Abstract


Iraqi J Pharm Sci , Vol.18 (1) , 2009                                                          Orodispersible tablet 
 

 83 
 

Preparation of a New Dosage Form of Metoclopramide 

Hydrochloride as Orodispersible Tablet
# 

Hussam H. Tizkam
*,1  

,    Alaa A. Abdul Rassol
**   

and    Ahmed A. Hussain
** 

*
 Ministry of Health, Baghdad, Iraq 

**
 Department of Pharmaceutics, College of Pharmacy, University of Baghdad, Baghdad , Iraq 

 

Abstract 
         Metoclopramide HCl (MTB) is a potent antiemetic drug used for the treatment of nausea and 

vomiting. Many trials were made to prepare a satisfactory MTB orodispersible tablet using direct 

compression method.Various super disintegrants were used in this study which are croscarmellose 

sodium (CCS), sodium starch glycolate (SSG) and crospovidone (CP). The latter was the best in terms 

of showing the fastest disintegration time in the mouth.Among the different diluents utilized, it was 

found that a combination of microcrystalline cellulose PH101 (MCC 101), mannitol, dicalcium 

phosphate dihydrate (DPD) and Glycine was the best in preparing MTB orodispersible tablet with 

fastest disintegration time in the mouth.The physical parameters of the prepared MTB orodispersible 

tablet were satisfactory as hardness (4 Kg), friability (0.5%) and mouth disintegration (23 sec).The 

overall results suggest that the prepared formula of MTB as orodispersible tablet could be utilized as a 

new dosage form for the oral administration. 

Key words: Orodispersible, metoclopramide, super disintegrant 

 

 الخالصة 
( يٍ انعقاراث  انفعانت فً عالج حاالث انخقٍؤ. ْذِ Metoclopramide HClٌعذ عقار انًٍخٕكهٕبزايٍذ ْاٌذرٔكهٕرٌذ )         

( باسخخذاو orodispersible tabletانذراست حخعهق بخصٍُع انًٍخٕكهٕبزايٍذ ْاٌذرٔكهٕرٌذ عهى شكم حبت سزٌعت انخحهم فً انفى )

( sodium starch glycolate( ٔيادة )croscarmellose sodiumشز.حى اسخخذاو عذة يٕاد يفككت ًْٔ يادة )طزٌقت انكبس انًبا

يٍ بٍٍ يٕاد انخخفٍف  (. ٌٔعذ األخٍز ْٕ األفضم ألٌ ٔقج ححههّ فً انفى كاٌ اسزع يٍ باقً انًٕاد انًفككت.crospovidoneٔيادة )

ٔانكالٌسٍٍ كاَج ًْ  dicalcium phosphate dihydrate)هٕر ٔانًاٍَخٕل ٔيادة )انًسخخذيت، ٔجذ بأٌ يادة انسهٍهٕس يجٓزي انخب

ٔكاَج انخصائص انفٍشٌائٍت نحبت انًٍخٕكهٕبزايٍذ  االفضم فً حصٍُع حبت انًٍخٕكهٕبزايٍذ ْاٌذرٔكهٕرٌذ سزٌعت انخحهم فً انفى.

ايا ٔقج انخحهم فً انفى فٕٓ % ٥٫٠فً حٍٍ كاَج انٓشاشت  كغى ٤انحبت  صالبتْاٌذرٔكهٕرٌذ سزٌعت انخحهم فً انفى جٍذة فًثال كاَج 

     ثاٍَت. ٢۳
Introduction 
         Orodispersible tablet is a solid dosage 

form containing a medicinal substance that 

disintegrates and/or dissolves rapidly in the 

mouth (either on or beneath the tongue or in 

the buccal cavity) without drinking water 

within up to three minutes. Upon placement in 

the mouth, orodispersible tablets absorb saliva 

rapidly into the tablet core allowing the super 

disintegrant to swell, rupture the tablet and 

liberate the individual components that form 

solution or suspension, which in turn can be 

swallowed easily without water. On the other 

hand, orodispersible tablet can also be 

swallowed intact as it is; i.e., as if it was a 

conventional tablet by using water to push it 

down to stomach 
(1)

.The orodispersible tablets 

have increased in popularity because 

consumers, all ages, find them convenient and 

easy to use. Since orodispersible tablets can be 

taken without water, therefore, bed-ridden, 

lying, standing, walking, talking, and traveling 

patients can use them easily any time and 

anywhere 
(2)

