International Journal of Trend in Scientific Research and Development (IJTSRD)

Volume 6 Issue 5, July-August 2022 Available Online: www.ijtsrd.com e-ISSN: 2456 – 6470

Formulation, Development and Evaluation of Fast Disintegrating

Tablet of Piroxicam using Solid Dispersion Technique
Mr. Yennuwar Dhiresh Pramod1, Mr. Sujit Kakade2,
Mrs. Trusha Shangrapawar3, Dr. Ashok Bhosale4
1
Student (Department of Pharmaceutics), 2Head of Department (Department of Pharmaceutics)
3
Assistant Professor (Department of Pharmaceutics), 4Principal
1, 2, 3, 4
PDEA’S SUCOPS&RC, Pune, Maharashtra, India

ABSTRACT How to cite this paper: Mr. Yennuwar

The solubility behavior of drugs remains one of the most exigent Dhiresh Pramod | Mr. Sujit Kakade |
aspects in formulation development. With the advent of Mrs. Trusha Shangrapawar | Dr. Ashok
combinatorial chemistry and high throughput screening, the number Bhosale "Formulation, Development and
of poorly water soluble compounds has dramatically increased. Evaluation of Fast Disintegrating Tablet
of Piroxicam using Solid Dispersion
Among all the newly discovered chemical entities, about 40-45%
Technique"
drugs fail to reach market due to their poor water solubility. Because Published in
of solubility problem, bioavailability of drugs gets affected and hence International Journal
solubility enhancement becomes necessary. In present study the of Trend in
attempts have been made to increase the dissolution of BCS class 2 Scientific Research
drug Piroxicam using hydrophilic polymers namely polyethylene and Development
glycol (PEG) 6000 and sodium lauryl sulphate as a surfactant by (ijtsrd), ISSN: 2456- IJTSRD50422
using solid dispersion technique. In solid dispersion microwave 6470, Volume-6 |
induced solid dispersion and conventional fusion method is Issue-5, August 2022, pp.157-176, URL:
compared. Drug-polymer complex was prepared using batch method. www.ijtsrd.com/papers/ijtsrd50422.pdf
Maximum dissolution rate was obtained of the complex prepared
Copyright © 2022 by author(s) and
from (Piroxicam + PEG6000 + SLS). A successful solubility
International Journal of Trend in
enhancement of drug complex was confirmed by taking drug release Scientific Research and Development
in phosphate buffer pH 6.8. The drug was characterized according to Journal. This is an
different compendial methods, on the basis of identification by UV Open Access article
spectroscopy, organoleptic properties and other tests. After that distributed under the
among the all formulation batches, solid dispersion (F16) was terms of the Creative Commons
selected for further tablet formulation batches, nine formulations Attribution License (CC BY 4.0)
were developed and studied. The values of pre-compression (http://creativecommons.org/licenses/by/4.0)
parameters was evaluated, results were within prescribed limits and
indicated good free flowing properties. The data obtained of post-
compression parameters such as weight variation, hardness, friability,
wetting time, water absorption ratio, content uniformity,
disintegration time and dissolution was found to superior over
conventional formulation. The F9 batch with disintegrating time 10 ±
0.52 second and dissolution 93.20 ± 0.61 % was selected as
optimized formulation and was found superior over other
formulation. Batch F9 was also subjected to stability studies for three
months and was tested for its disintegrating time, drug contents and
dissolution behavior monthly. F9 formulation after stability study
was found to be stable.
KEYWORDS: Piroxicam, Solid dispersion, Solubility, Dissolution,
Microwave Induced fusion Method

INTRODUCTION
Solid dispersions have attracted considerable interest various methods available to improve the solubility of
as an efficient means of improving the dissolution the new drug in which solid dispersion emerged
rate and hence the bioavailability of drugs. There are promising. A Solid dispersion generally composed of

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two components the drug and the polymer matrix. cellulose, Magnesium stearate, Mannitol, Talc
Hence, this approach is expected to form a basis for (Research lab fine chem. Mumbai).
the commercialization of many poorly water-soluble
Preformulation Studies of Piroxicam
and water-insoluble drugs in their solid-dispersion Organoleptic Evaluation, Melting point, Solubility
formulations in the near future. These poorly water profile and Loss on drying of Piroxicam drug for
soluble drugs i.e. BCS class II drugs absorption from identification and authentication of received sample
the gastrointestinal tract can be limited by a number for further formulation studies of solid dispersion [3, 4]
of factors; most significant contributors are poor
aqueous solubility & poor membrane permeability of Scanning of Piroxicam in Phosphate Buffer pH 6.8
the drug molecule. Therefore, the improvement of Solution
drug solubility thereby its oral bioavailability remains The standard solution (10ug/mL) was scanned from
one of most challenging aspects of drug development 200-400 nm on UV spectrophotometer (Shimadzu
process especially for oral drug delivery system. Out UV-1800). Primary standard solution of Piroxicam
of many categories, Non steroidal anti-inflammatory was prepared by dissolving 10 mg of Piroxicam in
drugs, Analgesic drugs are the most widely prescribed 100 mL of the phosphate buffer pH 6.8 solutions to
medication. Piroxicam is an Analgesic and non obtain a solution of 100 ug/mL Aliquot of 0.5 mL, 1.0
steroidal anti inflamatory drug commonly used to mL, 1.5 mL, 2.0 mL and 2.5 mL from the standard
relieve the pain and inflammation. Piroxicam belongs stock solution were transferred to 10mL volumetric
to BCS class II drugs which has low solubility and flask and the volume was adjusted up to the mark
high permeability. Piroxicam mostly permeable with phosphate buffer pH 6.8 to obtain a
through stomach but due to its solubility limitation it concentration of 5ug/mL, 10ug/mL, 15ug/mL,
can’t enter into systemic circulation. After this time 20ug/mL and 25ug/mL The absorbance was
Piroxicam goes in to small intestine where it is determined at 354 nm against blank. The calibration
solubilized but can’t permeate through its membrane curve is shown in Figure (2) and absorbances of
(Piroxicam having pH depended solubility and different concentration of Piroxicam are reported in
permeability). So, to improve dissolution of such drug Table (4) [7, 8, 9, 17]
is challenging and rational. Recently a totally unique Drug Excipient Compatibility Studies by using
approach supported the use of microwave FTIR Spectroscopy of Piroxicam and PEG 6000
irradiation has been proposed for the preparation of and SLS
SD. Microwaves irradiation (MW) could also be a Piroxicam, polymer and solid dispersion was
well-known method for heating and drying prepared and mixed with suitable quantity of
materials. Microwaves, with their ability to Potassium bromide. About 100mg of this sample was
penetrate any substance, allow the assembly of compressed to form a transparent pellet using a
heat in any point of the sample at the same time hydraulic press at 10 tons pressure. It was scanned
this is often because of the presence in it of from 4000 to 600 cm-1 FTIR Spectrophotometer. The
molecules characterized by a dipolar moment able interaction between drug-excipients was observed
to absorb microwave energy and convert it into from IR spectral studies by observing any shift in
heat. This phenomenon occurs when the peaks of drug in the spectrum of physical mixture of
microwave frequency is on the brink of the drug. [11, 12, 13]
resonance frequency of the polar molecules. The
efficient heating of materials by microwaves Formulation and Development of Solid Dispersion
depends on the capacity of a selected material to of Piroxicam
soak up microwave energy. Microwave energy has Solid dispersion of drug and polymer was prepared by
been employed to vary the crystalline state of a using Microwave induced fusion method and
drug, instead of conventional heating. [1, 2] conventional fusion method in various ratios such as
Piroxicam + PEG 6000 (1:1), Piroxicam + PEG 6000
MATERIALS AND METHODS + SLS (1:1:0.75), Piroxicam + PEG6000 (1:2),
Materials Piroxicam+PEG6000 + SLS (1:2:0.75), Piroxicam +
All materials used in present research were PEG 6000 (1:3), Piroxicam + PEG 6000 + SLS
commercial samples. Active pharmaceutical (1:3:0.75) Piroxicam + PEG 6000 (1:4), Piroxicam +
ingredient: Piroxicam (Aarti Pharma, Mumbai) PEG 6000 + SLS (1:4:0.75) and Solid dispersion
Hydrophilic polymers: Polyethylene glycol 6000, prepared by conventional fusion method were F1, F2,
Sodium lauryl sulphate (Research lab Fine chem. F3, F4, F5, F6, F7, F8 and solid dispersion prepared
Industry, Mumbai), Excipients: Sodium starch by microwave induced fusion method F9, F10, F11,
glycolate, Croscarmellose Sodium, Crospovidone, F12, F13, F14, F15 and F16 respectively.[11]
(Research lab fine chem. Islampur), Microcrystalline

