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Apparatus For Making Sodium Fluoride Labelled With F 18

Abstract: The present disclosure relates to an apparatus for making a sodium fluoride (NaF-18). The apparatus includes an ion exchange cartridge having a first inlet, second inlet, and a first outlet. A first source fluidically configured with the ion exchange cartridge through the first inlet, and configured to input fluoride (F-18) in the ion exchange cartridge. The irradiated F-18 undergoes a first anion exchange reaction inside the ion exchange cartridge. A second source fluidically configured with the ion exchange cartridge through the second inlet, and configured to input an aqueous material in the ion exchange cartridge. The aqueous material comprises saline water, and the aqueous material facilitates a second anion exchange reaction, inside the ion exchange cartridge, with the fluoride (F-18) to form the sodium fluoride (NaF-18). A container fluidically configured with the first outlet, and configured to receive the sodium fluoride (NaF-18), from the ion exchange cartridge, in a container.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
11 December 2021
Publication Number
24/2023
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
Parent Application
Patent Number
Legal Status
Grant Date
2025-10-07
Renewal Date

Applicants

Chitkara Innovation Incubator Foundation
SCO: 160-161, Sector - 9c, Madhya Marg, Chandigarh- 160009, India.

Inventors

1. KAUSHIK, Chanchal
Chitkara School of Health Sciences, Chitkara University, Chandigarh-Patiala National Highway, Village Jansla, Rajpura, Punjab - 140401, India.
2. SINGH, Manoj Kumar
Boston Ivy Healthcare Solutions Pvt. Ltd., 503, 5th Floor, B Tower, Millennium Plaza, Sushant Lok-1, Near Iffko Chowk Metro Station, Gurugram - 122002, Haryana, India.
3. PILLAI, MRA
Molecular Cyclotron Pvt. Ltd., Puthuvype Beach Rd, Belbo Junction, Vypin, Kochi, Kerala - 682508, India.
4. NAIR, KNS
Molecular Cyclotron Pvt. Ltd., Puthuvype Beach Rd, Belbo Junction, Vypin, Kochi, Kerala - 682508, India.

Specification

The present disclosure relates to the field of sodium fluoride
labelled with F-18. More particularly the present disclosure relates to an apparatus for making sodium fluoride labelled with F-18.
BACKGROUND
[0002] Background description includes information that may be useful in
understanding the present invention. It is not an admission that any of the
information provided herein is prior art or relevant to the presently claimed
invention, or that any publication specifically or implicitly referenced is prior art.
[0003] Sodium fluoride labelled with fluorine 18 (NaF-18]) is a positron-
emitting radiopharmaceutical first introduced several decades ago for skeletal imaging. Conventional modules for production of 18F-NaF are very costly resulting in its limited availability and therefore very few centres can afford the diagnosis of bone metastasis. The production cost is very high and also dissemination too. Presently available modules are cassette based and cost around 4000-5000 INR per production and time is around 15-20 minutes for production. The existing module such as NEPTIS and TRASIS are used for preparation of radiopharmaceuticals ad they are very costly which requires one time use and throw cassette for preparation of one radiopharmaceutical. Also, the infrastructure and maintenance of existing module is huge, complex and requires in depth training of staff as well. Limited availability of this radiopharmaceutical results in increased morbidity and very late diagnosis of disease.
[0004] There is, therefore, a need of an apparatus that us capable of
fabricating sodium fluoride labelled with F-18 at a reduced cost.
OBJECTS OF THE PRESENT DISCLOSURE
[0005] Some of the objects of the present disclosure, which at least one
embodiment herein satisfies are as listed herein below.
[0006] It is an object of the present disclosure to provide an apparatus for
making a sodium fluoride labelled with F-18.

