formulation and evaluation of lornoxicam microsponge tablets ... - IJPI

INTERNATIONAL JOURNAL OF 

RESEARCH ARTICLE 

PHARMACEUTICAL INNOVATIONS ISSN 2249-1031 

FORMULATION AND EVALUATION OF LORNOXICAM MICROSPONGE 

TABLETS FOR THE TREATMENT OF ARTHRITIS 

*Karthika.R , Elango.K , Ramesh Kumar.K , Rahul.K 

Department of Pharmaceutics, College of Pharmacy, Madras Medical College, Chennai, India 

Abstract 

The purpose of this study was to design novel drug delivery system containing Lornoxicam 

microsponges. Lornoxicam is a Non-steroidal anti-inflammatory drug used for the treatment 

of various inflammatory diseases. Microsponges containing Lornoxicam and Eudragit RS 

100 were prepared by quasi emulsion solvent diffusion method. The effects of drug to 

polymer ratios on physical characteristics of the microsponges were investigated. 

Compatibility of drug with adjuncts was studied by FT-IR. Production yield, loading 

efficiency, particle size analysis, surface morphology and in-vitro release studies were carried 

out. The microsponges were compressed into tablets. Mechanically strong tablets were 

obtained owing to the plastic deformation of sponge-like structure of microsponges. The 

effects of different stirring rates, amount of solvent, amount of emulsifier used on the 

physical characteristics of the microsponges were investigated. All the factors studied had an 

influence on the physical characteristics of the microsponges. In-vitro dissolution studies 

were done on all formulations and the results were kinetically evaluated and the release rate 

of Lornoxicam was found to be modified. This study presents a new approach based on 

microsponge drug delivery system. 

Keywords: Microsponges, Lornoxicam, Quasi-emulsion solvent diffusion method, 

Morphology, Release kinetics 

INTRODUCTION 

Many of conventional delivery systems 

require high concentrations of active 

agents to be incorporated for effective 

therapy because of their low efficiency as 

delivery systems. Thus novel drug delivery 

systems have been increasingly 

investigated to achieve targeted and 

controlled release of drugs. Microsponges 

are highly crosslinked, patented, porous, 

polymeric microspheres that acquire the 

flexibility to entrap a wide variety of 

active ingredients that are mostly used for 

Volume 3, Issue 2, March − April 2013 

prolonged topical administration and 

recently for oral administration. 

Microsponges are designed to deliver a 

pharmaceutically active ingredient 

efficiently at minimum dose and also to 

enhance stability, elegance, flexibility in 

formulation, reduce side effects and 

[1, 2] 

modify drug release profiles. 

Microsponges are prepared by several 

*Corresponding author 

Karthika.R 

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methods utilizing emulsion systems as 

well as by suspension polymerization in a 

liquid-liquid system. The most common 

emulsion system used is Quasi-emulsion 

solvent diffusion method. [2] 

Lornoxicam, a congener of tenoxicam, is 

a new NSAID belonging to the oxicam 

class. It is a strong analgesic and antiinflammatory 

NSAID as compared to 

other NSAIDs. Chemically its 6-chloro- 

4-hydroxy-2-methyl-N-2-pyridyl-2Hthieno-[2, 

3-e]-1, 2-Thiazine-3- 

carboxamide-1,1-dioxide. Like all 

NSAIDs, it acts by inhibiting the 

metabolites of COX branch of 

arachidonic acid pathway. Half-life of 

Lornoxicam is 3-5 hours, which increases 

the dosing frequency of the drug. The 

increased dosing frequency leads to side 

effects. Thus the present study is aimed at 

developing microsponge based novel 

drug delivery system containing 

Lornoxicam. The microsponges of 

Lornoxicam were prepared and 

characterized. They were formulated as 

tablets and subjected to in-vitro 

characterization for various attributes. [3] 

MATERIAL AND METHODS 

Lornoxicam was obtained as a gift 

sample from Glenmark Pharmaceuticals 

Ltd., Eudragit RS 100 was obtained from 

MMC Healthcare, Chennai, Polyvinyl 

alcohol was procured from S.D Fine- 

Chem Limited, Mumbai, Triethyl citrate 

was purchased from Himedia laboratories 

Pvt.Ltd, Ethanol was from 

ChangshuYangyuan Chemical, China, 

Magnesium stearate from Indian 

Research Products, Chennai, Micro 

crystalline cellulose from Kniss 


Laboratories, Chennai, Talc from S.S 

Chemicals, Chennai, Lactose from 

Microfine Chemicals, India. All other 

chemicals and solvents were of analytical 

reagent grade. 

