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Parenteral Preparations

2015 - 2014


Parenteral Preparations
* Definition
* Types of Injection
*
* Properties of Parenteral Preparations
-1
-2
-3
-3-1
-3-2
-4
-4-1
-4-2
-4-3
-5
-1
-2
-3
-6 Sterility
-7 Pyrogenes
* Solvents and Vehicles for
Injection
-1 Solvents for Injection
-1-1 Sterile Water for Injection
-1-2 Nonaqueous Solvents
-1-2-1
-I Vegetable oils
-II
-1-2-2
-I
-II )(PEG
-III
-2 Added Substances for Injection
-2-1 Added Substances
-2-1-2
-2-1-3
-2-1-4
-2-2 Antioxidants
-2-2-1
-2-2-2
-I
-II
-III
-IV
-V
-VI
2

-2-2-3
-
-
-2-3 antimicrobial agents
-2-3-1
-2-3-2
*
*
*
*
-1
-2
-2-1
-2-2
-2-3
*
-1
-1-1
-1-2 ) (
-1-2-1

-1-2-2
-1-2-3 Antioxidants
-1-2-4
-1-2-5
-1-2-6
-1-2-7
-2
-2-1
-2-2
-2-2-1
-1
-2
-3
-4
-5
-6
-2-2-2
-2-3
-2-4
-2-5
-1
-2
-3
-4


Parenteral Preparations
* Definition
)( Solutions Suspensions
Emulsions .Sterile
.
.
.1908
.
Pravaz .Limousin Pasteur

.
*

. :
) ( )Intravenous Route (I.V.
) ( )Intramuscular Route (.I.M
)Subcutaneous Route (.S.C
)Intradermal Route (.I.D
Intra-articular Route
Intra-spinal Route
Intra-arterial Route
Intra-cardiac Route


.
. 4
.
.
.
1 ) (15000
G )
(.
*
)

(

) . / .


:1 G 15000

.

:
5

-1 )
(
) (......
-2 :
- .
- .
-

.
-3

.
-4 .
-5

.

:
-6

.
-7 .
*

.


) (
.
-1

.
.


.

.

.
.

:
...
-2

....
.
.

.
6



.

.
-3
-3-1

.

.

)
(... .

.

.
" "
.
-3-2
:
-1 ) (

)( .
.
-2
.
.

.

:
.
. ) (...
.
.
. -4 pH
) (pH :
. . .7

. 7.40 - 7.35


.
) (7
.

: 4- 3.5
3.5 - 2.5 .

. 7.3
) (.... ) (...
) (..,Mg, Bi
) .(....
.
) ( .


.
.
-4-1
:
. . : -1 .3
.
. ) .(... )(...
"
" . .
) (2
. )( .
2 6.8
. .

. 2.5 4.5
.1 3.24 4.10
5.2 ...


:2 6.8

-4-2

.

4 .10
.

.

.

.

.
.

" "
.

.

.

"
"
) (.
-4-3
.

.

.
-5
-5-1
9


iso-osmose .iso-tonie

.
.

.
.


.


.



.



.

%5
.%10

) (% 47 45
% 10.5 ) .(3
%10 %5
)
%80 .(%5
)
(%10
) %10 %5 %5
( .

.


.

.

.

10

100 /
:3 .
-5-2


.
.
)
(.
0.1

) %0.45 ( ) %2.7
(.
% 1.35 .
-5-3

:
:1 1
% .
0.74 :
%
=

-
1

0.52
0.09
0.58

= 0.74


100

2
: = = .0.52
= 1 % 1 )
( = .0.09
= 2 % 1
) ( = .0.58
:2 %2
)( .
:
=
17

=
17

3.4
272.17

= 0.21

0.42 = 2 0.21
: = 1 ) ( =
0.21

= = 3.4
= = 272.17
11

100
0.48 ).(0.48 = 0.42 - 0.9
-6
.

.
.
.

.
.
.
: 160 180.

.
150
.
120 .
: 30 120 .
.

.
: 100 .

) .( .P.B.V
: )
% 0.2
(
) ( 30 .100 -98

15 .
.
: 80 )
( . 60
) ( .
30 .
.
.

.

12

: .
.

) .(..
: .
. .
: .
.
:
-7 Pyrogens

) 10( .
.

.

)180 - 200( . .
:
.


.
.

.
.
.
180 .
.

. .
*
-1
-1-1



.

.
13


.


.
:
(1
)
( .
(2
. :
. ) ( .
.
(3
.
(4
.
-1-2

.

.
.
) (...
) .(....


.
.

:
(1

.
(2
.
(3
.
(4 .
.
(5 .
(6
) (
.
-1-2-1
14


.

....
-I

.


.
.
)
(.
:
...
.
.
.


.
-II
.

)
( .
)5( .
.

.
.
-1-2-2

:
-I
5
.% 55
. % 50 - 40 .

) (
.

15


. .
) ( .

)( .

.
-II )(PEG
200
600 . PEG 300 .PEG 400
.
PEG

.
-III

.

.

.
.
-2
-2-1


.
.
) (
) ( )
(.

. :
.Co-solvents .Hydrotropes .Tensio-actifs .Complexants -2-1-1 Co-solvents

.

.

16


.

: 1.2 / . 13/
. 90
10 2.38 /:
x 0.9 = 1.08 1.2
x 0.1 = 1.30 13
2.38 /
1.9 /.

.

.
-2-1-2

. .
.

.
.

: )
( .

. )
( .

.
-2-1-3

.

) (.

) ( .
) .(4

)(4

17

.
) ( ) .(5
) .(6

)(6

)(5

5 200
.
.
.

.



.
.

:
80 60 40 20 .
Cremophor EL .
-2-1-4

.
:
. .
.
-2-2
)
1 (...
.

)
( .

.
-2-2-1

18

:

.
) (
.....
) (OH):(H
RH R + H
) (
) (RO
) (RH ) (ROOH )
(R .
:
R + O RO
2

R O2 + RH ROOH + R
) (
) (
:
R + R R - R
R+ RO2 R - O2 R
-2-2-2

.
:
)
(....
.
.
-2-2-2-1


.

7 )(
) 5(
.
3 5
.

19


:7 )( .pH
-2-2-2-2


) (.
-2-2-2-3
)
400 (
) (
.
.

.
.
-2-2-2-4

. .



.
)
(.

.EDTA
-2-2-2-5
)
( .
.



.
-2-2-2-6


.

) R (RO2
) ( .

:
In H + R RH + In
20

In H + RO2 ROOH + In
In ) (In H
) R
RO2 (
.
-2-2-3
-2-2-3-1

.
)
(
.


% 0.1 .
% 0.2 .
) 1 /(
10.
)
( .


.

) (.
1
.
:
....
1
. )
( . . .
-2-2-3-2
:
.
.
)
( . ) (BHT )
(BHA %0.01
.
.%0.1

.
BHA

21

BHT
.
-2-3



.

.
-2-3-1



.
:
) ( .
:
.

.

.
.
) 5 6
(
.

) (

.

.


.
.

.
.

.
.
-2-3-2

:

% 0.5
.
.75 / 25
.

22


) ( )(
.% 0.3
.
67 / 33 15 / 85 .
.

. .% 0.5

. .
% 0.5
.

0.002 .%0.004

) (
)( .
.


.
.% 0.15

23

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