




































Ahmed et al                                                                                                                                 Asian Journal of Dental and Health Sciences. 2022; 2(4):72-76   

[72]                                                                                                                                                                                                                  AJDHS.COM 

 

 

Available online at ajdhs.com 

Asian Journal of Dental and Health Sciences 
Open Access to Dental and Medical Research 

Copyright  © 2023 The  Author(s): This is an open-access article distributed under the terms of the CC BY-NC 4.0 
which permits unrestricted use, distribution, and reproduction in any medium for non-commercial use provided the 

original author and source are credited 
 

 

 

Physical Assessment and formulation development of Dome Matrix 
Controlled Release tablet of Diclofenac Sodium 

Sher Ahmed*, Ghulam Mustafa Shahwani, Abdul Gaffar, Muhammad Arsalan 

Faculty of Pharmacy, University of Balochistan, Quetta, Pakistan 

Article Info: 
_______________________________________ 
Article History: 
Received 11 Dec 2022      
Reviewed  26 Jan 2023 
Accepted 07 Feb 2023 
Published 25 Feb 2023 

_______________________________________ 
Cite this article as:  

Ahmed S, Shahwani GM, Gaffar A, Arsalan M, 

Physical Assessment and formulation 
development of Dome Matrix Controlled 
Release tablet of Diclofenac Sodium, Asian 
Journal of Dental and Health Sciences. 2022; 
2(4):72-76 

DOI: http://dx.doi.org/10.22270/ajdhs.v2i4.36      

_______________________________________
*Address for Correspondence:   

Sher Ahmed, Faculty of Pharmacy, University of 
Balochistan, Quetta, Pakistan 

Abstract 
___________________________________________________________________________________________________________________ 

In the last fifteen years where have significant acceleration in drug delivery research. In the early days 
of controlled release, development of pharmaceutical formulations was more idealized, with emphasis 
on the attainment of the illusive “zero-order release behavior”. When analyzing the swelling and release 
behavior of the Dome Matrix systems, it was demonstrated that the swelling behavior of the curved 
surfaces of the matrices strongly affected the drug release kinetics. The controlled release Dome matrix 
tablets containing Diclofenac sodium were prepared using a wet granulation process and polymers used 
xanthan gum, HPMC and Eudragit. Two different formulations were prepared; in first formulation the 
ratio was kept 60% active ingredient and 40% polymers subsequently in 2nd formulation 55% active 
ingredient 45% polymers. Precompression test angle of repose, Hausner’s ratio, Bulk Density, Tapped 
Density, Car’s Index were checked according to the specified standard procedure. All Physical 
Characteristics of dome tablets were analyzed. Drug release pattern was also analyzed by using USP 
apparatus II paddle method. The hardness, weight fluctuation, thickness, friability, drug content 
homogeneity, and in-vitro dissolution investigations of the manufactured controlled release tablets. All 
were examined and found within acceptable range. The F1 and F2 formulations performed well in tests 
and had a continuous drug release. The findings of this study showed that a polymer could be 
successfully used to formulate Diclofenac sodium Dome matrix tablets. The drug release was extended 
for 8 to 12 hours in all formulations using a drug to polymer ratio of 60:40, 55:45. The formulations are 
proved to have efficient drug release time. 

Keywords: Diclofenac sodium, Dome Matrix, Eudragit, Control release, Xanthan gum. 

 

INTRODUCTION 

In the last fifteen years there has been a significant 
acceleration in drug delivery research. In the early days of 
controlled release, development of pharmaceutical 
formulations was more idealized, with emphasis on the 
attainment of the illusive “zero-order release behavior”. 
Recently, research has returned to a more realistic approach 
for solution of pharmaceutical application problems. Thus, 
development of new pharmaceutical formulations is based on 
classical pharmaceutical technology (e.g., tablets, capsules, 
powders, FDA approved excipients), appropriately designed 
for the achievement of prolonged release (typically up to 24 h) 
with controlled, but not necessarily constant release rates 1.  

Formulations which might be capable of manipulate the 
discharge of drug have turn out to be a fundamental part of 
the pharmaceutical enterprise. mainly oral drug delivery has 
been the point of interest of pharmaceutical research for many 
years. This kind of drug shipping has been on the center of 
research due to its many benefits over conventional dosage. 
the focal point of this assessment is on matrix capsules 
because of their broadly use and ease of the system2. 

