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Pharmaceutical Evaluation of an Augmentin Brand Manufactured in Different Countries.

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Physicians often continue to prescribe brand-name drugs from the country of origin of the inventor to their patients even when less expensive of same brand drugs that are manufactured in different countries are available, despite it has been made by the same company. Some national authorities attract the inventors to establish their business and manufacture these brands to offer a cheaper brand drug than which made in country of origin to their citizens. Unfortunately Physicians in general and in Libya in particular tend to prescribe brand-name drugs which made in country of origin of the inventor, even without evidence of their therapeutic superiority. The objective of this project was to evaluate and compare the physicochemical equivalence and efficacy of different tablets of Augmentin® brand, that are available in Libyan local market, this brand is manufactured by GSK company in five different countries as; United Kingdom, Turkey, Greek, Ireland and Malta, the patients conscious about the selection of safest, effective as well as economical medicine. The proposed study has been performed to provide the evidence to the physicians and pharmacists that there is no superiority between among these products despite are manufactured in different countries, when they select the drugs for their patients. The physical parameters i.e. weight variation, thickness, hardness, disintegration, dissolution, potency (Antimicrobial susceptibility), as well as chemical assay were considered during the present study. All of these products had contents compatible with that required by Pharmacopeias and the dissolution profiles for all the drugs showed more than 92% of the active ingredient dissolved within 30 minutes. All drugs were approved with regard to tablets weight uniformity, thickness and hardness where the RSD % are between 0.74 % - 1.69 %, 0.35 % - 0.51 %, and 7.0 % - 8.9 %, respectively. The disintegration time of all samples also proved satisfactory, had completely disintegrated in less than 14 seconds.
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American Journal of Pharmacy and Pharmacology
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Keywords
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.""(
Pharmaceutical Evaluation of an
Augmentin Brand Manufactured in
Different Countries
Mohamed N. El Attug
1, *
, Amal Ammar
1
,
Serag Tunsi
1
,
Sohail Elmjrab
1
, Shukri Al-Sharif
1
, Abdulmonem Gobassa
2
,
Emhemmed Elgallal
2
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Email address
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Citation
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Abstract
,"! 4 "  " !! # 4  ", 4 # 4
 *   ! *   =* 4 ! ! # ! !
!4!"44"!!*!!   !  ! ,  !
"!,  !!! !!"  * !  !
!4!"!  44 ! "! ! #!"!", 4
#  ">  64!,,"! #! !  8,! !"!
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**"4 !", 7$"*4  $" !
 *!! ! "!  ,"""! ?*!" ! 44"!", 4 44
! 4 .#
@
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!4!",9A"!,4*44"!6A#7;,
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#!  ", ."! ", !  ! ""!
!!,  " #   ,  . 4  " ! "
"!  ! ?,!!"! !  4 4! 
# !(B 4  !"* #*   .
#  !*  #!  ! # 4 , "; ! !
13B!   ' B  C(B  B   B ! ' B2 (B
"*,  7 #!  4 ! ! ! * !4!", !
",#!!" 
1. Introduction
.="-!*!"!""!="!*!!"44!
4 !  4 !"! 4"  %  ! "! !" "# 4
.=" ,! ! D!"! !" ! ! "!* !! ! β!"!!
 7"!!!"!"!"4!"
C 0!& ).#et al.!!""!)*!!4!.#/!0!4!"344- 
!  44"!", !#! !="! !"!
!" β-!"!!  .="  ""!,4
! 2S, 5R, 6RC EF2R !  ,=,,
!",G !H , '=!!>!","
F  G!"!=,"!"
.#
@
 ! "! ! "! 4 . ="
,! .=  5#  . ! ! -!*!!
-!* 5# /
Fig. 1. Chemical structure of Amoxicillin (A) and Clavulanic acid (B).
.=" .=   !  ," !" 
in vitro !""! !"*, !#! 9!* !
9!#!* !"!  .="  *
"  #!! , !!"!! !
