DESC:FORM 2

THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003

COMPLETE

Specification
(See section 10 and rule 13)

TITLE: A dual chamber flexible vial with a customized two beveled needle with a Tamper evident cap for Injection

The following specification particularly describes the nature of this invention and the manner in which it is to be performed
TITLE: A dual chamber flexible vial with a customized two beveled needle with a Tamper evident cap for Injection
FIELD OF INVENTION
The present invention discloses a sterile two beveled needle comprising tamper evident cap that has a first tip which projected from the needle-top to engage in the patient's body and a second tip disposed in the female connector or Needle top with a cap to perforate the end of the vial so that, by means of manual pressure on the container of the vial, the solution contained therein can be injected through the needle into the patient's body. This invention also relates toa flexible dual chamber vial for injection made of plastic, more preferably made of polyethylene, in which constituents of the fluid mixture can be maintained in separate chambers and in which the separated constituents can be mixed in vitro, when desired, by placing the chambers in communication with one another. The separation is carried out by keeping the powder in a stem like plastic made container which operates through screw mechanism while the liquid stays in another chamber separated by a membrane. The active substances mingled with the diluent when desired pressing the screw thus forcing the stem to score on the membrane. Further press on the Nob breaks the membrane and the powder mix with the diluent. The present invention also relates to the combination of a sterile two chamber vial that has been molded as blow-fill-seal vial and a sterile two bevel needlewherein the needle consists of tamper evident cap that can be used for subcutaneous and/or Intramuscular administration of vial solution.

BACKGROUND OF THE INVENTION
At present to perform an injection in a patientsyringes consisting of a syringe body with a needlemounted in the head and a plunger slidable inside thesyringe body are used. On retraction of the plunger, thesolution for injection, which is generally contained in aglass vial, is drawn into the syringe body through theneedle. Then, the injection is performed and by pushingon the plunger said solution is injected from the syringebody through the needle into the patient's body. It is evidentthat said operation is rather awkward, impracticaland requires an excessive waste of time.
Prefilled syringes are known to the art, wherein to perform the injection the user must only push the plunger. However, even said syringes are excessively complex, not very versatile and not suitable for all types of medicinal solutions. Furthermore, in some cases themedicinal products that are in contact with the small steel cannula of the prefilled syringe can obstruct the inside hole of the needle.
Many recently approved parenteral drugs are based on biotechnological processes. In the past three years, more than 30% of the parenteral FDA approvals granted were for lyophilized substances. These drugs are extremely sensitive to external influences, such as oxygen, sunlight, and pH values, which, along with other factors, can degrade a substance and negatively affect its bioactivity. In the case of proteins and other recombinant substances, the simplest and safest way to maintain bioactivity is by using a liquid formulation. Water, however, is both a medium and a reaction partner that can cause hydrolysis or deamination, a form of hydrolysis of proteins. In addition, water increases chemical and physical instability, thereby allowing reactions with other substances. Liquid formulation does not allow sufficient long-term stability for many drugs. It makes sense, therefore, to remove as much water as possible from the liquid formulation to stabilize the substances until they are administered. The substance can be reconstituted with a diluent just before being injected.
Freeze-drying in primary packages has become a standard drying method. In the lyophilization process, the dissolved substance is frozen. The water is sublimated in a vacuum, and any remaining water is removed by raising the temperature slowly. The active substance and various excipients form a solid cake with an amorphous or crystalline structure. Depending on the formulation, the product will remain stable in this form for two to three years and can be reconstituted shortly before application.
Two different systems have become established for freeze-drying in primary packages vials and dual-chamber systems. With new drugs, the vial may be the best primary packaging system. The entire filling process and the system with all its components (i.e. stoppers, seals, and adapters) are less complex than dual-chamber systems and are therefore simpler to develop. On the other hand, administration of the drug is more complex because diluents must be added separately. To administer, the user meters the diluent from a second vial into a syringe and then adds the diluent to the lyophilized vial for reconstitution. Next, the reconstituted drug is withdrawn from the vial and, after changing the needle, administered to the patient. A volume of 1 mL of active substance typically requires overfill of 20% or more to ensure that an accurate dose is pulled into the syringe. For larger volumes, a lower overfill percentage is needed.