.Orodispersible tablet is the proper 

solution for dysphagia. Dysphagia is defined 

as difficulty swallowing food or liquids, which 

may be caused by normal physiologic response 

or as a result of disease state
(3)

. As a 

consequence of dysphagia, children and 

elderly patients do not take their medication as 

prescribed. It is estimated that as high as 50% 

of the population has this problem which 

results in a high prevalence of ineffective 

therapy 
(4)

.Other advantage of orodispersible 

tablets is fastening onset of action. They 

disintegrate in the mouth in a period of 

seconds in comparison to conventional tablets 

which may need up to 15 min to disintegrate 

completely in the stomach. Furthermore, a 

dissolution process for water-soluble drugs 

begins to initiate while the orodispersible 

tablet still in the mouth. These facts reflect 

why orodispersible tablets have rapid or ultra 

rapid onset of action 
(5)

. 

 
# 
Based on oral presentation in the seventh scientific conference of the College of Pharmacy /University 

of Baghdad held in 26-27 November 2008. 

1 Corresponding author  E-mail : tizkam@yahoo.com  

 Received   : 2/12/2008     

 Accepted   :  24 / 3/2009 

mailto:tizkam@yahoo.com


Iraqi J Pharm Sci , Vol.18 (1) , 2009                                                          Orodispersible tablet 
 

 83 
 

 Many side effects are associated with the 

conventional dosage forms such as tablets and 

capsules. For example, these dosage forms 

may lodge esophagus, causing local irritation. 

When the tablet or capsule disintegrates in 

stomach, it may release all of its content in the 

same area, which may cause a gastric irritation 

especially if the drug is highly water soluble 

due to the formation of localized high 

concentration. Regarding orodispersible tablet, 

it disintegrates and/or dissolves in the mouth 

and diluted subsequently with saliva, so no 

such side effect can take place.According to 

the above advantages, orodispersible tablets 

can be used for most cases, but their benefits 

can be doubled in certain clinical situations; 

among them are nausea and vomiting. During 

nausea and vomiting, it is better for the patient 

to take orodispersible tablet and not a 

conventional one due to the following 

reasons
(6)

: 

a. To avoid the stimulation of vomiting 
center in the CNS. This center is 

stimulated by GI distention which, in turn, 

is caused by food or fluid intake. If the 

patient takes conventional tablet, he 

should use a glass of water to swallow it 

and hence, vomiting reflux may be 

initiated, bringing about a new vomiting 

episode.  

b. Physiologic defense mechanism which 
makes the patient reluctant to drink. 

         Many products of orodispersible tablets 

have been launched worldwide over the past 

decade by the most famous drug companies. 

AstraZeneca, GlaxoSmithKlin, Eli Lilly, 

Pfizer, Wyeth, Squibb, Bristol-Myers, 

Schering Plough, Merck, Janssen and Organon 

are examples on these companies 
(7)

. 

Experimental 
Materials: 
         The following materials were used in this 

study: CCS and CP (Al-Hekma Drug Industry, 

Jordan), MTB, SSG and DPD (Samara Drug 

Industry (SDI), Iraq), lactose, mannitol and 

hydrochloric acid (HCl) (Riedal De Haen Ag 

Seelze Hanover, Germany), glycine (Fluka 

Chemi Ag, Switzerland), magnesium stearate 

(Mg St) (Barbeher, GmbH, Germany), 

Meclodin® tablet (SDI, Iraq), Primperan® 

tablet (Sanofi corp., France). 

Methods: 
Formulation of Orodispersible Tablet: 

Formulation of Control Orodispersible 

Tablets (without MTB):  

         Different control formulas (without 

MTB) were prepared and tested to obtain the 

best formula that disintegrates as fast as 

possible in the mouth (table 1). All formulas 

were prepared using direct compression 

technique. Each formula was formulated by 

mixing all the ingredients (except the 

lubricant) for 15 min after which the lubricant 

was added and blended for another 3 min. The 

final mixture was compressed using a double 

punch, Korsch, tablet machine with a 10 mm 

flat punch. 

 

Formulation of MTB Orodispersible Tablet:  

         MTB was incorporated with the best 

control formula (with regard to shortest 

disintegration time in the mouth) to obtain the 

final MTB orodispersible tablet that subjected 

subsequently to further investigations. The 

MTB orodispersible tablet was prepared by the 

same method mentioned above. 

