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"A Novel Synergistic Topical Applications Formulation For Joint Pains, Inflammation, Skin Care And The Process Of Preparing The Same"

Abstract: The present invention relates to a novel synergistic formulation effective in external application for pains and skin care. More particularly, the present invention relates to the herbal formulation for muscular pains, chronic joint pains, their related complications and useful for skin care. This novel synergistic formulation prepared by using extracts of Lygodium flexuosum and in combination with other plant extracts processed in composition with cinnamic aldehyde, eugenol and thymol in an inventive proportion. The formulation synergistically effective to prepare external application materials in plant based oil, waxy substances to perform liniment, balm, gel, lotion and spray.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
23 February 2015
Publication Number
35/2016
Publication Type
INA
Invention Field
PHARMACEUTICALS
Status
Email
Parent Application
Patent Number
Legal Status
Grant Date
2023-02-16
Renewal Date

Applicants

KAUSHAL KUMAR
DR. KAUSHAL KUMAR DEPARTMENT OF FOREST PRODUCTS & UTILIZATION, FACULTY OF FORESTRY BIRSA AGRICULTURAL UNIVERSITY KANKE, RANCHI-834006 JHARKHAND, INDIA

Inventors

1. KAUSHAL KUMAR
DR. KAUSHAL KUMAR DEPARTMENT OF FOREST PRODUCTS & UTILIZATION, FACULTY OF FORESTRY BIRSA AGRICULTURAL UNIVERSITY KANKE, RANCHI-834006 JHARKHAND, INDIA

Specification

FIELD OF THE INVENTION
The present invention relates to a novel synergistic formulation for chronic joint pains,
inflammation and skin care for topical application. The novel formulation is prepared by
using multiple extract of herbs along with suitable and safe composition particularly in
combination of extract of Lygodium flexuosum and root bark and leaves extract of
Calotropis spp, with thymol and menthol; seeds of Datura metel and cinnamaldehde;
leaves extract/oil of Piper betel and methyl salicylate. The extract of combination
suitable to add in tuipentine, eucalyptus and other similar plant oil to prepare the
formulation including balm, lotion, tincture, spray, cream, ointment added in waxy and
related pharmaceutical accepted base material. Moreover this invention relates to the
process for the preparation of the above synergistic composition and formulation.
BACKGROUND OF THE INVENTION AND RELATED PRIOR ART
There are various products in the market for the use of topical application for relief in
pains for arthritis in the form of balm, lotion, gel etc. They are mostly related either on
different kind of oil and chemicals providing temporarily relief. But for long term use it
effects hazardous for skin, irritation and sometimes allergic etc. Still, there is need to
develop formulation on the basis of novel composition selected from herbs as well as
suitability with the chemicals for synergistic efficacy and less in toxic.
The present invention provides an innovatively synergistic composition have efficacy for
joint pains, inflammation and skin care during topical application as alternative
approaches.

The plant based eucalyptus oil (http://en. wikipedia. org/wiki/Eucalyptus_oil ) and
turpentine oil used for joint pain. But the oil are mostly for just temporarily feeling of
relieve. The eucalyptus oil in patent US 68G0305 B1 used as composition for treatment of
respiratory tract. It is patented for fungicide WO/2008/011699 and making soap and
detergents in US patent 4251383 for soap and detergent as cleaning composition.
The turpentine oil is a fluid obtained by the distillation of resin obtained from pine trees.
It is known as 'Gandhbiroja' in ayurveda (Shrama.P.V.1998; Dravyaguna Vigyan, vol.11,
Chaukhamba Bharti Academy, Varanasi). But the oil is also used in paints, varnishes
(http://en.wikipedia.org/wiki/Turpentine) and other industrial use.
The use of such kind of oil for topical application is not much effective without
composition of herbs and other chemical ingredients. The various parts of leaves, seeds,
barks etc. of different plant admixed with some chemical compounds which are less toxic
and synergistic effective in innovative composition is the approach of the invention.
Pertaining to the invention Lygodium flexuosum is a climbing fern and their rhizome and
roots have many uses (Kumar, K.,2010, Indian Journal of Ancient Medicine and Yoga.
3(2): 85-90) but not effective singly particularly for arthritis, chronic joints pain and skin
care. The document 1075/KOL/2012 describes about herbal formulation used for treating
indigestion comprises with extract of Lygodium flexuosum in formulation along with