Preparation of Lornoxicam 

microsponges 

Lornoxicam microsponges were prepared 

by quasi emulsion solvent diffusion 

method. The internal phase consisted of 

Eudragit RS 100 (100mg) and triethyl 

citrate dissolved in 5ml ethanol. Triethyl 

citrate was used as plasticizer. This was, 

followed by addition of drug with gradual 

stirring. The internal phase was then 

poured into polyvinyl alcohol (0.5%w/v) 

solution in water, the external phase. 

After 2 hours of stirring the microsponges 

were formed due to the removal of 

ethanol from the system. The 

microsponges were filtered and dried at 

40˚C for 24 hours. The composition of 

microsponge formulations are given in 

table1. 

Fourier transform infrared analysis 

Infrared spectroscopy was conducted 

using FT-IR spectrophotometer and the 

spectrum was recorded in the wavelength 

region of 4000 to 400 cm -1 . The 

procedure consisted of dispersing the 

sample (drug alone, mixture of drug and 

excipients and the optimized formulation) 

in KBr and compressed into discs by 

applying a pressure of 5 tons for 5 

minutes in a hydraulic press. The pellet 

was placed in the light path and the 

spectrum was recorded. [4] 

Surface morphology of microsponges 

The surface morphology of the prepared 

microsponges was examined using a 

scanning electron microscope, operating at 

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20 kV. Dried microsponges were coated 

with gold–palladium alloy for 45sec under 

an argon atmosphere before observation. 

SEM photograph was recorded at different 

magnifications using Tescan VEGA3SBU 

SEM analyzer. [5] 

Determination of percentage yield [5] 

The production yield of the microsponges 

was determined by calculating accurately 

the initial weight of the raw materials and 

the weight of the microsponge obtained, 

W Pr 

Production yield = × 100 

W Th 

Where- 

W Pr = Practical mass of microsponges 

W Th = Theoretical mass (polymer + drug) 

Determination of loading efficiency [5] 

Lornoxicam microsponges equivalent to 

50 mg of the drug was taken in a 100 ml 

standard flask. 25 ml ethanol and 25ml of 

6.8 pH phosphate buffer were added and 

shaken for about half an hour and the 

volume was made upto 100 ml with 6.8 pH 

phosphate buffer. 2 ml of the solution was 

taken and diluted to 100 ml with 6.8 pH 

phosphate buffer. The absorbance of the 

resulting solution was measured at 376 nm 

and the content of LOX was calculated. 

The loading efficiency (%) of the 

microsponges was calculated. 

DC act 

Loading efficiency = × 100 

DC Theo. 

DC act. = Actual drug content in 


DC Theo. = Theoretical drug content 


Particle size analysis 

Particle size and size distribution of 

microsponge particles was determined 

using optical microscope. The values are 

given for the formulations in the form of 

mean particle size. 

Micromeritic properties 

The drug and blend of drug with excipients 

were evaluated for bulk density, tapped 

density, compressibility index, Hausner’s 

[6, 7] 

ratio and angle of repose. 

Preparation of tablet formulations 

After the preparation of lornoxicam 

microsponges, they were formulated as 

tablets by “Direct compression method”. 

All the ingredients were weighed 

accurately and mixed thoroughly. The 

lubricated blend was then compressed 

using 8 mm flat face punch. The 

composition of different formulations used 

in the study is shown in Table 2. 