Physical Parameters Measurement of the 

Prepared Orodispersible Tablets: 

 Content Uniformity:  

         this test was undergone for the prepared 

MTB orodispersible tablet. The content 

uniformity was performed by taking ten tablets 

and assayed individually. The requirement for 

this test is met if the amount of ingredient in 

each of the ten tablets lies within the range of 

85-115% of the label claim 
(8)

. 

Hardness:  

         the hardness of all the prepared 

orodispersible tablets (with and without MTB) 

were measured using Monsanto hardness 

tester. Results are expressed as a mean ± S.D 

(n=3). 

Friability:  

         the friability test was undergone for the 

prepared MTB orodispersible tablet using 

Roche friabilator for 4 min at 25 r.p.m. by 

taking ten tablets weighing them all together 

then placing them inside the tester. After their 

revolution, they were cleaned from dust and 

weighed again. The friability was calculated as 

the percent weight loss. If the reduction in the 

total mass of the tablets is more than 1%, the 

tablets fail the friability test 
(8)

. 

Disintegration Test:  
         Two types of disintegration tests were 

done for the prepared orodispersible tablets: by 

using the disintegration apparatus (in vitro test) 

and disintegration test in the mouth using 

healthy volunteers (in vivo test). 

 Conventional Disintegration Test (in vitro 

test):  
         the disintegration time of the prepared 

MTB orodispersible tablet was determined in 

different solutions (D.W, 0.1N HCl pH 1.2 and 

phosphate buffer pH 6.5). In addition, the 

disintegration time in D.W was determined for 

Meclodin® and Primperan® tablets as 



Iraqi J Pharm Sci , Vol.18 (1) , 2009                                                          Orodispersible tablet 
 

 04 
 

references. Disintegration apparatus with a basket rack assembly containing six open-

ended tubes and 10-mesh screen on the bottom 

was used. A tablet was placed in each tube of 

the basket and the time for complete 

disintegration of the six tablets was recorded
(8)

. 

 

Disintegration Test in the Mouth (in vivo 

test):  

         Five healthy volunteers were subjected to 

the measurement of the disintegration time in 

the mouth of all the prepared orodispersible 

tablets (with and without MTB). Prior to the 

test, all volunteers got a detailed briefing on 

purpose of this test, then they were asked to 

rinse their mouth with water. Then the 

prepared orodispersible tablet was placed on 

the tongue and immediately a stopwatch was 

started. They were allowed to move the 

orodispersible tablet against the upper palate of 

the mouth with their tongue and to cause a 

gentle tumbling action on the tablet without 

biting on it or tumbling it from side to side. 

Immediately after the last noticeable granule or 

fragment had disintegrated, the stopwatch was 

stopped and the time was recorded. The 

swallowing of saliva was prohibited during the 

test, and also saliva was rinsed from the mouth 

after each measurement. To check 

reproducibility, each volunteer repeated the 

test three times 
(9)

. 

Dissolution Test:  

         the basket method was used to determine 

the release profile of the drug from the 

prepared MTB orodispersible tablet. The test 

was carried out in three different dissolution 

media which are 900 ml of D.W, 0.1N HCl 

(pH 1.2) and phosphate buffer (pH 6.5) at 37 ± 

0.5 
0
C

 
with constant stirring speed of 50 r.p.m 

for 30 min. In addition, the release profiles of 

the Meclodin® and Primperan® tablets (as 

references) were also determined using 900 ml 

of D.W at the same test environments. At 

preset time intervals, 5 ml samples were 

withdrawn and the filtrate was refluxed back 

using 5 ml of fresh dissolution medium. 

Samples were filtered through microfilter and 

analyzed spectrophotometrically at the λmax 

of MTB 
(8)

. 

 

Factors Affecting Formulation: 

 Effect of Super Disintegrants Types and 

Concentrations on the Disintegration Time in 

the Mouth of the Prepared Control 

Orodispersible Tablets: 

         Formulas 1-12 (table 1) were utilized to 

study the effect of super disintegrant type 

(SSG, CCS and CP) and concentration (4, 8.5, 

18 and 40 mg/tablet) on the disintegration time 

in the mouth of the prepared control 

orodispersible tablets. Formulas 14-16 were 

prepared to reveal the effect of super 

disintegrants combination at three different 

concentrations (1.65, 4.4 and 9.5 mg/tablet) on 

the disintegration time in the mouth of the 

prepared control tablets. 

