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Table of content

Contents
Patent Search & Analytical Report (PSAR-1).....................................................................2
Patent Search & Analytical Report (PSAR-2).....................................................................6
Patent Search & Analytical Report (PSAR-3)...................................................................10
Patent Search & Analytical Report (PSAR-4)...................................................................15
Patent Search & Analytical Report (PSAR-5)...................................................................19
Summary of Patent search and analytical report:..............................................................24

Nikita Talekar Anand Pharmacy College, College Page 1


PSAR 1

Patent Search & Analytical Report (PSAR-1)


Part-1: Student details who has prepared Report

Details
Sr. No Item
1. College code* 205
Name of the
2. Anand Pharmacy College
college*
3. Name of student* Nikita Talekar
Enrollment
4. number 192050820009
of student*
Branch of study *
5. Pharmaceutics
Semester of
6. 3rd
study*
Title of your Formulation and Evaluation of Solid Self nano
7. Dissertation emulsifying Drug delivery system of Dabigatran and
Project* Piperine
Contact number
8. of +91 9586978404
student*
Email id of
9. talekarnikita37@gmail.com
student*
Name of your
10. Guide/Faculty Dr. Hardik B. Rana
mentor*
Contact number
of
+91 8155851416
11. your
Guide/Faculty
mentor*
Email id of your
12. Guide/Faculty hardikrana1439@gmail.com
mentor*

Part 2: Patent Search Technique Used

13. Patent Search World Intellectual Property Organization


Database used*
14. Keywords used Self nano emulsifying drug delivery
for
search (minimum

Nikita Talekar Anand Pharmacy College, College Page 2


PSAR 1

3)*
15. Search string Self nano emulsifying drug delivery in the title or abstract
used
(viz. key words
along with
Boolean
operators like
AND, OR, NOT
used)*
16. The number of 12
hits you are
getting (viz.
number of related
patents comes
after
using the above
search string)*

Part 3: Basic data of patented invention/Bibliographic data

Broad Category/
17. Field of HUMAN NECESSITIES
Invention*
Class of SNEDDs for improvement of bioavailability of a poorly
18.
invention* water-soluble drug
19. Title of Invention* Self –nanoemulsion of poorly soluble drug
Application
20. PCT/US2014/043198
number*
21. Filing date* June. 19, 2014
22. Priority date June.19, 2013
23. Publication date* Dec. 24, 2014
Publication
24. WO 2014/205226 A1
number
25. Patent number WO 2014/205226 A1
First Filled
26. US
Country*
Priority Country
(Name of
Countries where
27. US
patent filled &
relevant Patent
No)
Name of DESAI, Dipen; VAKA, Siva; SHAH, Navnit H; JAIN,
28.
Inventor/s* Anekant; PHUAPRADIT, Wantance
29. Name of KASHIV PHARM, LLC

Nikita Talekar Anand Pharmacy College, College Page 3


PSAR 1

Applicant*
Country of
30. US
applicant *
State of applicant
31. New Jersey
*
32. City of applicant Bridgewater

Part 4: Technical part of a patented invention

Provided a nano-emulsion forming formulation


eliminates the need for the dissolution of active
pharmaceutical ingredient particles in the
gastrointestinal tract. As the formulation is already
33. Abstract of Invention* in liquid form when it is administered, the
formulation maximizes the bioavailability and
minimizes pharmacokinetics variability induced by
concomitant food intake, and reduces the first-pass
metabolism.
A large number of useful drug substances have
poor solubility in water, which complicates their
successful administration by the oral route. In
many instances, only a small fraction of the
34. Limitation of prior art*
quantity of a drug in a unit dosage form will be
absorbed into the circulatory system, the remaining
drug simply passing through the digestive tract and
being excreated.
There was difficulty in the solubility of the drug in
Specific Problem
gastric media and therefore low bioavailability of
35. Solved/Objective of
drugs. That can be overcome through formulating
invention*
a self nano emulsifying drug delivery system.
36. Brief description of invention* The present inventor has researched to solve the
above problems and formulate the self nano
emulsifying drug delivery system for solving the
problem of solubility in aqueous media of poorly
soluble drug using the novel excipients.
Furthermore, in a method for producing a
SNEDDs, used the simple low shear mixing
processes. The pharmaceutical formulation
comprises an emulsifier, which can be non-ionic,
cationic, anionic, or amphoteric like polyoxyl
castor oils, polysorbates, etc. In some
embodiments, the emulsifier is present in two or
more combinations in different ratios. In some