Evaluation of Lornoxicam microsponge 

tablets 

The tablets of lornoxicam were evaluated 

for uniformity of weight. Thickness and 

diameter were measured by vernier 

calipers. Hardness was determined using 

Monsanto hardness tester and friability of 

tablets was determined by Roche 

friabilator. [7] 

Disintegration test 

One tablet was placed in each of the six 

tubes of basket, the assembly was 

suspended in water, maintained at 

temperature 37˚C±2˚C and the apparatus 

was operated. The time taken to 

disintegrate the tablet completely was 

noted. [7] 

Drug content 

Ten tablets were weighed and ground. The 

weight equivalent to 8 mg of drug was 

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taken and transferred to a 100 ml standard 

flask. 25 ml of ethanol and 25 ml of 6.8 

pH phosphate buffer were added and 

shaken for about half an hour and the 

volume was made up to 100 ml with 6.8 

pH phosphate buffer. The above solution 

was filtered and 5 ml of filtrate was taken 

and diluted to 100 ml with 6.8 pH 

phosphate buffer. The absorbance of the 

resulting solution was measured at 376 nm 

and the content of Lornoxicam was 

[7, 8] 

calculated. 

Uniformity of content 

Six tablets were randomly selected and 

tested for their drug content. The content 

of active ingredients of various 

formulations was calculated by measuring 

the absorbance of diluted solutions using 

UV-Visible Spectrophotometer at 376 nm. 

[7] 

In-vitro drug release studies 

Two step dissolution conditions was used 

in USP Type II (paddle) dissolution 

apparatus to simulate the physiological 

conditions of GIT – 2 hours in 900 ml of 

simulated gastric fluid (SGF, pH 1.2) and 

10 hours in 900 ml of simulated intestinal 

fluid (SIF, pH 6.8). The stirring rate was 

100 rpm and the temperature was 

maintained at 37 ± 0.5˚C. Aliquots of 

dissolution medium were withdrawn at 

predetermined time intervals and the same 

volume of medium was replenished to 

maintain the constant volume. The 

absorbance of the solutions was measured 

at 376 nm and the release was calculated. 

[8] 

Drug release kinetics 

The dissolution profile of optimized 

formulation was subjected to various 

models such as Zero order kinetics 


(percentage drug release against time), 

First order kinetics (log percentage drug 

unreleased against time), Higuchi 

(percentage drug released against square 

root of time), Korsemeyer-Peppas (log 

percent drug released against log of time) 

and Hixson-Crowell (cube root of 

cumulative percentage of drug remaining 

against time) to assess the kinetics of drug 

release from prepared Lornoxicam 

microsponges. 

RESULTS AND DISCUSSION 

Compatibility studies 

FT-IR spectra were recorded to assess the 

compatibility of the drug and excipients. 

FT-IR spectra of drug, physical mixture of 

drug and excipients were examined. In FT- 

IR spectra of Lornoxicam powder, 

characteristic O-H stretching band at 

3448.47 cm -1 , C-Cl stretching band at 

794.61 cm -1 , SO 2 streching band at 

1427.22 cm -1 and aromatic C=S stretching 

band at 1188.06 cm -1 were seen. These are 

the major peaks of the spectra of the drug. 

All these peaks were present in the spectra 

of formulation and thus confirm that the 

drug did not interact with the excipients. 

Evaluation of microsponge 

Particle size and shape 

The SEM photographs of the 

microsponges are shown in figure 4. 

Particle size analysis showed the particle 

size ranging from 75.6 to 45.5 µm and 

spherical in shape. Mean particle size of 

formulations M1 to M5 is given in table 4. 

Production yield and loading efficiency 

Production yield and loading efficiency of 

Lornoxicam microsponge formulation are 

given in table 4. Batch M1 to M5 shows 

production yield in the range of 69.35 to 

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89.65 % and loading efficiency in the 

range of 89.25 to 96.39 % as shown in 

table 4. 

Evaluation of tablets 

Micromeritic properties 

The Lornoxicam microsponge blends were 

free flowing as indicated by the values of 

bulk density (0.479 to 0.510 g/ml), tapped 

density (0.534 to 0.585 g/ml), 

compressibility index (10.29 to 12.82%) 

and Hausner’s ratio (1.11 to 1.14). Angle 

of repose ranged from 29.11 to 31.16. The 

values are given in Table 3. 

Physical evaluation and Drug content 

The Lornoxicam microsponge tablets were 

uniform in weight (0.178 to 0.181g). The 

thickness (2.5 mm) and diameter (8.00 

mm) of the tablets were uniform. The 

hardness of tablets was found to be 

between 4.25 and 4.75 kg/cm2, while the 

friability of the tablets ranged between 

0.44 and 0.6 %. The tablets have enough 

hardness to withstand stress during 

transport and handling. The disintegrating 

time of the various formulations were 

found to be between 2.12 and 3.0 min. 

