The present invention relates to a packaging kit for oral liquid formulation and method of dispensing the same.
Oral liquid dosage forms are one the most commonly used option for dispensing the drugs to the patients since ancient times. Oral formulations can be used to deliver a variety of drugs in many forms, e.g. solutions, suspensions, and emulsions. Drugs may be incorporated in liquid base such as; syrups, elixirs, mouth washes, gargles, tinctures, and the like. Unfortunately oral liquid formulations are associated with few problems, that include; accuracy of dose, and adherence to prescribed dosage regimen. Many improvements • have been incorporated, to solve these two basic problems. Package designs has been improved with passage of time, and several innovative designs were developed which incorporate additional devices in a kit of oral liquid formulation, e. g. dispensing caps, metered droppers, spoons, and so on. All these efforts have made the dispensing easier, safer and accurate to some extent.
A package design kit 'Sinus Rinse™' for pharmaceutical liquid formulation was developed by Neil Med pharmaceutical. The kit comprises two components, packed in a unit pack. First component of unit pack is a 'squeeze bottle' and second component of unit pack is '50 sachets'. This package kit is developed to provide an easy way for rinsing the nose. Sachets kept in unit pack comprise premixed preservative free sodium chloride and sodium bicarbonate mixture (pH balanced & isotonic for maximum comfort). Easy-squeeze bottle comes with volume marker. Each packet contains precisely measured mixture to mix with 8 oz. (240 mL) of lukewarm distilled water, taking the guesswork out of preparing this solution. The kit also contains step by step directions for use and extensive educational material that is simple to understand.
Even after many remarkable improvements in package designs for liquid formulations, the problem of adherence to prescribed dosage regimen remains unmet. In case of any oral liquid formulation the recovery will be directly proportional to extent of adherence to prescribed dosage regimen. More particularly in case of medications or drugs like antibiotics, if the patient misses any dose, in that case the recovery will be slower, prolonging the agony of the patient. Hence there is a great need to provide the patients an easy way, so that they can strictly follow the prescribed dosage regimen without placing any extra attention or effort, We have now made it possible by developing a package kit for oral liquid formulation which provide an easy option so that people don't miss their doses.
Hence in one general aspect there is provided a packaging kit for dispensing oral liquid formulation, comprising bottle and sachet.
In another general aspect there is provided a packaging kit for dispensing an oral liquid formulations comprising bottle containing multiple doses and one or more sachets containing single doses.
In anothei general aspect there is provided a packaging kit for dispensing oral cough formulation, comprising
bottle and one or more sachets.
In another general aspect there is provided a method of improving patient compliance by providing a packaging kit for dispensing oral liquid formulation comprising bottle and sachet.
Working individuals or school or college going individuals, or any patient who are on move or away from home, usually tend to miss their dose as it becomes quite inconvenient to carry the bottle of an oral liquid formulation along with them. The packaging kit of present invention provide the patients an easy and quite new. way, to strictly follow the prescribed dosage regimen of an oral liquid formulation, without placing any extra attention or effort. Present kit provides bottle comprising multiple doses of oral liquid formulation and one or more handy and convenient sachets. Patients can take their doses using bottle when they are at home, and can carry one or more handy sachets as per requirement, along with them and use the handy sachet to take dose when they are on move or in their work place. Further patients can again take their dose from bottle at night, when they are at home. In this way the present kit provides flexibility for patient to take their dose at home or when they are on move or away from home.
The term 'package kit' as used herein include a combination pack which comprises an outer carton (secondary pack) made up of any material like paper, laminated paper, plastic and the like. The outer carton has one or more partitions containing bottle and sachets such as a bottle (primary pack) filled with multiple doses of liquid formulation is present in one part of outer pack and sachets (primary pack) all filled with multiple doses of liquid formulation in other partition of outer pack, as shown in Fig. 1 and Fig. 2.
The term 'oral liquid formulation' as used herein includes any formulation which can be administered orally e.g. syrups, elixirs, mouthwashes, gargles, tinctures and the like. The oral liquid formulation may comprise one or more active ingredients along with other pharmaceutically acceptable excipients. The active ingredient contained in oral liquid formulation is selected from the varied class of drugs; for example, antitussive, mucolytics, expectorants, antibiotics, analgesics (opoids and nonopoids), sympathomimetics, parasympathomimetics, syphatholytics, parasympatholytics, antihistamines, antivirals, antifungals, antimalarials, nutritional supplements, and the like. More particularly the oral liquid formulation is a cough formulation.
The term 'bottle' as used herein includes a container used for dispensing the liquid oral formulation, of volume from 5 ml to 500 ml. more specifically 40 ml to 80 ml, which is made up of one or more of glass or any polymeric materials e.g. polyethylene polymers (HOPE, LDPE, or mixture thereof), PVC, PET, (single layer or multilayer) any organic or inorganic, metallic or non metallic materials and the like. The cap may be of any of the above mentioned plastic materials or metal and the bottle may be induction sealed or pressure sealed or sealed vide a tamperevident ring or not sealed.
The term 'sachet' as used herein includes pouches for dispensing the liquid oral formulation, of volume upto 20 ml, more specifically from 2-10 ml, made up of one or more of paper, laminated paper, plastic, organic or inorganic polymeric or copolymeric material (PVC, Polyethylene polymers, polyolefenes, nylon, EVOH, PVdC,
PET PP etc.), Aluminum and the like.
The term 'other pharmaceutically acceptable excipient' as used herein includes all physiologically inert additives used in the pharmaceutical art of dispensing. Examples may include aqueous and water miscible vehicles, coloring agents, flavoring agents, preservatives, buffering agent, stabilizing agents, surfactants, and
the like.

