45 Vol. 10 Issue 2 Feb 2019 IJPSR RA 10427
45 Vol. 10 Issue 2 Feb 2019 IJPSR RA 10427
45 Vol. 10 Issue 2 Feb 2019 IJPSR RA 10427
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3 authors, including:
All content following this page was uploaded by Satish A. Ahire on 02 February 2021.
Received on 14 June 2018; received in revised form, 05 August 2018; accepted, 07 August 2018; published 01 February 2019
iii. Fine particle characterization. Although as piroxicam have different side effects
iv. Powder flow. but, its pharmacological action is more as
piroxicam is an effective anti-inflammatory agent;
Solubility Analysis: it is an inhibitor of prostaglandin biosynthesis. The
Principal advantage of piroxicam is its long half-
i. Ionization constant – pKa.
life, which permits the administration of a single
ii. pH solubility profile.
daily dose. Piroxicam is approved in the United
iii. Common ion effect – KSP.
States for the treatment of rheumatoid arthritis and
iv. Thermal effects.
osteoarthritis. It also has been used in the treatment
v. Solubilization
of ankylosing spondylitis, acute musculoskeletal
vi. Partition coefficient.
disorders, dysmenorrhea, postoperative pain and
vii. Dissolution
acute gout 4. This paper helps to those people who
Stability Analysis: want to use piroxicam drug for their research. As
the piroxicam is very effective drug many
i. Stability in toxicology formulation. researchers use this drug some of the research
ii. Solution stability– pH stability profile. paper is listed below:
iii. Solid state stability - Bulk stability,
Compatibility. 1. Formulation and optimization of piroxicam
orodispersible tablets by central composite
design 4.
2. Development of proniosomal drug delivery
with a different type of penetration enhancers 5.
3. Characterization and in-vitro evaluation of
piroxicam suppositories 6.
4. Novel double loaded transferosomes:
evidence of superior anti-inflammatory
FIG. 1: PIROXICAM efficacy- a comparative study 7.
5. Design and evaluation of piroxicam
Piroxicam is an oxicam derivative medication microemulsion 8.
belonging to non steroidal anti-inflammatory drugs 6. Pharmaceutical cocrystal of piroxicam:
(NSAIDs) group, used to treat moderate to severe design, formulation, and evaluation 9.
inflammatory diseases such as rheumatoid arthritis, 7. Formulation and characterization of flexible
osteoarthritis, ankylosing spondylitis (Bechterew’s phosphatidylcholine vesicles for systemic
disease), tendinitis, bursitis, and for pain that is not delivery of piroxicam 10.
related to musculoskeletal system e.g. primary 8. Systematic development of transethosomal
dysmenorrhea and postoperative pain. It reduces gel system of piroxicam: formulation
pain, joint swelling, morning stiffness, and optimization, in-vitro evaluation and ex-vivo
improves the functionality of the joints during assessment 11.
chronic polyarthritis 2. 9. Development and validation of a sensitive
UV method for piroxicam: application for
PC has been classified in the biopharmaceutics skin permeation studies 12.
Drug Classification system as a Class II drug with
low solubility and high permeability. It EXPERIMENTAL WORK:
demonstrates a slow and gradual absorption via the Organoleptic Properties: The drug samples were
oral route and has a long half-life of elimination, studied for appearance, color, and odor. The results
rendering a prolonged therapeutic action and a are shown in Table 1.
delayed onset of anti-inflammatory and analgesic
effect 3 PC is well absorbed following oral Melting Point: The melting points of the drugs
administration; however, its use has been limited were determined by an open capillary method using
by a number of side effects, including bleeding and the melting point apparatus. The melting point is
ulceration. shown in Table 2.
DGS-2) for 48 h at 25 ± 0.5 °C under constant Thermogram, as shown in Fig. 9 and inference,
vibration. After this period the solutions were showed in Table 9.
filtered, diluted and analyzed by UV
spectrophotometer. Three determinations were Partition Coefficient (Kp): 16 The partition
carried out for each sample to calculate the coefficient of the drug was determined by shaking
solubility of the drug. The results are shown in equal volumes of oil and the aqueous phase in a
Table 7. separating funnel. A drug solution of 1 mg/ml was
prepared in distilled water, and 50 ml of this
Fourier Transform Infrared Spectroscopy of solution was taken in a separating funnel and
Drug: The infrared spectra of the pure drug were shaken with an equal volume of octanol for 10 min
recorded by Shimadzu FT-IR spectrometer. and allowed to stand for 24 h with intermittent
Samples were prepared by KBr disc method (2 mg shaking. Then, the aqueous phase was assayed
sample in 100 mg KBr) and examined in the before and after partitioning using a UV
transmission mode. Each spectrum was measured spectrophotometer to get the partition coefficient
over a frequency range of 4000-400 cm−1. The values which is shown in Table 10.
results are shown in Table 8 and Fig. 8.
RESULT AND DISCUSSION:
Differential Scanning Calorimetry (DSC) Study Organoleptic Properties: The Sample of drug
of Drug: DSC analysis was performed using received was studied for its organoleptic characters
Shimadzu-Thermal Analyzer DSC 60 on 2-5 mg such as color, odor, and appearance as it is one of
samples. The sample was heated in an open the first criteria for identification of compound and
nitrogen pan at a rate of 10 °C/min conducted over it shows results/properties which comply with
a temperature range of 30 to 230 °C for Piroxicam reported literature standards. The result is presented
under a nitrogen flow of 2 bar pressure. in the following Table 1.