On the other hand, dual-chamber system contains the active substance and the diluent in two separate chambers that remain unmixed until shortly before administration. The drug compound is lyophilized directly in-situ in the front chamber. After lyophilization, the diluent is filled into the second chamber. For administration, a simple "twist and push" forces the diluent through a glass bypass into the front chamber, where it is mixed with the active substance. Dual-chamber systems reduce overfill needed and increase precision in dosing because drug and diluent are premeasured. For example, in a dual-chamber lyophilization system in which the substance is lyophilized and reconstituted within the system. Dual-chamber systems also decrease risk of medication error by eliminating the use of multiple vials and needles.
Present invention illustrates a customized two beveled needle consisting of tamper resistant cap and a protective hub to provide a single use needle configuration to prevent unauthorized access and use of a needle port.
This invention also relates to a device which permits two components, at least one of which is a liquid, which are intended to be injected simultaneously, to be stored separately and mixed together in the same device. This invention relates to fluid dispensing devices in which constituents of the fluid mixture can be maintained in separate chambers and in which the separated constituents can be mixed in vitro, when desired, by placing the chambers in communication with one another.
Devices already available for this purpose all have one or more serious disadvantages.
In a two-chamber syringe described in German Patent Specification No. 1,791,012, the two chambers, one of which is constructed as a syringe, are connected by a slidable tube. This piece of tube slides so as to push out a seal between the chambers, whereupon the components can be mixed and drawn into the syringe. The disadvantage of this device is that construction of the connecting part is very laborious because the slidable piece of tube requires very precise finishing, especially for a vacuum-tight construction. A further disadvantage is that this device cannot be processed in an automated lyophilizing plant.
A device is described in French Patent Specification No. 1,201,070 in which a vessel is divided into two chambers by a constriction, which can be closed by a stopper. The stopper can be forced out of the constriction by piercing a closure membrane with a syringe and forcing air into one chamber, so that the two chambers are joined. This device cannot be produced or used in a lyophilization plant, which is a serious disadvantage with respect to maintaining sterile conditions during filling. Further problems are the difficulty of producing a vessel with such a precisely finished construction and fragmentation, i.e., release into the components of particles of membrane resulting from piercing the membrane. Thus, this device appears impractical for mass production.
Container devices having multiple compartments for separately enclosed materials to be mixed prior to use are described in U.S. Pat. Nos. 3,340,873, 3,354,883, 3,397,694, 3,411,503, 4,331,146, 4,412,836, and 4,330,531, having a thin diaphragm type membrane separating the two compartments. These systems are not considered entirely reliable because of inability to maintain a fluid-tight seal between the compartments. U.S. Pat. No. 3,464,414 discloses a rigid walled two chambered mixing vial utilizing hydraulic pressure to dislodge a plug member between the two chambers.
Prior art devices of this type have relied on a variety of different closure strategies. In U.S. Pat. No. 4,286,640 a hinged tamper proof cover can be seen having a pair of hemispherical body members hinged together along adjacent sidewall edges.
U.S. Pat. No. 5,513,695 illustrates a tamper evident sleeve for IV needles that have a pair of elongated hinge covers with a hinge which is removable to access a needle by user engagement pull tab extending therefrom.
US 8091727relates to a snap-over clamshell protective port cap for intravenous (IV) fluid containers.
U.S. Pat. No. 7,678,101 is directed to a locking catheter connector and connector system.
In U.S. Pat. No. 8,091,727 a snap over clam shell protective port cap is claimed having two halves hinged together with a puncture resistant lid portion so as to cover when applied onto the end of an injection port.
US 20140364804 discloses tamper resistant/evident cap cover for IV needle configurations to provide a single use engageable cap to prevent unauthorized access and use of an IV needle port. The cap cover has a threaded IV needle receiving base and a slidably disposed inter engagement locking clasp. Oppositely disposed tamper evident latching tabs are receivably secured into the base by multiple clasp barbs defining a first position for access and a second closed locked position.
U.S. Pat. No. 3308821 discloses to a connector assembly for a vial which minimizes the number of components in the connector assembly and which reduces the number of microbial barriers necessary to safeguard sterility of the system.