[0007] It is an object of the present disclosure to provide an apparatus for
making a sodium fluoride labelled with F-18, which is cost effective.
[0008] It is an object of the present disclosure to provide an apparatus for
making a sodium fluoride labelled with F-18, which is simple and easy to use.
[0009] It is an object of the present disclosure to provide an apparatus for
making a sodium fluoride labelled with F-18, which requires less maintenance
cost.
[0010] It is an object of the present disclosure to provide an apparatus for
making a sodium fluoride labelled with F-18 with a less fabrication cost.
[0011] It is an object of the present disclosure to provide an apparatus for
making a sodium fluoride labelled with F-18, which does not require electricity
for its operation.
SUMMARY
[0012] The present disclosure relates to the field of sodium fluoride
labelled with F-18. More particularly the present disclosure relates to an apparatus for making sodium fluoride labelled with F-18.
[0013] An aspect of the present disclosure pertains to an apparatus for
making a sodium fluoride (NaF-18). The apparatus includes an ion exchange cartridge having a first inlet, second inlet, and a first outlet. A first source fluidically configured with the ion exchange cartridge through the first inlet, and configured to input fluoride (F-18) in the ion exchange cartridge. The irradiated F-18 undergoes a first anion exchange reaction inside the ion exchange cartridge. A second source fluidically configured with the ion exchange cartridge through the second inlet, and configured to input an aqueous material in the ion exchange cartridge. The aqueous material comprises saline water, and the aqueous material facilitates a second anion exchange reaction, inside the ion exchange cartridge, with the fluoride (F-18) to form the sodium fluoride (NaF-18) . A container fluidically configured with the first outlet, and configured to receive the sodium fluoride (NaF-18), from the ion exchange cartridge, in a container.

[0014] In an aspect, the first inlet and the second inlet may be fluidically
configured with the ion exchange cartridge through a first valve, and a sequential input of the fluoride (F-18) and saline (NaCl) in the cartridge is controlled by the first valve.
[0015] In an aspect, a waste product of the first anion exchange reaction
may be taken out, before inputting the saline water in the ion exchange cartridge, from a second outlet of the ion exchange cartridge.
[0016] In an aspect, the waste product and the sodium fluoride (NaF-18)
pharmaceutical may be taken out of the ion exchange cartridge through a second
valve, and a sequential output of the waste product and the sodium fluoride (NaF-
18) from the ion exchange cartridge is controlled by the second valve.
[0017] In an aspect, the first valve and the second valve may be three-way
valves.
[0018] Various objects, features, aspects and advantages of the inventive
subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.
BRIEF DESCRIPTION OF DRAWINGS
[0019] The accompanying drawings are included to provide a further
understanding of the present disclosure, and are incorporated in and constitute a part of this specification. The drawings illustrate exemplary embodiments of the present disclosure and, together with the description, serve to explain the principles of the present disclosure. The diagrams are for illustration only, which thus is not a limitation of the present disclosure.
[0020] In the figures, similar components and/or features may have the
same reference label. Further, various components of the same type may be distinguished by following the reference label with a second label that distinguishes among the similar components. If only the first reference label is used in the specification, the description is applicable to any one of the similar

components having the same first reference label irrespective of the second reference label.
[0021] FIG. 1 illustrates exemplary representation of an apparatus for
making sodium fluoride labelled with F-18, in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION
[0022] The following is a detailed description of embodiments of the
disclosure depicted in the accompanying drawings. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the scope of the present disclosure as defined by the appended claims.
[0023] In the following description, numerous specific details are set forth
in order to provide a thorough understanding of embodiments of the present
invention. It will be apparent to one skilled in the art that embodiments of the
present invention may be practiced without some of these specific details.
[0024] The present disclosure relates to the field of sodium fluoride
labelled with F-18. More particularly the present disclosure relates to an apparatus for making sodium fluoride labelled with F-18.
[0025] The present disclosure elaborates upon an apparatus for making a
sodium fluoride (NaF-18). The apparatus includes an ion exchange cartridge having a first inlet, second inlet, and a first outlet. A first source fluidically configured with the ion exchange cartridge through the first inlet, and configured to input fluoride (F-18) in the ion exchange cartridge. The irradiated F-18 undergoes a first anion exchange reaction inside the ion exchange cartridge. A second source fluidically configured with the ion exchange cartridge through the second inlet, and configured to input an aqueous material in the ion exchange cartridge. The aqueous material comprises saline water, and the aqueous material facilitates a second anion exchange reaction, inside the ion exchange cartridge,