4  " 4 !"*,   "
#! " "  >,  -!*!" !"
-!*   ! !!"! "!, !  
" "   !,  !"*! 
!!"!! >, ", 4 
"#! !  " ! "! 
% !"!  ! # !"*, !#!  ""!,
! !! !!"!! 4?,
4 !4 # !" 74!
4 !=" ! "!*!" !"  .690)&7%&
@
" !=" 4 #!! ,  !
!"!! >, ! =  !"  " 4
!="  " !, !"! !, ! 
!=" F G %   IJ!K#!>!L
8 4 )! 0" !  4   !
"!!!"!,FG
%  !    *  !"!  "!  #
;  !*# ! ;   *
""" ! !  "!! !"!
4"     " !  
";" ! ! 4   * ! 
!4!!=FG 
7 6 A# " !#!   4
4" "!" ,!= FG  7
"! !*  !!  !* "!# 
!44"44""!"FCG
+!, 4  # !""#    4
? !  " "!  ?!, 4!" !"*
#"!!!"!4
 "4"! "!  ! ?!, 4 !"*
# 4  !#    =  4 4
=! !" !!  ", !"
!*!!, ! !!!"   ! 
!! ! !"* # 4 4 #"!
!*!!,FCG 
0!,*#"!*!44"*!
4 #  ?!, 4 #" # "  
!; 7!4!!
! "4 # "  %!  * 4 4!"
! IJK  # 4 #! !! !
? 4 #! ! !;#
!>! ! ?!, " 4 #" !!""!
"F2(G
%4!*!!!44!4#?!,!,
# "! 44 !  "44"* !  !,
! 3  *"!!""
!"4#! !
!"; 4 !""  ?!, ! !!  FG  7
,!""*!!,"!!!  
# *!! "; ! #!
  ",  ."!  " , ! 
!""!!!, " #,
!   in vitro !"*, 4 .# !#!
" ! ! !"! !   E.coli !
Staphylococcus aureus "!  9! -ve ! 9!
+ve #! !    * *,
  " ! "  " "!"  
#! ! 44# 4 !, !"
#!!!"!!,!4" 
2. Material and Methods
2.1. Material
2.1.1. Reagents & Solutions
. ""!   4 !!,"! #! ! 
 4 4"! 0! ! 0!
! AJ
K
  !# 44 7,!
K" !" 4 J " 4  44 !!
 ! .=" 7!  , 2 'B 
! 4 5;! !!,"! "!, ! 
"!*!!  , ('B ! ! 4 )!
3"! 4  ?!, 4 " M! "!
)! !!"!  )   ! 
A/ 4 4! "", ! 4 /3J -!, 
.! , # ! 0+!
0 04 0. 6. ! 4  !  
."!N!4!!",!!!"#, '
O!4,#3!9!, 
. !  # # ! -C
.!,"! !!" ! "  ." J<# !!,
 &  EJ <#!#!HE!"J<#!!,
 .H,!"!# E7,,!
/H 4 J  !! *  8 ! #
 , 4 !"! #!* !"! Escherichia coli
.7-- ( ! * !"! Staphylococcus
aureus.7--( 
2.1.2. Samples (Generic Drugs)
.#
@
 .=-!*  # 7! ! ,
9A!!""!"!, 
Table 1. Information about Augmentin products.
Sample Product Name Manufacture Site
 9A6
6A
 9A% %!
 9A7
7;,
 9A9
9;
 9A0 0!!
2.2. Equipments
2.2.1. Liquid Chromatographic System and
Conditions
7 !!, 4 .# "!  , #  
", "   6&5C 2

 ! !
4  " 658- 0 3.
!>-!A,N!! ,"#4!
8- ?!!,  0 3.3 !>
-! A, N!! ! ! $" 0 %8
.-J7 !> -! A, N!! ! 658-
6<<%"03.<!> -!
A, N!! 7 " ! ! !! ,
# * 0 -7K.- !> -!
A, N!!  3!! !"? !  , 8-
 4! *   !> -!