One of the representative examples of present invention is shown in Fig: 1.
Fig: 1 Packaging kit
(Figure Removed)
Fig: 2 Packaging kit(Figure Removed)

Fig: 1 and 2 discloses the packaging kit of present invention, which comprises following components;
1 Outer carton (secondary pack) has one or more partitions containing bottle and sachets, such as a bottle filled with multiple doses of liquid formulation is present in one part of outer pack and sachets all filled with multiple doses of liquid formulation in other partition of outer pack, as shown in Fig. 1 and Fig. 2.
2 Bottle: a container used for dispensing the liquid oral formulation, which is made up of one or more of glass
or any polymeric materials e.g. polyethylene polymers (HOPE, LDPE, or mixture thereof), PVC, PET, (single
layer or multilayer) any organic or inorganic, metallic or non metallic materials and the like. The cap may be of
any of the above mentioned plastic materials or metal and the bottle may be induction sealed or pressure
sealed or sealed vide a tamper evident ring or not sealed.
3 Sachet: pouches for dispensing the liquid oral formulation, made up of one or more of paper, laminated
paper, plastic, organic or inorganic polymeric or copolymeric material (PVC, Polyethylene polymers,
polyolefenes, nylon, EVOH, PVdC, PET, PP etc.), Aluminum and the like.
4 Product Information: Description is provided on outer carton and optionally on the bottle and sachet,
comprising composition details, recommended doses, and direction for dispensing.

WE CLAIM:
1. A packaging kit for dispensing oral liquid formulation, comprising bottle and sachet.
2 The packaging kit for dispensing of oral liquid formulation as per claim 1 wherein the bottle contains
multiple doses and sachet contains single dose.
3 The packaging kit for dispensing of oral liquid formulation as per claim 1 wherein the oral liquid
formulation is selected from syrups, elixirs, mouthwashes, gargles, and tinctures.
4 The packaging kit for dispensing of oral liquid formulation as per claim 1 wherein the formulation
comprises pharmaceutically active ingredients selected from one or more of antitussives,
mucolytics, expectorants, antibiotics, analgesics (opoids and nonopoids), sympathomimetics,
parasympathomimetics, syphatholytics, parasympatholytics, antihistamines, antivirals, antifungals,
antimalarials, nutritional supplements.
5. The packaging kit for dispensing of oral liquid formulation as per claim 1 wherein the formulation comprises pharmaceutically active ingredients and one or more pharmaceutically acceptable excipients.
6 The packaging kit for dispensing oral liquid formulation as per claim 3 and 4 wherein the formulation
is a cough syrup.
7 The packaging kit for dispensing of oral liquid formulation as per claim 1 comprising an outer carton
having one or more partitions containing the bottle and sachets in separate partitions.
8 The packaging kit for dispensing of oral liquid formulation as per claim 1 wherein the components
are made up of material selected from one or more of paper, laminated paper, glass, polymeric or
copolymeric materials e.g. polyethylene polymers (HOPE, LDPE, polyolefenes, or mixture thereof),
PVC, any organic or inorganic, metallic or non metallic materials.
9 A method of improving patient compliance by providing the packaging kit for dispensing the oral
liquid formulation.
10 A packaging kit for dispensing of oral liquid formulation as described and illustrated in the figures
herein.