Disintegrating time was found to be within 

the limits as the maximum time for 

uncoated tablets is 30 min. The drug 

content in various formulations varied 

between 91.22 and 100.6% w/w. (Table 5) 

[8] 

Uniformity of Drug content 

The percentage of drug content of all the 

formulations ranged from 96.85 and 100.7 

% w/w. All the formulations comply with 

the test for uniformity of content. 

In-vitro drug release 

The release profiles obtained for the 

microsponge tablets are presented in figure 


1. The profiles showed a bi-phasic release 

with an initial burst effect. In the first 2 

hrs, about 13 to 27% of the drug was 

released. Cumulative release for the 

microsponges after 12 hrs ranged from 86- 

96%. Drug release from the formulations 

decreased with increase in the amount of 

polymer in the microsponges. [9] 

Release Kinetics of the Optimized 

formulation 

The R 2 values for various release models 

are 0.919 for Zero order, 0.994 for First 

order, 0.966 for Higuchi, 0.948 for 

Korsemeyer-Peppas and 0.991 for Hixson- 

Crowell kinetics. The drug release follows 

first order kinetics and the mechanism 

followed is Hixson-Crowell. 

Effect of stirring rate on microsponges 

The effect of stirring rate on the size of 

microsponges was studied. As the stirring 

speed was increased, microsponges of 

smaller size were obtained. When the rate 

of stirring was increased from 200 to 400 

rpm, the mean particle size decreased from 

59.67 µm to 35.81µm. It was also 

observed that at higher stirring rates 

employed, turbulence was created within 

the external phase, polymer then adhered 

to the stirrer and the production yield 

decreased, but the drug content increased, 

as shown in table 6. [9] 

Effect of volume of internal phase on 


It was observed that on increasing the 

volume of internal phase from 5 to 15 ml 

microsponges were not formed. This may 

be due to the decrease in viscosity of 

internal phase. It was observed that the 

particle size, production yield and drug 

content decreased on increasing internal 

phase volume. The result suggests that the 

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amount of ethanol need to be controlled 

within an appropriate range to affect not 

only the formation of quasi-emulsion 

droplets at the initial stage but also the 

solidification of drug and polymer in the 

droplets. The good microsponges were 

produced only when 5 ml of internal phase 

was used, as shown in table 7. [10] 

Effect of amount of emulsifying agent 

on microsponges 

The production yield and mean particle 

size were greatly affected by the amount of 

emulsifying agent. The increase in the 

amount of emulsifying agent resulted in 

larger microsponges. This could be due to 

the increased viscosity. The increased 

amount of emulsifying agent decreased the 

production yield and drug content but 

increased the mean particle size as shown 

in the table 8. [10] 

Conclusion 

This study presents a new approach for the 

preparation of modified microsponges with 

prolonged release characteristics. The 

prepared microsponges exhibited 

characteristics of an ideal delivery system. 

The unique compressibility of 

microsponges offers a new alternative for 

producing mechanically strong tablets. 

References 

1. Swetha A, Gopal Rao M, Venkata 

Ramana K, Niyaz Basha B, Koti 

Reddy V. Formulation and In-vitro 

evaluation of Etodolac entrapped in 

Microsponge based drug delivery 

system. International Journal of 

Pharmacy 2011; 1(2): 73-80. 

2. Markand Mehta, Amish Panchal, 

Viral H Shah, Umesh Upadhyay. 


Formulation and In-vitro 

evaluation of controlled release 

Microsponge gel for topical 

delivery of Clotrimazole. 

International Journal of Advanced 

Pharmaceutics 2012; 2(2): 93-101. 

3. Prasad Byrav D S, Medhi B, 

Prakash A, Patyar S, Wadhwa S. 

Lornoxicam : A Newer NSAID. 

IJPMR 2009; 20(1): 27-31. 

4. Afsar C Shaikh, Sayyed Nazim, 

Shaikh Siraj, Tarique Khar, Siddik 

Patel M, Mohammad Zameeruddin, 

Arshad Shaikh. Formulation and 

evaluation of sustained release 

tablets of Aceclofenac using 

hydrophilic matrix system. IJPPS 

2011; 3(2): 145-148. 

