The present invention relates to a delivery device in the form of twin chamber comprising a bottle and a capsule assembly wherein a capsule assembly further comprises plunger having elastomeric seals on the outer wall and said twin chamber is activated by pull mechanism using knob feature.
[003] BACKGROUND OF THE INVENTION
[004] Many chemicals or food ingredients or supplements are extremely sensitive to external influences, such as oxygen, sunlight, hydrolysis, and pH values, which, along with other factors, can harm their activity. Since water can act as both a medium and a reaction agent that can cause hydrolysis of any chemical. In addition, water increases chemical and physical instability of a substance in reaction with other substances. One way to stabilize liquid formulation comprising unstable substance, is by reconstituting with a diluent/water just before administration.
[005] US8613372B2 discloses a dispensing cap for a container comprises a generally cylindrically shaped body portion having a closed top end and an open bottom end, the closed top end being integrally formed with the body portion and comprising a diaphragm portion. A generally cylindrically shaped inner wall axially extends from the closed top end towards the open bottom end of the body portion and defines a chamber for holding an additive substance, wherein the chamber has an opening towards the open bottom end of the body portion. The body portion and the inner wall define a receptacle therebetween for receiving a mouth of the container from the open bottom end of the body portion and sealing the mouth of the container. A plunger axially extends from the diaphragm portion towards the opening of the chamber, wherein the diaphragm and the plunger have a closed position and an open position. A chamber closure member for sealing the chamber's opening is attached to the plunger,

wherein the chamber closure member is configured for cooperating with the inner wall and seal the chamber when the diaphragm and the plunger are in the closed position. The body portion, the closed top end and the inner wall are integrally formed.
[006] Various conventional closures which separate drug substance and diluent are known since past many years, which include closure, dual container or any other liquid containing bottles. These closures are prone to tampering and does not provide complete sealing of the powder from external environment as well as from the liquid present in the device.
[007] The present disclosure is directed to overcome one or more limitations stated above or any other limitations associated with the prior art.
[008] SUMMARY OF THE DISCLOSURE
[009] One or more shortcomings of conventional systems are overcome, and additional advantages are provided through the assembly as claimed in the present disclosure. Additional features and advantages are realized through the techniques of the present disclosure. Other embodiments and aspects of the disclosure are described in detail herein and are considered a part of the claimed disclosure.
[0010] The present disclosure achieves the above-stated objective by providing a delivery device in the form of twin chamber. The twin chamber activated by pull mechanism comprising a bottle and a capsule assembly wherein the capsule assembly further comprises a plunger having elastomeric seals on the outer wall.
[0011] The foregoing summary is illustrative only and is not intended to be in any way limiting. In addition to the illustrative aspects, embodiments, and features described

above, further aspects, embodiments, and features will become apparent by reference to the drawings and the following detailed description.
[0012] BRIEF DESCRIPTION OF DRAWINGS
[0013] The novel features and characteristics of the disclosure are set forth in the description. The disclosure itself, however, as well as a mode of use, further objectives and advantages thereof, will best be understood by reference to the following detailed description of an embodiment when read in conjunction with the accompanying drawings. One or more embodiments are now described, by way of example only, with reference to the accompanying drawings wherein like reference numerals represent like elements and in which:
[0014] FIG. 1 illustrates a twin chamber device with shrink sleeve comprising capsule
assembly (1), elastomeric seals (2), plunger assembly (3), capsule cap (4), secondary
cap (5).
[0015] FIG. 2 Illustrates the section view after the user pulls secondary cap from the
device by rotate and pull action.
[0016] FIG. 3 Illustrates the section view after the user grips plunger knob and pull up
till an audible click is heard.
[0017] FIG. 4 Illustrates the section view after locking the plunger to activation
position whereby the bottom seal will be above the opening provided in the capsule
cap thus exposing the powder chamber to the liquid chamber.
[0018] FIG. 5 Illustrates the section view after user unscrews the capsule from the
bottle neck for subsequent use and storage, the bottle shall be closed with the secondary
cap, provided as part of the primary package.

[0019] Skilled artisans will appreciate that elements in the drawings are illustrated for simplicity and have not necessarily been drawn to scale. For example, the dimensions of some of the elements in the drawings may be exaggerated relative to other elements to help to improve understanding of embodiments of the present invention.
[0020] DETAILED DESCRIPTION OF THE PRESENT DISCLOSURE
[0021] While the embodiments in the disclosure are subject to various modifications and alternative forms, specific embodiment thereof has been shown by way of example in the figures and will be described below. It should be understood, however, that it is not intended to limit the disclosure to the particular forms disclosed, but on the contrary, the present disclosure is to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure.
[0022] It is to be noted that a person skilled in the art would be motivated from the present disclosure and modify various features of the system or method, without departing from the scope of the disclosure. Therefore, such modifications are considered to be part of the disclosure.
[0023] Accordingly, the drawings show only those specific details that are pertinent to understand the embodiments of the present disclosure, so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skilled in the art having the benefit of the description herein.
[0024] The terms "comprise", "comprising", or any other variations thereof used in the disclosure, are intended to cover a non-exclusive inclusion, such that a system and method that comprises a list of components does not include only those components but may include other components not expressly listed or inherent to such system, method, or assembly, or device.

