Types of parenteral products
Injections are sterile, pyrogen free solutions or dispersions (emulsion or suspension) of one or more drugs in a suitable solvent. Injections are prepared using aqueous solvent if possible.
Injections which are formulated as dispersion (emulsion or suspension) should be stable so that after shaking a homogenous dose of drug can be withdrawn. Single dose injections should not have antimicrobial agent or preservative and injections having antimicrobial agent should not be given by intracisternal, intrathecal, epidural route. Multidose injections have a suitable antimicrobial agent in sufficient concentration. The multidose containers are equipped to ensure protection of the contents after partial withdrawn. The contents of multidose preparations generally should not exceed 30ml to minimize the risk of contamination due to multiple penetrations of the closure. Example: Insulin injection
These are sterile, pyrogen free aqueous solutions or emulsions (O/W type) usually prepared to be isotonic. These are prepared for administration in large volume (more than 100ml) and do not contain any antimicrobial agent or preservative. Example: Dextrose solution
Powder for injections or sterile powders:
Drugs which are not stable in solution form are prepared as dry sterile solids which are dissolved in water for injection just before administration. Sterile powders may be prepared by freeze-drying, sterile recrystallization or spray drying methods. Example: Cefuroxime sterile powder
Concentrate for injections:
These are sterile, pyrogen free solutions which are diluted with prescribed volume of sterile water for injection at the time of administration.
These are sterile solid preparations having one or more drugs placed into the body subcutaneous or intramuscular tissues by a minor surgery. These provide controlled release of the drug over a period of time at the site of implantation. Example: Probuphine