US Pat. No. 2012/0097707 relates to a device for packaging and dispensing fluid products, and more particularly a flexible pocket for a device for packaging and dispensing fluid products, that are liquid or pasty, of the pocket-vial type, that is to say comprising a flexible pocket placed in a rigid receptacle and associated with a pump or a valve making it possible to keep the fluid product in the flexible pocket away from the air in good conditions and to dispense if from the pocket by actuating the pump or the valve.
US Pat. No. 3288318 relates particularly to an inexpensive, unbreakable plastic vial or container for use in obtaining or receiving samples of blood and other fluids from farm animals and herds for purposes of diagnosis and subsequent treatment.
US 9108777 discloses a child resistant container made from blow-molded plastic which comprises a vial having an outlet port; a pre-determined volume of aseptic fluid disposed sealed within the vial; a cap detachable from the vial; and, a resilient guard having a first and second ends which are integral to the vial on opposing sides. The resilient guard is designed to not be separated from contact with the vial and has a mid-portion which is initially positioned above the top of the cap to prevent cap removal. The safety container is preferably single use.
The basic concept of BFS is that a vial is formed, filled, and sealed in a continuous process without human intervention, in a sterile enclosed area inside a machine. Thus, BFS can be used to aseptically manufacture sterile pharmaceutical liquid dosage forms. Along with that the two beveled needle is directly attached to the vial thus making this invention as an effortless and economic mode of administration.
Hence an attempt was made by the authors of the present invention to develop a dual chamber vial for injection and a relative safety devicefor a needle for a vial that are economical, simple tomake and at the same time practical for the user.
The inventors of present invention have eliminated all the drawbacks related to both the vial and dual chamber systems and conjoined them in a single device i.e., a vial having two chambers separating the diluent from therapeutic agents keeping the powder in a stem like plastic made container which operates through screw mechanism while the liquid stays in another chamber separated by a membrane. The active substances mingled with the diluent when desired pressing the screw thus forcing the stem to score on the membrane. Further press on the Nob breaks the membrane and the powder mix with the diluent.
Another part of the uniqueness of the device is to provide a customized needle attached with a flexible vial of dual chamber comprising of powder dispensed in 1st chamber and liquid in another chamber, wherein the needle can be double beveled and consists of tamper evident cap. Whenever the tamper evident cap is removed that will lead to exposure of two bevel needle and that will pierce the dual chamber flexible vial. Thus the medicament is administered. Along with that the two beveled needle is directly attached to the dual chamber flexible vial thus making this invention as an effortless, and economic mode of administration and also safer to administer the medicaments in form of solutions or suspensions.

BRIEF DESCRIPTION OF THE FIGURES
Other features of the present invention will be more readily understood from the following detailed description of exemplary embodiments thereof when read in conjunction with the accompanying drawings.
FIG.1 describes the front view of stem like upper chamber (Plunger) clearly indicating the screw like threads on the body of the stem.
FIG.2 describes the complete view of the device of the present invention along with the two beveled needle with tamper evident cap.
FIG.3 describes the steps involved to manufacture a Dual Chamber vial using Blow-Fill-Seal Technique.

SUMMARY OF THE INVENTION
One of the embodiments of the present invention discloses a tamper resistant/evident cap cover for two beveled needle configurations to provide a single use engageable cap to prevent unauthorized access and use of needle port.
Another embodiment of present invention relates with use of unique two bevel needle with internal threads and a protective hub.
Another embodiment of the invention provides a needle with tamper evident cap and protective hub is welded on to the dual chamber vial. It is used with a simple twist and turn to 'activate' for product delivery. One anti-clockwise twist will break it open at the ring and the clockwise twist will fix the needle on to the vial by piercing through the vial top. This needle can be made unique by adding flanges to provide for better grip.The two bevel needle is being used as it is Sharp, pointed, curved, and it is recommended for septum penetration.
Another embodiment of present invention illustrates a flexible vial consisting of Dual chamber made of plastic, more preferably made of polyethylene.
Another embodiment of present invention discloses a tamper evident needle, wherein the needle can be double bevel. Whenever the tamper evident cap is removed that will lead to exposure of two bevel needle and that will pierce the flexible dual chamber vial. Thus the medicament is administered.
Another embodiment of invention is along with that the two beveled needle is directly attached to the flexible dual chamber vial making it as an effortless and economic mode of administration and also safer to administer the medicaments in form of solutions or suspensions.