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Table 1 Formulation of Drug and Polymer
Formulations / Batches Composition Method Ratio
F1 Piroxicam+ PEG 6000 Conventional Fusion Method 1:1
F2 Piroxicam +PEG 6000 +SLS Conventional Fusion Method 1:1:0.75
F3 Piroxicam + PEG 6000 Conventional Fusion Method 1:2
F4 Piroxicam +PEG 6000 +SLS Conventional Fusion Method 1:2:0.75
F5 Piroxicam +PEG 6000 Conventional Fusion Method 1:3
F6 Piroxicam + PEG 6000+SLS Conventional Fusion Method 1:3:0.75
F7 Piroxicam +PEG 6000 Conventional Fusion Method 1:4
F8 Piroxicam + PEG 6000+SLS Conventional Fusion Method 1:4:0.75
F9 Piroxicam+ PEG 6000 Microwave Induced Fusion Method 1:1
F10 Piroxicam +PEG 6000 +SLS Microwave Induced Fusion Method 1:1:0.75
F11 Piroxicam + PEG 6000 Microwave Induced Fusion Method 1:2
F12 Piroxicam +PEG 6000 +SLS Microwave Induced Fusion Method 1:2:0.75
F13 Piroxicam +PEG 6000 Microwave Induced Fusion Method 1:3
F14 Piroxicam +PEG 6000 +SLS Microwave Induced Fusion Method 1:3:0.75
F15 Piroxicam +PEG 6000 Microwave Induced Fusion Method 1:4
F16 Piroxicam + PEG 6000+SLS Microwave Induced Fusion Method 1:4:0.75
Conventional Fusion Method
In conventional fusion method the polymer was heated to molten mass and to this weighed amount of Piroxicam
was added with continuous stirring with or without SLS until mixture get melt completely and drug molecules
are get dispersed uniformly in polymer occur. Solidification was allowed to occur at room temperature. The
product was stored in a dessicator for 24 h and then pulverized using a porcelain mortar and pestle. The
pulverized powder was passed through 100# sieve to get uniform particle size. [11]
Microwave Induced Fusion Method
In microwave induced fusion method microwave energy used to prepare solid dispersion. The drug and
hydrophilic polymer will get fused together to form solid dispersion. Solid dispersion is prepared by placing the
mixture of drug and polymer in porcelain dish and subjected to microwave radiation. Only one sample is place at
a time inside the microwave oven. Only one sample is placed at a time inside the microwave oven. Porcelain
dish is place in room temperature to solidify molten mass. The solid dispersion is placed in desiccators for 24 hr.
and then product is pulverize using a porcelain mortar and pestle. The pulverize powder is pass through 100#
sieve. [11]
Comparative Solubility and Dissolution Study to Select the Optimum Batch of Solid Dispersion
Comparative solubility and dissolution study of Piroxicam and Solid dispersion batches to select the optimum
batch of solid dispersion for further studies.
Solubility study of Solid Dispersion and Piroxicam
Solubility measurement of Piroxicam were performed according to a published method. The amount of solid
dispersion powder containing 2.5mg equivalent Piroxicam was weighed accurately in volumetric flask was
dissolved 5ml distilled water by sonication for 15 min subsequently, the solutions were filtered through a
Whatman filter paper no. 1 Filtered solution was diluted properly with distilled water. The diluted solution was
analyzed for the Piroxicam in UV at 354nm.[11]
In vitro Dissolution Study of Pure Drug and Solid Dispersion Using Conventional Fusion Method and
Microwave Induced Fusion Method.
Dissolution profiles of Piroxicam and solid dispersion were determined using the USP Type II Dissolution test
apparatus (Electrolab Model TDT-08L) set with a paddle speed of 50 rpm. Dissolution was performed in 900 ml
of phosphate buffer pH 6.8 maintained at 370± 0.50C. The 20 mg of Piroxicam, and The solid dispersion
containing equivalent of 20mg of Piroxicam and PEG 6000 (1:1, 1:0.75, 1:2, 1:2:0.75, 1:3, 1:3:0.75, 1:4,
1:4:0.75) Conventional Fusion Method and Microwave Induced Fusion Method batches of solid dispersion from
F1 to F16 was taken in a muslin cloth and tied to the rotating paddle kept in vessel of dissolution apparatus the
paddle was rotated at 50 rpm. Aliquot of dissolution medium, 5 ml was withdrawn at specified time and filtered
through Whatmann filter paper. The amount of drug dissolved was determined by UV-Visible
spectrophotometer by measuring the absorbance of the sample at 354 nm. An equal volume of fresh medium,