 Effect of Diluents Types and Concentrations 

on the Disintegration Time in the Mouth of 

the Prepared Control Orodispersible Tablets: 

         Formulas 17-32 (table 1) were utilized to 

check the effect of diluent type (MCC101, 

MCC102, mannitol, lactose, L-HPC, DPD and 

glycine) alone and as combination of them at 

different concentrations on the disintegration 

time in the mouth of the prepared control 

orodispersible tablets. 

 

 

Table (1): Composition of the Control Orodispersible Formulas 

 

Material 

      (mg) 

 

 

Formula 

S
S

G
 

C
C

S
 

C
P

 

M
C

C
 1

0
1

 

M
C

C
 1

0
2

 

M
a

n
n

ito
l 

L
a

c
to

se
 

L
 -H

P
C

 

D
P

D
 

G
ly

c
in

e
 

M
g

 S
t 

T
o

ta
l W

e
ig

h
t 

(m
g

) 

1 
4 

(2.5%) 

  
159 

      
1 164 

2 
8.5 

(5%) 
  159 

      
1 168.5 

Table (1): Continued. 



Iraqi J Pharm Sci , Vol.18 (1) , 2009                                                          Orodispersible tablet 
 

 04 
 

 Material 

     (mg) 

 

 

 

 

Formula 

S
S

G
 

C
C

S
 

C
P

 

M
C

C
 1

0
1

 

M
C

C
 1

0
2

 

M
a

n
n

ito
l 

L
a

c
to

se
 

L
 -H

P
C

 

D
P

D
 

G
ly

c
in

e
 

M
g

 S
t 

T
o

ta
l W

e
ig

h
t 

(m
g

) 

3 
18 

(10%) 
  159 

      
1 178 

4 
40 

(20%) 
  159       1 200 

5  
4 

(2.5%) 
 159 

      
1 164 

6  
8.5 

(5%) 
 159 

      
1 168.5 

7  
18 

(10%) 
 159 

      
1 178 

8  
40 

(20%) 
 159 

      
1 200 

9   
4 

(2.5%) 
159 

      
1 164 

10   
8.5 

(5%) 
159 

      
1 168.5 

11   
18 

(10%) 
159 

      
1 178 

12   
40 

(20%) 
159 

      
1 200 

13   
54 

(25%) 
159 

      
1 214 

14 
1.65 

(1%) 

1.65 

(1%) 

1.65 

(1%) 
159 

      
1 164.95 

15 
4.4 

(2.5%) 

4.4 

(2.5%) 

4.4 

(2.5%) 
159 

      
1 173.2 

16 
9.5 

(5%) 

9.5 

(5%) 

9.5 

(5%) 
159 

      
1 188.5 

17 
  

40  
15

9 

     
1 200 

18 
  

40  
 

159 
    

1 200 

Table (1): Continued 



Iraqi J Pharm Sci , Vol.18 (1) , 2009                                                          Orodispersible tablet 
 

 04 
 

 Material 

     (mg) 

 

 

 

 

Formula 

S
S

G
 

C
C

S
 

C
P

 

M
C

C
 1

0
1

 

M
C

C
 1

0
2

 

M
a

n
n

ito
l 

L
a

c
to

se
 

L
 -H

P
C

 

D
P

D
 

G
ly

c
in

e
 

M
g

 S
t 

T
o

ta
l W

e
ig

h
t 

(m
g

) 

19 
  

40  
  

159 
   

1 200 

19   40    159    1 200 

20 
 

 40 80 79      1 200 

21 
  

40 80 
 

69 10 
   

1 200 

22 
  

40 80  79     1 200 

23 
  

40 59  100     1 200 

24 
  

40 40  120     1 201 

25 
  

40 20  140     1 201 

26 
  

40 20  140  2   1 203 

27 
  

40 20  140  23   1 224 

28 
  

40 20  140  50   1 251 

29 
  

40 20  140   11  1 212 

30 
  

40 20  140   23  1 224 

31 
  

40 20  140   50  1 251 

32 
  

40 20  140   23 55 1 279 

 

 

 

Effect of pH on Conventional Disintegration 

Time of the Prepared MTB Orodispersible 

Tablet: 

The effect of pH on conventional 

disintegration time of the prepared MTB 

orodispersible tablet was done using Erweka 

disintegration apparatus with 0.1N HCl 

solution (pH 1.2) and phosphate buffer (pH 

6.5) as the disintegration media. 