Another embodiment of present invention discloses the route of administration as intramuscular or subcutaneous.
Another embodiment of the present invention discloses use of wings or flanges on the shoulder of the vial for better grip.
One of the embodiment of the present invention discloses a flexible vial for injection according to the invention comprising dual chamber separated by a membrane, wherein one chamber contains liquid diluent and another chamber having a stem like shape contains the powdered therapeutic agent. The body of the vial is made of an elastically deformable plastic material specifically thermo plastic material and has a male connector, suitable to be coupled with a female connector or needle top with a cap which supports an injection needle.
Another embodiment of the present invention discloses a dual chamber flexible vial made of plastic more specifically thermo plastic and most specifically Polyethylene.
One of the unique embodiment of the present invention describes the top chamber comprising powder material having a stem like shape works on screw mechanism.
Again another embodiment of the present invention illustrates that top chamber is separated from bottom chamber comprising liquid diluent, by means of a membrane made of a same material as of the vial.
Another embodiment of the present invention describes the mechanism of vial operation. The active substances mingled with the diluent when desired pressing the screw thus forcing the stem to score on the membrane. Further press on the Nob breaks the membrane and the powder mix with the diluent.
Embodiments of the invention employ aseptic blow, fill and seal fabrication operations that do not require post-formation autoclaving for sterilization to mold the vials.
Another embodiment of present invention describes two chambers of the said vial are manufactured separately by using different mold. Top chamber has a unique stem like structure and having screw like threads on it while bottom chamber is manufactured following conventional blow-fill-seal technique. Once the top chamber got filled by powder and bottom chamber by liquid then both the chamber are sealed together separating by means of a membrane.
One of the embodiments of the present invention discloses that the present invention can be used to carry a wide range of therapeutic agents as lyophilized form.
It is noted that aspects of the invention described with respect to one embodiment, may be incorporated in a different embodiment although not specifically described relative thereto. That is, all embodiments and/or features of any embodiment can be combined in any way and/or combination. Applicant reserves the right to change any originally filed claim or file any new claim accordingly, including the right to be able to amend any originally filed claim to depend from and/or incorporate any features of any other claim although not originally claimed in that manner. These and other objects and/or aspects of the present invention are explained in detail in the specification set forth below.
DETAILED DESCRIPTION
The present invention now is described more fully hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, this embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the inventionto those skilled in the art.
Like numbers refers to like elements throughout. In the figures, the thickness of certain lines, layers, components, elements or features may be exaggerated for clarity. Broken lines illustrate optional features or operations unless specified otherwise. One or more features shown and discussed with respect to one embodiment may be included in another embodiment even if not explicitly described or shown with another embodiment.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items. As used herein, phrases such as "between X and Y" and "between about X and Y" should be interpreted to include X and Y. As used herein, phrases such as "between about X and Y" mean "between about X and about Y." As used herein, phrases such as "from about X to Y" mean "from about X to about Y."
The term “Tamper Evident” thereof meansa device or process that makes unauthorized access to the protected object easily detected. Seals, markings or other techniques may be tamper indicating.
The term ‘’Dual chamber vial or Dual chamber flexible vial or dual chamber’’ is hereby described in the specification as ‘’Vial or flexible vial’’, unless otherwise described contrary to above.
The term “Needle” discloses an object thatis any thin and cylindrical object which has a sharp bevel on its end. A medical needle is hollow and has a hole in the middle to allow the flow of medication into the body of a human being or animal. Medical needles consist of three parts made of stainless steel because of its high resistance to corrosion. The three parts of a needle are the shaft, which is the longest part of the needle, the bevel, which is the slanted tip of the needles, and the hub, which fits firmly onto the tip of the syringe or the vials.
When a needle penetrates into the body of a human being or animal, the bevel, which is the slanted tip of the needle, creates a narrow hole in the skin of a person to allow the fluid in the syringe to be injected into the person.
Once the needle is withdrawn from the skin of a person, the slit closes to limit the leakage of medication or blood.
For an intramuscular injection (IM), a 21 and 23 gauge needles which are 1 to 1.5 inches long are preferred or recommended for an adult while a 25 to 27 gauge needle which is 1 inch long is recommended for a child.
