VITAMIN K1 INJECTION DEVICE KIT”
FIELD OF THE INVENTION:
This invention relates to a simple, convenient, user-friendly, ready to
administer pre-filled syringe injection device, for delivery of medication
product used for the prophylaxis and treatment of vitamin K deficiency
bleeding in the neonates and other age groups.
BACKGROUND OF THE INVENTION:
Vitamin K (Phytonadione) is used to prevent bleeding in people with blood
clotting problems or too little vitamin K in the body. Phytonadione is in a
class of important medications called vitamins. It works by providing
vitamin K that is needed for blood to clot normally in the body. It helps to
make various proteins that are needed for blood clotting and the building
of bones. It functions as a cofactor required for the activity of vitamin Kdependent proteins, which include factors II (prothrombin), VII, IX, and X,
in addition to protein C and protein S. Prothrombin is a vitamin Kdependent protein directly involved with blood clotting. Osteocalcin is
another protein that requires vitamin K to produce healthy bone tissue.
Vitamin K1 is a fat-soluble vitamin that is present in leafy green
vegetables. It is essential for normal coagulation. In vitamin K deficiency,
phytonadione therapy replenishes stores. Vitamin K is absorbed in the
intestinal tract similarly to the way that most dietary lipids are absorbed by
uptake into micelles composed of bile salts. They are absorbed into
intestinal enterocytes into the lymphatic system and reach venous
circulation by way of the thoracic duct. Estimates are that over 60% of
absorbed vitamin K will be excreted from the body. Phytonadione is
metabolized in the liver and then excreted in the bile and urine.
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Vitamin K is approved by major regulatory agencies and marketed in
several countries and available as Phytonadione injection or Vitamin K
injection and is indicated for treatment of Hypoprothrombinemia due to
Vitamin K deficiency or interference, and prophylaxis and treatment of
Vitamin K-deficiency bleeding in neonates.
The USFDA approved Phytonadione Injectable Emulsion, USP,
1mg/0.5mL on Mar 01, 1976 to International Medication Systems (IMS) for
treatment of Hypoprothrombinemia due to Vitamin K Deficiency or
interference and prophylaxis and treatment of Vitamin K-deficiency
bleeding in neonates. Phytonadione Injectable Emulsion, USP is available
in 1 mg (1 mg/0.5 mL) single-dose vials and a SAF-T-Jet® vial injector.
IMS Phytonadione Injection drug product contains 2 mg phytonadione, 20
mg polysorbate 80, 20.8 mg propylene glycol, 0.34 mg sodium acetate,
and 0.00004 mL glacial acetic acid in water for injection. Additional glacial
acetic acid or sodium acetate anhydrous may have been added to adjust
pH to meet USP limits of 3.5 to 7.0. The air above the liquid in the
individual containers has been displaced by flushing with nitrogen during
the filling operation. However other Phytonadione injectable products with
different compositions are also commercially available in the market.
IMS phytonadione injection is available and supplied as Phytonadione
Injectable Emulsion USP, 1 mg/0.5 mL injector is a disposable, manually
operated, supplied in unit use packages containing one single-dose vial
and a SAF-T-Jet® vial injector, 27 G x ½” needle which needs to be
assembled before administration. At the time of injection, the single-dose
vial needs to be aligned and assembled to vial injector, and the drug is
injected by threading the vial into injector with three half turns. Further,
assembling SAF-T-Jet® vial injector has several steps which has to be
done by skilled clinician or nurse at the healthcare setup.
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Steps to be performed before administration of phytonadione injection
through SAF-T-Jet® vial.
1. Remove the protective caps from vial and injector.
2. Align vial such that the injector needle is centered on the
stopper.
Thread vial into injector 3 half turns; this will allow the needle to
penetrate the stopper* (*CAUTION: IMPROPER ENGAGING
MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT
INJURY)
DO NOT PUSH VIAL INTO INJECTOR; THIS MAY CAUSE
MISALIGNMENT OF THE INJECTOR NEEDLE.
3. i. Flip the shield down
ii. Remove Needle cover pulling straight up (DO NOT TWIST).
Expel air.
4. i. After injection, push tab forward with thumb to flip shield
toward needle.
ii. With a FIRM, QUICK motion, press down against a flat
surface until an audible “click” is heard. This sound indicates
shield activation. Note: Audible click may not be heard on small
needle sizes: visual confirmation is required.