Modified or controlled release oral drug shipping structures 
have, over the last few a long time, been shown to offer 
advantages over conventional structures 3. those consist of 
improved patient compliance 4, selective pharmacological 
motion; decreased aspect-impact profile and decreased dosing 
frequency 5. these structures might also therefore have a 

notably useful results in healing efficacy. managed release 
offers prolonged transport of medication and upkeep of 
plasma degrees inside a healing variety6. 

Drug delivery has become an integral feature of novel 
therapeutic formulations. Drug delivery systems (DDS) allow 
the release of the necessary drug amount to the correct site 
and with the desirable kinetics. Most oral drug delivery 
systems on the market are swell able or swelling matrices, i.e., 
monolithic systems triggered by the process of water 
transport in the polymer and the associated drug transport 
outwards. Swell able matrices respond in the presence of 
water or biological fluids by changing dimensions and volume 
by water uptake, allowing the drug to diffuse out of the dosage 
form. The main component of the swell able matrix is a 
hydrophilic polymer, initially in its glassy state. When this 
matrix is in contact with the biological fluid, swelling occurs 
due to an abrupt change from a glassy to a rubbery state. The 
person polymer chains, at the start in the unperturbed 
country, soak up water so that their stop-to-give up distance 
and radius of gyration expand inside the new solvated nation. 
that is because of the decreasing of the everyday glass 
transition temperature of the polymer, determined by means 
of the swelling agent feature attention and depending on 
temperature and thermodynamic interactions of the 
polymer/solvent system 7. 

When analyzing the swelling and release behavior of the Dome 
Matrix systems, it was demonstrated that the swelling 
behavior of the curved surfaces of the matrices strongly 

                       Open Access                                                                                                                                                                                                         Research Article                                                                           

http://jddtonline.info/
http://dx.doi.org/10.22270/ajdhs.v2i4.36


Ahmed et al                                                                                                                                 Asian Journal of Dental and Health Sciences. 2022; 2(4):72-76   

[73]                                                                                                                                                                                                                  AJDHS.COM 

affected the drug release kinetics. Indeed, the drug release 
from the convex base is faster and more linear than from the 
concave base. For further microscopic and molecular analysis, 
it is desirable to measure the dynamics of swelling evolution 
and, in particular, the front movement of this curved geometry 
that cannot be examined with the optical techniques 
previously used with the flat base matrix 8. 

MATERIAL AND METHODS 

Equipment’s 

UV/VI’S spectrophotometer, Tableting machine, HPLC, 
Dissolution apparatus, Vernier caliper, Disintegration 
apparatus, Friabilator, Hardness tester, USP 26 Apparatus, 
Hydroxypropyl methylcellulose (Premium Methocel K100M), 
Ultrasound equipment, Eudragit S 100, Xanthan Gum, Mg state 
and Acetone 

Pre-formulation Studies 

Standard Diclofenac Sodium Graph 

The standard curve of Diclofenac Sodium were drawn 
according to the standard procedure by using 100 mg of 
Diclofenac sodium in 100 ml solvent (pH  6.7). This solution 
was further kept for 30 minutes complete dissolution and 
different dilutions made as per standard procedures. 

Precompression. 

The pre-formulation studies will be conducted according to 
standard method as prescribed which comprised of angle of 
repose, Hausner’s ratio, Bulk Density, Tapped Density, Carr’s 
Index according to the specified standard procedure 

Procedure 

Formulation Development 

The active ingredient was kneaded in a motor and pestle and 
after kneaded this powder was pored through science no 125 
and then mixed with polymers and ingredient. Two different 
formulations were prepared, in first formulation the ratio was 
kept 60% active ingredient and 40% polymers subsequently 
in 2nd formulation 55% active ingredient 45% polymers. All 
the ingredients were mixed thoroughly for 15 minutes than 
with the help of tableting machine Magnesium striate in 
acetone was used to lubricate the punches of the tableting 
machine to keep them from sticking.. The punches were 
shaped differently in four different shapes that was 
cylindrically flat base matrices, The second cylindrical matrix 
has a flat base, the third one has a convex base, and the fourth 
matrix has a concave base. 

Physical Characteristics of dome tablet 

Weight Variation Test 

Weight variation for tablets have been randomly selected and 
weighed individually with the help of an analytical stability. 
The average weights were determined and the proportion 
deviations from imply values had been calculated. The 
proportion weight version for each tablet was anticipated in 
keeping with the following formulation: 

% Weight variation = (common Weight-individual Weight) / 
character Weight × 100 

Surface area measurement  

Surface area of the dome tablets were performed according to 
the specification of all formulation. 