5. Sarat Chandra Prasad M, Ajay M 

B, Nagendra Babu, Prathyusha P, 

Audinarayana N, Bhaskar Reddy 

K. Microsponge Drug Delivery 

System : A Review. Journal of 

Pharmacy Research 2011; 4(5): 

1381-1384. 

6. Debajyoti Ray, Amresh K Prusty. 

Designing and In-vitro studies of 

Gastric floating tablets of Tramadol 

Hydrochloride. International 

Journal of Applied Pharmaceutics 

2010; 2(4): 12-16. 

7. Indian Pharmacopoeia (2010) : 

Ministry of Health and Family 

Welfare, Government of India, 

Controller of Publication, New 

Delhi, India. 

8. Uma Maheswari A, Elango K, 

Daisy Chellakumari, Saravanan K, 

Anglina Jeniffer Samy. 

Formulation and Evaluation of 

Controlled Porosity Osmotic 

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Tablets of Lornoxicam. IJPSR 

2012; 3(6): 1625-1631. 

9. Vikas Jain, Ranjit Singh. 

Dicyclomine loaded Eudragit based 

Microsponge with potential for 

Colonic Delivery: Preparation and 

Characterization. Tropical Journal 

of Pharmaceutical Research 2010; 

9(1): 67-72. 

10. Manoj Kumar Mishra, Mukesh 

Shikhri, Rishikesh Sharma, 

Mahesh Prasad Goojar. 

Optimization, formulation 

development and characterization 

of Eudragit RS 100 loaded 

Microsponges and subsequent 

colonic delivery. IJDDHR 2011; 

1(1): 8-13. 

Table 1: Composition of Lornoxicam microsponge containing eudragit RS 100 

Ingredient M 1 M 2 M 3 M 4 M 5 

Lornoxicam(g) 0.1 0.3 0.5 0.7 0.9 

Eudragit RS 100 (g) 0.1 0.1 0.1 0.1 0.1 

Polyvinyl Alcohol (g) 0.5 0.5 0.5 0.5 0.5 

Triethyl citrate (ml) 0.5 0.5 0.5 0.5 0.5 

Ethanol (ml) 5 5 5 5 5 

Water (ml) 200 200 200 200 200 

Table 2: Composition of Lornoxicam tablets 

Formulation 

code 

Lornoxicam 

microsponges (mg) 

Micro crystalline 

cellulose (mg) 

Magnesium 

stearate (mg) 

Talc 

(mg) 

Lactose 

(mg) 

F1 16.00 30 5.4 9 119.60 

F2 10.66 30 5.4 9 124.94 

F3 9.60 30 5.4 9 126.00 

F4 9.14 30 5.4 9 126.45 

F5 8.88 30 5.4 9 126.72 


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Table 3: Micromeritic properties of Lornoxicam and powder blend 

Drug and 

Blends 

Bulk density* 

(g/ml) 

Tapped 

density* (g/ml) 

Compressibility 

index* (%) 

Hausner’s 

ratio* 

Angle of 

repose* 

Drug 0.312±0.012 0.454±0.014 31.2±0.16 1.452±0.06 47.57˚±0.34 

MB1 0.51±0.006 0.585±0.004 12.82±0.21 1.14±0.03 30.2˚±0.19 

MB2 0.489±0.002 0.560±0.003 12.67±0.24 1.14±0.07 29.7˚±0.69 

MB3 0.479±0.003 0.534±0.006 10.29±0.28 1.11±0.05 31.16˚±0.68 

MB4 0.489±0.005 0.560±0.008 12.67±0.34 1.14±0.09 30.1˚±0.83 

MB5 0.492±0.04 0.558±0.017 11.82±0.19 1.13±0.05 29.11˚±0.20 

* Mean of three readings 

Table 4: Evaluation of Lornoxicam microsponges 

Formulation Production yield (%) Loading efficiency (%) Mean particle size (µm) 

M1 69.35 89.25 75.60 

M2 79.3 90.00 64.20 

M3 84.77 93.38 62.20 

M4 78.20 96.95 54.40 

M5 89.65 96.39 45.50 


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% DRUG RELEASE 




Table 5: Physical evaluation and drug content 

Formu 

-lation 

Uniformity 

of weight * 

Diameter 

# (mm) 

Thickness 

# (mm) 

Hardness# 

(kg/cm 2 ) 