 

  



Iraqi J Pharm Sci , Vol.18 (1) , 2009                                                          Orodispersible tablet 
 

 08 
 

Results and Discussion 
Effect of Super Disintegrants Types and 

Concentrations on the Disintegration Time in 

the Mouth of the Prepared Control 

Orodispersible Tablets: 
         Table (2) shows that the best super 

disintegrant type was CP with a concentration 

of 40 mg/tablet. This fact is represented in 

formula 12, which showed the fastest 

disintegration time in the mouth (27 sec). 

Furthermore, to ensure that the super 

disintegrant critical concentration of CP is 40 

mg, another formula (formula 13) was made 

using 54 mg of CP. It was found that formula 

13 disintegrated more slowly than formula 12 

and showed mouth disintegration of 29.5 sec. 

On the other hand, the combination used in 

formulas 14-16 were not effective in lowering 

the disintegration time of the orodispersible 

tablets in the mouth since their disintegration 

time was relatively high and ranged from 40-

60 sec. This may be caused by a competition 

between these super disintegrants on the little 

amount of water that found in the mouth 

knowing that 0.35-1.0 ml/min is the total 

volume of saliva available under normal 

conditions 
(10)

. 

 

 

Table (2): The Effect of Super Disintegrants Types and Concentrations on the Disintegration 

Time in the Mouth of the Prepared Control Orodispersible Tablets * 

 

No 
Composition (mg) Disintegration Time 

in the mouth (sec) SSG CCS CP MCC101 Mg St 

1 4   159 1 44 ± 14 

2 8.5   159 1 53 ± 18 

3 18   159 1 66 ± 19 

4 40   159 1 110 ± 27.3 

5  4  159 1 45 ± 13 

6  8.5  159 1 45 ± 14 

7  18  159 1 42 ± 16 

8  40  159 1 79 ± 24 

9   4 159 1 58 ± 15.3 

10   8.5 159 1 50 ± 20.7 

11   18 159 1 39 ± 14.1 

12   40 159 1 27 ± 5.1 

13   54 159 1 29.5 ± 6.3 

14 1.65 1.65 1.65 159 1 43 ± 7.8 

15 4.4 4.4 4.4 159 1 40 ± 15 

16 9.5 9.5 9.5 159 1 59 ± 18 

        *Results are expressed as mean ± S.D. (n=3) 

 

Effect of Diluents Types and Concentrations 

on the Disintegration Time in the Mouth of 

the Prepared Control Orodispersible Tablets: 

         The super disintegrant concentration of 

CP (40 mg/tablet) was kept constant through 

out this part of the study to find out the best 

diluent that may be used for the preparation of 

control orodispersible tablet as shown in (table 

3).MCC acts as auxiliary tablet disintegrant 

because of its water absorbing capacity 
(11)

. 

The latter advantage gives the reason for the 

necessity for the inclusion of MCC in the 

formulation of orodispersible tablets. 

Practically, no difference was found between 

MCC 101 (formula 12) and MCC102 (formula 

17) and they showed a mouth disintegration of 

27 and 28 sec, respectively. Besides, 

combining two grades of MCC (MCC 101 and 

MCC 102) as in formula 20 gave slower 

disintegration time in the mouth (37 sec) than 

each grade alone.Table (3) also shows that 

mannitol was better than lactose in preparing 



Iraqi J Pharm Sci , Vol.18 (1) , 2009                                                          Orodispersible tablet 
 

 00 
 

tablet with shorter disintegration time in the 

mouth. The mouth disintegration time for 

mannitol containing formula (formula 18) and 

lactose containing formula (formula 19) were 

28 and 37 sec, respectively. This difference in 

disintegration time may be due to the fact that 

mannitol has slower dissolution kinetics, that 

is to say; lactose tends usually to dissolve 

rather than disintegrate, forming a viscous 

layer on the surface of the tablet which slows 

down the penetration of water (or saliva) into 

the tablet core 
(12)

. On the other hand, formula 

21 showed slower disintegration time in the 

mouth (39 sec) than both formulas 18 and 19 

indicating that such combination is not 

effective in lowering the disintegration time in 

the mouth.Formulas 22-25 were utilized to 

study the effect of combining MCC 101 and 

mannitol at different concentrations on 

disintegration time in the mouth. Although 

formulas 22, 24 and 25 showed the same 

disintegration time in the mouth (26 sec), 

formula 25 was selected to complete the study 

because it contains the largest amount of 

mannitol which in turn, imparts sweet and cool 

taste on the prepared orodispersible 

tablet.Formulas 26-28 were utilized to study 

the effect of L-HPC on disintegration time in 

the mouth of the prepared control 

orodispersible tablet. It was found that L-HPC 

prolonged the disintegration time in the mouth 

at all concentrations, therefore, it can not be 

used in the preparation of orodispersible 

tablets.Formulas 29-31 were formulated using 

three different concentrations of DPD. 