Further to this the vial or cartridge has the dose marking such as (1mg-0.5
mL and 0.5 mg-0.25mL) on the label which is clearly visible before
insertion to the SAF-T-Jet vial. However, once the vial or cartridge is
inserted into the SAF-T-Jet vial, clear visibility of the cartridge is difficult as
the SAF-T Jet vial is opaque in nature and has 2 layers within. Though the
cartridge is prefilled, visibility of the dose marking is difficult to know if the
dose has been completely dispensed or administered to the patient
leading to dosing errors which is undesirable. Required dosing of Vitamin
5
K has to be administered to the patients, dosing errors may lead to other
major complications.
SAF-T-jet injector vial is disclosed in US patent no 3739780, wherein it
discloses a medicament injector comprising a cylindrical vial.
US patents 10028921 and 11096907 discloses stable Phytonadione
compositions for parenteral administration are provided which comprise
(E) isomer of phytonadione at or greater than 97% w/w as the active
ingredient and is substantially free of (Z) isomer. Said compositions are
stable, sterile, and particulate-free. Further, said compositions reduce or
avoid allergic reactions to benzyl alcohol and polysorbate. Further, it
mentions that the compositions may be administered in a non-reacting
glass or non-reacting polymeric container selected from a vial container or
a pre-filled syringe container.
US20190328971A1 discloses apparatus includes a housing, a
medicament container and a movable member. The medicament container
is configured to move within the housing between a first position and a
second position in response to a force produced by an energy storage
member. Dependent claim 3 claims Vitamin B12 as one of component.
SAF-T-jet device has disadvantages such as, assembling of drug vial and
in the event of improper handling of SAF-T-jet device during assembling it
may result in glass breakage and subsequent injuries.
Considering above steps, precautions for preparation of the SAF-T jet
injection product, which is tedious, time consuming, and skilled persons
are required to prepare the same. Further, in order to understand the
procedure or any error during the injection preparation steps may cause
unnecessary delay of medication to the patient and also the product may
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get damaged due to the errors in preparation. Further, there may be dose
variabilities leading to further consequences if the precautions are not
taken care of during the device preparation.
In view of the above complexities of preparation and administration of the
medication, there is unmet need in the art to develop a simple, easy and
quick delivery device to administer the medicine to the patient. Hence, the
present invention provides a simple, convenient, user-friendly ready to
administer delivery device. The present invention provides ease of
administration of vitamin K1 injection to the patient by pre-filled syringe or
auto injector injection device.
SUMMARY OF THE INVENTION:
One object of the present invention is to provide ease of administration of
vitamin K1 injection to the patient.
Another object of the present invention is to provide a simple, convenient,
user-friendly, ready to administer pre-filled syringe injection device, for
delivery of medication product used for the prophylaxis and treatment of
vitamin K deficiency bleeding in the neonates and other age groups.
Another object of the present invention is to provide a simple, convenient,
user-friendly auto injector injection device, for delivery of medication
product used for the prophylaxis and treatment of vitamin K deficiency
bleeding in the neonates and other age groups.
In one embodiment, of the present invention is to provides ready to use,
ready to administer, ready to inject, or ready to dilute composition of
emulsion, colloidal solution and/ or other biphasic liquid medication
comprising therapeutic quantity of vitamin K1.
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In one embodiment, of the present invention provides the composition of
Vitamin K1 delivered through parenteral routes such as subcutaneous,
intramuscular, or intravenous route of administration.
In one embodiment, the present invention provides the composition of
Vitamin K1 can be injected in the range of 1 mg to 50 mg as unit dose
compositions based on the requirement.
In one embodiment, the present invention provides the prefilled syringe
injection device with a staked needle with rigid needle shield wherein, the
medication is injected by pushing the pre-attached plunger rod.
In one embodiment, the present invention provides ready to use prefilled
syringe system is accompanied with suitable safety device system.
In one embodiment, the present invention provides prefilled injection
device which doesn’t require pre-assembling with multiple steps before
administration.
In one embodiment, the present invention injection device, provide better
shield performance and/or functionality of safety needle in comparison to
other devices.
In one embodiment, the present invention injection device comprises
injectable composition used for the treatment of Vitamin K deficiency in
emergency use.
In one embodiment, the present invention provides prefilled syringe
injection device comprises injectable composition of Vitamin K1 is used for
the treatment of Vitamin K deficiency related disease and disorders.