Nikita Talekar Anand Pharmacy College, College Page 4


PSAR 1

embodiments, a co-solvent ingredient for the drug


is also present like propylene glycol, ethanol, etc.
The formulation can be contained in soft capsules.
After a swallowed capsule containing a
formulation is ingested, the contained formulation
will mix with gastric fluids and stomach
contractions can assist in forming a nanoemulsion
having a globule size less than 200nm.
37. Number of claims* 21
Patent Status
(Applied/Published/Granted/In
38. Published
force/
Failed to maintain/Expired)
How much related this
invention with your
Dissertation project?
39. 50 - 60%
*(Indicates % relation range
viz. > 75 %, 50 to 75%, < 50
%)
Do you have any idea to do
Anything around the said
Invention to improve it? (If
40. NO.
yes
- give a short note in max. 200
words) *
NB: All questions having * are compulsory to be answered for each Patent

Nikita Talekar Anand Pharmacy College, College Page 5


PSAR 2

Patent Search & Analytical Report (PSAR-2)


Part-1: Student details who has prepared Report

Details
Sr. No Item
1. College code* 205
Name of the
2. Anand Pharmacy College
college*
3. Name of student* Nikita Talekar
Enrollment
4. number 192050820009
of student*
Branch of study *
5. Pharmaceutics
Semester of
6. 3rd
study*
Title of your Formulation and Evaluation of Solid Self nano
7. Dissertation emulsifying Drug delivery system of Dabigatran and
Project* Piperine
Contact number
8. of +91 9586978404
student*
Email id of
9. talekarnikita37@gmail.com
student*
Name of your
10. Guide/Faculty Dr. Hardik B. Rana
mentor*
Contact number
of
+91 8155851416
11. your
Guide/Faculty
mentor*
Email id of your
12. Guide/Faculty hardikrana1439@gmail.com
mentor*

Part 2: Patent Search Technique Used

Patent Search
13. World Intellectual Property Organization
Database used*
14. Keywords used Self micro emulsifying drug delivery system
for
search (minimum

Nikita Talekar Anand Pharmacy College, College Page 6


PSAR 2

3)*
Search string
used
(viz. key words
along with Self micro emulsifying drug delivery system
15.
Boolean
operators like
AND, OR, NOT
used)*
The number of
hits you are
getting (viz.
number of related
16. 10
patents comes
after
using the above
search string)*

Part 3: Basic data of patented invention/Bibliographic data

Broad Category/
17. Field of HUMAN NECESSITIES
Invention*
Class of
18. Self micro emulsifying drug delivery
invention*
Self –micro emulsifying drug delivery system of
19. Title of Invention*
abiraterone or abiraterone acetate
Application
20. PCT/EP20 13/064618
number*
21. Filing date* Jul. 10, 2013
22. Priority date Jul. 11, 2012
23. Publication date* Jan. 16, 2014
Publication
24. WO 2014/009434 A1
number
25. Patent number WO 2014/009434 A1
First Filled
26. Switzerland
Country*
Priority Country
(Name of
Countries where
27. Switzerland
patent filled &
relevant Patent
No)
28. Name of LEGEN, Igor; PETERNEL, Luka; NOVAK STAGOJ,
Inventor/s* Mateja; HOMAR, Miha; ROZMAN PETERKa, Tanja,

Nikita Talekar Anand Pharmacy College, College Page 7


PSAR 2

KLANCAR, Uros

Name of
29. SANDOZ AG
Applicant*
Country of
30. Switzerland
applicant *
State of applicant
31. NA
*
32. City of applicant Basel