[0025] The following paragraphs describe the various components of the drug delivery device of the present disclosure according to an embodiment of the present description.
[0026] A first aspect of the present invention relates to a twin chamber device activated by a pull mechanism for the delivery of a substance comprising
1. a capsule assembly (1) having the substance comprising
a) a capsule cap (4),
b) a plunger assembly (2) having a plunger body and elastomeric seals (3), and
c) a secondary cap (5)
2. a bottle having a liquid;
wherein the said twin chamber once activated by pull mechanism using knob feature causes plunger to pull up creating space between capsule cap and plunger and leads to mixing of the substance with the liquid.
[0027] According to another aspect of the present invention relates to a twin chamber device activated by a pull mechanism for the delivery of a substance comprising
1. a capsule assembly (1) having the substance comprising
a) 6a capsule cap (4),
b) a plunger assembly (2) having a plunger body and elastomeric seals (3), and
c) a secondary cap (5)
2. a bottle having a liquid;
wherein the said twin chamber once activated by pull mechanism using knob feature causes plunger to pull up creating space between capsule cap and plunger and leads to mixing of the substance with the liquid.

[0027] The term "substance" as used herein includes drugs, chemicals, detergents,
flavorings, vitamins, energy boosting formulation, medication, purification and
tranquil drinks or any combination of these ingredients. The drugs may include
antibiotics such as amoxicillin and clavulunic acid, cetylcholine chloride,
acetylcamitine, actinobolin, aluminum methionate, aminopentamide, aminopyrine
hydrochloride, ammonium bromide, ammonium valerate, amobarbital sodium,
anthiolimine, antimony sodium tartrate, antimony sodium thioglycollate, aprobarbital,
arginine, aspirin, atropine N-oxide, avoparcin, azithromycin monohydrate, betahistine
mesylate, betaine, bethanechol chloride, bismuth subnitrate, bupropion, butamirate,
buthalital sodium, butoctamide, cacodylic acid, calcium chloride, calcium
glycerophosphate, calcium iodide, carbachol, carnitine, caspofungin, ceruletide,
chlorophyllin sodium-copper salt, choline alfoscerate, choline salicylate, choline
theophyllinate, cilastatin, citicoline, cobalt dichloride, cromolyn disodium, cupric
sulfate pentahydrate, cyanocobalamin, cyclobutyrol, cysteine hydrochloride,
deaminooxytocin (L-isomer, anhydrous), deanol hemisuccinate, demecarium bromide,
dexamethazone phosphate disodium salt, DL-dexpanthenol, dibucaine hydrochloride,
dichlorophenarsine hydrochloride, diclofenac sodium, diethylcarbamazine citrate,
dimethyl sulfoxidem, drotebanol, echinomycin, ephedrine (anhydrous), ergotamine,
ethanolamine, fencamine hydrochloride, ferric chloride, ferrous iodide, ficin,
gadobenate dimeglumine, gentamicin C complex sulfate, guanidine, heparin,
hexadimethrine bromide, hexamethonium tartrate, hexobarbital sodium, histamine,
hydrastine hydrochloride, hyoscyamine hydrobromide, S-[2-[(l-
iminoethyl)amino]ethyl]-2-methyl-L-cysteine, imipramine N-oxide, isometheptene hydrochloride, isosorbide, levothyroxine sodium, lichenifonnins, lobeline sulfate, magnesium chloride hexahydrate, magnesium trisilicate, menadione, mercaptomerin sodium, mersalyl, metaraminol, methacholine chloride, methantheline bromide, methantheline chloride, methitural sodium, L-methyldopa sesquihydrate, methylmethioninesulfonium chloride, mildiomycin, minocycline hydrochloride,

