Top 5 Injectable Types For Parenteral Products
The U.S. Pharmacopeia recognizes the following types of parenteral products. Solutions are the most common type of injectable, as emulsions and suspensions are difficult to formulate with easy injectability.
#1: A drug injection
A drug solution that is ready for injection.
#2: A drug for injection
A dry solid that becomes a drug solution for injection after being mixed with an appropriate solution.
#3: A drug injectable suspension
A liquid preparation of a drug solid suspended in a liquid medium.
#4: A drug for injectable suspension
A dry solid that becomes a drug suspension for injection after being mixed with an appropriate solution.
#5: A drug injectable emulsion
A liquid drug preparation where the drug substance is dissolved or dispersed in an emulsion medium.
What is the difference between a solution, an emulsion, and a suspension?
In the context of injectables, a solution is a homogeneous mixture. In other words, the drug substance is soluble in the liquid until it is mixed in such in such a way it dissolves into a uniform solution. An emulsion is a suspension of droplets of one liquid in another. Emulsions occur because the two liquids are incapable of mixing into a homogenous solution. For an emulsion, the drug is included in one of the two liquids. A suspension is a heterogeneous mixture. In a suspension, insoluble drug particles are dispersed throughout a liquid without mixing. In other words, the solid drug particles are suspended in the liquid.
Exceptions for biological injectables
Pharmacopeial definitions for sterile injectables do not apply to biologics because of their unique nature and licensing requirements.
How are injectables packaged?
Parenteral products can be packaged as large and small-volume injections. Any product 100 mL or less is a small-volume injection. All large-volume injectables must be terminally sterilized. However, most small-volume injections are not terminally sterilized. Injectables can also be packaged as pre-filled syringes or as pharmacy bulk packages. A pharmacy bulk package contains multiple single doses of either a drug injection, drug for injection, or drug injectable emulsion. Suspensions are not included in pharmacy bulk packages, and each dose is penetrated only once with a sterile device to dispense its contents.
Summary
Overall, the U.S. Pharmacopeia recognizes drug injection, a drug for injection, drug injectable emulsion, drug injectable suspension, and a drug for suspension as five types of parenteral products. These five types of parenteral products do not apply to biological injectables due to their unique nature. Solutions are homogeneous mixtures with the drug substance, while emulsions and suspensions are heterogeneous mixtures. Parenteral products are packaged as large-volume injections, small-volume injections, pre-filled syringes, and pharmacy bulk packages. It is essential to know which type of injectable your pharmaceutical product falls into and how you would like to package your injectable to obtain the best manufacturing process to preserve the sterility and functionality of your injectable product.
MycoScience is a contract manufacturing organization specializing in sterile syringe and vial filling. MycoScience also offers Preservative Efficacy Testing, Sterilization Validations, Bioburden Testing, Cleaning Validations, Microbial Aerosol Challenge Testing, Accelerated Aging, Microbiology Testing, Cytotoxicity Testing, Bacterial Endotoxin Testing, EO Residual Testing, Package Integrity Testing & Environmental Monitoring services medical devices and allied industries. MycoScience is an ISO 13485 certified facility.
References
Michael J. Akers. Sterile Drug Products Formulation, Packaging, Manufacture, and Quality. Drugs and the Pharmaceutical Sciences. Informa Healthcare. 2010.