A, N!! 7 !!, ! 4  !!
4.#!P)8)-7-J-2= C%3
O!,%! !"#!= C%3
 ' O 68)-K .!,"! /4 6. 
 !  4 !!, 4. # !* 
 5 1!  8 7 !4 ! 
$"O87-*! ! !!
!Q-6<"!*# 
2.2.2. Instruments for Non-Official (Physical)
Test
744"!,*! !
4!!,  )1I)A.
@
 7.1 4 4!!, 
! "!  )1I)A.
@
 7/J I73 4
! ! "; #  #!
!!!)1I)A.
@
0R74#! 
   )1I)A.37C 4  
5 7!4 %4!1 "", %1 # 
4 4"! , %1 3!! !"? !  ,
%1  4! *   !> -!
A, N!!  %"!  0 ' K*
04"#"! 
2.3. Methods
2.3.1. Stranded Preparation
. 4" 4 .=" ! ! ,
*#  # 4 .=" ,! /
!!"! -"! 14" !! /-1 
84*"4!;*!!14"
 4 -!*  I! ! , *#  # 4
-!* 14"/-184!*"
4!; 
I# #4AJ
K

!* 84
!  *" 4!;  !  44 !4 !
!  ( 8 4  44  !
",! ! !84 !  ! 
!!4!!! 
5 ",   !! "!  !# , #
'  # 4 .=",! !!  C 
#"!*!!!-!*!"!"!*
8444 
744!#,#!*
 C # 4 !" ! ! !   # 4
!" ! !   8 4 4
! 
0!     !!, ." J% <# !!,
, !;  #  #4   !
  ""! 4!; ! !  8 4 4 ! !
;!>41!,!-!, 
2.3.2. Preparation of Inoculum
8* ! 4 " 4 Staphylococcus aureus !
Escherichia coli   !#!  #  - 
#,!!"!#4!'- 
.4"!""!
84!" 
2.3.3. Samples Preparation
.! #  !  !*!# #
!#   !  #?*!.=84
*"4!;*  !! 84 
 !   8 4 *" 4!; !  ,
 ! ( 8 4 44  8 4 0! 
" !  O#8
4! ""! 4 ;# ! 
 
7 !! 4 ! 4 " , !" !  
#!"!"! 4!"; 4#8!
  #8 4 !=" ! -!*!! "*, 
7!4 # ! ?!,8444
!!*", 
2.3.4. Assay of Content of Active Ingredient
344 "   #  !!, , 8-
 !""#  6 &5 C FG   O#8 4
.= 6"4"!#!,,!
7! 
5# ! ,"!"!#!4.="
!4-!*!"!"/-1 
2 0!& ).#et al.!!""!)*!!4!.#/!0!4!"344- 
Table 2. Chromatographic conditions, assay of content by USP 31-NF26
method FG
Mobile phase Buffer :Methanol (95:5 v/v)
) %"!"B
-7 S-
5! 8
3"6< 
%$"*  O8
%   ! 4 #   !# 4 
 .44"!" !
!!!!,"!"!  
!""!#F
G  %   !  "4  ? ! 4
!"* # 5#    ,"! "!#!
*!, 4 4* .# "  0 *!! "
!  44"* !" # *  *#
"!=",FG 
Fig. 2. Typical chromatogram of Amoxicillin (BPCRS).
Fig. 3. Typical chromatogram of Clavulanic acid (BPCRS).
Fig. 4. Typical LC chromatograms overlay of five Augmentin drugs.
."!N!4!!",!!!"#, (
2.3.5. Dissolution Test
3    ! 4   4
# *#  ! !   !!>
" in vitro FCG  7  !*!!, 4 # 4
!  3#  ,  *
""!  * # ! 4! 4  ?!,
"   ! !"!" "", 4
 ! !# 4 " ! ! ! #
*  " ** # !4  "
4#"!!
!"!*!!,4#4!