mitoxantrone dihydrochloride, morpholine, muscarine chloride, nafronyl acid oxalate, narceine, nicotine, nicotinyl alcohol, nolatrexed dihydrochloride, omeprazole, oryzacidin, oxalic acid, oxophenarsine hydrochloride, panthenol, pantothenic acid (sodium salt), papain, penicillamine hydrochloride, penicillin G (potassium salt), pentamethonium bromide, pentamidine isethionate, pepsin, perazine dihydrochloride, phenobarbital, sodium 5,5-diphenyl hydantoinate, phethenylate sodium, phosphocreatine (calcium salt tetrahydrate), physostigmine sulfate, pilocarpine hydrochloride, pipemidic acid, podophyllotoxin-P-D-glucoside, potassium carbonate, potassium iodide, pralidoxime mesylate, prednisolone sodium phosphate, procainamide hydrochloride, procaine butyrate, L-proline, promazine hydrochloride, propamidine isethionate, prostacyclin sodium, pyridostigmine bromide, pyronaridine, quinacillin disodium, quinoline, radioactive sodium iodide, reserpilic acid dimethylaminoethyl ester dihydrochloride, secobarbital sodium, silver fluoride, sodium acetate, sodium bromide, sodium propionate, sodium dibunate, sodium dichromate(VI), sodium nitrite, sodium pentosan polysulfate, sodium valproate, soluble sulfamerazine, stibocaptate, streptomycin, succinylcholine bromide, succinylcholine iodide, sulfaquinoxaline, sulisatin disodium, suramin sodium, tamoxifen citrate, taurocholic acid, terazosin hydrochloride, thiobutabarbital sodium, thiopental sodium, ticarcillin disodium, 2,2,2-trichloroethanol, trientine, triethanolamine, triftazin, tolazoline hydrochloride, vinbarbital sodium, viomycin, vitamin B12, zinc iodide, and combinations, pharmaceutically acceptable hygroscopic and/or deliquescent salts and variants thereof. The drug may be a protein or probiotics to be reconstituted before drinking. In particular, the drug is in powdered or granulated form. In particular, the device is suitable for drugs having hygroscopic properties for example sodium oxybate, aripiprazole, Pyridostigmine Bromide, and the like. In particular unstable substances, to be reconstituted at the time of use or administration. The composition will remain stable after reconstitution for atleats about 10-15 days.

Total weight of blend of drug and excipient may range from about 3 grams to about 30 grams. Liquid composition may be present in an amount of about 20ml to about 100ml.
[0028] The knob feature as used herein may allow the user to grip the plunger for pull up action during activation of the device.
[0029] The "twin chamber device" as used herein includes bottle having liquid and capsule assembly having a substance which is reconstituted or mixed with said liquid before the use or administration. Bottle is having threaded neck on to which capsule assembly is threaded. In particular, the capsule assembly is assembled via thread mating onto the container neck. The bottle is activated by pull mechanism. Pull causes plunger to pull up creating space between capsule cap and plunger.
[0030] According to the one of the embodiments of this aspect, the bottle may be manufactured by injection blow molding and comprise external threads on its neck.
[0031] The term "capsule cap" as used herein is a cylindrical component with its interior surface containing thread features which will mate with the corresponding threads in the container neck. The capsule interior consists of a bore with an additional longitudinal secondary wall and the bore will have a closed bottom. The secondary wall may consists of radial slot like openings on its lower portion. This feature avoids the risk of user drinking liquid without activating the product, by rotationally locking plunger to the bottle thread which prevents unscrewing of capsule cap without pulling up the plunger.
[0032] According to another embodiment of this aspect, the plunger is cylindrical and will be seated within the closed bore present in the interior of capsule. The space

formed within the walls of the plunger and capsule bottom will house the powdered drug.
[0033] According to another embodiment of this aspects, a plunger further comprises a pair of legs that originate radially from the plunger top surface and project downward longitudinally and are designed to slot into a pair of thread breaks provided on the bottle neck. These legs are accommodated through two pockets within the capsule which allows the plunger legs to slot into the two thread break features. These legs ensure any accidental rotation of the capsule prior to the plunger pull up for twin chamber activation.
[0034] According to another embodiment, the plunger further comprise a flexible annular lip provided on the outer surface of the plunger just above the slots provided for the elastomeric seals, this annular ring will interact with another annular ring feature with a semicircular profile provided on the interior surface of the capsule secondary wall and during plunger pull action the lip interaction will provide the audible feedback and eventual locking of the plunger in the activated position. The term "elastomeric seals" as used herein is made up of TPE, BromoButyl, Neoprene, Silicone, EPDM and FKM.
[0035] Two annular elastomeric seals may be mounted onto slots provided on the outer wall of the plunger. These elastomeric seals will have an interference fit with capsule interior surface and these seals will be positioned above and below the slots provided on the capsule thus creating a sealing between the liquid contained in the bottle and the powder chamber as well as sealing the liquid chamber from the external environment.
[0036] A secondary cap as used herein will have thread features on its internal surface designed to mate with the threads provided on the container and it may be mounted

over the capsule cap with the help of a locking lip feature provided on the top surface of the capsule cap which locks with an annular groove feature below the threads provided on the secondary cap. A set of rib like features are provided on the annular groove at regular intervals so that upon rotation of the cap the ribs will ride over the locking lips of the capsule cap and the secondary cap gets detached. For subsequent use and storage, the bottle may be closed with the secondary cap.
[0037] According to another embodiment, the twin chamber further may comprise shrink sleeve. The shrink sleeve may cover the top of the capsule assembly till the neck ring on the bottle. The shrink sleeve covering the capsule may provide the tamper evident proof.
[0038] A second aspect of the present invention relates to a twin chamber device for delivery activated by a pull mechanism for the delivery of a substance comprising
1) a capsule assembly (1) having the substance comprising
a) a capsule cap (4),
b) a plunger assembly (2) having plunger body comprising a pair of legs and a flexible annular lip and elastomeric seals (3),
c) a secondary cap (5)