several plant materials. The document of US Patent 7634846 is process for producing a
surface finish sheet.
Datura metel is called 'Dhatur' in ayurveda and the compound atropine and hyoscyamine
are vailable in the seeds. The invention of the document WO 2011154958 Al is for
herbal topical formulation composition aqueous of leaves for eradication of lice in
animals wherein the said herbal extract is detoxified with neem. The patent
WO2012131721A4 discloses Datura metal as an herbal compositions and medicaments
thereof for treatment of filariasis.
The document WO 2008139483 A1 describes about method and preparation of herbal
extract of Calotropis gigantea for cancer treatment while in patent US 2008/ 0280995 Al
latex of Calotropis procera uses as anticancer agent Reference is also available about
Piper betel known as 'Tambul' in ayurveda and useful in pain when applied externally
(Shrama.P.V.1998; Dravyaguna Vigyan, vol.II, Chaukhamba Bharti Academy, Varanasi).
The published document US 20110142969 Al describes about extract of Piper betel
leaves for the treatment of human malignancies by inducing oxidative stress. In patent
WO 2002049655 Al deals about extract of Piper betel leaves as immunomodulator.
The above plants ingredients many significant properties. However, the whole herbal
composition of rhizome and roots of Lygodium flexuosum, leaves of Piper betel Datura
metel seeds, root bark and leaves of Calotropis spp. are itself less effective rather to

treated and processed the materials with eugenol, thymol, cinnamic aldehyde and methyl
salicylate become highly synergistic through the innovative novel composition and also
safe from skin irritation and allergic in repeated use.
The publication number US 2014/0287121 Al is for method for preparing a botanical
extract and a flavor system comprising a botanical extract produced by the process for
use in beverages are provided.Also provided is a flavor system comprising a botanical
extract comprising at least one of thymol, eugenol, carvacrol,cinnamic aldehyde and
eucalyptol.
OBJECT OF THE INVENTION:
The primary object of the present invention is to provide a novel synergistic herbal
formulation for relief in chronic joint pains and safe for skin.
Still other object of the present invention to provide the herbal formulation for chronic
joint pains and muscular pain and the useful for skin care, etc which is prepared by using
composition particularly combination of extract of Lygodium flexuosum and root bark
and leaves extract of Calotropis spp. with thymol and menthol; seeds of Datura metel
and cinnamaldehde; leaves extract/oil of Piper betel and methyl salicylate in
combination.
Yet, one another object is of invention the formulation which is extract of combination
suitable to add in turpentine, eucalyptus and other similar plant oil to prepare the

formulation including balm, lotion, tincture, spray, cream, ointment added in waxy and
related pharmaceutical accepted base material..
Another object of the present invention is to provide a novel synergistic composition
mixing with oil like turpentine, eucalyptus, mustard and similar for topical application in
the affected area of joint pain, arthritis, inflammation and related complications.
Another object of the present invention is to provide the novel herbal composition which
is safe, effective and devoid of side effects.
Another object of the present invention is to provide the herbal composition and
medicament thereof of the present invention is simple, natural, attractive and convenient
to use.
Another object of the present invention is to provide the herbal composition wherein the
'Ratanjot' powder from different species of Arnebia is only for use as colour of liniment
preparation.
Another object of the present invention is to provide the herbal composition wherein the
mixture of Calotropis procera or Calotropis giganta leaves used any one or mixture of
both or as substitute.
Yet important object of the present invention is a synergistic formulation the 70-80 % oil
base is suitable for formulation wherein the extract composition is 20- 30 %. The