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prewarmed at 370C was replaced into the dissolution medium after each sampling to maintain the constant
volume throughout the test. Three trials for each batch were performed and average percentage drug release. [11]
Comparative Dissolution Study of Piroxicam and solid dispersion
The dissolution of pure drug is compare with solid dispersion by conventional fusion method (F8) and
microwave induced fusion method (F16) which is shown in Table 12 and graph was plotted to show % drug
release which was represented in Figure 10
Selection of Optimum Batch of Solid Dispersion for formulation of Fast Disintegrating Tablet
For Selection of the optimum batch Solid Dispersion Technique, the dissolution of the pure drug Piroxicam and
its Solid Dispersion by Conventional Fusion Method and Microwave Induced Fusion Method is compare.
EVALUATION OF SOLID DISPERSION [11, 13]
Physical appearance
Visual inspection of all batches of solid dispersions such as color and appearance.
Percentage yield Study of Solid Dispersion
Percentage yield was calculated with respect to dry product. Based on the practical yield (P.Y) obtained a0nd the
calculated theoretical yield (T.Y), % yield was calculated by using the following formula:
PY (%) = [Practical weight/Theoretical weight (Drug +Carrier)] ×100 ......Eqn1
Where,
a = Practical weight of solid dispersion obtained
b = Theoretical weight of solid dispersion preparation.
Drug Content
Determination of drug content in solid dispersion powder solid dispersion equivalent to 20 mg of Piroxicam was
accurately weighed and transferred to a 100 ml volumetric flask. About 30 ml of distilled water was added and
flask was shaken to dissolve the contents completely and the volume was made up to the mark with distilled
water. The concentration of this resulting solution was 100µg/ml. From this solution, 1 ml of solution was taken
in another 10 ml volumetric flask, and volume was made up to 10 ml with distilled water. The solution was
analyzed spectrophotometric at 354 nm against corresponding reagent blank. The analysis was carried out in
triplicate and drug contents were determined. [11, 14]
Characterization of Microwave Induced Solid Dispersion
FT-IR Spectroscopy
Infrared spectra matching approach was used for the detection of any possible chemical reaction between the
drug and the excipients. Piroxicam, polymer and solid dispersion was prepared and mixed with suitable quantity
of Potassium bromide. The interaction between drug-excipients was observed from IR spectral studies by
observing any shift in peaks of drug in the spectrum of mixture of drug. [14]
Differential Scanning Calorimetry (DSC)
In drug formulation it is essential to evaluate the possible interactions between the active principle and the
excipients, as the choice of the excipients should be performed in relation to the drug delivery, to their
compatibility with the same drug and to the stability of the final product. Piroxicam powder was mixed with
various excipient and the resulting mixture was kept in sealed glass vials. Mixture should be examined under
Nitrogen to eliminate oxidative and pyrolytic effect at a standard heating rate (2, 5 or 100 C per minute) on DSC.
Thermograms of pure drug are used as a reference. [14]
XRD STUDIES
X-ray powder diffractometry was carried out to investigate the effect of complexation process on crystallinity of
drug. Powder X-ray diffractometry were carried out using a D8 Advance (Bruker) scanner with filter Ni, Cu, Kα
radiation, voltage 40kV and a current of 20 mA. The scanning rate employed was 1°/min over the 5° to 50°
diffraction angle (2θ) range. The XRPD patterns of drug powder and drug-polymer complex were recorded. The
comparative XRPD patterns of pure drug and drug- polymer complex were given in Figures 14 and 15 [11, 14]
FORMULATION OF FAST DISINTEGRATING TABLET OF PIROXICAM USING SOLID
DISPERSION TECHNIQUE
After evaluation of solid dispersion of Piroxicam prepared by conventional fusion method and microwave
induced fusion method, fast dissolving tablets were prepared according to formula given in Table 2 [15, 16]

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Table 2 Formulation of Fast Disintegrating Tablet
Formulations F1 F2 F3 F4 F5 F6 F7 F8 F9
Ingredient Unit Formula (mg per tablet)
Solid Dispersion complex
118.55 118.55 118.55 118.55 118.55 118.55 118.55 118.55 118.55
equivalent to 20 mg Piroxicam
Sodium starch glycolate 6 10.5 15 - - - - - -
Crosscarmellose sodium - - - 6 10.5 15 - - -
Crospovidone - - - - - - 6 10.5 15
Microcrystalline cellulose 120 115.5 111 120 115.5 111 120 115.5 111
Mannitol 50 50 50 50 50 50 50 50 50
Magnesium Stearate 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5
Talc 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5 2.5
Total 300 300 300 300 300 300 300 300 300
EVALUATION OF POWDER BLEND FOR FAST DISINTEGRATING TABLET
Method: Accurate quantity of drug and all ingredients were weighed according to formula and powder except
mannitol and magnesium sterate was blended homogeneously in mortar and pestle for 15 minutes. Prepared
powder blend was passed through sieve No. #60. Finally, mannitol and magnesium sterate passed through sieve
No. #30 was added and further mixed for 10 minutes. The powder blend was evaluated for angle of repose, bulk
density, Tapped density, Compressibility Index and Hausner’s ratio. [7, 11]
MANUFACTURING OF FAST DISINTEGRATING TABLET OF PIROXICAM CONTAINING SOLID
DISPERSION BY DIRECT COMPRESSION METHOD
The fast disintegrating tablets were prepared by direct compression method with the use of different
superdisintegrants namely Croscarmellose sodium, Sodium starch glycolate, Crospovidone. Microcrystalline
cellulose, Mannitol was used as a diluents and Mg. Stearate was used as lubricant.. Accurate quantity of drug
and all ingredients were weighed according to formula and powder except mannitol and Magnesium sterate was
blended homogeneously in mortor and pestle for 15 minutes. Prepared powder blend was passed through sieve
no. #60. Finally, mannitol and Magnesium sterate passed from sieve no. #30 added and was further mixed for10
minutes. Accurately weighed 300 mg homogeneously mixed powder blend was fed manually and compressed
with constant compression force and hardness on 16 stations tablet compression machine with 5 mm,
breakthrough, and flat faced punches. Total nine formulations were prepared.
EVALUATION OF FAST DISINTEGRATING TABLET
The prepared tablets of piroxiam were evaluated for post cimression parameters like
Appearance
The tablets were visually observed for capping, chipping and lamination. [11,17]
Thickness
Three tablets were selected randomly from each batch and thickness was measured by using Vernier Caliper.
[11,17]

Hardness
Hardness or tablet crushing strength (Fo) the force required to break a tablet in a diametric compression was
measured using Pfizer Hardness Tester. For each formulation, the hardness of 6 tablets was determined using the
Pfizer hardness tester. The tablet was held along its oblong axis in between the two jaws of the tester. At this
point, reading should be zero kg/cm2. Then constant force was applied until the tablet fractured. The value at this
point was noted in kg/cm2. [7,11,17]
Friability
Friability of the tablets was determined using Roche Friabilator. This device subjects the tablets to the combined
effect of abrasions and shock in a plastic chamber revolving at 25 rpm and roping the tablets height of 6 inches
in each revolution. [7]
Previously weighed sample of tablets was placed in the riabilator and were subjected to 25 revolutions. Tablets
were dedusted using a soft muslin cloth and reweighed, the friability (F) is given by the formula.