For a subcutaneous (SQ) injection, a 25 to 27 gauge needle which is 3/8 to 5/8 inches long is recommended for both children and adults. However, some medications such as Byetta for diabetes recommend the use of a 30 to 31 gauge needle which is 1/3 inch long. These types of needles are chosen because, for one reason, the subcutaneous medications are injected and deposited on the loose connective tissues which are supplied with fewer blood vessels hence low absorption rate of the medication into the blood stream of a person. Another reason is that this layer of tissue consists of many pain receptors which dictate the use of non-irritating, water-soluble medications in small doses.
Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the specification and relevant art and should not be interpreted in an idealized or overly formal sense unless expressly so defined herein. Well-known functions or constructions may not be described in detail for brevity and/or clarity.
Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is inverted, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
It will be understood that when an element is referred to as being "on", "attached" to, "connected" to, "coupled" with, "contacting", etc., another element, it can be directly on, attached to, connected to, coupled with or contacting the other element or intervening elements may also be present. In contrast, when an element is referred to as being, for example, "directly on", "directly attached" to, "directly connected" to, "directly coupled" with or "directly contacting" another element, there are no intervening elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.
The term "sterile" and derivatives thereof means that the noted device or material meets or exceeds defined (e.g., food or medical) guidelines of sterility so as to be substantially (if not totally) free of contaminants for at least a defined shelf life so as to be suitable for intended uses, e.g., clinical, health, or consumer product testing for the presence of toxins, microbes, microorganisms or other target constituents in a sample undergoing analysis. The sample can undergo analysis while held in the container. The sample may be transferred after transport and/or culturing in the container for analysis.
The term "aseptic" is used interchangeably with the word "sterile". In some embodiments, the aseptic processing or fabrication complies with GMP (Good Manufacturing Practice) industry guidelines such as those associated with Guidance for Industry--Sterile Drug Products Produced by Aseptic Processing--Current Good Manufacturing Practice, U.S. Department of Health and Human Services Food and Drug Administration, September 2004. The term "sterile environment" refers to an environment that complies with his GMP and can be defined using a suitable clean room.
The term "parison" refers to a preform of material that is subsequently blown into a shape defined by an enclosed mold using pressurized gas using conventional blow molding processes (typically extrusion-based methods) as is well known to those of skill in the art.
Further characteristics of the invention will be made clearer by the detailed description that follows, referring to a purely exemplary and therefore non-limiting embodiment thereof, illustrated in the appended drawings, in which:
• Fig 1 illustrates the view of the Upper chamber (Plunger). It contains a stem like structure and operates with a screw mechanism. The upper chamber (plunger) is filled with solid powder and contains a Nob to press for applying force on the membrane that separates both the Chamber.
• Fig 2 describes the complete view of the device of the present invention along with the two beveled needle with tamper evident cap. The present invention discloses a vial made of plastic more specifically Polyethylene, comprising two chambers (i) Top Chamber and (ii) Bottom Chamber and being separated by a membrane. Upper Chamber contains a stem like structure and operates with a screw mechanism. It is filled with solid powder and contains a Nob to press for applying force on the membrane that separates both the Chamber. The stem has a slanting end. So while the Nob is pressed the sharp slanting edge of the stem like plunger will create a score on the membrane and further application of force tears the membrane apart. Thus the powder mixes with the diluent liquid.
The figure also describes the customized two beveled needle comprising tamper evident needle cap.
• Fig 3 describes the steps involved to manufacture a Dual Chamber vial using Blow-Fill-Seal Technique.
The vial described in present invention contains two chambers wherein the top chamber comprises a stem like Plunger, a nob to operate and the powdered medicaments and the bottom chamber contains the liquid diluent. The said two chambers are manufactured separately using different mold. The top chamber contains the screw like threads and operates on screw mechanism while the bottom chamber is manufactured using the conventional Blow-Fill-Seal techniques.
1) Preparation of bottom chamber by BFS Technique: A plastic parison, extruded from polymer, is accepted by the opened blow mold and cut below the die of the parison head. The main mold closes and simultaneously seals the bottom. The special mandrel unit settles onto the neck area and forms the parison into a container using compressed air or vacuum. By way of the special mandrel unit, the product is precisely measured by the dosing unit and liquid is filled into the container. But before the container is finally sealed it comes across second step i.e., attachment of Upper chamber.