4!!#4!#,#*#
#!!4F'G 
."** !*!!, " 4 
**!*!!,4!#,
 *    %!,   
* !!  # # ! ! "
4! !" "!,  !# "
! ! F2G  -!#!" " 4
!#*!4"!! 
7! 
Table 3. Chromatographic conditions for dissolution by USP31-NF26
methodFG
Mobile phase Buffer :Methanol (95:5 v/v)
) %"!"B
-7 S-
5! 8
3"6< 
%$"*  O8
2.3.6. Uniformity of Weight Determination
7 ! # , !   ! !
!"!  !4 # F(G  % 
!4,4!!4!T!"*
#!="!" J#*!!,4
!,"!=",44"!"#*FG 
.   !  !  !"  !  
!!>!#F2G
2.3.7. Diameter and Thickness
Measurements
7 ,"!  4  ! !#  
, 4  !!   ! 4! ! 
#4! 7!
!";=>4!F(G 
2.3.8. Hardness Test
7!!  !, = !  4" ?
!;  ! FG      ! 
, 4 !  !  ! " " !
!";#!## !#  .#  44"!
 4 ! !   "!  
,"#"  !
 "  4 #  ! !# #
!";!## ! !#  !;# "# 
"#  J! !, !44" ! 4!, !
#!   % !, !44" #  !
!!!,!44"!*!!,FG
2.3.9. Disintegration Test
7 #!   *   
!  "! #!   " 
 !"  ! ?  !  =!
"FG
-#! ! "
!,4="4!#4"!#
"!!#"4!!!
!# 4!" 4;4 ! 4
! !*# !!, 4 " FG  7 #!
* # !"  ! "! 4!" !! 
#!!!"!4!!
  !  #!
! "!#  #   , 4 4 
FCG  %! !#4! !!4
!  4! ! ! !  " "  
4,FG %!
4!#! 
2.3.10. Infrared (IR)
%  !!"!   4 4"! 4
" , "# 4  4"! #    %1
!!, !  ! "! 4 ! %1 "
 ! 4 4" !! !     5#   
I"  !"?, %1  4!*  
!>-!A,N!! 
7 %1  !   , !#  !"
.# " !  .=" ! 8
"!*!! 4" !" BPCRS ,  !
" ! "  "!  C "
U
   V   ! !! " FG
7 ! ! ! !=!  
" !   .# " " 
!!*>"!
.= !-!* /-1 
2.3.11. Antimicrobial Susceptibility (Potency)
Tests [11]
7."!",4!"
!44"",4# 6!
"  ! 4   !   # 4
! ! " "#!  -,!
.!,!",4# 
  8 4 * 4 "! " 4 Staphylococcus
aureus and Escherichia coli !!84!"
   .4 # "!#!  
!!4,!!; .4!
! ";  4 !! ! ! 
"!  4   !  "! ! '-
4    .4  !! "! ! 
* 4  > 4  #  
444!" 4 ! *"!", # !
4!#!!,  ! !!= "
!#4!"#!*,
 ! ""! !!  > ! "! R 4 %
 0!& ).#et al.!!""!)*!!4!.#/!0!4!"344- 
!","!#!" ."!
> 4  !#!  ! ! *  /,
"!#   4 Escherichia coli  !>  "
!  >  ! ! 4  Staphylococcus aureus
!>!5# C 
Fig. 5. Typical IR spectra of amoxicillin trihydrat and lithium Clavulanate (BPCRS).
Fig. 6. The inhibition zone of the five Augmentin sample (GSKU, GSKI, GSKT, GSKG, GSKM) on the both type of the bacteria.
3. Results and Discussion
3.1. Results
7 ?!, "   4  44
4!!!>7!!C 
.44"!"!!""#6&5
C 2 FG  5  !!, 4 !*!# # " 
*!4#!# !" "*!,
,   ! &07 W  B ! !*! #  !
!" 4  !    !  "
*!  !  B 4  ! *!  7 !
#!* 
7";4!!!!,>7! .