Drug Release Parameter 

By using USP apparatus II paddle method. The rotation will be 
kept 75rpm and the temperature will be kept 75% and the 
medium will be filled upto 900ml. the samples will be 
collected accordingly to the different time intervals. 

Mathematical Interpretation 

For evaluation of the percentage release of dissolution 
compared with the standard were calculated by statistical 
formula. 

A= a.b.ceq. 1 

Fraction release = 
 

 
  

 

  
. A/a.b.c eq. II 

Hardness Test 

Hardness Test was determined by using “Monsanto” type 
hardness tester. The mean crushing strengths (hardness 
values) were determined. 

Friability Test  

For friability test, drugs were randomly selected, weighed and 
located into the Friabilator chamber set at 25 rpm for 1 
minute. The capsules had been weighed once more and the 
variations in weight have been calculated as the percentage 
friability. 

Dissolution  

Dissolution studies were performed according to USP 
monographs or standards. The basket rotation was kept 100/ 
rounds per minute and temperature maintained accordingly at 
37 ± 0.1 0C. Than the sample (5ml) were collected at time 
intervals specified, after that the samples were be examined 
by the help of UV- Visible Spectrophotometer.  

RESULTS 

Standard Diclofenac Sodium Graph 

The standard graph of Diclofenac Sodium (Table 1) displays 
strong linearity, with R2 values of 0.1856 and 0. 0.1968 in 0.2 
NHCl (Fig. 1) and pH 6.7 buffer (Fig. 2), under a maximum of 
295 nm, demonstrating that it abides by Lambert's "Beer-law." 

Table 1: Standard Diclofenac Sodium Graph 

Conc. 
(mcg/ml) 

Absorbance at 295nm 

0.1 NHCl 6.7 pH Buffer 

5. 0.149 0.145 

10. 0.218 0.238 

15. 0.328 0.362 

20. 0.438 0.443 

25. 0.412 0.555 

30. 0.505 0.661 

35. 0.618 0.779 

40. 0.760 0.848 

45. 0.732 0.944 

50. 1.309 1.021 

R
2 0.1856 0.1968 

 

 



Ahmed et al                                                                                                                                 Asian Journal of Dental and Health Sciences. 2022; 2(4):72-76   

[74]                                                                                                                                                                                                                  AJDHS.COM 

 

1.2 

 

1 

 

0.8 

 

0.6 

 

  0.4 

 

  0.2 

 

  0 

    0                    10                   20                   30                    40                   50        60 

 Concentration(Mcg/ml) 

Figure 1: Diclofenac Sodium Standard Graph in 0.1 NHCl 

 

 

 

1.2 

 

1 

 

0.8 

 

0.6 

 

   0.4 

 

   0.2 

 

   0 

0              10              20                30               40               50             60 

Concentration(Mcg/ml) 

Figure 2. Diclofenac Sodium Standard Graph in 6.7 pH Buffer 

 

Granule Characterization 

The Carr's index, bulk density, tapped density, drug content, 
and attitude of repose were used to characterise the matrix 
pill granules. Angle of repose decreased to less than 35 
degrees, and Carr's index values for all batches of granules 

were less than 21, suggesting genuine flow ability and 
compressibility. For all of the batches, Hausner's ratio was 
substantially lower than 1.25, indicating proper flow homes. In 
excess of 90% of all the granules of various formulations' 
medication content. 

 

 

 

 

 

 

 

 

 

 

 

y = 0.0199x + 0.0285  

R
2
 = of 0.1856 

 

A
b

so
rb

a
n

c

e 
A

b
so

rb
a
n

c

e 

 

 

 

 

 

 

 

 

y = 0.0198x + 0.0493  

R
2
 = 0.1968 

 



Ahmed et al                                                                                                                                 Asian Journal of Dental and Health Sciences. 2022; 2(4):72-76   

[75]                                                                                                                                                                                                                  AJDHS.COM 

Table 3: Physical Properties of Precompression Blend: 

Formulations Angle of repose (° ) Bulk Density 
(g/ml) 

Tapped Density 
(g/ml) 

Carr’s Index 
(%) 