2) The Upper chamber that has been prepared separately using different mold and filled with powder through a nozzle, finally sits on the bottom chamber. So the Top Chamber and Bottom Chamber got separated by mean of upper wall of bottom chamber and lower wall of upper chamber.
3) Now finally the head mold closes and forms the required seal by vacuum. With the opening of the blow mold, the container exits from the machine and the cycle repeats itself.
The uniqueness behind using a two bevel needle particularly is that it is Sharp, pointed, curved, non-coring needle bevel recommended for septum penetration. As the intended route of administration is Intramuscular or subcutaneous so above are qualities that a needle must possess.
Another part of the uniqueness of the device is to provide a flexibledouble chamber vial with a tamper evident cap, wherein the needle can be double bevel. Whenever the tamper evident cap is removed that will lead to exposure of two bevelneedle and that will pierce the flexible dual chamber vial. Thus the medicament is administered. Along with that the two beveled needle is directly attached to the flexible dual chamber vial thus making this invention as an effortless and economic mode of administration and also safer to administer the medicaments in form of solutions or suspensions.
The tamper evident cap has four projections that kept pierced inside the protective hub that have four aperture where the projections fit accurately thus forming a strong anchorage between the protective hub of the needle and the tamper evident cap. At the time of use that tamper evident cap is removed and the device becomes ready to use.
One of the embodiment of the present invention describes the Blow-Fill-Seal process used for the preparation of dual chamber flexible vial. Blow-fill-seal (BFS) packaging is a process wherein extruded resin, such as polyethylene (PE) or polypropylene (PP), is blown in a sterile and pyrogen-free state into a mold shaped in the desired form of a container. Following the formation of a container, the container cools and is then filled with product and sealed.
A plastic parison, extruded from polymer, is accepted by the opened blow mould and cut below the die of the parison head. The main mould closes and simultaneously seals the bottom. The special mandrel unit settles onto the neck area and forms the parison into a container using compressed air or vacuum. By way of the special mandrel unit, the product is precisely measured by the dosing unit and liquid is filled into the container. After the special mandrel unit retracts, the head mould closes and forms the required seal by vacuum. With the opening of the blow mould, the container exits from the machine and the cycle repeats itself.
The basic concept of BFS is that a dual chamber flexible vial is formed, filled, and sealed in a continuous process without human intervention, in a sterile enclosed area inside a machine. Thus, BFS can be used to aseptically manufacture sterile pharmaceutical liquid dosage forms.
The antibiotics include and not limited to Amikacin, Gentamicin, Kanamycin A, Neomycin, Netilmicin, Tobramycin, Paromomycin, Streptomycin, Spectinomycin, Geldanamycin, Rifaximin, Ertapenem, Doripenem, Imipenem, Meropenem , Cefadroxil, Cefazolin, Cefalexin, Clindamycin, Lincomycin, Daptomycin, Azithromycin, Erythromycin, Roxithromycin, Ampicillin/sulbactam, Ceftarolinefosamil, Nafcillin sodium, Norfloxacinetc and related compounds.
The present invention is also useful for the administration of Potential actives like Insulin, Heparin, Epinephrine, and Vitamin B-12 and not limited to former agents but also can be utilized for the administration of following agents.
The present invention is also suitable for the administration of pharmaceutical agents include, but are not limited to, anticancer agents or antineoplastics, antimicrotubule agents, immunosuppressive agents, anesthetics, hormones, agents for use in cardiovascular disorders, antiarrythmics, antibiotics, antifungals, antihypertensives, antiasthmatics, analgesics, anti-inflammatory agents, anti-arthritic agents, and vasoactive agents. The invention is useful with many other drug classes as well. More specifically, suitable pharmaceutical agents include, but are not limited to, taxanes, (e.g., Taxol® (paclitaxel), and Taxotere™ (docetaxel)), epothilones, camptothecin, colchicine, amiodarone, thyroid hormones, vasoactive peptides (e.g., vasoactive intestinal peptide), amphotericin, corticosteroids, propofol, melatonin, cyclosporine, rapamycin (sirolimus), tacrolimus, mycophenolic acids, ifosfamide, vinorelbine, vancomycin, gemcitabine, SU5416, thiotepa, bleomycin, diagnostic radiocontrast agents, and derivatives thereof.