TABLE 1: COMPARISON OF THE RESULT OF ORGANOLEPTIC CHARACTERS OF DRUG SAMPLE WITH
THE REPORTED STANDARDS
S. no. Identification Test Observed Result Reported Standard 17,18
1 Appearance Powder Off-white to light tan or light yellow powder
2 Colour White White / Off-white
3 Odor Odorless Odorless
Spectra for the drug in methanol observed in the Preparation of Beer Lambert’s Plot:
range of 200 nm to 400 nm which it shows In Phosphate buffer (pH 7.4): Beer Lambert’s
absorption maxima at about 227 nm and 334.5 nm plot of the drug was prepared in Phosphate buffer
and minimum at about 242 nm which is shown in (pH 7.4).
Fig. 2.
A linear relationship was obtained in between
concentration (2-10 µg/ml), and the absorbance of
the drug in phosphate buffer (pH 7.4) with an R2
value of 0.999 at 276 nm is shown in calibration
curve shown in Fig. 5 and line equation, y= 0.072x-
0.0038.
TABLE 4: ABSORBANCE VALUE FOR DIFFERENT
CONCENTRATIONS OF DRUG IN PHOSPHATE
BUFFER (pH 7.4)
S. no. Concentration (μg/ml) Absorbance (nm)
FIG. 2: λmax FOR THE DRUG IN METHANOL 1 0 0.000
2 2 0.140
Spectra for the drug in methanolic HCl observed in 3 4 0.287
the range of 220 nm to 400 nm for 0.0007% w/v 4 6 0.429
solution of 0.01M methanolic HCl - absorption 5 8 0.574
maxima at about 242 nm and 334 nm and minimum 6 10 0.717
at about 270 nm which is shown in Fig. 3.
In Methanol: Beer Lambert’s plot of the drug was Fourier Transform Infrared Spectroscopy of
prepared in Methanol. A linear relationship was Drug: As we know, the infrared spectroscopy
obtained in between concentration (2-10 µg/ml) mostly used for the identification of organic
and the absorbance of the drug in Methanol with an compound whose spectra are complex and provides
R2 value of 0.9999 at 276 nm is shown in numerous maxima and minima that are useful for
calibration curve Fig. 7 line equation, y=0.0728 x- comparison purpose. Infrared spectroscopy finds
0.0005. widespread application to qualitative and
quantitative analysis as no two compounds (except
TABLE 6: ABSORBANCE VALUE FOR DIFFERENT
CONCENTRATIONS OF DRUG IN METHANOL
optical isomers) give similar absorption spectra in
S. no. Concentration (μg/ml) Absorbance (nm) the IR region. The powdered mixture of drug
1 0 0.000 sample and KBr was taken in a sampler, and the
2 2 0.144 spectrum was recorded by scanning in the
3 4 0.296 wavelength region of 4000-400-1cm using FTIR
4 6 0.436
spectrophotometer.
5 8 0.582
6 10 0.728
The FTIR spectra of piroxicam were taken which is
shown in Fig. 8. The principal peak for IR of drug
sample matched with the standard spectrum for
Piroxicam which is shown in Table 8.
Differential Scanning Calorimetry (D.S.C.) 1988). Therefore, from obtained result drug have
Study of Drug: The endotherm of melting 1000 times more soluble in the partitioning solvent
corresponds to the portion of the DSC curve that is (octanol).
far from the baseline and later returns to it. Melting
TABLE 10: COMPARISON OF THE RESULT OF
is a physical process that results in the phase
PARTITION COEFFICIENT (Kp) DRUG SAMPLE
transition of a substance from solid to liquid. This WITH THE REPORTED STANDARDS
occurs when the internal energy of the solid S. no. Observed value Reported standard54
increase, typically by the application of heat which 1 3.09 3.06
increases the substance’s temperature to the
melting point. In DSC, as the temperature CONCLUSION: In the present work, the
increases, the sample eventually reaches its melting preformulation study of piroxicam drug was done.
temperature (Tm). The melting process results in an Preformulation studies have a significant part to
endothermic peak in the DSC curve. play in anticipating formulation problems and
identifying a logical path in both liquid and solid
DSC studies were performed for drug sample. The dosage form technology. This study shows a
DSC thermogram of commercial drug sample is satisfactory result for all characterization such as
presented in Fig. 9 and interpretation is shown in organoleptic properties, calibration curve, DSC,
Table 9. Thermogram of DSC of the drug shows partition coefficient, etc. All results matched with
melting in the range between 203.45 to 206.11 ºC, the reported standard.
and the sharp peak was seen at 201.20 ºC. So, it
shows that it is an endothermic reaction. The ACKNOWLEDGEMENT: The author thankful to
following figure shows the endothermic peak of the Dr. Anil G. Jadhav and Mr. Satish A. Ahire for
drug with height -25.76 mW. their valuable guidance.
CONFLICT OF INTEREST: We declare that we
have no conflict of interest.
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