Int. J. Pharm. Sci. Rev. Res., 30(1), January – February 2015; Article No.

53, Pages: 299-305 ISSN 0976 – 044X

Research Article

Formulation Development and Compatibility Study of Dexketoprofen Injection

Used in the Management of Post-Operative Pain
Srikant Pimple*, Pravin Maurya, Krupal Salunke, Ruby Singh, Dr. Mukund Gurjar, Mahesh Shah
Research and Development, Emcure Pharmaceuticals Limited, Pune, Maharashtra, India.
*Corresponding author’s E-mail: [email protected]

Accepted on: 10-11-2014; Finalized on: 31-12-2014.

ABSTRACT
Dexketoprofen Trometamol is an active enantiomer of racemic Ketoprofen categorized as non-steroidal anti-inflammatory drugs
(NSAIDs). It is used in the symptomatic treatment of acute pain of moderate to severe intensity, when oral administration is not
appropriate such as post-operative, renal colic and low back pain. The present study was undertaken with an intention to develop a
stable and effective parenteral formulation containing Dexketoprofen Trometamol in a hydro alcoholic medium. Compatibility study
was performed to evaluate the physical and chemical stability of Dexketoprofen Trometamol Injection and all data indicates that the
drug product was physically compatible and chemically stable. Formulation of Dexketoprofen Trometamol injection was developed
in line with the reference drug product. Aseptic filling was preferred for sterilization due to increase of R-isomer in presence of heat.
Thermal cycling and Photostability Study were also performed to study the stability at adverse conditions and indicates that drug
product is stable. Admixture compatibility study of drug product was performed with Normal Saline (0.9% Sodium Chloride Injection
USP), Glucose (5% Dextrose Injection USP) and Ringer lactate solution (Lactate Ringer Solution USP). Results of admixture study
indicate that the drug product is compatible with all above diluents. Accelerated stability study was performed at different time
intervals and justified by relevant stability results. Bacterial endotoxin, Sterility test and Bioburden test were also performed and
results were found satisfactory.
Keywords: Dexketoprofen Trometamol, Compatibility Study, Photostability Study, Thermal Cycling, Admixture Study, Stability Study.

INTRODUCTION Ketoprofen. Racemic Ketoprofen is used as an anti-

inflammatory agent and is one of the most potent in vitro

P ain is a common surgery-related reason for

unexpected hospital admissions. Inadequate pain
control can result not only into harmful
physiological consequences like nausea, vomiting,
increased rate of venous thromboembolism, and delayed
inhibitors of prostaglandin synthesis. The effect is due to
the (S)(+)-enantiomer (Dexketoprofen), while the (R)(-)-
enantiomer is devoid of such activity. The racemic
Ketoprofen exhibits little stereo selectivity in its
pharmacokinetics7-9.
wound healing, but also psychological ill-effects like
anxiety, anger, depression, and reduced patient The main objective of the present study was to formulate
satisfaction1. a stable parenteral formulation of Dexketoprofen
Trometamol. Compatibility study and accelerated stability
Nonsteroidal anti-inflammatory drugs (NSAIDs) and
study was performed to check the physical and chemical
opioids are considered effective analgesics for
stability of the drug product.
postoperative pain control2. NSAIDs alone provide
adequate pain relief after minor surgery and have been MATERIALS AND METHODS
shown to reduce opioid requirement following major
Materials
surgeries3.
Dexketoprofen Trometamol was procured from Emcure
Parenteral formulation are widely used especially when
Pharmaceuticals Ltd. Ethanol (96 per cent) was received
an immediate physiologic response is needed, in
from M/s Commercial Alcohols, Sodium Chloride and
emergency conditions and administering those drugs that
Sodium Hydroxide was received from Merck. The USP
are destroyed in gastrointestinal tract. These are the drug
Type I amber glass vials and rubber stopper were
delivery system of choice for non-co-operative nauseous
obtained from Schott and Stelmi.
and unconscious patients4. Injections include a wide
variety of therapeutic agents, e.g., for the treatment of Method
cancer, infections, cardiovascular diseases, arthritis,
Hot water for Injection was stored in a sterilized S.S. 316L
inflammatory diseases, diabetes, hormonal deficiencies
jacketed manufacturing tank equipped with stirrer.
and many other disease states including life threatening
5 Cooling of water for Injection was done up to 20 °C to 25
emergency conditions .
°C by circulating chilled water through jacket of the
Dexketoprofen Trometamol is a newly developed NSAID manufacturing tank. Dexketoprofen Trometamol, Sodium
belonging to the aryl-propionic acid group6. chloride, Ethanol, and Sodium hydroxide were dissolved
Dexketoprofen is the dextrorotatory enantiomer of in water for Injection in the tank under stirring. Volume