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In one embodiment, the present invention provides prefilled syringe
injection device comprises injectable composition of Vitamin K1 is used for
the treatment of Vitamin K sensitive disease and disorders.
DETAILED DESCRIPTION OF THE INVENTION:
The present invention relates to a simple, convenient, user-friendly, ready
to administer pre-filled syringe injection device, for delivery of medication.
The present invention relates to a simple, convenient, user-friendly, ready
to administer pre-filled syringe injection device, for delivery of medication
product used for the prophylaxis and treatment of vitamin K deficiency
bleeding in the neonates and other age groups.
The term “Vitamin K” or “phytonadione” includes the compound,
pharmaceutically acceptable salts thereof, isomers, solvates, prodrugs,
complexes and hydrates, anhydrous forms thereof, and any polymorphic
or amorphous forms or combinations thereof.
The term "vitamin K" as used herein includes a group of lipophilic,
hydrophobic vitamins that are needed for the post-translational
modification of certain proteins, mostly required for blood coagulation.
Chemically, they are 2-methyl-1,4-naphthoquinone derivatives. Vitamin K1
is also known as phylloquinone or phytomenadione (also called
phytonadione), and vitamin K2 is also known as menaquinone or
menatetrenone. There are three synthetic forms of vitamin K, vitamins K3,
K4, and K5, which are used in many areas including the pet food industry
(vitamin K3) and for inhibiting fungal growth (vitamin K5).
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The term “pharmaceutically acceptable salts” includes pharmaceutically
acceptable salts, solvates, hydrates, anhydrates, enantiomers, esters,
isomers, polymorphs, tautomers, complexes and thereof.
The term “ready-to-use” or “ready to administer” or “ready to inject” or
“ready to dilute” refers to a liquid composition for parenteral administration.
The terms “composition” and “formulation” refer to preparations comprising
Vitamin K or Phytonadione or phytomenadione or Vitamin K1 or
phylloquinone or pharmaceutically acceptable salts thereof with
pharmaceutically acceptable solvent or carriers or excipients; in a form
suitable for administration to a mammal.
The terms “injectable composition”, or “injection composition” or “injectable
formulation” or “injection formulation” refer to preparations comprising
Vitamin K or Phytonadione or phytomenadione or Vitamin K1 or
phylloquinone or pharmaceutically acceptable salts thereof; in a form
suitable for administration to a mammal.
The term “Therapeutically effective amount” or “therapeutic quantity”
means an amount of a compound that, when administered to a subject for
treatment or prophylaxis of disease or disorder or amount of a compound
that is effective in therapy, or an amount sufficient to provide a therapeutic
effect. The “therapeutically effective amount” or “therapeutic quantity” can
vary depending on the compound, the disease and its severity, and the
age, weight, etc., of the subject to be treated.
The term “substantially dissolved" relates to 0.1% to 99% of total Vitamin
K or Phytonadione or phytomenadione or Vitamin K1 or phylloquinone or
pharmaceutically acceptable salts thereof is dissolved in the compositions.
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The term "stable" or "stability" as used herein includes both physical and
chemical stability. Stability parameters include but not limited to potency,
stable pH value and other important physico-chemical parameters.
The term "physical stability" refers to compositions free from particles and
that do not significantly change during storage.
The term "chemical stability" relates to a limited formation of impurities,
limited decrease in potency and the like.
Vitamin K may exist as a mixture of two isomers, known as (E) and (Z)
isomers. The precise ratio of these isomers in a given drug product
composition is unknown. Some commercial preparations may contain up
to 20% of the cis (Z) isomer. See for example, Budavari, S. (ed.). The
Merck Index - Encyclopedia of Chemicals, Drugs and Biologicals. Rahway,
N.J.: Merck and Co., Inc., 1989., p. 1580. Commercially available
phylloquinone (Phytonadione) is prepared synthetically and may contain
not only 2′,3′-trans-phylloquinone (not less than 75%), but also 2′,3′-cisphylloquinone (up to 21% as per USP XXXII).
Existing Phytonadione or Vitamin K injections are supplied and
commercially available as ampoules and SAF-T-jet injection vials.
Packaging material plays a very important role for finished pharmaceutical
compositions. In packaging materials there are primary packaging,
secondary packaging materials. Primary Packaging material plays an
important role while packaging the finished pharmaceutical composition as
the composition is in direct contact with the primary packaging material.