#  !*  #!  ! "; 
13B4!"; B B 
7!! 4 !!!!,> 7!
! #  !*  #!  ! ! 
13B4!!' B2 (B 
7 #!  4 ! ! ! *
!4!",!!!!",#!
!  "  7 4  ! 
."!N!4!!",!!!"#, 
7! 
Table 4. Non official (Physical) tests.
Product Name Weight mg (± RSD) Diameter mm (± RSD) Thickness mm (± RSD)
Hardness N (± RSD)
Disintegration Sec.
9A6
2 W   W  ' W ' ( W2 (  '
9A7 CC W C(  W 
C (CW   'W2   
9A9
2 CW  2 W 2
C C'W  ( W2 2  
9A%
C C(W 2 ( ((W 2 ' W   W2 '  C
9A0 'C 'W '  W (
' (W   W'   
7!     4 !#  "
4, !   4  . 4  4*
!!,>!!""!!?
, 6 ! " !## 4 (    B 4
.=!-!* 344!#
!(B4!"*#* 
! " !&872 B4
.=!2B4-!* 
744!4# 
3.1.1. Official (Phar macopeial) Results
74K44"!!7!!
C 
(i). Content of Active Ingredient
7  " 4, !  ,  4
# *!!  7 !  # !""!, !
*!,!"! 5"
!"* "  !"  ! "!"! #
#  4  "  
4!  1  = ! "!# 4
"! ?!, !  !* !! *!
13B 
(ii). Dissolution
7  4 4  " ! #
#  !#!  !=" ! -!*!" !"
4" /-1  " ! #   !
( B 4  !"* # *    
7! 
Table 5. Determination of Amoxicillin & Clavulanic acid content (Assay) and (Dissolution) test.
Product Name % Content of Amox. % Dissolution of Amox. % Content of Clav. % Dissolution of Clav.
9A6
(' C (2   2(  
9A7 (C  (2 'C
(2 22  2(
9A9
(C ( (C 'C
((   
9A%
( C (C 2
   'C
9A0 ('  ( (2
 (C  
3.1.2. Non Official (Pharmacopeial) Results
7444"!!7!
!C 
(i). Weight Uniformity
7, ! 4 !" !  *!,
#  ! !!,"! !!"     
7!C 
Table 6. Uniformity of weight
Product
Name
Min weight
(mg)
Max weight
(mg)
Average weight
(mg)
RSD
(%)
9A6
C  (  2   
9A7 ( ' (2 2
CC   C(
9A9
2 ( 2( 
2 C  
9A%
  22  C C(  2
9A0 C  2( 
'C ' 0.74
(ii). Hardness
.#44"!4!,
"   !  " 4#
! !#!;#"#!
!!#!# 
.#!*#!!"
!! ! 4   !*  & !  
7!   .4" ! &   ?
4!4!",! 
(iii). Disintegration
7 ? 4  ! ! ! 'WQ- 
= ! 4 !" !  !   #!
4!!!*!4!",!!!!
", #!   " !  
7! 
(iv). Infrared (IR)
7!"#4"L %1 !! !#! Amoxicillin
trihydrat and Lithium Clavulanate (BPCRS) %1 !! 
!! ( B 74!"! ",
#!%1!"# 
(v). Antimicrobial Susceptibility (Potency)
Test
/!."0"!.!,6


4  !!, 4  #"  4.=" 
-!*!" !"  # #  -,! .!,
 !4 4  ! ! !!  7
 0!& ).#et al.!!""!)*!!4!.#/!0!4!"344- 
!7!'2!( 
Table 7. Zone of Inhibition of Samples.
Product
Name Zone of Inhibition against avg.(mm) Escherichi coli Zone of Inhibition against avg.(mm) Staphyl. aureus
9A6
C C ( 
9A7
28.47 ( '
9A9
C 2 30.10
9A% C '( ( C
9A0 ' ( ( 2'
X-"!4.= -!* F0.02µg/0.005µgG20 µL
Table 8. Zone of inhibition of standard.