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Int. J. Pharm. Sci. Rev. Res., 30(1), January – February 2015; Article No. 53, Pages: 299-305 ISSN 0976 – 044X

was adjusted with water for Injection, and bulk solution

Table 1: Manufacturing Formula and Manufacturing steps
was blanketed with nitrogen gas. pH of bulk solution (at
25 °C) was recorded. Sr. No. Ingredients Qty/ mL
Preformation Study 1 Dexketoprofen 25.00 mg
As a part of pre-formulation studies, following 2 Sodium Chloride 4.00 mg
compatibility and stability studies were performed 3 Ethanol (96 per cent) 100.00 mg
4 Sodium Hydroxide q.s. to adjust pH
 Metal (SS316L) compatibility study
5 Water for Injection q.s. to 1 mL
 Platinum cured silicone tubing compatibility study
 Filter compatibility study Manufacturing Material/Equipment used
steps Manufacturing steps
 Stopper compatibility
Preparation of
SS316L vessel
bulk solution
 Freeze thaw study
0.45 µm membrane PVDF filters and 0.22 µm
Filtration
 Photostability study membrane PVDF filter
Filling 2 mL Amber glass vials
 Admixture Studies
Stoppering and
 Filter validation study Sealing
13 mm rubber stopper & 13 mm aluminium seal

Table 2: Metal (SS316L) Compatibility Data at Room Temperature (~20-25°C)

Test Specification Initial 24 hrs 48 hrs 72 hrs

Description Clear, Colorless solution Complies Complies Complies Complies

pH Between 6.5 and 8.5 7.2 7.3 7.3 7.3

Not less than 95.0% and not more

Assay (by HPLC) than 105.0% of labelled amount of 100.7% 103.6 % 103.3 % 104.6 %
Dexketoprofen (C16H14O3)

Related Substances (by HPLC)

a) Related Compound A NMT 0.2 % ND ND ND ND

b) Any other individual

NMT 0.1 % 0.01 % 0.01 % 0.01 % 0.01%
impurity

c) Total impurities NMT 0.6 % 0.02 % 0.02 % 0.03 % 0.03 %

R-isomer content by HPLC NMT 0.5 % 0.15 % 0.16 % 0.16 % 0.16 %

*ND: Not Detected

Table 3: Platinum Cured Silicone Tube Compatibility Data at Room Temperature (~20-25°C)

Test Specification Initial 24 hrs 48 hrs

Description Clear, Colorless solution Complies Complies Complies

pH Between 6.5 and 8.5 7.2 7.3 7.3

NLT 95.0% and NMT 105.0% of

Assay (by HPLC) labelled amount of Dexketoprofen 100.7% 102.5 % 104.4 %
(C16H14O3).

Related Substances (by HPLC)

a) Related Compound A NMT 0.2 % ND ND ND

b) Any other individual
NMT 0.1 % 0.01 % 0.01 % 0.02 %
impurity
c) Total impurities NMT 0.6 % 0.02 % 0.03 % 0.04 %

R-isomer content by HPLC NMT 0.5 % 0.15 % 0.16 % 0.16 %

*ND: Not Detected

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Int. J. Pharm. Sci. Rev. Res., 30(1), January – February 2015; Article No. 53, Pages: 299-305 ISSN 0976 – 044X

Table 4: PVDF Membrane Filters Compatibility Data at Room Temperature (~20-25°C)