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Drug Content
Content uniformity test is used to ensure that every tablet contains the amount of drug substance intended with
little variation among tablets within a batch. Five tablets were selected randomly and average weight was
calculated. Tablets were crushed in a mortar and accurately weighed and the amount of average tablet was taken
from the crushed blend. then, the sample was transferred to the 100ml volumetric flask and was diluted up to the
mark with pH 6.8 phosphate buffer. the content was shaken periodically and kept for 24 hours for dissolution of
drug completely. The solution was filtered and appropriate dilutions were made. The drug content in each tablet
was estimated at 354nm against pH 6.8 phosphate buffer as a blank reference and reported. [11, 17, 18]
Weight Variation Method
Twenty tablets were randomly selected from each batch and individually weighed. The average weight and
standard deviation of 20 tablets was calculated. The batch passes the test for weight variation test if not more
than two of the individual tablet weight deviate from the average weight. [7, 17]
% F = (Initial wt. - Final wt. / Initial wt.) × 100. ………..Eqn2
Disintegration time Method
The disintegration time of tablet was determined by using Disintegration test apparatus. Tablets were placed in
disintegration test assembly and disc was placed was placed on tablets in each glass tube of assembly. The
assembly was dipped in a vessel containing 900ml phosphate buffer pH 6.8 at 370C. The time for disappearance
of tablet residue above mesh was noted as disintegration time. [7]
Wetting time of water absorption Ratio
Wetting Time: wetting time of dosage form is related with the contact angle. wetting time of the mouth
dissolving tablets is another Important parameter, which needs to be assessed to give an insight into the
disintegration properties of the tablets; a lower wetting time cause faster disintegration of the tablet can be
measured using a simple procedure. [7, 17, 18]
Method: five circular tissue papers of 10 cm diameter were placed in a petri dish. 10ml of water was added to
petri dish, a tablet was carefully placed on the surface of the tissue paper. the time required for water to reach
upper surface of the tablet was noted as wetting time.
Water absorption ratio(R): the weight of the tablet before keeping in the petri dish was noted (Wb). The wetted
ablet from the petri dish was taken and re weighed (Wa) using the same.
R=100×Wa- Wb/Wb ………………Eqn3
Where,
Wb =Weight of tablet before water absorption
Wa = Weight of tablet after water absorption
In-vitro Dissolution studies
Dissolution profiles of piroxicam tablets were determined using the USP Type II Dissolution test apparatus set
with a paddle speed of 100 rpm. Dissolution was performed in 900 ml of maintained at 370 ± 0.50 C. Aliquot of
dissolution medium, 5 ml was withdrawn at 5, 10, 15, 20, 25, 30 and 40 min with 5 minutes interval, and filtered
through Whatmann filter paper. The amount of drug dissolved was determined by UV-Visible
spectrophotometer by measuring the absorbance of the sample at 354 nm. An equal volume of fresh medium,
prewarmed at 370C was replaced into the dissolution medium after each sampling to maintain the constant
volume throughout the test. Three trials for each batch were performed and average percentage drug release was
calculated by using disso software. [7, 11, 13]
STABILITY STUDY
Stability of a formulation can be defined as the time from date on manufacture of the formulation until its
chemical or biological activity is not less than a predetermined level of labeled potency and its physical
characteristics have not changed appreciably or deleteriously. Formulation and the development of a
pharmaceutical product are not complete without proper stability analysis, carried out on it to assess the physical
and chemical stability and the safety. The purpose of stability testing is to provide evidence on how the quality
of a drug substance or drug product varies with time. Under the influence of a variety of environmental factors
such as temperature, humidity and light, enabling recommended storage conditions, re-test periods and shelf
lives. Generally, the observation of the rate at which the product degrades under normal room temperature
requires a long time. To avoid the undesirable delay, the principles of accelerated stability studies are adopted.

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The International Conference on Harmonization (ICH) Guidelines titled “Stability testing of new drug substance
and products” (QIA) describes the stability test requirements for drug registration application in the European
Union, Japan and United States of America. ICH specifies the length of study and storage conditions.
Long-term testing 250C ± 20C/60 % RH ± 5% for 12 months.
Short term testing 300C ± 20C/65 % RH ± 5% for 1 month.
Accelerated testing 400C ± 20C/75 % RH ± 5% for 6 months.
Stability studies for the present work carried out at 400C ± 20C/75% ± 5% RH for the selected formulation for 3
months.
Method
The selected formulations were packed in tightly closed container which were tightly plugged with cotton and
capped. They were then stored at 400C ± 20C /75 % RH ± 5% for 3 months and evaluated for their physical
appearance, hardness, disintegrate time, dissolution testing and drug content at specified intervals of time. The
drug solutions were further scanned to observe any possible spectral change. [11]
Result and Discussion
Preformulation Studies of Piroxicam
Organoleptic properties received sample of piroxicam oduorless, fine off white to light yellow powder. The
melting point of piroxicam was found to be 199-2010C. The reported melting point of Piroxicam was 198-2000C.
The Piroxicam is practically insoluble in water and freely soluble in methanol and chloroform. The percentage
loss on drying after 4 hours was found to be 0.5%. The sample passes test for loss on drying as per the limits
specified in I.P. (N.M.T. 0.4%) all results are complies as per I.P.
Scanning of Piroxicam in Phosphate Buffer pH 6.8 Solution
The absorption maxima were found to be at 354 nm in phosphate buffer pH 6.8.
Figure 1 Scanning of Piroxicam in Phosphate Buffer pH 6.8 Solution

Calibration Curve of Piroxicam in Phosphate Buffer pH 6.8

Standard curve of Piroxicam was determined by plotting absorbance Vs concentration at 354nm. Using solution
prepared in Phosphate Buffer pH 6.8 at 354nm; it follows Beer’s law. The R2 value was found to be 0.9992.
Absorbance value were depicted in Table 3
Table 3 Calibration Curve of Piroxicam in Phosphate Buffer pH 6.8
Sr.no. Concentration (µg/ml) Absorbance
1 5 0.203
2 10 0.389
3 15 0.587
4 20 0.751
5 25 0.965

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Figure 2: Standard Graph of Piroxicam in Phosphate Buffer pH 6.8

Calibration Curve of Piroxicam in Distilled Water

Standard curve of Piroxicam was determined by plotting absorbance Vs concentration at 354nm. Using solution
prepared in Distilled water at 354nm; it follows Beer’s law. The R2 value was found to be 0.998. Absorbance
value were depicted in Table 4
Table 4 Calibration Curve of Piroxicam in Distilled Water
Sr.no. Concentration (µg/ml) Absorbance
1 5 0.016
2 10 0.031
3 15 0.042
4 20 0.057
5 25 0.071
Figure 3 Calibration Curve of Piroxicam in Distilled Water

Drug Excipient Compatibility Studies Using Fourier Transform Infra red Spectroscopy of Piroxicam and
PEG 6000 and SLS
Major functional groups present in Piroxicam show characteristic peaks in IR spectrum. Table 5 shows peaks
observed at different wave numbers and the functional group associated with these peaks. The major peaks are
identical to functional group of Piroxicam. Hence, the sample was confirmed as Piroxicam.