Well
Number Zone of Inhibition against avg.(mm) Escherichia coli Zone of Inhibition against avg.(mm) Staphyl. aureus
 2 (  
 2 (  '
    (
   C 
.*!# (   
X-"!4.= -!* F0.02µg/0.005µgG20 µL
Table 9. Mean difference from the standards.
Well
Number Difference against (mm) Escherichia coli Difference against (mm) Staphy. aureus
9A6
2.78  2(
9A7
 (  C
9A9
 (  
9A%  C 6.24
9A0    
X-"!4.= -!* F0.02µg/0.005µgG20 µL
. "! > 4  !#!  ! !
* /,"!#4Escherichia coli !
> " !  >  ! ! 4 
Staphylococcus aureus ! >  /, ;#  
,!"*,44*" !    7!'
" ! ! ,9A  6 A#9A6
!   , !"*, C C   
" ! !  7;, 9A7 ! # ,
!"*, 2 '  !#! Escherichia coli * 
"!!%!!,!"*,
( C"!!9;!#
, !"*,    !#! Staphylococcus
aureus
3.2. Discussion
77!!C"!!!
!!,> # !!!! 4 ?!, "
, 44"! "! 6 ! !!"! 6
/ !!"! / ! )! !!"!
 ) FG ""4#!
*!,  # "!"! !" ! #!
"!!""   # "; ! !
> "4"  !" #    
" # !4!"#    ="
!!!"!!"44"!",4" 7!!,
4 4, 4 !    ""; #, !#
  4 ! !"  7! 4 44#
!, 44  ?!, !! "#  " 4
!"*#FG 
7! ! ! $"  "!"! "; #
" !";# !# !!  !
!# 5 !,! "!*
4"!"!!" J#4!,  "!!",
! 4" ! !  #   ;, 
44"!"!"!,"!4!"*
# !  "  44"!",  J! 
!4!,!  #! ! 
  . *, ! ! !, = ! "!
F'G 
.  7! !  "  !* 
"4!!"; 7,"!!!,
#!  !   "!!", 4 
!!""! 4  !  !"* #
"! 4  !>!  ! 
#!  ! !" "!#  "!"
4!" ! 4!*#!
!!*!!,4#F'2G
74!#!!,7!
!  !*!# " 4 .=  ! -!*  !# 
!!,> " !# 4 (  B    B  "
!  %!    " 4 .="
 " !  9;    "  4
-!*!! "  !*!# " ! ((  B 
."!N!4!!",!!!"#, 
*!!!#"*!
4( BY B6!!!"!FG 
7,!,4,""#,
!? 4!!4 " 
! 2 B ! 2 B 4  -!*!! ! .="
"*,   *    
!4*! 
7 4"  !" 4 !# 
 4     !!""!
?*!"!!?!," 3
#! !*!"   ! "!    "4 
 4 # #! ! " #!# 
?!, # !!,   !; " 
  4 !"  ?!, 4 #
!*!!   8,! !;  "!# 
!*!!,4#4*!" 
.#!*#!#!
  " !"!0!!
9A0 !   13 B  'B !  B 4
# 4, ! ! "; "*, !
7!!C 
7!4,!44"!",4#!,!4
"!!,!"!", 7!4
.="!-!*!!44"!
( B   B!!;!!4!"*
# !"""!!"! 
I!  44"*  "4 ,  ,
!"*,44*"!#!!!
!!4"!",4#9A6 
4. Conclusion
. ! -" !  " 4 ! ! 4
.#C#!!4!",!"!,
 44 "  "   "4"
? 4 ?!, "  4 !"! F
G !,  4, 4 # 4 !
#!!!,!!"!", 
7$"! "!  ""!"!
4*!.#!C#!4!",!
"!,  44 " , #  44"! !
44"!  6 ! !!"! /
!!"!!)!!!"!FG /,
;#   !!,"! "? ! !   
*!!"$"!4!