Part 4: Technical part of a patented invention

The present invention relates to a self- micro


emulsifying drug delivery system comprising a
compound abiraterone acetate or a
33. Abstract of Invention*
pharmaceutically acceptable salt, hydrate, or
solvate thereof, at least one fatty acid ester, and at
least one surfactant.
The prior available inventions abiraterone acetate
is classified as a BCS class IV drug. Abiraterone
acetate has an aqueous solubility of <0.01 mg/mL.
34. Limitation of prior art*
Accordingly, it would be desirable to improve the
bioavailability of abiraterone acetate and to reduce
the necessary daily dose of abiraterone acetate.
The object of the present invention to improve the
solubility and dissolution rate of abiraterone
acetate. It is another object of the invention, to
provide a formulation with improved
bioavailability of abiraterone acetate. It is a further
object of the invention to reduce the necessary
Specific Problem daily dose of abiraterone acetate. It is an additional
35. Solved/Objective of object of the invention to reduce the food effect of
invention* abiraterone acetate. According to the present
invention this object is achieved by a self-micro
emulsifying drug delivery system comprising
abiraterone acetate or a pharmaceutically
acceptable salt, hydrate, or solvate thereof, a fatty
acid ester or a mixture of fatty acid esters, and at
least one surfactant.
36. Brief description of invention* The present invention describes that SMEDDS
means a mixture of drug, lipids, and surfactants,
optionally with one or more solubilizers which are
converted to oil-in-water microemulsions when it

Nikita Talekar Anand Pharmacy College, College Page 8


PSAR 2

comes to contact with gastrointestinal fluid after


oral administration. Microemulsions generally
exhibit a droplet size from 1000nm to <200nm.
37. Number of claims* 15
Patent Status
(Applied/Published/Granted/In
38. Published
force/
Failed to maintain/Expired)
How much related this
invention with your
Dissertation project?
39. 50%
*(Indicates % relation range
viz. > 75 %, 50 to 75%, < 50
%)
Do you have any idea to do
Anything around the said
YES. Much attention should be given to
Invention to improve it? (If
40. formulating the globule size of <100nm to make it
yes
nanoemulsion.
- give a short note in max. 200
words) *
NB: All questions having * are compulsory to be answered for each Patent

Nikita Talekar Anand Pharmacy College, College Page 9


PSAR 3

Patent Search & Analytical Report (PSAR-3)


Part-1: Student details who has prepared Report

Details
Sr. No Item
1. College code* 205
Name of the
2. Anand Pharmacy College
college*
3. Name of student* Nikita Talekar
Enrolment
4. number 192050820009
of student*
Branch of study *
5. Pharmaceutics
Semester of
6. 3rd
study*
Title of your Formulation and Evaluation of Solid Self nano
7. Dissertation emulsifying Drug delivery system of Dabigatran and
Project* Piperine
Contact number
8. of +91 9586978404
student*
Email id of
9. talekarnikita37@gmail.com
student*
Name of your
10. Guide/Faculty Dr. Hardik B. Rana
mentor*
Contact number
of
+91 8155851416
11. your
Guide/Faculty
mentor*
Email id of your
12. Guide/Faculty hardikrana1439@gmail.com
mentor*

Part 2: Patent Search Technique Used

Patent Search
13. World intellectual property organization(WIPO)
Database used*
14. Keywords used Method, SNEDDS
for
search (minimum

Nikita Talekar Anand Pharmacy College, College Page 10


PSAR 3

3)*
Search string
used
(viz. key words
along with
15. Method for SNEDDS
Boolean
operators like
AND, OR, NOT
used)*
The number of
hits you are
getting (viz.
number of related
16. 12
patents comes
after
using the above
search string)*

Part 3: Basic data of patented invention/Bibliographic data

Broad Category/
17. Field of HUMAN NECESSITIES
Invention*
SNEDDS as targeting drug delivery for decreasing
Class of
18. toxicity
invention*
PHARMACEUTICAL COMPOSITION FOR
Title of
19. ENHANCING ANTICANCER EFFICACY OF
Invention*
TAMOXIFEN
Application
20. WO 2013/008083 Al
number*
21. Filing date* 11 July 2012
22. Priority date 13 July 201 1
23. Publication date* 17 January 2013
Publication
24. WO 2013/008083 Al
number
25. Patent number WO 2013/008083 Al
First Filled
26. India
Country*
Priority Country
(Name of
Countries where
27. India
patent filled &
relevant Patent
No)