The structure of the dual chamber flexible vial according to the invention and the manufacturing process thereof allow injectable drugs to be inserted therein, ready for use and in single-dose disposable package.
The dual chamber vial includes a body that is blow molded as will be discussed further below. The body can be a molded polymeric body (e.g., a thermoplastic material body) which can be made from a single layer of polymeric (plastic) material. The material used to form the container body can be selected so that the container body is visually transmissive and substantially impermeable at normal environmental pressures allowing for a suitable shelf life. Unlike conventional containers, the container body is not required to have the necessary characteristics to be autoclaved (e.g., withstand the high temperature, high pressure and steam of autoclaving). Examples of useful materials include, but are not limited to polycarbonate, polyolefin such as polypropylene (PP), polyethylene (PE), or cyclic olefin (COC), polyester such as polyethylene terephthalate (PET) or polyethylene napthalate (PEN), polyamide (nylon), or other well-known materials in the plastics art. Within Polyethylene, LDPE (Low density poly ethylene) as well as HDPE (High density polyethylene) both can be used as the polymeric body. Amorphous plastics such as amorphous nylon exhibit high transparency and may also be suitable.
The forgoing is illustrative of embodiments of the present invention and is not to be construed as limiting thereof. Although a few exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention.
From the foregoing it will be understood that the embodiments of the present invention described above are well suited to provide the advantages set forth, and since many possible embodiments may be made of the various features of this invention and as the device herein described may be varied in various parts, all without departing from the scope of the invention, it is to be understood that all matter hereinbefore set forth or shown in the accompanying drawings is to be interpreted as illustrative and that in certain instances some of the features may be used without a corresponding use of other features, all without departing from the scope of the invention.
Further the present invention has been illustrated in the different figures. The following specific and non-limiting steps for functioning need to be construed as merely illustrative, and do not limit the present disclosure in any way whatsoever.

Comparative Examples:
A study was conducted following present invention and Conventional Pre filled Syringe without tamper evidence in which few patients were given Tamper evident needle with dual chamber Flexible Vial of drug solution/ Suspension and Conventional Prefilled Syringe without Tamper evidence and results are documented below:

With Tamper Evidence Without Tamper Evidence
Patient Compliance (easy handling) Acceptable Acceptable with difficulty
Safety Acceptable Not Acceptable
Identification (Used/ To be used) Acceptable Not Acceptable

Dated: Aug 22, 2018
,CLAIMS:We Claim,
1. A sterile two beveled needle comprising tamper evident cap wherein the needle has a first tip which projected from the needle top to engage in the patient’s body and a second tip disposed in the female connector or needle top with a cap to perforate the end of the vial.
2. A two beveled needle according to claim 1, wherein the needle is controlled by means of manual pressure on the container of the vial, the solution contained therein can be injected through the needle into the patient’s body.
3. A sterile two beveled needle according to claim 1 and 2, wherein the needle penetrates a flexible dual chamber vial made of plastic, more preferably made of polyethylene, in which the lyophilized medicament and the diluent can be maintained in separate chambers.
4. A sterile two beveled needle according to claim 1 -3, wherein the needle penetrates a flexible dual chamber vial containing lyophilized medicament and the diluents in two separate chambers and the separated constituents can be mixed in vitro, when required, by placing the chambers in communication with one another.
5. A sterile two beveled needle according to claim 1 and 3, wherein the needle penetrates a flexible dual chamber vial wherein the lyophilized medicament and the diluent are kept separated by keeping the powder in a stem like plastic made container which operates through screw mechanism while the liquid diluent stays in another chamber separated by a membrane.
6. A sterile two beveled needle according to claim 1 and 4, wherein the needle penetrates a flexible dual chamber vial wherein the lyophilized medicament and the diluent are kept separated and they mix, when required, pressing the Nob attached with the stem like screw thus forcing the stem to score and break the membrane.
7. A sterile two beveled needle according to claim 1 and 4, wherein the needle penetrates a flexible dual chamber vial wherein the lyophilized medicament and the diluent are kept separated in two chambers made of plastic in a blow-fill-seal mechanism.
8. A sterile two beveled needle according to claim 1, wherein the needle consists of tamper evident cap, can be used for subcutaneous and/ or intramuscular administration of the medicament.