Formula 30 was disintegrated faster than 

formulas 29 and 31 indicating that the best 

concentration of DPD is that used in the 

preparation of formula 30 (which is 23 

mg/tablet and selected later to compete the 

study).Glycine is used in orodispersible tablet 

because of its effect as disintegration 

accelerator. Thus, the addition of glycine 

decreased the mouth disintegration of the 

tablet from 25 sec (formula 30) to 23 sec 

(formula 32). In addition, glycine has good 

flow and sweet taste, therefore, it was used in 

the past to hide the bitter taste of saccharine 
(13)

.Table (3) shows that the best control 

orodispersible formula (in terms of showing 

the fastest disintegration time in the mouth) 

was formula 32 since its disintegration time in 

the mouth was 23 sec. 

 

Table (3): Effect of Diluents Types and Concentrations on the Disintegration Time in the 

Mouth of the Prepared Control Orodispersible Tablets (with out MTB) * 

 *Results are expressed as mean ± S.D. (n=3) 

F
o

r
m

u
la

 

C
P

 

M
C

C
1

0
1

 

M
C

C
1

0
2

 

M
a

n
n

ito
l 

L
a

c
to

se
 

L
-H

P
C

 

D
P

D
 

G
ly

c
in

e
 

M
g

 S
t 

Disintegrati

on time in 

the mouth 

(sec) 

17 40  159      1 28 ± 4.9 

18 40   159     1 28 ± 8.5 

19 40    159    1 37 ± 12 

20 40 80 79      1 37 ± 12.9 

21 40 80  69 10    1 39 ± 7.4 

22 40 80  79     1 26 ± 4.9 

23 40 59  100     1 27 ± 6.4 

24 40 40  120     1 26 ± 7.8 

25 40 20  140     1 26 ± 7.0 

26 40 20  140  2   1 34 ± 10.0 

27 40 20  140  23   1 41 ± 9.0 

28 40 20  140  50   1 43 ± 8.0 

29 40 20  140   11  1 38 ± 7.8 

30 40 20  140   23  1 25 ± 9.1 

31 40 20  140   50  1 44 ± 11 

32 40 20  140   23 55 1 23 ± 5.3 



Iraqi J Pharm Sci , Vol.18 (1) , 2009                                                          Orodispersible tablet 
 

 04 
 

Formulation of MTB Orodispersible Tablet:  

         Formula 32 was the best control 

orodispersible formula, to which MTB, 

saccharine sodium and flavor were added. 

Table (4) shows the final MTB orodispersible 

formula (formula 33) which was subjected to 

further evaluation tests. 

 

Table (4): Composition of the Selected 

(Final) MTB Orodispersible Tablet 

(formula 33). 

 

Physical Parameters Measurement of the 

Prepared Orodispersible Tablets: 

Content Uniformity: 
         The content uniformity of the prepared 

MTB orodispersible tablet (formula 33) was 

complied with BP criteria. No tablet from ten 

tablets lies out of the range of 85-115% of the 

label claim. These results indicated that the 

dosage form had uniform distribution and 

proper dose of the active ingredient
(8)

.  

 

Hardness: 
         The hardness of all the prepared 

orodispersible tablets (with and without MTB) 

was kept constant at 4 kg by controlling the 

compression force between approximately  4-7 

tone/cm
2
. 

 

Friability: 

         The friability of MTB orodispersible 

tablet (formula 33) was 0.5% which is 

acceptable according to BP criteria 
(8)

. 

Disintegration tests: 

Conventional Disintegration Time of 

the Prepared MTB Orodispersible 

Tablet (in vitro test): 

         The conventional disintegration test of 

the prepared MTB orodispersible tablet 

(formula 33) as well as Meclodin® and 

Primperan® tablets (as references) was 

determined using D.W as disintegration 

medium. The disintegration time of the 

prepared MTB orodispersible tablet was only 

6 sec. In contrast, the disintegration time of 

Meclodin® tablet was 220 sec while that of 

Primperan® tablet was 120 sec as shown in 

figure (1). The disintegration time of the 

prepared MTB orodispersible tablet was also 

shorter than that obtained by other 

researchers
(14)

. 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Figure (1): The disintegration time 

(conventional) of the prepared MTB 

orodispersible (formula 33), Meclodin® and 

Primperan® tablets using D.W at 37±0.5 
0
C   

(results are expressed as mean ± SEM, n=3). 