Primary packaging generally includes ampoules, vials, cartridges, bottles,
bags, and the like. Further to close or to seal the primary containers,
elastomers are widely used in primary parenteral packaging as stoppers
for vials, plungers and tip caps for pre-fillable syringes, plungers and seals
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for cartridges and ports for plastic bags. Hence, choosing the primary
packaging is of prime importance. As the phytonadione injection is
supplied in ampoules, use of ampoules for this injection has several
disadvantages.
Dose wastage while withdrawing medication from the ampoule as it must
be scored and broken, indirectly leading to dose variation if there is any
spillage from ampoule. Further while withdrawing the composition in a
syringe from ampoule there may be some left over of the solution again
leading to dose variation. Further, there may be stability issue due to head
space in the ampoule leading to degradation of the composition. While
breaking the ampoule, it is likely that small glass pieces may enter in the
product and may go unnoticed. This may be very serious issue, as the
proposed formulation is intended for neonatal age population. Hence,
there are several disadvantages of the composition when supplied in
ampoules.
Similarly, SAF-T-jet injector vial has several disadvantages as mentioned
in the background of this invention.
Therefore, considering these issues the present invention provides a
simple, convenient, user-friendly pre-filled syringe injection device, for
delivery of medication to the patients which overcomes the above issues
or complications.
Further, the present invention provides a simple, convenient, user-friendly
auto injector device, for delivery of medication to the patients which
overcomes the above issues or complications.
The commercially available Vitamin K injectable ampoules may have
stability issues or less stable due to the head space oxygen. Though
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nitrogen gas is purged after the ampoule filling there may be some
nascent oxygen leading degradation of composition.
The present invention provides injection device to overcome the stability
issues which have been existing in the ampoules due to the head space
oxygen.
The present invention solves the stability issues by providing injection
devices such as prefilled syringe, autoinjectors where these issues are
taken care by the proper filling and minimal head space and hence
stability is noticed to satisfactory levels.
Phytonadione injection is also supplied in ampoules, wherein the use of
ampoules has its own drawbacks, such as before administration the health
care worker or clinician has to keep the syringe, ampoule ready. Further to
break the ampoule a clean snap should be used, while breaking if too
much force is applied it can cause the ampoule to shatter, if the ampoule
shatters, discard it and use a new ampoule, using the new ampoules,
hence leading to loss of the ampoule. Another drawback of the ampoule is
while cutting the ampoule small glass pieces may also drop inside the
ampoule, which may go unnoticed and if not observed it may be difficult to
identify as vitamin K injection is biphasic liquid or colloidal solution. Hence
this minute glass pieces may be administered to the patients or
sometimes, they may choke the needles leading to improper withdrawal of
the injection and final wastage of the ampoules.
During emergency conditions, pre-filled syringe is very useful and
important for immediate and quick action to the patients. As Vitamin K or
phytonadione injection is used to cure the Vitamin K related deficiencies,
which are linked to the blood clotting factors, hence these are the most
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critical injection that acts in life saving indirectly. Hence, injectable prefilled syringe device is very useful in these types of situations.
During emergency conditions, auto injectors are very useful and important
for immediate and quick action to the patients. As Vitamin K or
phytonadione injection is used to cure the Vitamin K related deficiencies,
which are linked to the blood clotting factors, hence these are the most
critical injection that acts in life saving indirectly. Hence, prefilled syringe or
auto injector device is very useful in these types of situations.
In one embodiment, the present invention provides prefilled injection
device are composed of the barrel, piston, plunger rod, needle and tip cap
or needle shield, and includes a variety of modification options for each of
these components.
In one embodiment, the present invention provides prefilled injection
device with improved safety of needles comprises introduction of
retractable needles. A syringe equipped with this option appears with the
needle extended from the syringe prior to use and the needle retracts into
the syringe when the plunger is completely depressed.
In one embodiment, the present invention provides prefilled injection
device with staked or fixed needle.
In one embodiment, the present invention provides prefilled injection
device which is operated manually and supplied in unit use packages
containing one prefilled syringe set affixed with a 27 G x ½” needle (staked
needle) with rigid needle shield cap and safety needle shielding system.
14
In one embodiment, the present invention injector device has graduations
or markings is pre-printed on the syringe barrel of the container making it
visible to the clinician or health care practioner.