Batch No.: 372/013
Test Specification
Initial 24 hrs 48 hrs
Description Clear, Colorless solution Complies Complies Complies
pH Between 6.5 and 8.5 7.2 7.3 7.3
NLT 95.0% and NMT 105.0% of
Assay (by HPLC) labelled amount of Dexketoprofen 101.1% 101.5 % 102.9 %
(C16H14O3).
Related Substances (by HPLC)
a) Related Compound A NMT 0.2 % ND ND ND
b) Any other individual
NMT 0.1 % 0.01 % 0.01 % 0.01%
impurity
c) Total impurities NMT 0.6 % 0.01 % 0.03 % 0.03 %

R-isomer content by HPLC NMT 0.5 % 0.15 % 0.16 % 0.16 %

*ND: Not Detected

Metal (SS316L) Compatibility Study with Unfiltered Bulk Compatibility of Dexketoprofen Injection with Rubber
Solution Stopper

SS 316L vessel is used as storage tank for prepared The container-closure system is an essential part of the
solution and as such must not interact with the drug final presentation of a pharmaceutical product. It defines
product. The effect of SS 316L vessel on formulation was the closure, protection, and functionality of a container
tested. About 60 mL of the unfiltered bulk solution was while it ensures the safety and quality of the drug product
stored into SS 316L vessel and was kept at room over the product shelf life. To establish the compatibility
temperature for 72 hrs. Samples were periodically of Dexketoprofen Injection with rubber stopper, prepared
collected from the container at 24, 48 & 72 hours and bulk solution of Dexketoprofen Injection was filtered
given for analysis of the bulk solution for Description, pH, through 0.45 micron and 0.22 micron PVDF membrane
RS (Related Substances) & assay. The analytical results filters. Filtered solution was filled in 2 mL USP Type -I
are given in the Table 2. amber glass vials, stoppered and sealed with rubber
stoppers and aluminum seal. Sealed vials were subjected
Platinum Cured Silicone Tube Compatibility Study with at different Stability conditions. The analytical results of
Unfiltered Bulk Solution stopper compatibility study are given in the Table 5.
In pharmaceutical manufacturing, silicone tubing is used Thermal Cycling (Freeze Thaw & Cool Thaw Cycle) Study
in transfer of solution and as such must not interact with
the drug product. About 40 mL of the unfiltered bulk The Freeze thaw & Cool thaw cycle study ensures that the
solution was stored into glass container. Clean dried and product attributes at the extreme conditions of
autoclaved Platinum cured silicone tubing of approximate temperature are not altered. This study was designed to
10 cm length was immersed into the glass container and simulate the conditions that the product may experience
kept at room temperature for 48 hrs. Samples were during shipping.
periodically collected from the container at 24 & 48 hours Following procedure was followed for Freeze Thaw &
and given for analysis of the bulk solution for description, Cool Thaw Cycle
pH, RS & assay. The analytical results are given in the
Table 3. Cool Thaw Cycle Study

PVDF Membrane Filters Compatibility Study with  Cycle-I

Unfiltered Bulk Solution Charge the samples in upright orientation in the
The compatibility study of filter is the most important test refrigerator maintained at temperature between 2 °C to 8
for sterility of any Injectable formulation. About 40 mL of °C for 2 days. On 3rd day remove all vials from the
the unfiltered bulk solution was stored into glass refrigerator. Place the above samples in the 40 ± 2 °C / 75
container. Clean and dried 0.45µm and 0.22µm PVDF ± 5 % RH chamber for 2 days.
membrane filter was immersed into the glass container  Cycle-II
and the container was kept at room temperature for 48
On 5th day remove all the vials from the 40 ± 2 °C / 75 ± 5
hrs. Samples were periodically collected from the
% RH stability chamber. Store them in refrigerator
container at 24 & 48 hours and given for analysis of the
maintained at temperature between 2 °C to 8 °C for 2
bulk solution for description, pH, RS & assay. The
days. On 7th day remove all vials from the refrigerator.
analytical results are given in the Table 4.