! " ! ",   "4"! 4 "
(  B    B  !    ! 2 B
! 2 B4  -!*!! ! .=""*, 
. " !", 4  !
4,4 #!";4, !
44"!",!!"!", 
Acknowledgement
7 !   =  #!  
3! 4 3# - !  8,! - 4 5
! 3# - -53- 9# 78,! 4
*#"?4"!,#
!" ; !  0 1!! 93  .!> .
.,!4!"! 
References
FG 8*3  0  T!8!"!! !!,!""!
!" Z-"!"#,*((2 '2 
FG J!!7 !K%  T."!!"4"
 ! ! !"!! T )! $! 4 ! ""
C' 
FG 19  & T7 ,!!";#4.# T
!"!$!*(2C.. 
FG A!  1;!1 ! . & N 6 &!! T.="
! ! " !" %N !!"  
' 
FG 3!,0 N 3!,0 N 5N 0 -,9 1 -< 
JT%!"4&%-)#"#"!4
!",!=4*44"*"!"
4 ! !4 ,[ $! 4  ."! "# 4
"!#,\( (C2'C 
FCG -44 N  ! N  T.="-!*!" !"Y
"! T."!$!4!,##,'
2 2 
F'G /!; 9   3# " 7    ! 4
!  ?!, !  ! ! 4 ! #
*, , % 9    /!; M -  7  1 )
0 !!"" & ];0!" 3;;%"   
  
F2G K,0 . .#;K . .1 / K;K . 
M %! K  .  -!!* !!, 4 # ! 4
4!= ,! !  7"! N! 4
!!""!1!"CC' 
F(G ) .# 0  .! .  / . .  . !, J 
0!! .  . 0# 7   ! !!""! !4
4*44#"!4!8,!
!; IN!4!!""!1!"
% 
FG IJ! K#!>!J*! !
!!#",9*! 
FG 6!!!"! 

  &!! 5!,C

  6 ! !!"! -* 1";*03
2 
FG /!!"!

  7!,K44" 8
6A#2 
FG N!!!!"! 70,4J! 8!!
I4!7;,N!!C 
FG 9! .  A %"  !!""%

  %!
-/M3((( 
FG .;!! I *!;! 7  !" . 
!!""! +!, 4 &4 4 "!
""!,!*!!7!! N!4J!""
 
FCG .# &  .  7!#  0  )  . ) 
!!"" 7 "" 4 !# 4 #  &
];-"8*#((C  C'C2 
 0!& ).#et al.!!""!)*!!4!.#/!0!4!"344- 
F'G .## 8  8   !# 4 % 8  I  3
) ."!!!", . " !!""!
"? ! !# 4 !! 8" 
('   
F2G & &  6>";%  MK$ )  K  +!,"
! !  , 4 "!#!, 
 " 4=!" ! !;  &#! 
"4"1!"!)!,'22 
F(G /!;9   !. & 1  7!%8  8!"!J 
. 8! MN 8 A!# ) 7,! !" 4
! !!", 6   .  8!M 5# (2C   (
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... Similarly, in a study to evaluate the pharmaceutical quality of tablets of Augmentin brands that are available in Libyan local market found that all the analyzed drugs attain standards of quality recommended by official compendia of the United States Pharmacopeia (USP), British Pharmacopeia (BP) and European Pharmacopoeia (Ph. Eur.) 20 . ...
... The recorded ranges were 21.71 mm (CU) to 23.30 mm (CL). Tablet hardness or Tablet Breaking Force is a very important quality control parameter and the accepted values for hardness of tablets are 4 to 10 26 . The friability of studied ten brands of tablets was within accepted ranges as less than 0.5% and complied with USP-NF criteria (1%) 18 . ...
... Similarly, in a study to evaluate the pharmaceutical quality of tablets of Augmentin brands that are available in Libyan local market found that all the analyzed drugs attain standards of quality recommended by official compendia of the United States Pharmacopeia (USP), British Pharmacopeia (BP) and European Pharmacopoeia (Ph. Eur.) 20 . ...
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