This is the first article on Injection dosage form and in coming days i will be writing very good articles on injection dosage form which will provide you a basic knowledge on Injections .
Preparation of water for injection:
An injection is a product which is required to be administered by a hypodermic needle through one or more layers of skin.
Injection dosage form should meet and comply with following specifications
1.Must be sterile , free from microbial contamination
2.It should be completely free from Pyrogens , i have given over this blog about what are pyrogens .
3.Injections should be free from particulate matters.
Basic composition of a Injections
1.Active medicament , active ingredient
Vehicle most frequently used for injections or parantral dosage form is water for injections .
Pyrogens are organic metabolic waste of microorganisms or dead micro organisms ,it is produced mainly by bacteria and moulds .
Most potent pyrogens are produced by by gram negative organisms (Bacterial endo-toxins).
Pyrogens are generally lipopoly saccharides and some times are in conjugation with peptides,the lipid portion is responsible for pharmacological action and polysaccharides moiety is responsible for its solubility in water.
Molecular weight ranges from 15000 to 4000000 .Pyrogens are highly water soluble , they are responsible for producing raise in body temperature and chills , Cutaneous vasoconstriction , rigours ,aches, rise in arterial blood pressure , these responses to pyrogen varies from route of administration and amount of indictable preparation administered.Most sever effect is seen on large volume parantral administration by IV route which is critical to patients.
Major sources of contaminations are :
How to eliminate pyrogens in injectable dosage form
1.Dry heat sterilisation
By using Heat , heat the material which we want to make pyrogen free for following conditions
A. 180 ºC FOR 3 to 4 Hours
B. 269 ºC FOR 45 mins
C. 600 ºC for 1 mins
Vehicle being ( Here we most refer to water for injection ) used for injection preparation is rendered sterile and pyrogen free by method of distillation,
Water may be pretreated by passing through Charcoal bead and ion exchange resin , during distillation Kmno4 can be added in water which is required to be distilled for destruction of oxidisable impurities , and it also serves as a checke for efficiency of distillation.
We should through away first 10 to 20% of distillate as it may contain dissolved gases , also
the last 5 to 10 % of water of remaining water should not be distilled to carry over of decomposed product if any .
Distillate (Pure distilled water ) should be collected in pyrogen free sterile container and stored at 80 ºC for or 50 ºC for period not exceeding 24 hrs .
Tanks used for storing pyrogen free distilled water should have UV lamps to ensure sterility, and water should not be allowed to remain stagnant , it should b in continuous circulation loop.
Read my earlier article on reverse osmosis for production of water for pharmaceuticals
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Detailed information about Injections , injectable dosage form , its requirements of c gmp for injections.Good manufacturing practice guide for pharmaceuticals manufacturing
Quality assurance for pharmaceuticals