Nikita Talekar Anand Pharmacy College, College Page 11


PSAR 3

JAIN, Sanyog; BHUSHINGE, Omesh, Mallappa; JAIN,


Name of
28. Amit, Kumar; SWARNAKAR, Nitin, Kumar; HARDE,
Inventor/s*
Harshad, Prakash
Name of National Institute Of Pharmaceutical
29.
Applicant* Education And Research (Niper)
Country of
30. India
applicant *
State of applicant
31. Punjab
*
32. City of applicant Mohali

Part 4: Technical part of a patented invention

The present invention relates to a novel


pharmaceutical composition of Tamoxifen for
enhancing its anti-cancer efficacy with reduced
33. Abstract of Invention* toxicity. The composition is in a form of a self-
nano emulsifying drug delivery system (SNEDDS)
comprising Tamoxifen, an oily phase, a surfactant,
and a co-surfactant.
A self nano emulsifying formulation of Tmax
citrate containing Maisine 35-1 (16.4%), Caproyl
90 (32.8%), Cremophor RH40 (32.8%), and
propylene glycol (16.4%) has been developed and
characterized in vitro containing 1.6 % of
Tmxcitrate [Elnaggar et al., 2009]. However,
Elnaggar et al. describe the use of two oily phases
for the formulation of SNEDDS for Tmax. Using
one additional component indirectly increases the
cost of the formulation and hence makes the large
scale production of these systems more difficult.
34. Limitation of prior art* Besides, the above-described report on the
development of SNEDDS is limited to the
evaluation of Tmax efficacy in vitro only. It has
not undertaken the full investigation of the Tmax
bioavailability. Thus, taking the limitations of the
existing knowledge into consideration, there seems
to be a continuing need for Tmax formulations
which can provide a more efficient means of
administering Tmax with improved bioavailability,
without causing undesired side effects. Also, a
formulation with improved stability and hence
longer shelf life is desirable.
Specific Problem The object of the present invention is to develop a
35.
Solved/Objective of pharmaceutical composition of Tmax in a self

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PSAR 3

nano emulsifying drug delivery system (SNEDDS)


with enhanced oral bioavailability, augmented
anticancer efficacy, and reduced toxicity for
invention* effective treatment of breast cancer. A further
object is to develop a stable SNEDDS formulation
of Tmx using specific oily phases and specific
surfactant/co-surfactant combinations.
The present invention discloses a pharmaceutical
composition of Tmx in a self nano emulsifying
drug delivery system (SNEDDS) for enhancing its
anticancer efficacy. Further, the compositions have
high oral bioavailability, reduced toxicity, and
higher stability when compared with the prior art
formulations. Capmul MCM was selected as the
oily phase based on the optimum solubility of Tmx
in oil. Cremophor EL and ethanol were selected as
surfactants and co-surfactants from a large pool of
excipients, depending upon their nano emulsifying
ability for oily phase Capmul MCM. Pseudo
ternary phase diagrams were constructed to
identify the efficient self- nano emulsification
region in different dilution media viz., water,
buffer pH 1.2, and buffer pH 6.8. Optimized
formulation, containing Cremophor EL-Ethanol-
36. Brief description of invention* Capmul MCM: Tmx (40:1 w/w) in the ratio of
30:10:60 were selected based on its ability to form
nanoemulsion in simulated gastric and intestinal
fluid. The formulation was found to be robust
when tested for its long-term room temperature
stability of three months and short-term excursion
of freeze-thaw cycles. The SNEDDS formulations
of the present invention demonstrated 3.75 times
enhancement in oral bioavailability as compared to
the Tmax citrate solution and 8.97 times as
compared to the Tmax base solution. Moreover,
the SNEDDS formulation showed improved
anticancer efficacy and reduced hepatotoxicity
when tested in DMBA (7, 12-
dimethyl[a]benzanthracene) induced breast tumor
model when compared to the SNEDDS (Tmx
citrate) formulations and commercially available
Tmx citrate.
37. Number of claims* 19
38. Patent Status Published
(Applied/Published/Granted/In
force/