In an embodiment, assembling of drug vial is not required for present
invention device, and in the event of improper handling of SAF-T-jet
device during assembling may result in glass breakage and subsequent
injuries.
In one embodiment, the pre-filled syringes are filled with therapeutically
required composition and the plunger rod is previously inserted.
In one embodiment, the present invention provides injection device having
safety needle shield system, has an advanced feature that the shield shall
be activated automatically by firmly pushing the plunger soon after the
dose is administered.
In one embodiment, the present invention injector device is disposable,
manually operated, supplied in unit use packages containing one prefilled
syringe set affixed with staked needle with rigid needle shield cap and
safety needle shielding system.
Another aspect, the present invention is not limited solely to such a
prefilled syringe device in foregoing description. A person skilled in the art
understands that various modifications to the described prefilled syringe
device may be implemented within the scope of the present disclosure.
In one embodiment, the pre-filled syringe device as such can be discarded
easily since the device is equipped with the safety device.
15
In one embodiment, the present invention injection device minimizes the
handling errors like improperly attached needle leads to leaking of the
therapeutic composition, thereby leading to less dose or dose inaccuracy.
In another embodiment, the present invention injection device reduces the
device handling/assembling time and reduces the risks by eliminating the
additional steps before and after administration of the injection.
In another embodiment, present invention injection device enhances user
convenience, reduces risk of contamination and is familiar to the end
users.
In another embodiment, present invention provides staked needle syringe
device which provides the safety to the patient by maintaining the integrity
of the drug product.
In one embodiment, the compositions are provided to a subject in need
thereof with a composition in a container that is amenable to deliver the
ready to use composition. Said container is provided in 1 ml, 2 ml, 5 ml, 10
ml, glass or plastic vial. Alternatively, a ready-to-administer composition
may be provided in a pre-filled syringe. Such pre-filled syringes are able to
deliver drug solution volumes from about 0.1 ml to about 10 ml. For
example, about 0.1 ml, 0.2 ml, 0.25 ml, 0.3 ml, 0.4 ml, 0.5 ml, 0.75 ml, 1.0
ml, 1.25 ml, 1.5 ml, 2.0 ml, 3.0 ml, 5.0 ml, 10 ml, of drug solution volume
can be delivered to patients. In all cases, the containers of said vials or
pre-filled syringes may be made of type-1 glass, or non-reacting polymeric
material such as polypropylene or polyethylene or a mixture thereof.
Several non-reacting containers are known in the art. The non-reacting
containers described herein include not only the vial or pre-filled syringe
that makes up the bulk of the container structure, but also any other part of
the container that comes in contact with the drug solution, such as
16
stoppers, plungers, etc. These also are made of type-1 glass or nonreacting polymeric materials.
In one aspect the injection composition is administered intramuscularly. In
another aspect, the injection compositions are administered
subcutaneously or intravenously.
In some embodiments, the devices can also prevent device tampering by
a user and/or multiple uses of the same syringe device. In some
embodiments, the syringe devices described herein can be used in a
critical situation for delivery of an emergency and/or time sensitive
pharmaceutical agent in response to a drug or substance overdose. The
syringe devices can include a syringe that includes a dose of at least one
pharmaceutical agent and can deliver a therapeutic dose of the
pharmaceutical agent that can be less than the amount of pharmaceutical
agent in the syringe.
The term “Vitamin K sensitive diseases or disorders” or “Vitamin K
deficiency sensitive diseases or disorders” or “Vitamin K deficiency related
disease and disorders” as used herein includes but not limited to
preventing and/ or treating haemorrhagic disease of the newborn and/
adults, blood coagulation disorders of the newborn and/ adults, treatment
of a haemorrhagic disease, treatment of Hypoprothrombinemia due to
Vitamin K deficiency or Interference, coagulation disorders which are due
to faulty formation of factors II, VII, IX and X, anticoagulant-induced
hypoprothrombinemia caused by coumarin or indanedione derivatives,
hypoprothrombinemia due to antibacterial therapy, hypoprothrombinemia
secondary to factors limiting absorption or synthesis of vitamin K, e.g.,
obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac
disease, intestinal resection, cystic fibrosis of the pancreas, and regional
enteritis, other drug-induced hypoprothrombinemia where it is definitely
17
shown that the result is due to interference with Vitamin K metabolism,
e.g., salicylates, prophylaxis and treatment of Vitamin K-deficiency
bleeding in neonates and/ adults.