composition in ratio thymol and menthol 4:6 in addition of equal quantity in addition for
extract of Lygodium flexuosum and Calotropis procera/Calotropis gigantea.
Yet one object of novel synergistic formulation the ratio 8:2 in between extract of
Lygodium flexuosum, Calotropis procera/Calotropis gigantea and in composition of
thymol and menthol.
An important object of the invention a novel synergistic formulation wherein the 20 - 30
% material of plant extract including safe chemical composition mixed with turpentine
oil, eucalyptus oil and mustard oil or similar seed oil added for preparation of formulation
for topical or external application in liniment form. The extract of combination suitable to
add in turpentine, eucalyptus and other similar plant oil to prepare the formulation
including balm, lotion, spray, gel, cream added in waxy and related pharmaceutically
accepted base with or without add of 'Ratanjot' a plant based coloring materials
Another object of the present invention is the manufacturing method for herbal medicine
is simple, effective and keeping the views of cost effectiveness.The herbal composition
and medicament thereof is useful in the treatment of human being.
Object on novelty of this instant invention lies on the composition of the ingredients of
above herbal composition along with safe ration of chemicals suitable for solubility and
miscibility in a particular ratio and their process of preparing the composition.

STATEMENT OF THE INVENTION
In accordance with the present invention there is provide a new process using extract of
Lygodium flexuosum and root bark and leaves extract of Calotropis spp. with thymol and
menthol; seeds of Datura metel and cinnamaldehde; leaves extract/oil of Piper betel
containing more percentage ofeugenol and methyl salicylate in combination. The extract
of combination suitable to add in turpentine, eucalyptus and other similar plant oil to
prepare the formulation including balm, lotion, tincture, spray, cream, ointment added in
waxy and related pharmaceutical accepted base material. Moreover this invention relates
to the process for the preparation of the above composition thereof.
SUMMARY OF THE INVENTION
The present invention relates to a novel synergistic herbal formulation for chronic joint
pains and inflammation etc. More particularly, the present invention relates to the herbal
formulation for chronic joint pains and muscular pain and the useful for skin care, etc
which is prepared with suitable and safe composition particularly combination of extract
The novel formulation is prepared by using multiple extract of herbs along with suitable
and safe composition particularly combination of extract of Lygodium flexuosum and root
bark and leaves extract of Calotropis spp. with thymol and menthol; seeds of Datura
metel and cinnamaldehde; leaves extract/oil of Piper betel containing more percentage of
eugenol and methyl salicylate in combination. The extract of combination suitable to add
in turpentine, eucalyptus and other similar plant oil to prepare the formulation including
balm, lotion, tincture, spray, cream, ointment added in waxy and related pharmaceutical
accepted base material. Moreover this invention relates to the process for the preparation
of the above composition thereof.

4. DETAILED DESCRIPTION OF THE INVENTION
A number of herbs have been found to be effective in treating for chronic joint pains and
muscular pain and the useful for skin care etc. Although research in the field of herbal
medicines has increased, much remains to be learned about the effectiveness of such
herbal remedies for chronic joint pains and muscular pain and the useful for skin care
etc. It is due to the method of use is of external application in affected areas wherein
chances of damage of skin. Furthermore, the invention has providing choice of patients
and physicians to take advantages in the form of topical liniment, oil, balm, ointment,
lotion and spray formulation from the novel synergistic composition
Accordingly, there still exists an ongoing need for developing new synergistic herbal
extract combination which is safe and effective devoid of side effects and to treat the
joint pain, arthritis and skin care. The present invention satisfies these needs, as well as
others, and generally overcomes the deficiencies found in the background art.
Accordingly, there still exists an ongoing need for developing new synergistic herbal
extract combination which is safe and effective devoid of side effects and to treat the
joint pain, arthritis and skin care. The present invention satisfies these needs, as well as
others, and generally overcomes the deficiencies found in the background art. There is a
novel process with inventive synergistic composition as follows:

Unit material I
a) Dust and moist free fresh materials, free from pathogen and all kind of foreign
particles the shade dried and coarsely powdered materials of rhizome and roots of
Lygodiumflexuosum of a known quantity extracted in ethanol.
b) The standard phytochemical method used for evaporation of ethanol and the
extractive value calculated.
c) The coarse powder of root bark and leaves in equal quantity of Calotropis
procera/ Calotropis gigantea any one from both species extracted in ethanol as of
step (a, b) and their extractive value calculated. The mixture of Calotropis
procera or Calotropis giganta leaves and root bark is used with any one or
mixture of both or as substitute of one another.
d) The extracts obtained in (b) and (c) mixed in the ratio of 6:4 respectively.
e) The material thymol and menthol mixed in ratio 4: 6.
f) In the whole material (d) mixed added with (e) in the ratio 8:2.
Unit material II
g) The seeds of Datura metal likewise (a) extracted in petroleum ether and the
extractive as step (b) obtained.
h) The 0. 04 ratio of cinnamaldehde is added in material as obtained in (g).

Unit material III
i) The Piper betel leaves of ethanol extractives/ Piper betel leaves oil containing
more percentage of eugenol in equal quantity.
j) The methyl salicylate added in extract as obtained in step (i) in the ratio 8:2
The composition of all the three Units is based on the solubility, miscibility and
synergistic in novelty in ratio 6: 2:2 from Unit I, Unit II and Unit III respectively.
In an embodiment the temperature for extraction of plant material is according to
standard boiling points used as per standard phytochemical methods .
In another embodiment, the 20 - 30 % material of Unit I-III, mixed with turpentine oil,
eucalyptus oil and mustard oil or similar seed oil added for preparation of formulation for
topical or external application in liniment form.
Yet, in another embodiment's balms, gel and lotion, spray, cream prepared by use of 20-
30 % materials in base or pharmaceutically accepted medium, wax substances etc.
Yet, a one important embodiment the ratio of composition is also for adjustment and
maintenance of neutral PH.



In an embodiment under clinical evaluation as per methodology of ayurvedic treatment
more than 90 % patients responded for relief in joint pains, 85 % in inflammation in the
age group of 16- 70 years within 2 days when evaluated after use of topical application
twice for a period of 7 days.
Yet, in another important embodiment there are not any kinds of symptoms of skin
allergies, irritation, itching etc. on topical application although the patient was
irrespective of sex and religion.

ADVANTAGES OF THE INVENTION
1. The present invention provides a novel synergistic composition comprising
therapeutically effective ratio of herbal extracts along with effective chemical
- components invention for treating or preventing chronic joint pains, muscular pain,
inflammation etc in a subject in need thereof.
2. The present invention provides use of the novel synergistic composition which is
safe for skin and has no irritation, allergic etc. in repeated use in a subject in need
thereof.
3. The present invention provides a process for the preparation of novel herbal
composition of the present invention.
4. The present invention provides the novel herbal composition which is safe, effective
and devoid of side effects.
5. The present invention provides the novel composition which is having economic
significance in comparison to the commonly available allopathic, synthetic drugs and
other market products.
The present invention as described above, it is to be understood that this invention is not
limited to particular methodologies and materials described, as these may vary as per the
person skilled in the art. It is also to be understood that the terminology used in the
description is for the purpose of describing the particular embodiments only, and is not
intended to limit the scope of the present invention.

Therefore, the foregoing is considered as illustrative only of the principles of the
invention. Further, since numerous modifications and changes will readily occur to those
skilled in the art, it is not desired to limit the invention to the exact formulation as
described, and accordingly, all suitable modifications and equivalents may be resorted to,
falling within the scope of the invention.