Nikita Talekar Anand Pharmacy College, College Page 13


PSAR 3

Failed to maintain/Expired)
How much related this
invention with your
Dissertation project?
39. 50%
*(Indicates % relation range
viz. > 75 %, 50 to 75%, < 50
%)
Do you have any idea to do
Anything around the said
Invention to improve it? (If
40. No
yes
- give a short note in max. 200
words) *
NB: All questions having * are compulsory to be answered for each Patent

Nikita Talekar Anand Pharmacy College, College Page 14


PSAR 4

Patent Search & Analytical Report (PSAR-4)


Part-1: Student details who has prepared Report

Details
Sr. No Item
1. College code* 205
Name of the
2. Anand Pharmacy College
college*
3. Name of student* Nikita Talekar
Enrollment
4. number 192050820009
of student*
Branch of study *
5. Pharmaceutics
Semester of
6. 3rd
study*
Title of your Formulation and Evaluation of Solid Self nano
7. Dissertation emulsifying Drug delivery system of Dabigatran and
Project* Piperine
Contact number
8. of +91 9586978404
student*
Email id of
9. talekarnikita37@gmail.com
student*
Name of your
10. Guide/Faculty Dr. Hardik B. Rana
mentor*
Contact number
of
+91 8155851416
11. your
Guide/Faculty
mentor*
Email id of your
12. Guide/Faculty hardikrana1439@gmail.com
mentor*

Part 2: Patent Search Technique Used

Patent Search
13. The United States Patent Application Publication
Database used*

Nikita Talekar Anand Pharmacy College, College Page 15


PSAR 4

Keywords used
for Dabigatran
14.
search (minimum
3)*
Search string used
(viz. key words
along with
15. Boolean Dabigatran
operators like
AND, OR, NOT
used)*
The number of
hits you are
getting (viz.
number of related
16. 09
patents comes
after
using the above
search string)*

Part 3: Basic data of patented invention/Bibliographic data

Broad Category/
17. Field of HUMAN NECESSITIES
Invention*
Class of
18. Pharmaceutical oral dosage form
invention*
Pharmaceutical Oral dosage forms comprising
19. Title of Invention* Dabigatran etexilate and it's Pharmaceutically acceptable
salts
Application
20. 13/807,882
number*
21. Filing date* Jul. 1, 2011
22. Priority date Jul. 12, 2010
23. Publication date* Jul. 11, 2013
Publication
24. US 2013/0177652 A1
number
25. Patent number US 2013/0177652 A1
First Filled
26. Slovenia
Country*
27. Priority Country Slovenia
(Name of
Countries where
patent filled &
relevant Patent

Nikita Talekar Anand Pharmacy College, College Page 16


PSAR 4

No)
Name of
28. Vesna Kroselj
Inventor/s*
Name of KRKA, TOVARNAZDRAVIL, D.D.,
29.
Applicant* NOVO MESTO
Country of
30. Slovenia
applicant *
State of applicant
31. NOVO MESTO
*
32. City of applicant D.D.

Part 4: Technical part of a patented invention

The invention relates to pharmaceutical oral


dosage forms of
the active substance ethyl 3-(2-4-
(hexyloxycarbonylamino-imino-methyl)-
33. Abstract of Invention* phenylaminol-methyl-methyl1Hbenzimidazole-5-
carbonyl)-pyridin-2-yl-amino-propionate
(dabigatran etexilate) and the pharmacologically
acceptable salts thereof, in particular, dabigatran
etexilate methanesulfonate.
The etexilate and dabigatran etexilate
methanesulfonate, in particular, is strongly
dependant on the pH value, with increased
solubility at acidic pH. On the other hand, it is
34. Limitation of prior art*
chemically unstable in an acidic environment and
particularly Susceptible to hydrolysis of the pro-
drug forming moieties, as well as polymorphic
form transformations.
The present invention relates in a preferred
embodiment to an improved solid oral dosage form
of dabigatran etexilate, in particular dabigatran
etexilate methanesulfonate, and the process for its
Specific Problem
production. Dabigatran etexilate comprising pellets
35. Solved/Objective of
are prepared by Suspension/solution layering of
invention*
tartaric acid onto spherical neutral or tartaric acid
cores without the use of the powder layering
method, followed by an isolating layer and active
pharmaceutical ingredient layer.
36. Brief description of invention* The present invention relates in a preferred
embodiment to an improved solid oral dosage form
of dabigatran etexilate, in particular dabigatran
etexilate methanesulfonate, and the process for its
production. Dabigatran etexilate comprising pellets

