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Wednesday, 24 September 2014

Sterile Preparations


There are pyrogen free preparations that are subject to sterilization:        
                          1. Parental preparation.
                           2. Ophthalmic preparation.
I) Parental preparation:
are aqueous or non aqueous, sterile and pyrogen free preparations administrated by injection into the body tissues.
Advantage:

1.  It is provide rapid response (emergency)
2.  It is suitable for drug that are:
a.  Destroyed by GIT secretions e.g. insulin.
b.  Poorly absorbed by GIT.
c.   Irritation of GIT.
d.  Prolong drug action.
Disadvantage:
1.  Pain or damage at a site of injection.
2.   All products must be sterile.
3.  It is expensive.
4.  Administration by wrong route may be fetal.
5.  It needs experience personal.
Route of administration:………………………………...
…………………………………………………………………………………………………………………………………

Type of parental preparation:
·       Solution
·       Emulsion
·       suspension
Formulation of parental drugs involves of all the following factors:
1.  The route of administration.
2.  The volume of the injection.
3.  The vehicle.
4.  The osmotic pressure of solution
5.  The preservative.
6.  The pH of solution.
7.  The stability & method of sterilization.
8.  The specific gravity.
9.  Type of containers or closures.
Additive: these are the substance which are added to the parental formulation for maintain the solubility, stability, sterility, isotonicity and to facilitate the administration.
General procedure in parental preparation:
1.  The lab should be free from dust or microorganism.
2.  UV lamp to destroy the M.O.
3.   Used anti microbial agent to clean & disinfectant the lab wall.
4.  Personal should wear sterilized cloth.
5.  Borosilicate glass used for packaging because:
a.  Compatible.
b.  Thermo stable.
c.  Non reactive.
6.  Rubber closure (mixture of natural & synthetic rubber) e.g. neoprene.
Sterilization the parental preparation by:
·       Dry heat sterilization.
·       Moist heat sterilization.
·       Filtration.
Quality control of parental preparation:
1.  Sterility test.
2.  Pyrogen test.
3.  Clarity test.
4.  Leaker test.
5.  Safety test.

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