I Claim
1) A novel synergistic formulation and process which comprises an effective ratio
of combination of extract of rhizome and root of Lygodium flexuosum and root
bark and leaves extract of Calotropis spp. with thymol and menthol; seeds of
Datura metel and cinnamaldehde; leaves extract/oil of Piper betel and methyl
salicylate.
2) A synergistic formulation as claim in 1 the extract of combination suitable to add
in turpentine, eucalyptus and other similar plant oil to prepare the formulation
including balm, lotion, spray added in waxy substances and related base.
3) A synergistic formulation as claim in 1 the 70-80 % oil base is suitable for
formulation wherein the extract composition is 20- 30 % .
4) A synergistic formulation as claim in 1 wherein the composition in ratio thymol
and menthol 4:6 in addition of equal quantity in addition for extract of Lygodium
flexuosum and Calotropis procera/Calotropis gigantea,
5) A novel synergistic herbal formulation as claimed in claim 1 wherein the mixture
of Calotropisprocera or Calotropis giganta leaves and root bark is used with any
one or mixture of both or as substitute of one another.
6) A novel synergistic herbal formulation as claimed in claim 1 the ratio 8:2 in
between extract of Lygodium flexuosum, Calotropis procera/Calotropis gigantea

and in composition of thymol and menthol.
7) A process for preparing the novel synergistic herbal formulation as claimed in
claim 1 which comprises :
Unit material I
a) Dust and moist free fresh materials, free from pathogen and all kind of foreign
particles the shade dried and coarsely powdered materials of rhizome and roots of
Lygodiumflexuosum of a known quantity extracted in ethanol.
b) The standard phytochemical method used for evaporation of ethanol and the
extractive obtained.
c) The coarse powder of root bark and leaves in equal quantity of Calotropis
procera/ Calotropis gigantea any one from both species extracted in ethanol as of
step (a, b) and their extractive value calculated. The mixture of Calotropis
procera or Calotropis giganta leaves and root bark is used with any one or
mixture of both or as substitute of one another.
d) The extracts obtained in (b) and (c) mixed in the ratio of 6:4 respectively.
e) The material thymol and menthol mixed in ratio 4: 6.
f) In the whole material (d) mixed added with (e) in the ratio 8:2.
Unit material II
g) The seeds of Datura metal likewise (a) extracted in petroleum ether and the
extractive as step (b) obtained.
h) The 0. 04 ratio of cinnamaldehde is added in material as obtained in (g).

Unit material III
i) The Piper betel leaves of ethanol extractives/ Piper betel leaves oil containing
more percentage of eugenol in equal quantity.
j) The methyl salicylate added in extract as obtained in step (i) in the ratio 8:2
8) A novel synergistic formulation with novel process as claim in 1 which
comprises composition of all the three Units as claim in 7 is based on the present
invention in respect to solubility, miscibility and synergistic in novelty in ratio 6:
2:2 from Unit I, Unit II and Unit III respectively.
9) A novel synergistic formulation as claim in 1. wherein the 20 - 30 % material of
Unit I-III, mixed with turpentine oil, eucalyptus oil and mustard oil or similar
seed oil added for preparation of formulation for topical or external application in
liniment form and extract of combination suitable to add in turpentine,
eucalyptus and other similar plant oil to prepare the formulation including balm,
lotion, spray, gel, cream added in waxy and related pharmaceutically accepted
base with or without add of 'Ratanjot' a plant based coloring materials.
10) A novel synergistic formulation as claim in 1 is effective for joint pains,
muscular pain, arthritis for external application on effected area of human body
with safe for skin; however strictly not for applicable in eyes, nose and sensitive
portion of body, not for oral taking, any kind of children's uses, application in
wound, eczema and skin diseases.