Friability 

^ (%) 

Drug 

content # 

Uniformity 

of content ҂ 

Disintegration 

time # (min) 

(g) 

(%w/w) (%w/w) 

F1 0.179± 8±0.0 2.5±0.0 4.4±0.45 0.44± 100.6±0.02 100.69±0.52 2.12±0.06 

0.006 

0.023 3 

3 

F2 0.179± 8±0.0 2.5±0.0 4.25±0.25 0.47± 96.38±0.05 100.60±1.07 2.19±0.05 

0.005 

0.012 4 

6 

F3 0.180± 8±0.0 2.5±0.0 4.75±0.25 0.60± 91.22±0.01 96.85±0.859 2.78±0.01 

0.002 

0.025 8 

F4 0.181± 8±0.0 2.5±0.0 4.25±0.25 0.53± 93.09±0.03 100.7±0.632 2.52±0.05 

0.003 

0.019 2 

F5 0.178± 8±0.0 2.5±0.0 4.35±0.33 0.47± 95.9±0.027 99.76±0.927 3.0±0.02 

0.005 

0.015 

*mean of 20 readings. # mean of 5 readings. ^mean of 3 readings. ҂mean of 6 readings 

120 

100 

80 

60 

40 

20 

F1 

F2 

F3 

F4 

F5 

0 

0 2 4 6 8 10 12 14 

TIME IN HOURS 

Figure1: Release study of various formulations 


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Table 6: Effect of stirring rate on Lornoxicam microsponges 

Formulation Internal phase composition External 

phase 

Stirring 

rate 

Production 

yield (%) 

Drug Polymer Ethanol water PVA 

(rpm) 

(g) (g) (ml) 

(%) 

F5 0.9 0.1 5 200 0.5 200 80.07 

0.9 0.1 5 200 0.5 300 75.18 

0.9 0.1 5 200 0.5 400 73.96 

Mean 

particle 

diameter 

* (µm) 

59.67± 

3.15 

48.19± 

6.89 

35.81± 

4.56 

%Drug 

content 

* 

84.17± 

1.3 

90.02± 

2.4 

94.23± 

1.7 

* Mean of 5 readings 

Table 7: Effect of internal phase composition on Lornoxicam microsponges 


phase 

Stirring 

rate 

Production 

yield (%) 


(rpm) 

(g) (g) (ml) 

(%) 

F5 0.9 0.1 5 200 0.5 300 79.29 

0.9 0.1 10 200 0.5 300 68.34 

0.9 0.1 15 200 0.5 300 66.85 


Mean 

particle 

diameter 

* (µm) 

45.5± 

5.39 

41.99± 

6.89 

38.25± 

7.24 

%Drug 

content 

* 

93.95± 

1.6 

86.21± 

0.9 

80.05± 

0.5 


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Log Cum % Drug Remaining 




Table 8: Effect of emulsifying agent on Lornoxicam microsponges 


phase 

Stirring 

rate 

Production 

yield (%) 


(rpm) 

(g) (g) (ml) (ml) (%) 

F5 0.9 0.1 5 200 0.25 300 82.3 

0.9 0.1 5 200 0.5 300 78.69 

0.9 0.1 5 200 0.75 300 69.05 


Mean 

particle 

diameter 

* (µm) 

46.49± 

7.11 

50.17± 

6.45 

66.25± 

5.67 

%Drug 

content 

* 

92.81± 

0.8 

90.23± 

0.4 

85.87± 

0.6 

2.5 

2 

1.5 

y = -0.115x + 2.057 

R² = 0.994 

1 

0.5 

0 

0 2 4 6 8 10 12 

Time 

Figure 2: A plot of First order kinetics 


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Cube root of % drug remaining 




5 

4.5 

4 

3.5 

3 

2.5 

2 

1.5 

1 

0.5 

0 

y = -0.266x + 4.628 

R² = 0.991 

0 2 4 6 8 10 12 14 

Time in Hours 

Figure 3: A plot of Hixson-Crowell kinetics 

Figure 4: SEM image of Lornoxicam Microsponges 


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