Nikita Talekar Anand Pharmacy College, College Page 17


PSAR 4

are prepared by Suspension/solution layering of


tartaric acid onto spherical neutral or tartaric acid
cores without the use of the powder layering
method, followed by an isolating layer and active
pharmaceutical ingredient layer. Optionally, an
overcoat can also be applied to increase the
abrasion resistance and shelflife of the final pellets
It has surprisingly been found out that dabigatran
etexilate, in particular, dabigatran etexilate
methanesulfonate pellets can also be prepared
according to a much simplified and technologically
less demanding process than powder layering of
tartaric acid crystals with tartaric acid dust and
with an aqueous solution of tartaric acid and acacia
acting as glue. The dried coated pellets (i.e. starter
pellets) obtained by such a process are round,
Smooth, and of narrow size distribution. Their
Surface is Smooth and the coating applied to them
is firm. No satellites, therefore, protrude into the
isolating layer and Subsequently the layer
comprising the active pharmaceutical ingredient
thus leading to a stable and bioequivalent
pharmaceutical product.
37. Number of claims* 20
Patent Status
(Applied/Published/Granted/In
38. Published
force/
Failed to maintain/Expired)
How much related this
invention with your
Dissertation project?
39. 50
*(Indicates % relation range
viz. > 75 %, 50 to 75%, < 50
%)
Do you have any idea to do
Anything around the said
Invention to improve it? (If
40. No
yes
- give short notes in max. 200
words) *
NB: All questions having * are compulsory to be answered for each Patent

Nikita Talekar Anand Pharmacy College, College Page 18


PSAR 5

Patent Search & Analytical Report (PSAR-5)


Part-1: Student details who has prepared Report

Details
Sr. No Item
1. College code* 205
Name of the
2. Anand Pharmacy College
college*
3. Name of student* Nikita Talekar
Enrollment
4. number 192050820009
of student*
Branch of study *
5. Pharmaceutics
Semester of
6. 3rd
study*
Title of your Formulation and Evaluation of Solid Self nano
7. Dissertation emulsifying Drug delivery system of Dabigatran and
Project* Piperine
Contact number
8. of +91 9586978404
student*
Email id of
9. talekarnikita37@gmail.com
student*
Name of your
10. Guide/Faculty Dr. Hardik B. Rana
mentor*
Contact number
of
+91 8155851416
11. your
Guide/Faculty
mentor*
Email id of your
12. Guide/Faculty hardikrana1439@gmail.com
mentor*

Part 2: Patent Search Technique Used

Patent Search
13. European Patent Application
Database used*
14. Keywords used Novel oral anticoagulants

Nikita Talekar Anand Pharmacy College, College Page 19


PSAR 5
for
search (minimum
3)*
15. Search string Novel oral anticoagulants
used
(viz. key words
along with
Boolean
operators like
AND, OR, NOT
used)*
16. The number of 7
hits you are
getting (viz.
number of related
patents comes
after
using the above
search string)*

Part 3: Basic data of patented invention/Bibliographic data

Broad Category/
17. Field of HUMAN NECESSITIES
Invention*
The present invention relates to the use of a NOAC for
Class of
18. preventing the atrial remodeling that promotes the
invention*
occurrence or maintenance of atrial fibrillation
Novel oral anticoagulants (NOACs) for preventing
19. Title of Invention*
development and aggravation of atrial fibrillation
Application
20. 15160648.0
number*
21. Filing date* 24.03.2015
22. Priority date -
23. Publication date* 28.09.2016
Publication
24. 2016/39
number
25. Patent number EP 3 072 514 A1
First Filled
26. France
Country*
27. Priority Country France
(Name of
Countries where
patent filled &
relevant Patent

