps of:
i. Filing the drug or the pharmaceutical composition into the bottle;
ii. inserting the bottle of step i) within the lined carton;
iii. sealing impermeable liner of the lined carton of step ii) under the vacuum.
wherein during application of vacuum, upper portion of pouch gets detached from the inner surface of the carton and acquires the shape of the bottle.
Example 1
Procedure i. Aluminium foil based laminated liner was fixed within a carton with a glue to
obtain lined carton;
ii. Lined carton of step i) was closed from the bottom; iii. Atorvastatin tablets were filled into the bottle; iv. Bottle pack of step iii) was inserted within the lined carton of step ii); v. The liner of the lined carton of step iv) was sealed under the vacuum; vi. Carton of step v) was then sealed from outside.
This process is further explained in the Figure 1.

WE CLAIM:
1. A packaging kit for a light, moisture and/or oxygen sensitive drug comprising
a lined carton which comprises a bottle containing the drug wherein liner of
the lined carton is made up of impermeable material and said liner is sealed
under vacuum.
2. The packaging kit according to claim 1 wherein the drug is in the form of
pharmaceutical composition.
3. The packaging kit according to claim 1 wherein the liner of the lined carton is
an aluminium foil based laminate, a metal deposited laminate and a polymeric
film or laminate.
4. The packaging kit according to claim 3 wherein the laminate further
comprises polymer selected from the group consisting of polyethylene (PE),
bi-axially oriented polypropylene (BOPP), PET (polyethylene terpthalate) or
oriented polyamide (OPA) and the like.
5. The packaging kit according to claim 1 wherein bottle is made of
thermoplastic polymers such as polyethylene, polypropylene,
polyvinylchloride, polycarbonate, polyamide, polystyrene,
polytetrafluroethylene and the like.
6. The packaging kit according to claim 1 wherein the bottle is made of high
density polyethylene.
7. The packaging kit according to claim 1 wherein the carton is made of paper
board or coated paper board or polymeric material.
8. The packaging kit according to claim 1 wherein the bottle or the kit may
further comprise oxygen or moisture absorber.
9. The packaging kit according to claim 1 wherein the packaging kit is prepared
by a process comprising the following steps of:
i. Filing the drug into the bottle;
ii. Inserting the bottle of step i) within the lined carton;
iii. sealing impermeable liner of the lined carton of step ii) under the vacuum
10. The packaging kit for light, moisture and/or oxygen sensitive drug as
described herein.