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Int. J. Pharm. Sci. Rev. Res., 30(1), January – February 2015; Article No. 53, Pages: 299-305 ISSN 0976 – 044X

Place them in the 40 ± 2 °C / 75 ± 5 % RH chamber for 2 The analytical results are given in the Table 6.
days.
Photostability Study
 Cycle-III
The study was carried out in Photostability chamber with
On 9th day remove all the vials from the 40 ± 2 °C / 75 ± 5
samples as follows
% RH stability chamber. Store them in refrigerator
maintained at temperature between 2 °C to 8 °C for 2  Test Sample
days. On 11th day remove all vials from the refrigerator.
Product filled in amber glass vials
Place them in the 40 ± 2 °C / 75 ± 5 % RH chamber for 2
days.  Control Sample
Upon completion of Cycle-III, remove all samples from Product filled in amber glass vials wrapped by aluminium
the 40 ± 2 °C / 75 ± 5 % RH chamber. foil.
Cool Thaw Cycle Study (Study-I)  Carton Pack
Product filled in amber glass vials and packed in a carton.
The vials were exposed to light for an overall illumination
of not less than 1.2 million lux hours and an integrated
near ultraviolet energy of not less than 200 watt
hours/square meter. The analytical results of various tests
performed in the Photostability studies are presented in
the Table 7.
Filter validation study
Thermal Cycle (Freeze Thaw & Cool Thaw Cycle) Study  Bubble Point Test
 Cycle-I A bubble point test is a test designed to determine the
Charge the samples in upright orientation in the freezer pressure at which a continuous stream of bubbles is
maintained at temperature between -10 °C to -20 °C for 2 initially seen downstream of a wetted filter under gas
days. On 3rd day remove all vials from the freezer. Place pressure. The point at which the first stream of bubbles
the above samples in the 40 ± 2 °C / 75 ± 5 % RH chamber emerges is the largest pore. Therefore, the bubble point
for 2 days. value can be used to obtain a relative measure of the size
of the single largest pore in a filter element. The purpose
 Cycle-II of this study was to determine the minimum product
On 5th day remove all the vials from the 40 ± 2 °C / 75 ± 5 bubble point value for the sterilizing grade hydrophilic
% RH stability chamber. Store them in freezer maintained durapore membrane wetted with Dexketoprofen
at temperature between -10 °C to -20 °C for 2 days. On 7th Injection. The bubble point of the filter was detected at
day remove all vials from the freezer. Place them in the 34.4 psi at 19-25 °C and the limit of the filter was 50 psi.
40 ± 2 °C / 75 ± 5 % RH chamber for 2 days.
 Extractable Test
 Cycle-III The primary function of filter devices is to remove
th
On 9 day remove all the vials from the 40 ± 2 °C / 75 ± 5 unwanted contaminants from pharmaceutical products.
% RH stability chamber. Store them in freezer maintained Unwanted contaminants could include environmental
at temperature between -10 °C to -20 °C for 2 days. On debris, insoluble materials, microorganisms, etc.
11th day remove all vials from the freezer. Place them in Depending on the nature and level of contaminants in the
the 40 ± 2 °C / 75 ± 5 % RH chamber for 2 days. Upon pharmaceutical products as well as the characteristics of
completion of Cycle-III, remove all samples from the 40 ± the product itself, a particular filter type is selected.
2 °C / 75 ± 5 % RH chamber. During the filtration process the pharmaceutical product
could potentially extract materials from the filter device.
Thermal Cycle (Freeze Thaw & Cool Thaw Cycle) Study Extractables from filter devices have been extensively
(Study-II) studied and such studies are part of filter device
validation.
All filter components have undergone toxicity testing,
including USP Class VI testing. USP Class VI testing uses
very aggressive time and temperature protocols and
extraction solutions including saline, 5 % ethanol in saline,
polyethylene glycol, and vegetative oil. In all cases the
extracts have been shown to be non-toxic.

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 Bacterial Retention Study preparation Dexketoprofen Trometamol Injection was