with the fluoride (F-18) to form the sodium fluoride (NaF-18). A container
fluidically configured with the first outlet, and configured to receive the sodium
fluoride (NaF-18), from the ion exchange cartridge, in a container.
[0026] In an embodiment, the first inlet and the second inlet can be
fluidically configured with the ion exchange cartridge through a first valve, and a
sequential input of the fluoride (F-18) and saline (NaCl) in the cartridge is
controlled by the first valve.
[0027] In an embodiment, a waste product of the first anion exchange
reaction can be taken out, before inputting the saline water in the ion exchange
cartridge, from a second outlet of the ion exchange cartridge.
[0028] In an embodiment, the waste product and the sodium fluoride
(NaF-18) pharmaceutical can be taken out of the ion exchange cartridge through a
second valve, and a sequential output of the waste product and the sodium
fluoride (NaF-18) from the ion exchange cartridge is controlled by the second
valve.
[0029] In an embodiment, the first valve and the second valve can be
three-way valves.
[0030] FIG. 1 illustrates exemplary representation of an apparatus for
making sodium fluoride labelled with F-18, in accordance with an embodiment of
the present disclosure.
[0031] As illustrated, an apparatus 100 for making a sodium fluoride
(NaF-18) can include an ion exchange cartridge 102 having a first inlet 104,
second inlet 106, and a first outlet 108. The ion exchange cartridge 102 can
include quaternary methyl ammonium (QMA) cartridge. A first source (not
shown) can be fluidically configured with the ion exchange cartridge 102 through
the first inlet 104, and can be configured to input fluoride (F-18) in the ion
exchange cartridge 102. The irradiated F-18 can undergo a first anion exchange
reaction inside the ion exchange cartridge 102. A second source 112 can be
fluidically configured with the ion exchange cartridge 102 through the second
inlet 106, and can be configured to input an aqueous material in the ion exchange
cartridge 102.

[0032] In an embodiment, the aqueous material can include 0.7%-0.9%
saline water (NaCl). The aqueous material can facilitate a second anion exchange reaction, inside the ion exchange cartridge 102, with the fluoride (F-18) to form the sodium fluoride (NaF-18). A container 120 can be fluidically configured with the first outlet 108, and can be configured to receive the sodium fluoride (NaF-18), from the ion exchange cartridge 102 the sodium fluoride is received from the ion exchange cartridge after filtration through a millipore filter (not shown). The first inlet 104 and the second inlet 106 can be fluidically configured with the ion exchange cartridge 102 through a first valve 114. A sequential input of the fluoride (F-18) and saline (NaCl) in the cartridge 102 can be controlled by the first valve 114.
[0033] In an embodiment, a waste product of the first anion exchange
reaction can be taken out, before inputting the saline water in the ion exchange cartridge, from a second outlet 116 of the ion exchange cartridge 102. The waste product and the sodium fluoride (NaF-18) pharmaceutical can be taken out of the ion exchange cartridge 102 through a second valve 118. A sequential output of the waste product and the sodium fluoride (NaF-18) from the ion exchange cartridge 102 can be controlled by the second valve 118. The first valve 114 and the second valve 118 can be a three-way valve.
[0034] In an embodiment, the second reaction can replace chloride with
the F-18 from the NaCl saline water. The apparatus 100 can be made of but not
limited to plastic and PVC Teflon tubing and base metal plate. The first source
and the second source can be fluidically coupled with the ion exchange cartridge
through the PVC Teflon tubing. This reduces overall fabrication cost of the
apparatus, also, the proposed apparatus is portable and does not require any
electric input to operate thereby further reducing operational cost.
[0035] Moreover, in interpreting the specification, all terms should be
interpreted in the broadest possible manner consistent with the context. In particular, the terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or

combined with other elements, components, or steps that are not expressly referenced. Where the specification claims refer to at least one of something selected from the group consisting of A, B, C ....and N, the text should be interpreted as requiring only one element from the group, not A plus N, or B plus N, etc.
[0036] While the foregoing describes various embodiments of the
invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof. The scope of the invention is determined by the claims that follow. The invention is not limited to the described embodiments, versions or examples, which are included to enable a person having ordinary skill in the art to make and use the invention when combined with information and knowledge available to the person having ordinary skill in the art.
ADVANTAGES OF THE INVENTION
[0037] The proposed invention provides an apparatus for making a sodium
fluoride labelled with F-18.
[0038] The proposed invention provides an apparatus for making a sodium
fluoride labelled with F-18, which is cost effective.
[0039] The proposed invention provides an apparatus for making a sodium
fluoride labelled with F-18, which is simple and easy to use.
[0040] The proposed invention provides an apparatus for making a sodium
fluoride labelled with F-18, which requires less maintenance cost.
[0041] The proposed invention provides an apparatus for making a sodium
fluoride labelled with F-18 with a less fabrication cost.
[0042] The proposed invention provides an apparatus for making a sodium
fluoride labelled with F-18, which does not require electricity for its operation.