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FTIR Studies of Piroxicam
Figure 4 FTIR Spectrum of Piroxicam

Table 5 Interpretation of FTIR Spectrum of Piroxicam

Reference Peak Reported Peak
Sr.no. Functional Group
Wavenumber(cm-1) Wavenumber(cm-1)
1 773.45 771.55 Ortho-di substituted ring
2 1149.57 1149.61 SO2-NH group
3 1300.02 1303.92 Pyridine
4 1435.04 1435.09 Methyl
5 1525.69 1527.67 Tertiary amine group
6 1629.85 1627.97 Amide carbonyl
7 3338.78 3340.82 Cubic polymorphic form
FTIR Studies PEG 6000
Figure 5 FTIR Spectrum of PEG 6000

Table 6 Interpretation of FTIR Spectrum of PEG 6000

Reference Peak Observed Peak
Sr.no. Functional Group
Wavenumber(cm-1) Wavenumber(cm-1)
1 3500-3000 3502.85 O-H Stretching
2 3000-2500 2885.60 OH Bending
3 2000-1500 1350.22 C-H stretching
4 1500-1000 1141.90 C=O Stretching

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FTIR Studies Sodium lauryl Sulphate
Figure 6 FTIR Spectrum of SLS

Table 7 Interpretation of FTIR Spectrum of SLS

Reference Peak Observed Peak
Sr.no. Functional Group
Wavenumber(cm ) Wavenumber(cm-1)
-1

1 1350-1140 1216.64 S=O Sulphate

2 1375-1450 1372.1 C=N Stretching of pyridine
3 3000-2800 2916.96 C-H Stretching
4 1300-1000 1078.26 O-H (Alcohol H-bonded) stretching
5 1465 1466.67 C-H Alkane stretching
Mixture of Piroxicam, PEG 6000 and SLS
Figure 7 FTIR Spectrum of Piroxicam, PEG 6000 and SLS Mixture

Table 8 Interpretation of FTIR Spectrum of Piroxicam, PEG 6000 and SLS Mixture
Reference Peak Reported Peak
Sr.no. Functional Group
Wavenumber(cm-1) Wavenumber(cm-1)
1 773.45 771.55 Ortho-di substituted ring
2 1149.57 1149.61 SO2-NH group
3 1300.02 1342.50 Pyridine ring
4 1435.04 1465.09 Methyl group
5 1525.69 1527.67 Tertiary amine group
6 1629.85 1627.97 Amide carbonyl
7 3338.78 3340.82 Cubic polymorphic form
In spectrum of pure drug and polymer is showed in figure 4 - 7. In above IR spectra the peak of drug and
polymer are showed in Table 5 - 8. All these peaks have appeared in physical mixture indicating no chemical
interaction between Piroxicam and polymer.

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The formulation of solid dispersion prepared by both methods i.e., Conventional Fusion Method and Microwave
induced Fusion method in various ratios such as Piroxicam and PEG with and without SLS (1:1, 1:1:0.75, 1:2,
1:2:0.75, 1:3, 1:3:0.75 1:4, 1:4:0.75) Solid dispersion prepared by conventional Fusion Method were F1, F2, F3,
F4, F5, F6, F7, F8 and solid dispersion prepared by microwave Induced Fusion Method F9, F10, F11, F12, F13,
F14, F15 and F16 respectively.
Solubility study of various solid dispersion trial batches was performed. Solid dispersion prepared by microwave
induced fusion method improved solubility of Piroxicam as compared to pure drug and solid dispersion prepared
by conventional fusion method. The batch F16 was more soluble than pure drug and other formulation batches.
Table 9 Solubility Study of Solid Dispersion
Formulations Drug: Carrier Solubility (µg/ml)
Pure drug Pure drug 2.285
F1 Piroxicam + PEG 6000 (1:1) 9.428
F2 Piroxicam + PEG 6000 (1:1:0.75) 20.85
F3 Piroxicam + PEG6000 (1:2) 17.28
F4 Piroxicam + PEG 6000 + SLS (1:2:0.75) 29.42
F5 Piroxicam + PEG6000 (1:3) 25.14
F6 Piroxicam + PEG 6000 + SLS (1:3:0.75) 40.14
F7 Piroxicam + PEG 6000 (1:4) 34.42
F8 Piroxicam + PEG 6000 (1:4:0.75) 51.57
F9 Piroxicam + PEG 6000 (1:1) 13.714
F10 Piroxicam + PEG 6000 (1:1:0.75) 28.71
F11 Piroxicam + PEG6000 (1:2) 24.42
F12 Piroxicam + PEG 6000 + SLS (1:2:0.75) 37.28
F13 Piroxicam + PEG6000 (1:3) 31.57
F14 Piroxicam + PEG 6000 + SLS (1:3:0.75) 47.91
F15 Piroxicam + PEG 6000 (1:4) 42.28
F16 Piroxicam + PEG 6000 + SLS (1:4:0.75) 63.71
Out of eight formulations F8 shown maximum drug release i.e., 85.47±0.19%. Solid dispersion (F8) of
Piroxicam, PEG 6000 with and without SLS prepared by conventional fusion method significantly improved its
solubility and dissolution rate.
Table 10 Dissolution profile of solid dispersions prepared by conventional fusion Method
Time Cumulative % Drug Release
(min) F1 F2 F3 F4 F5 F6 F7 F8
0 00 00 00 00 00 00 00 00
11.35 ± 19.94 ± 18.24 ± 32.89 ± 26.45 ± 39.63 ± 31.39 ± 42.48 ±
5
0.81 1.22 0.73 1.21 1.14 1.24 1.19 0.93
22.06 ± 33.57 ± 31.89 ± 43.52 ± 36.44 ± 50.23 ± 40.35 ± 54.77 ±
10
0.63 1.13 0.62 0.64 0.93 1.15 0.75 0.64
30.63 ± 41.21 ± 39.23 ± 50.36 ± 43.83 ± 58.92 ± 51.46 ± 63.54 ±
15
0.44 0.96 0.26 0.49 0.52 1.29 0.82 1.04
39.09 ± 51.60 ± 48.73 ± 59.41 ± 55.54 ± 65.46 ± 59.46 ± 70.19 ±
20
0.36 0.56 0.84 0.52 0.63 1.65 0.95 1.14
47.26 ± 57.21 ± 54.19 ± 65.12 ± 62.16 ± 71.46 ± 67.28 ± 76.56 ±
25
0.59 0.66 0.63 0.47 0.67 1.33 0.61 0.85
53.11 ± 64.57 ± 61.23 ± 71.45 ± 67.64 ± 77.63 ± 72.69 ± 81.26 ±
30
1.09 0.75 0.34 0.71 0.83 0.23 0.91 0.98
59.22 ± 70.89 ± 68.47 ± 76.32 ± 72.88 ± 82.12 ± 78.29 ± 85.47 ±
40
0.26 0.64 1.05 0.33 1.34 0.44 1.13 0.79
*Result are mean of three determinations