2) a bottle having liquid
3) shrink sleeves covering the top of the capsule assembly till the neck ring on the bottle
wherein the said twin chamber once activated by pull mechanism using knob feature causes plunger to pull up creating space between capsule cap and plunger and leads to mixing of the substance with the liquid.
The mechanism of twin chamber for the drug delivery may be described as

1) The user tears away the shrink sleeve provided on the device.
2) After this, the user pulls secondary cap from the device by rotate and pull action as the lip will ride over the rib features provided on the secondary cap groove.
3) The user has to then grip plunger knob and pull up till an audible click is heard due to the flexible ring feature on the plunger riding over the annular locking ring of the capsule cap.
4) At this point the annular locking ring will be slotted in between the flexible ring feature of the plunger and the elastomeric ring mounting feature of the plunger. Thus, locking the plunger will be activation position. Bottom seal will be above the opening provided in the capsule cap thus exposing the powder chamber to the liquid chamber. The user has to provide shaking action to ensure all the powder will be washed out of the capsule.
5) User unscrews the capsule from the bottle neck since the plunger longitudinal legs are no longer slotted onto the thread break features of the bottle neck. After removing the capsule assembly, the entire engine can be disposed of by the user.
6) For subsequent use and storage, the bottle shall be closed with the secondary cap, provided as part of the primary package.

We Claim:

1. A twin chamber device for delivery activated by a pull mechanism for the delivery
of a substance comprising
1) a capsule assembly (1) having a substance comprising
a) a capsule cap (4),
b) a plunger assembly (2) having plunger body and elastomeric seals (3), and
c) a secondary cap (5)
2) a bottle having a liquid wherein the said twin chamber once activated by pull
mechanism using knob feature causes plunger to pull up creating space between
capsule cap and plunger and leads to mixing of the substance with the liquid.
2. The twin chamber device as claimed in claim 1, wherein the plunger is cylindrical and will be seated within the closed bore present in the interior of capsule.
3. The twin chamber device as claimed in claim 1, wherein a plunger further has a pair of legs that originate radially from the plunger top surface and project downward longitudinally.
4. The twin chamber device as claimed in claim 3 wherein the legs are designed to slot into a pair of thread breaks provided on the bottle neck.
5. The twin chamber device as claimed in claim 1, wherein the elastomeric seals are two and will be mounted onto slots provided on the outer wall of the plunger.
6. The twin chamber device as claimed in claim 1, wherein the twin chamber further comprises shrink sleeve.

7. The twin chamber device as claimed in claim 1, wherein the plunger further comprises flexible annular lip on the outer surface.
8. The twin chamber device as claimed in claim 7, wherein the flexible annular lip interaction will provide the audible feedback and eventual locking of the plunger in the activated position

9. The twin chamber device as claimed in claim 1, wherein the substance may be stored
in an amount of about 3 grams to about 30 grams.
10. The twin chamber device as claimed in claim 1, wherein the liquid is present in bottle in an amount of about 20 mL to about 100 mL.
11. A twin chamber device for the delivery activated by a pull mechanism for the delivery of a substance comprising
1) a capsule assembly (1) having a substance comprising
a) a capsule cap (4),
b) a plunger assembly (2) having plunger body comprising a pair of legs and flexible annular lip and elastomeric seals (3),
c) a secondary cap (5)

2) a bottle having liquid
3) shrink sleeve covering the top of the capsule assembly till the neck ring on the bottle
wherein the said twin chamber once activated by pull mechanism using knob feature causes plunger to pull up creating space between capsule cap and plunger and leads to mixing of the substance with the liquid.
12. A twin chamber device for delivery activated by a pull mechanism for the delivery
of a drug comprising
1) a capsule assembly (1) having a drug comprising
d) a capsule cap (4),
e) a plunger assembly (2) having plunger body and elastomeric seals (3), and
f) a secondary cap (5)

2) a bottle having a liquid wherein the said twin chamber once activated by pull mechanism using knob feature causes plunger to pull up creating space between capsule cap and plunger and leads to mixing of the drug with the liquid.