Hausner’s ratio 

F1 26.70 0.311 0.231 13.94 1.16 

F2 27.34 0.305 0.410 14.43 1.17 

 

 
 

 

5.4 Matrix tablet physical evaluation: 

Table Four provides the effects of the matrix tablets' 
consistency of weight, hardness, thickness, friability, and 
medication content. Due to the fact their weights various 
among 119.nine and 120.5 mg, all the capsules from unique 
batches met the legitimate requirements for weight 
uniformity. The matrix drugs' hardness numerous from 5.50 
to 5. Forty-five kg/cm, and their friability become much less 

than zero.38 percentage, displaying that they had been 
compact and difficult. The medicinal drugs' thickness ranged 
from three.22 to a few.37 mm. all the formulations met the 
medication's content material requirements, containing 95 to 
99 percentage Diclofenac Sodium and precise drug 
homogeneity. cloth becomes discovered. as a result, all the 
bodily attributes of the organized capsules were located be 
nearly inside control. 

 

Table 4: Physical Matrix tablets' evaluation 

F.Code Hardness (kg/cm2) † Thickness (mm) ‡ Weight (mg) ‡ Friability (%) Drug content * (%) 

F1 5.49 ±0.54 3.56±0.18 126.9±1.44 0.37 95.89±1.39 

F2 5.45±0.41 3.07±1.27 131.5±0.52 0.38 99.76±0.79 

All of the values cited in above desk taken mean ± well-known Deviation (SD), n=three 
† All the values noted in above table taken mean ± general Deviation (SD), n=6 
‡ All the values stated in above table taken suggest ± popular Deviation (SD), n=20 

 

 

 

0

5

10

15

20

25

30

Angle of repose ( ° )Bulk Density (g/mL) Tapped Density
(g/mL)

Carr’s Index (%) Hausner’s ratio 

Physical Properties of Precompression Blend 

F1

F2

0

20

40

60

80

100

120

140

Hardness (kg/cm2) Thickness (mm) Weight (mg) Friability (%) Drug content(%)

Physical Evaluation of Matrix Tablets 

F1

F2



Ahmed et al                                                                                                                                 Asian Journal of Dental and Health Sciences. 2022; 2(4):72-76   

[76]                                                                                                                                                                                                                  AJDHS.COM 

Theoretical Release Profile and Dose Calculations 

The dose that was calculated early than the necessary full dose 
for two times-day by day maintain release system of 
Diclofenac Sodium changed into found to be a 100 mg as well 
as its theoretical release profile is stated in Table2. 

Table 2: Theoretical Release Profile of Diclofenac Sodium 
from SR tablets 

Time (hours) Cumulative % Release 
1 25.15 
2 32.18 
3 39.99 
4 45.98 
6 61.01 
8 73.90 

10 87.19 
12 > 90 

 

 

DISCUSSION 

One of the most cuttingedge sectors of controlled drug deliver
y is oral medicine distribution such dosage forms offer a 
considerable benefit in terms of patient adherence At least a 
twofold reduction in dosing frequency is achieved with the 
extended release dosage form. 
When compared to the medicine delivered in an immediaterel
ease (conventional) dose form. Diclofenac sodium is an 
analgesic and anti-inflammatory medication. It is primarily 
utilized in the treatment of surgical inflammation and acute 
painIt is a member of the class of painkillers known as non-
steroidal anti-inflammatory medicines (NSAIDs). 
Inflammation is frequently treated with it, discomfort, acute 
gout, and ankylosing spondylitis, particularly in low back pain. 
For this reason, a therapeutic concentration of 100mg/day is 
required. The therapeutic dose must be maintained for at least 
24 hours. Because typical doses release the full medication in a 
matter of minutes Therapeutic levels are only sustained for a 
brief period of time. requiring the administration of a second 
dose as a result, a Diclofenac Sodium sustained release 
formulation that releases the medicine over a 22-hour period 
is advantageous. 

The goal of this research is to develop and test Diclofenac 
Sodium extended-release Dome matrix tablets. To improve the 
release, polymers such as 48 mg Xanthan Gum and 54 mg 
Eudragit S100 were used to make the controlled release 
matrix tablet. 

CONCLUSION 

The goal of this study was to prepare Diclofenac sodium-
controlled release Dome matrix tablet formulation that would 
keep therapeutic levels of the drug constant for more than 12 
hours. These types of formulation would be safer and 

continuous release which ultimately benefits the community 
in response to diseases. 