   

 

Disintegration Time of the Prepared MTB 

Orodispersible Tablet in the Mouth (in vivo 

test): 

         The disintegration time of the prepared 

MTB orodispersible tablet (formula 33) in the 

mouth was found to be 23 sec (S.D=7.5, 

n=15). This result is quite satisfactory 

regarding BP criteria, which states that the 

disintegration time of orodispersible tablets in 

the mouth should not exceed 180 sec 
(8)

. Not 

only acceptable in terms of BP, formula 33 

had faster mouth disintegration than 

orodispersible tablets prepared by other 

researchers 
(15)

 and also faster than some of the 

commercialized products. For example, the 

disintegration time in the mouth of Benadryl® 

(USA), DuraSolv® (USA), Nimesulide® 

(Switzerland) and Nippon® (Japan) 

orodispersible tablets are 40, 45, 30 and 30 

sec, respectively 
(16,17)

 as shown in figure (2). 

 

 

 

 

 

 

 

Material Amount (mg/tablet) 

MTB 10 

CP 40 

MCC 101 20 

Mannitol 140 

DPD 23 

Glycine 55 

Saccharine sodium 2 

Flavor 1 

Mg St 1 

Total weight  292 

0

50

100

150

200

250

MTB

orodispersible

tablet

Meclodin®tablet prim peran®tablet

D
i
s
i
n

t
e
g

r
a
t
i
o

n
 
t
i
m

e
 
(
s
e
c
)



Iraqi J Pharm Sci , Vol.18 (1) , 2009                                                          Orodispersible tablet 
 

 04 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Figure (2): The disintegration time in the 

mouth of Benadryl®, DuraSolv®, 

Nimesulide®, Nippon® and the prepared 

MTB orodispersible tablets (formula 33). 

 

Dissolution Test: 

         The dissolution test for the prepared MTB 

orodispersible tablet (formula 33) as well as 

Meclodin® and Primperan® tablets (as 

references) was done using 900 ml of D.W as a 

dissolution medium at 37±0.5 
0
C

 
with constant 

stirring speed of 50 r.p.m for 30 min. Table (5) 

shows the result of the dissolution test. 

Figure (3) indicates that the prepared MTB 

orodispersible tablet showed faster release rate 

than both Meclodin® and Primperan® tablets. 

The release time (T 75%) of the prepared MTB 

orodispersible tablet was 10-fold and 5-fold 

faster than that of Meclodin® and Primperan® 

tablets, respectively.Statistically, there is 

highly significant difference (P<0.05) among 

samples at 1, 2, 5, 10 and 15 min time intervals 

between Meclodin® and the prepared MTB 

orodispersible tablets. In addition, significant 

difference was found between samples at 1 and 

2 min time intervals between Primperan® and 

the prepared MTB orodispersible tablets. 

These facts are clarified in figure (4).To 

accurately confirm the preference of the 

prepared MTB orodispersible tablet (formula 

33) release profile compared to that of 

Meclodin® and Primperan® tablets, 

mathematical expressions had been used. To 

compare the dissolution profiles of two 

formulations (test and reference), the 

difference factor (F1) and similarity factor (F2) 

are useful. The F1 and F2 functions can be 

calculated according to the following 

equations 
(18)

: 

100

1

1
1 






























n

t

n

t

Rt

TtRt

F

 

 

 
































 100
1

1log50
5.0

1

2
2

n

t

TtRt
n

F

 

indicate clearly the high significant difference 

among these three formulations. 

 

 

Table (5): The Percent Release of MTB from the Prepared Orodispersible (formula 33), 

Meclodin® and Primperan® Tablets in D.W at 37±0.5 
0
C * 

Time Interval 

(min) 

% Release of MTB 

from Meclodin® 

Tablet 

% Release of MTB 

from Primperan® 

Tablet 

% Release of MTB from the 

prepared MTB 

Orodispersible Tablet 

1 32 ± 2.1 † 42 ± 3.1 † 77 ± 2.3 

2 43 ± 2.1 † 55 ± 2.8 † 81 ± 2.3 

5 48 ± 0.8 † 84 ± 6.6 88 ± 4.2 

10 78 ± 2.1 † 96 ± 3.0 97 ± 1.9 

15 95 ± 1.1 † 99 ± 0.5 99 ± 0.2 

20 99 ± 0.4 100± 0.0 98 ± 0.8 

30 100 ±0.0 99 ± 0.0 99 ± 1.0 

* Results are expressed as mean ± S.D (n=3). 