In one embodiment, the present invention provides prefilled syringe
injection device comprises injectable composition of Vitamin K1 is used for
the treatment of Vitamin K sensitive diseases and disorders.
In one embodiment, the present invention provides prefilled syringe
injection device comprises injectable composition of Vitamin K1 is used for
the treatment of Vitamin K deficiency related diseases and disorders.
To further illustrate the invention, the following example is provided. It is to
be understood that these examples are provided for illustrative purposes
and are not to be construed as limiting the scope of the present invention
in any manner whatsoever.
Example 1:
Table 01: Vitamin K1 Composition
The stability studies were performed for composition mentioned in Table 1
for two different batches (Batch 1 & Batch 2).
S. No. Material Description Qty/mL Qty./unit
1 Vitamin K1 2.00 mg 1.00 mg
2 Polysorbate 80 20 mg 10.0 mg
3 Propylene glycol 20.8 mg 10.4 mg
4 Sodium acetate anhydrous 0.34 mg 0.17 mg
5 Glacial acetic acid 0.00004 mL 0.00002 mL
6 Water for Injection q.s to 1 mL q.s to 0.5 mL
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The 6-month stability studies were performed for Batch 1 of Vitamin K1
composition mentioned in Table 1. The stability of the Vitamin K1
composition was monitored at different stability conditions such as
25°C/60%RH and 400C/75% RH for 6 months and results seem to be
satisfactory.
The stability study results for batch 1 are summarized in table 2 below:
Table 02: Experimental details (Batch 1)
Parameters
Time
points
Initial –
250C/60% RH
6M – 250C/60%
RH
6M – 400C/75%
RH
Physical parametres
Description CYS CYS CYS
pH 5.7 5.8 5.9
Assay 103.8% 103.5% 92%
Total impurities 0.74% 2.24% 5.14%
#CYS- Clear Yellow Solution, RH- Relative humidity
The long-term stability studies were performed for Batch 2 of Vitamin K1
composition mentioned in Table 1. The stability of the Vitamin K1
composition was monitored for 3 months at 25°C/60%RH, 6 months at
25°C/60%RH and 12 months at 25°C/60%RH and results seems to be
satisfactory.
The stability study results for batch 2 are summarized in table 3 below:
Table 03: Experimental details (Batch 2)
Parameters
Time Points
Initial
3M -
25°C/60%RH
6M -
25°C/60%RH
12M -
25°C/60%RH
Description CYS CYS CYS CYS pH 5.6 5.4 5.5 5.6"
Assay 105.7 % 104.9 % 105.0% 99.0 % Total Impurities 0.77 % 1.62 % 2.53 % 4.45 %
CYS - Clear Yellow Solution; RH: Relative Humidity
Dated this day 24th day of July 2024
Name: PATEL Hiren
19We Claim: 1. A ready to administer pre-filled syringe injection device, comprising: composition comprises therapeutically effective amount of vitamin K; wherein said device provides ease of administration in patients for the prophylaxis and treatment of vitamin K deficiency bleeding, wherein said device is simple, convenient and user-friendly.
2. The pre-filled syringe injection device as claimed in claim 1, comprises ready to use, ready to administer, ready to inject, or ready to dilute composition of emulsion, colloidal solution and/ or other biphasic liquid medication composition comprising therapeutic quantity of vitamin K1. 3. The pre-filled syringe injection device as claimed in claim 1, are used for administration of Vitamin K1 injectable composition parenterally such as subcutaneous, intramuscular, or intravenous injection. 4. The pre-filled syringe injection device as claimed in claim 1, provides ease of administration in patients like neonates and other age groups. 5. The pre-filled syringe injection device as claimed in claim 1, comprises the medication Vitamin K1 in the range of 1 mg to 50 mg as unit dose or multidose compositions.
6. The pre-filled syringe injection device as claimed in claim 1, is provided with a staked needle having rigid needle shield; wherein the medication is injected by pushing the pre-attached plunger rod.
7. The injection device as claimed in claim 1, is ready to use prefilled syringe system accompanied with suitable safety device system.
208. The prefilled syringe injection device as claimed in claim 1, is provides ease of administration without pre-assembling of device with multiple steps before administration.
9. The prefilled syringe injection device as claimed in claim 1, used to treat Vitamin K deficiency related diseases and disorders.