The controlled release Dome matrix tablets containing 
Diclofenac sodium are made using a wet granulation process 
and various grades of polymers Xanthan gum, HPMC and 
Eudragit. 

Diclofenac Sodium is an analgesic remedy. As a result, an 
attempt become made to hold the therapeutic awareness 
regular for an extended time. This was achieved with the aid of 
growing a drug shipping machine with a regulated launch. 
these managed launch Dome matrix tablets had been in most 
cases designed to launch the drug for an extended time, i.e., 12 
hours, and to absolutely launch the drug at the same time as 
fending off excessive dosage periodicity. The hardness, weight 
fluctuation, thickness, friability, drug content homogeneity, 
and in-vitro dissolution investigations of both formulations 
were within the acceptable range and the released rates were 
near 90% in 12 hours. The findings of this study showed that a 
polymer could be successfully used to formulate Diclofenac 
sodium control release Dome matrix tablets. The drug release 
mechanism of these formulations were checked and compared 
with other formulations, it was found that all these 
formulations were extended for 8 to 12 hours with different 
drug to polymer ratio of 60:40, 55:45. The formulations are 
proved to increased release time. As a result, it can be stated 
that Diclofenac sodium in the form of a once-daily controlled 
release matrix tablet has a reasonable extended-release 
profile, suggesting that it may improve therapeutic efficacy. 
The drawbacks and restrictions of extended-release 
medications are overcome and removed by the new 
formulation. 

REFERENCES 

1. DiMasi, J.A., et al., Trends in risks associated with new drug 
development: success rates for investigational drugs. Clinical 
Pharmacology & Therapeutics, 2010; 87(3):272-277. 
https://doi.org/10.1038/clpt.2009.295 

2. Powell, W.W., Learning from collaboration: Knowledge and 
networks in the biotechnology and pharmaceutical industries. 
California management review, 1998; 40(3):228-240. 
https://doi.org/10.2307/41165952 

3. Singh, B.N. and K.H. Kim, Floating drug delivery systems: an 
approach to oral controlled drug delivery via gastric retention. 
Journal of Controlled release, 2000; 63(3):235-259. 
https://doi.org/10.1016/S0168-3659(99)00204-7 

4. Rosenstock, I.M., Understanding and enhancing patient compliance 
with diabetic regimens. Diabetes care, 1985; 8(6):610-616. 
https://doi.org/10.2337/diacare.8.6.610 

5. Group, D.U.A., Paroxetine: a selective serotonin reuptake inhibitor 
showing better tolerance, but weaker antidepressant effect than 
clomipramine in a controlled multicenter study. Journal of 
Affective Disorders, 1990; 18(4):289-299. 
https://doi.org/10.1016/0165-0327(90)90081-I 

6. Kumari, A., S.K. Yadav, and S.C. Yadav, Biodegradable polymeric 
nanoparticles based drug delivery systems. Colloids and Surfaces 
B: Biointerfaces, 2010; 75(1):1-18. 
https://doi.org/10.1016/j.colsurfb.2009.09.001 

7. Colombo, P., et al., Swellable matrices for controlled drug delivery: 
gel-layer behaviour, mechanisms and optimal performance. 
Pharmaceutical science & technology today, 2000; 3(6):198-204. 
https://doi.org/10.1016/S1461-5347(00)00269-8 

8. Dahlberg, C., et al., Polymer swelling, drug mobilization and drug 
recrystallization in hydrating solid dispersion tablets studied by 
multinuclear NMR microimaging and spectroscopy. Molecular 
pharmaceutics, 2011; 8(4):1247-1256. 
https://doi.org/10.1021/mp200051e

 

0

20

40

60

80

100

1 2 3 4 5 6 7 8

C
u

m
m

u
la

ti
ve

 %
 R

el
ea

se
  

Time (hour) 

Diclofenac Sodium Theoretical Release Profile 
from SR Tablets 

https://doi.org/10.1038/clpt.2009.295
https://doi.org/10.2307/41165952
https://doi.org/10.1016/S0168-3659(99)00204-7
https://doi.org/10.2337/diacare.8.6.610
https://doi.org/10.1016/0165-0327(90)90081-I
https://doi.org/10.1016/j.colsurfb.2009.09.001
https://doi.org/10.1016/S1461-5347(00)00269-8
https://doi.org/10.1021/mp200051e