† Significant difference (P<0.05) 

40

45

30 30

23

0

5

10

15

20

25

30

35

40

45

50
D

u
ra

S
o

lv
®

ta
b

le
t

B
e
n

a
d

ry
®

ta
b

le
t

N
im

e
s
u

li
d

e
®

ta
b

le
t

N
ip

p
o

n
®

 t
a
b

le
t

M
T

B

o
ro

d
is

p
e
rs

ib
le

ta
b

le
t

M
o

u
th

 d
is

in
te

g
ra

ti
o

n



Iraqi J Pharm Sci , Vol.18 (1) , 2009                                                          Orodispersible tablet 
 

 04 
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
Figure (3): T 75% release of MTB from 

Meclodin®, Primperan® and MTB 

orodispersible tablets (formula 33) in D.W 

at 37±0.5 
0
C 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Figure (4): The release profiles of MTB 

from the prepared MTB orodispersible 

(formula 33), Meclodin® and Primperan® 

tablets in D.W at 37± 0.5 
0
C. 

 
 

Effect of pH on Conventional Disintegration 

Time of the Prepared MTB Orodispersible 

Tablet: 

         Two ways are possible to administer 
orodispersible tablets. The first one is by 

putting the tablet in the mouth and waiting it to 

disintegrate without the aid of water. 

Alternatively, orodispersible tablet can be 

taken as a conventional tablet by using 

drinking water to push it down. Hence, two 

possible pH may face the tablet during its 

disintegration, which are either the neutral pH 

(6.5) in the mouth or the acidic pH (1.2) in the 

stomach 
(19)

. Therefore, conventional 

disintegration test was made at these two pH 

so as to reveal the effect of pH, if any, on 

disintegration time of the prepared MTB 

orodispersible tablet and to ensure that this 

tablet disintegrates rapidly in all pHs. The 

effect of pH on disintegration time of the 

prepared MTB orodispersible tablet was 

undergone using Erweka disintegration 

apparatus with 0.1N HCl (pH 1.2) and 

phosphate buffer (pH 6.5) as the disintegration 

media. The disintegration time of the prepared 

MTB orodispersible tablet was 13 sec in pH 

1.2 and 16 sec in pH 6.5 as shown in figure 

(4).It is obvious from these results that the 

disintegration time of the prepared MTB 

orodispersible tablet was not affected by 

changing the pH of the disintegration medium. 

This fact may be due that the super 

disintegrant (CP) used in the formulation of 

the prepared MTB orodispersible tablet does 

not affect by such change in the pH, therefore, 

tablet disintegration did not affect significantly 

by the shift of the pH 
(19)

. 

 

References: 
1. Fu Y., Jeong S., Park K., Fast-melting 

tablets based on highly plastic granules. J. 

of Controlled Release. 2005; 109: 203-

210. 

2. Edlin M., Innovative drug delivery 
methods should demonstrate value. 

Managed Healthcare Executive. 2007; 

17(2): 37-38. 

3. Mann G., Crary M., Pill Swallowing by 
Adults With Dysphagia. Arch. 

Otolaryngol. Head Neck Surg. 2005; 131: 

970-975. 

4. Harada T., Narazaki R., Nagira S., 
Ohwaki T., Aoki S., Iwamoto K., 

Evaluation of the Disintegration Properties 

of Commercial Famotidine 20 mg Orally 

Disintegrating Tablets Using a Simple 

New Test and Human Sensory Test. 

Chem. Pharm. Bull. 2006; 54 (8): 1072-

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5. Ciper M., Bodmeier R., Modified 
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Biopharmaceutics. 2006; 62: 178-184. 

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Versus Placebo for the Prevention of 

Postdischarge Nausea and Vomiting After 

10

5

1

0

2

4

6

8

10

12

Meclodin®tablet prim peran®tablet MTB orodispersible

tablet

T
7
5
%

(
M

in
)

0

20

40

60

80

100

120

0 10 20 30 40

Time (min)

%
 M

T
B

 R
e
le

a
s
e
d

 

Meclodin® tablet

Primperan® tablet

MTB orodispersible

tablet



Iraqi J Pharm Sci , Vol.18 (1) , 2009                                                          Orodispersible tablet 
 

48 

Ambulatory Surgery. Anesth. Analg. 

2002; 94: 1199-1200. 

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Evaluation of the Disintegration Properties 

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