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Figure 8 Dissolution Profile of Solid Dispersions Prepared by Conventional Fusion Method

*Result are mean of three determinations

Out of eight formulations F16 showed maximum drug release i.e., 96.24±0.04 %. Solid dispersion (F16) of
Piroxicam with polymer PEG 6000 and surfactant SLS prepared by microwave induced fusion method
significantly improved its solubility and its dissolution rate.
Table 11 Dissolution profile of solid dispersion prepared by microwave induced fusion method.
Time Cumulative % Drug Release
(min) F9 F10 F11 F12 F13 F14 F15 F16
0 00 00 00 00 00 00 00 00
16.28 ± 23.14 ± 22.17 ± 34.17 ± 30.11 ± 46.05 ± 37.03 ± 54.33 ±
5
0.66 1.12 0.69 0.80 0.62 1.44 0.96 0.82
26.99 ± 37.40 ± 34.30 ± 46.61 ± 41.86 ± 56.44 ± 48.36 ± 63.12 ±
10
0.63 0.80 0.46 0.72 1.23 0.41 0.77 0.64
34.36 ± 48.39 ± 42.78 ± 55.96 ± 52.63 ± 65.97 ± 57.21 ± 72.55 ±
15
0.52 0.46 1.13 0.64 0.73 1.07 1.25 0.44
43.87 ± 56.89 ± 49.53 ± 63.41 ± 60.63 ± 73.19 ± 66.59 ± 79.88 ±
20
1.14 1.06 1.21 0.75 1.14 1.06 1.27 0.95
52.69 ± 63.59 ± 57.01 ± 70.55 ± 68.74 ± 78.51 ± 73.42 ± 84.57 ±
25
0.61 1.11 1.04 0.61 0.44 1.15 0.60 1.02
61.47 ± 71.23 ± 66.79 ± 78.60 ± 73.99 ± 83.48 ± 79.34 ± 89.11 ±
30
1.32 0.63 1.17 1.33 0.92 1.26 1.35 1.28
68.77 ± 76.09 ± 74.56 ± 81.20 ± 79.24 ± 87.96 ± 84.44 ± 96.24 ±
40
0.94 1.21 0.94 0.92 0.83 0.72 1.29 0.84
*Result are mean of three determinations
Figure 9 Dissolution Profile of Solid Dispersions Prepared by Microwave Induced Fusion Method

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Table 12 Percent drug release of Piroxicam and solid dispersion by conventional fusion method (F8)
and microwave induced fusion method (F16)
Time Cumulative % Drug Release
(Min) Pure Drug F8 F16
0 0.00 00 00
5 06.21 ± 0.34 42.48 ± 0.93 54.33 ± 0.82
10 08.91 ± 0.52 54.77 ± 0.64 63.12 ± 0.64
15 11.75 ± 0.63 63.54 ± 1.04 72.55 ± 0.44
20 13.38 ± 0.92 70.19 ± 1.14 79.88 ± 0.95
25 15.92 ± 0.45 76.56 ± 0.85 84.57 ± 1.02
30 17.51 ± 0.61 81.26 ± 0.98 89.11 ± 1.28
40 18.95 ± 0.95 85.47 ± 0.79 96.24 ± 0.84
*Result are mean of three determination
Figure 10 Comparative Dissolution Profile of Piroxicam, F8 and F16

It was concluded that the F16 formulation gives highest drug release i.e. 96.24% in 40 min, in Phosphate Buffer
pH 6.8 whereas the F8 formulation and pure drug was found to be 81.26% and 18.95% drug release in Phosphate
Buffer pH 6.8 in 40 min. In that comparative study microwave induced solid dispersion exhibit significant
improvement in solubility and dissolution rate compared to that of pure drug.
Selection of Optimum Batch of Solid Dispersion for formulation of Fast Disintegrating Tablet
From solubility and dissolution studies all batches of microwave induced fusion method shows improved drug
solubility and dissolution rate than conventional fusion method, Hence F16 formulation of microwave induced
fusion method is selected for further formulation of fast disintegrating tablet.as shown in table no 10, 11, 12.
All batches of Piroxicam solid dispersion are off white colored and amorphous powder in nature. It is further
confirmed by x ray diffraction studies.
Different trial batches of solid dispersion show % practical yield from range 86.79 to 97.63%. Batch F16
Showed 97.63 % practical yield.
Table 13 Percentage Practical Yield of Solid Dispersion
Formulation Ratio Initial weight (mg) Final Weight (mg) % Practical Yield
F1 1:1 2000 1.899 94.96
F2 1:1:0.75 2.750 2.6367 95.88
F3 1:2 3000 2.883 96.11
F4 1:2:0.75 3.750 3.517 93.80
F5 1:3 5000 4.722 94.44

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F6 1:3:0.75 4.750 4.745 95.31
F7 1:4 5000 4.804 96.09
F8 1:4:0.75 5.750 5.543 96.40
F9 1:1 2000 1.952 97.63
F10 1:1:0.75 2.750 2.697 98.09
F11 1:2 3000 2.896 96.56
F12 1:2:0.75 3.750 3.646 97.23
F13 1:3 4000 3.873 96.83
F14 1:3:0.75 4.750 4.689 97.89
F15 1:4 5000 4.868 97.36
F16 1:4:0.75 5.750 5.529 98.16
(Drug is taken in 1000 mg)
The drug Content of Solid Dispersion of Piroxicam optimized formulation F16 Piroxicam + PEG 6000 + SLS
(1:4:0.75) was found to be 97.00 % indicating good content in solid dispersion.
In spectrum of pure drug and microwave induced solid dispersion is showed in figure 4 and 11 In above IR
spectra the peak of drug and polymer are showed in Table 5 - 8. All these peaks have appeared in formulation
and physical mixture indicating no chemical interaction between Piroxicam and polymer.
Figure 11 FTIR Studies of Microwave Induced Fusion Solid Dispersion