done (Table 1).
Bacterial retention study was performed to check the
sterility and integrity of filter. The main objective of the present study was to evaluate
the physical and chemical stability of Dexketoprofen
Performance of sterilizing grade filter has been
Trometamol Injection.
demonstrated to be acceptable as the membrane
retained the B. diminuta challenge concentration equal to Compatibility study of Dexketoprofen Trometamol
or greater than 1*107 cfu per cm2 of effective filtration Injection with platinum cured silicon tubes, metal (SS316
area. L), PVDF membrane filters and stoppers were performed.
So it was concluded that the challenge test was passed. Compatibility study results indicate that there was no
significant degradation in Dexketoprofen Trometamol
Bacterial Endotoxin Test
Injection in contact with platinum cured silicon tubes,
Bacterial Endotoxin test is performed to detect the metal (SS316 L), and PVDF membrane filters at room
°
pyrogens present in the Dexketoprofen Trometamol temperature (~20 - 25 C) over a period of 24 hours and
Injection, using Gel clot technique given in the Ph. Eur. 48 hours respectively (Table 2, 3 and 4).
The limit of bacterial endotoxin in finished product is not Rubber stopper compatibility study was also performed
more than 2.33 IU/mg of Dexketoprofen. and analytical results were found well within the specified
limits (Table 5).
Sterility Test
Thermal cycling and photo stability study was also
Sterility test is performed for determination of aerobic
performed on the drug product. Results obtained from
and anaerobic bacteria, yeast and mould present in the
Freeze thaw and Cool thaw studies indicate that the
Dexketoprofen Trometamol Injection, and the sterility
product was thermo stable and it can withstand thermal
test complies with the method given in the Ph. Eur.
excursions in the range of -10 °C to 40 °C ± 2 °C / 75 ± 5 %
There is no evidence of microbial growth found in the RH (Table 6).
test; the product examined complies with the test for
In Photostability study no significant degradation was
sterility.
observed on Dexketoprofen Trometamol injection vials
Bioburden upon exposure to light, hence the product was photo
stable (Table 7).
Bioburden test is performed to determine the number of
viable microorganism present in the bulk solution of In addition to compatibility study Admixture study was
Dexketoprofen Trometamol Injection, prior to filling. performed with Normal Saline (0.9 % Sodium Chloride
Injection USP), Glucose (5% Dextrose Injection USP) and
The tested Bioburden limit for bulk solution of
Ringer lactate solution (Lactated Ringer’s Solution USP) at
Dexketoprofen Trometamol Injection is NMT 10
room temperature (at 25 °C) and at 2 to 8 °C up to 24
cfu/100mL.
hours and it was observed that Dexketoprofen
Admixture Studies Trometamol Injection 50 mg/2mL was compatible with
the above injections.
Admixture Studies of drug product with following diluents
have been performed as suggested in PIL of reference Formulation was developed according to the reference
product. drug product and excipients used were similar as listed in
1. Normal Saline (0.9% Sodium Chloride Injection USP), PIL of reference product.

2. Glucose (5% Dextrose Injection USP) and Sterilized microbial retentive filters used for filtration and
filling of vials as terminal sterilization cannot be done due
3. Ringer lactate solution (Lactate Ringer Injection USP) to increase of R-isomer in presence of heat.
From the Admixture Study data, it was concluded that Vials of Dexketoprofen Trometamol injection were kept
Dexketoprofen Trometamol Injection 50 mg/2mL is at accelerated (40 °C ± 2° C / 75 ± 5 % RH), intermediate
compatible at room temperature (at 25 °C) and at 2 to 8 (30 °C ± 2°C / 65 ± 5 % RH) & long term (25 °C ± 2 °C / 60 ±
°C up to 24 hours when admixed with Normal Saline (0.9 5 % RH) condition for 1, 2, and 3 months for stability
% Sodium Chloride Injection USP), Glucose (5 % Dextrose study.
Injection USP) and Ringer lactate solution (Lactate Ringer
Injection USP). All results obtained from stability studies were found to
be well within the specified limits. Microbial study was
RESULTS AND DISCUSSION also conducted on the drug product such as Bacterial
NSAIDs have been shown to provide effective Endotoxin test, Sterility test, and Bioburden Test and
postoperative analgesia in orthopaedic surgery. In the results were found satisfactory. Container closure
present study formulation of stable parenteral integrity test was also performed and found satisfactory.