Documents

Application Documents

# Name Date
1 198-KOL-2015-Form 2(Title Page)-230215.pdf 2015-02-28
1 198-KOL-2015-RELEVANT DOCUMENTS [28-09-2023(online)].pdf 2023-09-28
2 198-KOL-2015-Form 1-230215.pdf 2015-02-28
2 198-KOL-2015-IntimationOfGrant16-02-2023.pdf 2023-02-16
3 198-KOL-2015-PatentCertificate16-02-2023.pdf 2023-02-16
3 198-KOL-2015-FER.pdf 2019-01-31
4 198-KOL-2015-FER-POST HEARING SUBMISSION-30-01-2023.PDF 2023-01-30
4 198-KOL-2015-(26-07-2019)-REPLY TO EXAMINATION REPORT.pdf 2019-07-26
5 198-KOL-2015-US(14)-HearingNotice-(HearingDate-18-01-2023).pdf 2022-12-27
5 198-KOL-2015-(26-07-2019)-MARKED-UP COPY.pdf 2019-07-26
6 198-KOL-2015-(26-07-2019)-FORM-5.pdf 2019-07-26
6 198-KOL-2015-(21-04-2022)-NBA APPROVAL.pdf 2022-04-21
7 198-KOL-2015-(26-07-2019)-FORM-3.pdf 2019-07-26
7 198-KOL-2015-(26-07-2019)-ABSTRACT.pdf 2019-07-26
8 198-KOL-2015-(26-07-2019)-FORM-2.pdf 2019-07-26
8 198-KOL-2015-(26-07-2019)-CLAIMS.pdf 2019-07-26
9 198-KOL-2015-(26-07-2019)-CORRESPONDENCE.pdf 2019-07-26
9 198-KOL-2015-(26-07-2019)-FORM-18.pdf 2019-07-26
10 198-KOL-2015-(26-07-2019)-FORM-1.pdf 2019-07-26
11 198-KOL-2015-(26-07-2019)-CORRESPONDENCE.pdf 2019-07-26
11 198-KOL-2015-(26-07-2019)-FORM-18.pdf 2019-07-26
12 198-KOL-2015-(26-07-2019)-CLAIMS.pdf 2019-07-26
12 198-KOL-2015-(26-07-2019)-FORM-2.pdf 2019-07-26
13 198-KOL-2015-(26-07-2019)-ABSTRACT.pdf 2019-07-26
13 198-KOL-2015-(26-07-2019)-FORM-3.pdf 2019-07-26
14 198-KOL-2015-(21-04-2022)-NBA APPROVAL.pdf 2022-04-21
14 198-KOL-2015-(26-07-2019)-FORM-5.pdf 2019-07-26
15 198-KOL-2015-(26-07-2019)-MARKED-UP COPY.pdf 2019-07-26
15 198-KOL-2015-US(14)-HearingNotice-(HearingDate-18-01-2023).pdf 2022-12-27
16 198-KOL-2015-(26-07-2019)-REPLY TO EXAMINATION REPORT.pdf 2019-07-26
16 198-KOL-2015-FER-POST HEARING SUBMISSION-30-01-2023.PDF 2023-01-30
17 198-KOL-2015-FER.pdf 2019-01-31
17 198-KOL-2015-PatentCertificate16-02-2023.pdf 2023-02-16
18 198-KOL-2015-Form 1-230215.pdf 2015-02-28
18 198-KOL-2015-IntimationOfGrant16-02-2023.pdf 2023-02-16
19 198-KOL-2015-RELEVANT DOCUMENTS [28-09-2023(online)].pdf 2023-09-28
19 198-KOL-2015-Form 2(Title Page)-230215.pdf 2015-02-28
20 198-KOL-2015-FORM-27 [11-05-2025(online)].pdf 2025-05-11
21 198-KOL-2015-FORM-27 [11-05-2025(online)]-1.pdf 2025-05-11

Search Strategy

1 TKDLsearchstrategy_31-01-2019.pdf
2 searchstrategy_10-09-2018.pdf

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