Table 14 Interpretation of FTIR Spectrum of Microwave Induced Fusion Method

Reference Peak Reported Peak
Sr.no. Functional Group
Wavenumber(cm-1) Wavenumber(cm-1)
1 773.45 771.55 Ortho-di substituted ring
2 1149.57 1149.61 SO2-NH group
3 1300.02 1303.92 Pyridine ring
4 1435.04 1435.09 Methyl group
5 1525.69 1527.67 Tertiary amine group
6 1629.85 1627.97 Amide carbonyl
7 3338.78 3340.82 Cubic polymorphic form
The DSC of Piroxicam shown in Figure 12 Piroxicam showed a characteristic sharp endothermic peak at
203.33°C which is near to its standard reported melting point. From this it is confirms that given drug sample is
of Piroxicam is in pure form.

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Figure 12 DSC Studies of Piroxicam

The DSC curve of pure piroxicam exhibited a single endothermic response corresponding to the melting of drug.
Onset of melting was observed at 203.33°C, where as pure PEG 6000 showed a melting endotherm at 55.22°C.
Thermograms of SDs showed the absence of a piroxicam peak, suggesting that piroxicam is completely soluble
in the liquid phase of polymer or absence of crystalline nature of piroxicam. However, the melting peak of PEG
6000 in SDs was observed at slightly lower temperature (52-57°C) than that of pure PEG 6000. The Formulation
of piroxicam, SLS and PEG 6000 also showed no endothermic peak of piroxicam. It is speculated that piroxicam
dissolved in PEG 6000 during the DSC measurement, only one endothermic peak at 55.22°C corresponding to
PEG 6000 was observed. The crystalline piroxicam is converted to its amorphous form which is confirmed by
DSC and further by XRD study. (Fig.15
Figure 13 DSC Studies of Microwave Induced Fusion Solid Dispersion

X-ray diffraction of piroxicam displayed five major peaks shows at diffraction angles (2Ø0) 14.46°, 17.65°,
19.690, 26.68° and 27.32° were observed with intense peak at 17.650 and 27.320indicating the crystalline nature
of Piroxicam. (Fig-14)

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Figure 14 XRD Studies of Piroxicam

The absence of sharp peaks in the solid dispersion indicates the crystalline nature of Piroxicam is converted into
amorphous nature absence of a piroxicam peak, suggesting that Piroxicam is completely soluble in the liquid
phase of polymer or absence of crystalline nature of Piroxicam. It is confirmed that piroxicam is solubilized or
fused with polymer and also confirms the amorphous nature of Piroxicam. (Fig.14)
Figure 15 XRD Studies of Microwave Induced Fusion Solid Dispersion

EVALUATION OF POWDER BLEND FOR FAST DISINTEGRATING TABLETS

The characterization of mixed blend was done for determination of mass-volume relationship parameter. The
evaluated parameter angle of repose, bulk density, tapped density, hausner’s ratio and compressibility index was
reported in Table 15.

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Table 15 Evaluation of powder blend for fast disintegrating tablets
Angle of Bulk Density Tapped Density Hausner’s Carr’s Compressibility
Formulations
repose (Ɵ) (gm/cm3) (gm/cm3) Ratio (HR) index (%)
F1 25.58 ± 0.63 0.44 ± 0.010 0.51 ± 0.043 1.15 ± 0.42 13.72 ± 0.20
F2 27.67 ± 0.65 0.47 ± 0.019 0.53 ± 0.029 1.12 ± 0.32 11.32 ± 0.39
F3 25.53 ± 0.49 0.45 ± 0.023 0.51 ± 0.016 1.13 ± 0.38 13.72 ± 0.45
F4 26.42 ± 0.45 0.44 ± 0.029 0.52 ± 0.014 1.16 ± 0.20 15.38 ± 0.42
F5 25.78 ± 0.23 0.46 ± 0.078 0.53 ± 0.031 1.15 ± 0.16 15.21 ± 0.36
F6 28.04 ± 0.57 0.44 ± 0.096 0.52 ± 0.039 1.18 ± 0.22 13.20 ± 0.16
F7 26.65 ± 0.13 0.47 ± 0.056 0.54 ± 0.010 1.14 ± 0.71 12.96 ± 0.47
F8 27.66 ± 0.49 0.44 ± 0.063 0.51 ± 0.021 1.15 ± 0.38 13.72 ± 0.67
F9 25.79 ± 0.39 0.46 ± 0.076 0.52 ± 0.026 1.13 ± 0.28 11.53 ± 0.41
* Result are mean of three dimensions
MANUFACTURING OF FAST DISINTEGRATING TABLET OF PIROXICAM CONTAINING SOLID
DISPERSION BY DIRECT COMPRESSION METHOD
EVALUATION OF FAST DISINTEGRATING TABLETS
All the formulations were subjected for weight variation, thickness, hardness, friability, drug content, in vitro
disintegration time, wetting time, water absorption ratio, in vitro dissolution studies were carried out. All the
formulations were passed the parameter which was reported in Table 16
Table 16 Evaluation of Fast Disintegrating Tablets
Thickne Drug Weight Disintegr Wettin % Water
Hardness Friability
Formulations ss Content variations ation g time absorptio
(Kg/cm2) (%)
(mm) (%) (mg) time (sec) (sec) n ratio
4.39 ± 3.26 ± 0.72 ± 95.85 ± 24 ± 81.26 ±
F1 300 ± 1.51 59 ± 0.3
0.02 0.31 0.25 0.89 0.57 1.08
4.44 ± 3.36 ± 0.81 ± 96.21 ± 20 ± 90.28 ±
F2 302 ± 1.02 48 ± 0.5
0.03 0.55 0.34 0.44 0.41 0.69
4.30 ± 3.24 ± 0.69± 96.25 ± 17 ± 114.40 ±
F3 300 ± 0.93 37 ± 0.6
0.03 0.44 0.33 0.56 0.33 1.015
4.32± 3.36 ± 0.63± 95.89 ± 49 ± 78.45 ±
F4 298 ± 1.15 42 ± 0.3
0.01 0.86 0.18 0.96 0.56 0.96
4.36 ± 3.33 ± 0.79± 96.50 ± 43 ± 84.34 ±
F5 303 ± 0.89 34 ± 0.2
0.05 0.45 0.22 0.11 0.41 0.61
4.49 ± 3.22 ± 0.72± 96.83 ± 38 ± 93.12 ±
F6 299 ± 0.96 26 ± 0.4
0.1 0.92 0.31 0.63 0.22 1.55
4.38 ± 3.30 ± 0.62± 96.40 ± 22 ± 84.24 ±
F7 301 ± 0.65 23 ± 0.2
0.05 0.59 0.42 0.56 0.47 093
4.41 ± 3.39 ± 0.50± 96.15 ± 18 ± 96.66 ±
F8 300 ± 0.96 16 ± 0.5
0.05 0.43 0.26 0.23 0.42 0.85
4.40 ± 3.25 ± 0.71 ± 97.00 ± 13 ± 119.80 ±
F9 300 ± 0.49 10 ± 0.6
0.03 0.71 0.29 0.11 0.52 0.76
*Results are mean of three determinations.
In vitro % Drug Release of Drug from Tablet
All the nine formulations were subjected for the in vitro dissolution studies using tablet dissolution apparatus
(USP). Phosphate Buffer pH 6.8 was used as dissolution medium. The sample were withdrawn at different time
intervals, Filter and analyzed at 354nm. Cumulative % drug release was calculated on the basis of mean amount
of Piroxicam present in respective table. The result obtained in the in vitro drug release for all formulations F1 to
F9 are tabulated in Table 17 The plots are presented in figure no 10.17. The superdisintrgrants such as
crospovidone (2%, 3.5% and 5%), SSG (2%, 3.5% and 5%), and CCS (2%, 3.5% and 5%), were used in
different proportions.