We Claim:

1. An apparatus for making a sodium fluoride (NaF-18), the apparatus
comprising:
an ion exchange cartridge having a first inlet, second inlet, and a
first outlet;
a first source fluidically configured with the ion exchange cartridge through the first inlet, and configured to input an irradiated fluoride (F-18) in the ion exchange cartridge, wherein the fluoride (F-18) undergoes a first reaction inside the ion exchange cartridge;
a second source fluidically configured with the ion exchange cartridge through the second inlet, and configured to input an aqueous material in the ion exchange cartridge, wherein the aqueous material comprises saline water, and the aqueous material facilitates a second reaction, inside the ion exchange cartridge, with the fluoride (F-18) to form the sodium fluoride (NaF-18); and
a container fluidically configured with the first outlet, and configured to receive the sodium fluoride (NaF-18), from the ion exchange cartridge, in a container.
2. The apparatus as claimed in claim 1, wherein the ion exchange cartridge comprises quaternary methyl ammonium (QMA) cartridge.
3. The apparatus as claimed in claim 1, wherein the first inlet and the second inlet are fluidically configured with the ion exchange cartridge through a first valve, and a sequential input of the fluoride (F-18) and saline (NaCl) water in the ion exchange cartridge is controlled by the first valve.
4. The apparatus as claimed in claim 1, wherein a waste product of the first anion exchange reaction is taken out, before inputting the saline water in the ion exchange cartridge, from a second outlet of the ion exchange cartridge.
5. The apparatus as claimed in claim 3, wherein the waste product and the sodium fluoride (NaF-18) pharmaceutical are taken out of the ion

exchange cartridge through a second valve, and a sequential output of the waste product and the sodium fluoride (NaF-18) from the ion exchange cartridge is controlled by the second valve.
6. The apparatus as claimed in claim 4, wherein the first valve and the second valve are three-way valves.
7. The apparatus as claimed in claim 1, wherein the sodium fluoride is received from the ion exchange cartridge after filtration through a millipore filter.

Documents

Application Documents

# Name Date
1 202111057727-STATEMENT OF UNDERTAKING (FORM 3) [11-12-2021(online)].pdf 2021-12-11
2 202111057727-POWER OF AUTHORITY [11-12-2021(online)].pdf 2021-12-11
3 202111057727-FORM FOR STARTUP [11-12-2021(online)].pdf 2021-12-11
4 202111057727-FORM FOR SMALL ENTITY(FORM-28) [11-12-2021(online)].pdf 2021-12-11
5 202111057727-FORM 1 [11-12-2021(online)].pdf 2021-12-11
6 202111057727-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [11-12-2021(online)].pdf 2021-12-11
7 202111057727-EVIDENCE FOR REGISTRATION UNDER SSI [11-12-2021(online)].pdf 2021-12-11
8 202111057727-DRAWINGS [11-12-2021(online)].pdf 2021-12-11
9 202111057727-DECLARATION OF INVENTORSHIP (FORM 5) [11-12-2021(online)].pdf 2021-12-11
10 202111057727-COMPLETE SPECIFICATION [11-12-2021(online)].pdf 2021-12-11
11 202111057727-Proof of Right [31-12-2021(online)].pdf 2021-12-31
12 202111057727-FORM 18 [25-08-2023(online)].pdf 2023-08-25
13 202111057727-FER.pdf 2025-01-21
14 202111057727-FORM-5 [21-07-2025(online)].pdf 2025-07-21
15 202111057727-FER_SER_REPLY [21-07-2025(online)].pdf 2025-07-21
16 202111057727-DRAWING [21-07-2025(online)].pdf 2025-07-21
17 202111057727-CORRESPONDENCE [21-07-2025(online)].pdf 2025-07-21
18 202111057727-CLAIMS [21-07-2025(online)].pdf 2025-07-21
19 202111057727-US(14)-HearingNotice-(HearingDate-08-09-2025).pdf 2025-08-14
20 202111057727-FORM-26 [03-09-2025(online)].pdf 2025-09-03
21 202111057727-Correspondence to notify the Controller [03-09-2025(online)].pdf 2025-09-03
22 202111057727-US(14)-ExtendedHearingNotice-(HearingDate-09-09-2025)-1530.pdf 2025-09-05
23 202111057727-Correspondence to notify the Controller [05-09-2025(online)].pdf 2025-09-05
24 202111057727-Written submissions and relevant documents [24-09-2025(online)].pdf 2025-09-24
27 202111057727-IntimationOfGrant07-10-2025.pdf 2025-10-07

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