Nikita Talekar Anand Pharmacy College, College Page 20


PSAR 5
No)
Name of
28. Hatem, Stéphane; Dufilho, Monique; Jumeau, Céline
Inventor/s*
Université Pierre et Marie Curie - Paris 6; INSERM
Name of (Institut National de la Santé
29.
Applicant* et de la Recherche Médicale); APHP (Assistance
Publique - Hôpitaux de Paris)
Country of
30. France
applicant *
State of applicant
31. Paris
*
32. City of applicant Avenue Victoria

Part 4: Technical part of a patented invention

The present invention relates to a novel oral


anticoagulant (NOAC) for use for
preventing the development and/or
33. Abstract of Invention*
aggravation of atrial fibrillation or
complications thereof in a subject with no
or low risk of thromboembolism.
Until 2009, the only available oral
anticoagulants for thromboprophylaxis in
patients with AF were vitamin K
antagonists (VKAs). Novel oral
anticoagulants (NOACs) have become
34. Limitation of prior art* alternative options to VKAs for these
patients. Indeed, NOACs are associated
with the greatest benefits by preventing
ischemic stroke, together with a significant
reduction in major bleeding, particularly
intracranial hemorrhage.
One object of the invention is a NOAC for
use in preventing the development and/or
aggravation of atrial fibrillation (AF) in a
subject. Another object of the invention is a
Specific Problem method for preventing the development
35.
Solved/Objective of invention* and/or aggravation of AF in a subject,
wherein said method comprises
administering a therapeutically effective
amount of at least one NOAC to the
subject.
36. Brief description of invention* The present invention also relates to a

Nikita Talekar Anand Pharmacy College, College Page 21


PSAR 5
composition comprising at least one
NOAC, preferably a direct thrombin
inhibitor, more preferably dabigatran or a
derivative or a salt or solvate thereof
(preferably dabigatran etexilate) or S35972.
The composition comprises a
therapeutically effective amount of at least
one NOAC. The present invention also
relates to a pharmaceutical composition
comprising at least one NOAC, preferably
a direct thrombin inhibitor, more preferably
dabigatran or a derivative or a salt or
solvate thereof (preferably dabigatran
etexilate) or S35972, in combination with
at least one pharmaceutically acceptable
excipient. In one embodiment, the
pharmaceutical composition comprises a
therapeutically effective amount of at least
one NOAC. The present invention also
relates to a medicament comprising at least
one NOAC, preferably a direct thrombin
inhibitor, more preferably dabigatran or a
derivative or a salt or solvate thereof
(preferably dabigatran etexilate) or S35972.
In one embodiment, the medicament
comprises a therapeutically effective
amount of at least one NOAC. The present
invention also relates to a composition,
pharmaceutical composition, or
medicament of the invention for preventing
the development and/or aggravation of AF
or complications thereof in a subject.
37. Number of claims* 13

Patent Status
38. (Applied/Published/Granted/In force/ Published
Failed to maintain/Expired)

How much related this invention with


your Dissertation project? *(Indicates
39. 50%
% relation range viz. > 75 %, 50 to
75%, < 50 %)

Nikita Talekar Anand Pharmacy College, College Page 22


PSAR 5

Do you have any idea to do


Anything around the said Invention to
40. improve it? (If yes No
- give a short t notes in max. 200
words) *

NB: All questions having * are compulsory to be answered for each Patent

Nikita Talekar Anand Pharmacy College, College Page 23


SUMMARY

Summary of Patent search and analytical report:

Dabigatran is a poorly water-soluble drug which is a novel oral anticoagulant act as direct
thrombin (factor IIa) inhibitor.

Many attempts have been made to overcome this issue of aqueous solubility and
bioavailability of a drug with a different technique. The review of the literature done so
far has not reflected anywhere the exploration of Dabigatran in a combination of Piperine
in a SNEDDS formulation with incorporating the parachute effect for precipitation
inhibitor.

Hence, the present work intends the preparation of an Immediate release of Solid
SNEDDS by incorporating the parachute effect of a Dabigatran is a combination of a
Piperine.

Nikita Talekar Anand Pharmacy College, Anand Page 24

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