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Table 5: Analytical Results of Stopper Compatibility Study

Vial & stopper: 2mL amber glass vial with 13 mm Stelmi rubber stopper and 13 mm
aluminium seal.
Tests Specification
40°C ± 2° C/ 75 ± 5 % RH 25°C ± 2° C / 60 ± 5 % RH

Initial 1M 3M 6M 6M
Description Clear, colorless solution Complies Complies Complies Complies Complies
pH Between 6.5 and 8.5 6.9 6.8 6.8 6.8 6.8
Related Substances (by HPLC)

a) Related Compound A NMT 0.2 % ND ND ND ND ND

b) Any other individual

NMT 0.1 % 0.02% 0.03% 0.05% 0.06% 0.07%
impurity
c) Total impurities NMT 0.6 % 0.04% 0.05% 0.06% 0.08% 0.10%
R-isomer content by
NMT 0.5 % 0.13% 0.16% 0.19% 0.25% 0.16 %
HPLC
NLT 95.0% and NMT 105.0%
Assay (by HPLC) of labelled amount of 99.5 % 101.2 % 101.8 % 103.2 % 101.7 %
Dexketoprofen
*ND: Not Detected

Table 6: Analytical Results of Freeze Thaw & Cool Thaw Cycle Study
Thermal cycling Results
Test Specification
Initial Study I Study II

Description Clear, colorless solution Complies Complies Complies

pH Between 6.5 and 8.5 7.5 7.4 7.4

Not less than 95.0% and not more than

Assay (by HPLC) 105.0% of labelled amount of 100.5% 99.9% 99.0%
Dexketoprofen (C16H14O3).
Related Substances (by HPLC)
a) Related Compound A NMT 0.2 % ND ND ND
b) Any other individual
NMT 0.1 % ND 0.03% 0.03%
impurity

c) Total impurities NMT 0.6 % 0.00% 0.03% 0.03%

R-isomer content by HPLC NMT 0.5 % 0.11% 0.12% 0.12%

*ND: Not Detected

Table 7: Analytical Results of Photo Stability Study

Photostability study
Test Specification
Dark Control Carton Control
Initial Test sample
sample Sample
Description Clear, colorless solution Complies Complies Complies Complies

pH Between 6.5 and 8.5 7.5 7.4 7.4 7.4

Not less than 95.0% and not more than

Assay (by HPLC) 105.0% of labelled amount of 100.5% 100.0% 99.9% 99.7%
Dexketoprofen (C16H14O3)
Related Substances (by HPLC)
a) Related Compound A NMT 0.2 % ND ND ND ND
b) Any other individual
NMT 0.1 % ND 0.03% 0.02% 0.03%
impurity

c) Total impurities NMT 0.6 % 0.00% 0.03% 0.02% 0.03%

R-isomer content by
NMT 0.5 % 0.11% 0.12% 0.13% 0.12%
HPLC

*ND: Not Detected

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Int. J. Pharm. Sci. Rev. Res., 30(1), January – February 2015; Article No. 53, Pages: 299-305 ISSN 0976 – 044X

CONCLUSION 3. D. F. Murphy, “NSAIDs and postoperative pain,” British

Medical Journal, 306(6891), 1993, 1493–1494.
On the basis of present research work it can be concluded
that parenteral formulation containing Dexketoprofen 4. Avis KE, Herbert A. Lieberman and Lachman,
Pharmaceutical Dosage form: Parenteral Medication. 2nd
Trometamol was found compatible with all the contact
Ed. New York, Marcel Dekker Inc; 2004, 17-18.
materials used during formulation and was stable.
5. Y. S. Nagaraja, T. S. Nagaraja, D. R. Bharathi and T. O.
Admixtures of Dexketoprofen Injection with Normal Manjunatha, Formulation and evaluation of Ofloxacin
Saline, Glucose and Ringer lactate solution were aqueous injection, International Journal of Pharmacy & Life
physically compatible and chemically stable. Sciences, 3(10), 2012, 2015-2020.
Accelerated stability studies at different conditions were 6. M. H. Hanna, K. M. Elliott, M. E. Stuart-Taylor, D. R.
performed and results were found well within limits. So it Roberts, D. Buggy & G. J. Arthurs, Comparative study of
can be concluded that a robust, reproducible, and stable analgesic efficacy and morphine-sparing effect of
formulation of Dexketoprofen Trometamol Injection was intramuscular Dexketoprofen trometamol with Ketoprofen
or placebo after major orthopedic surgery, Blackwell
developed.
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Source of Support: Nil, Conflict of Interest: None.

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