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Table 17 In vitro Cumulative % Drug Release from Tablets
Time Cumulative % Drug Release
(min) F1 F2 F3 F4 F5 F6 F7 F8 F9
0 00 00 00 00 00 00 00 00 00
25.24 ± 28.74 ± 31.12 35.02 ± 38.42 ± 41.23 ± 43.76 ± 48.12 ± 52.36 ±
5
0.76 1.21 ±0.71 1.12 0.94 0.76 0.79 0.7 4 0.81
39.26 ± 43.92 ± 48.22 ± 49.78 ± 53.75 ± 58.63 ± 58.49 ± 62.26 ± 66.22 ±
10
0.65 1.02 0.66 0.64 0.65 0.69 0.65 0.89 0.36
48.25± 52.47 ± 57.02 ± 61.36 ± 64.81 ± 67.84 ± 68.45 ± 72.55 ± 75.98 ±
15
0.91 0.66 0.86 0.96 0.89 0.81 0.66 0.65 0.85
53.66 ± 58.81 ± 63.44 ± 67.47 ± 70.48 ± 73.45 ± 75.18 ± 79.01 ± 82.61 ±
20
0.63 0.42 0.94 0.41 0.65 0.99 0.71 0.62 0.92
58.44± 62.47± 68.55 ± 71.42 ± 75.64 ± 78.64 ± 79.22 ± 83.47 ± 87.06 ±
25
0.59 0.97 1.27 1.18 0.64 1.02 0.69 0.93 0.69
61.56 ± 66.56 ± 71.85 ± 75.64 ± 77.63 ± 81.24 ± 83.03 ± 86.17 ± 91.02 ±
30
0.48 0.62 1.26 0.69 0.92 1.5 0.46 0.73 0.72
68.77± 71.73 ± 73.25 ± 77.32 ± 80.12 ± 83.63 86.34 ± 90.11 ± 93.20 ±
40
0.74 1.31 1.10 0.89 1.22 ±1.23 0.91 0.49 0.61
*Results are mean of three dimensions
The rapid dissolution was observed in formulation F9 releases 93.20% ± 0.61 at the end of 40 minutes. Rapid
dissolution might be due to fast breakdown of particles and rapid absorption of drugs. The drug release was
completely achieved in shorter duration of time. In all the formulations the drug release within 40 minutes. High
dissolution may occur due to faster breakdown.
Figure 16 Cumulative % drug release of F1-F9 formulations

In comparative study F9 formulation gives higher percent drug release compare to other remaining eight
formulations at the end of 40 minutes and graphical representation is shown in Figure 16 Therefore, it was
concluded that the best optimized batch was found to be F9 because of lesser disintegration time and highest
percentage drug release at the end of 40 min among all the formulations. Because it containing crosspovidone
superdisintegrant with fast wetting time and highest swelling property.
STABILITY STUDY
The Fast disintegrating tablet of solid dispersion of Piroxicam, F9 batch were subjected to stability study at
temperature 40°C ± and relative humidity 75% ± for three months. After each month tablet were analyzed for
hardness, friability, disintegration time, dissolution time and drug content. The results are as follows.

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Table 18 Stability Study of Fast Disintegrating Tablets of Optimized Formulation
F9 at 400C ± 20C /75 % RH ± 5%
Parameters After 1 After 2 After 3
Formulation Initial
Evaluated Month Month Month
Hardness (Kg/Cm2) 3.25 ± 0.71 3.23 ± 0.89 3.18 ± 0.68 3.12 ± 0.41
Friability (%) 0.71± 0.29 0.71 ± 0.79 0.83 ± 0.25 0.69 ± 0.89
F9 Disintegration Time (sec) 10 ± 0.6 10 ± 0.4 11 ± 0.5 11 ± 0.3
Content Uniformity (%) 97.00 ± 0.11 97.00 ± 0.30 96.36 ± 0.23 96.22 ± 0.75
Cumulative % Drug Release 93.20 ± 0.61 93.14 ± 0.39 92.42 ± 0.36 92.11 ± 0.56
*Results are the mean of three determinations
From the results of Table 18 it is concluded that, the fast disintegrating tablets of solid dispersion of Piroxicam
from tablet F9 batch are physically stable and retained their original properties when stored at temperature 400C
± 20C, 75 % RH ± 5% and after three months there was no significant difference in disintegration time,
cumulative % drug release, hardness, friability and drug content.
Conclusion Acknowledgements
Overall, the results concluded that suitable formulated The authors express their sincere thanks to Aarti
solid dispersion F9 of Piroxicam with polymer pharma (Mumbai, India) for providing drug sample
Polyethylene glycol 6000 and surfactant as sodium and Research lab Fine chem. Industry, (Mumbai,
lauryl sulphate prepared by microwave induced India) for providing polymers. The authors also
fusion method in the ratio (1:4:0.75), improved its acknowledge P.D.E.A’s Shankarrao Ursal College of
solubility and dissolution rate. Alteration of surface Pharmaceutical Sciences and Research Center,
property of drug particles may be responsible for Kharadi for providing facilities to carry out the
enhanced dissolution rate of Piroxicam from solid research work
dispersion compared to pure Piroxicam. It was
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