| title for liquid preparations that are drug substances or solutions thereof | [Drug] Injection |
| title for liquid preparations of solids suspended in a suitable liquid medium | [Drug] Injectable suspension |
| - title for liquid preparations of drug substances dissolved or dispersed in suitable emulsion medium | [Drug] Injectable emulsions |
| - dry solids + suitable vehicles → solutions conforming in all respects to the requirements for injections | [Drug] For injection |
| - dry solids that + suitable vehicles
→preparations conforming to the requirements for Injectable Suspensions | [Drug] For injectable suspension |
| SPECIAL CONSIDERATIONS ASSOCIATED WITH PARENTERAL THERAPY | 1 Look-alike Products
2 Adsorption of Drugs
3 Handling and Disposal of Chemotherapeutic Agents for Cancer |
| Does not enter into the circulatory system
Packaged as LVP | IRRIGATION AND DIALYSIS SOLUTIONS |
| - intended to bathe or wash wounds, surgical incisions, or body tissues | Irrigation Solutions |
| - separations of substances from one another in solution by taking advantage of their differing diffusibility through membranes
- Peritoneal Dialysis and Hemodialysis | Dialysis Solutions |
| EXAMPLES OF IRRIGATION SOLUTIONS | 1 Acetic Acid Irrigation, USP
2 Neomycin and Polymixin B Sulfates Solution for Irrigation, USP
3 Ringer’s Irrigation, USP
4 Sodium Chloride Irrigation, USP
5 Sterile Water for Irrigation USP |
| Some precautions observed during manufacture, storage & use of products to prevent entry of contaminants | 1 Once opened, ampul cannot be resealed, unused portion not retained & used (content loss sterility)
2 Prime requisite of parenteral soln: clarity
- sparkling clear & free of particulate matter
3 During mfture, parenteral soln is filtered before it goes into the container
4 Containers are selected:
- Chemically resistant to the soln
- Highest quality to minimize chances of container components leaching into the solns
5 During container filling – use laminar flow hoods
6 Personnel mfg parenterals
- provided with monofilament fabrics (does not lint), face hoods, caps, gloves & disposable shoe covers to prevent contamination
7 After filling & sealing: visual/automatic inspection for particulate matter
- clarity : test requirement done to avoid distribution & use of parenterals that contain particulate matter |
