Biomaterial Database

The effect of residual moisture in lyophilized smallpox vaccine on its stability at different temperatures. 1972

J D Sparkes, and P Fenje

In a study of the influence of residual moisture on the potency of freeze-dried smallpox vaccine, vaccine lots with moisture contents between 0.36% and 6.7% were used. These lots were stored at 4 degrees C, 24 degrees C, and 37 degrees C for up to 6 months, or were exposed to 100 degrees C for up to 3 hours, and were sampled at regular time intervals for assay. No loss in potency occurred at 4 degrees C where the moisture content was 4.8% or less. At 24 degrees C the critical moisture level was 2.5%, and at 37 degrees C it was 0.36%. At 100 degrees C the potency loss was more rapid and there were significant losses after 1 hour at a moisture level of 2.4% or more. A residual moisture content of less than 1% seems to be essential for satisfactory storage of freeze-dried smallpox vaccine.

UI	MeSH Term	Description	Entries
D004355	Drug Stability	The chemical and physical integrity of a pharmaceutical product.	Drug Shelf Life,Drugs Shelf Lives,Shelf Life, Drugs,Drug Stabilities,Drugs Shelf Life,Drugs Shelf Live,Life, Drugs Shelf,Shelf Life, Drug,Shelf Live, Drugs,Shelf Lives, Drugs
D005612	Freeze Drying	Method of tissue preparation in which the tissue specimen is frozen and then dehydrated at low temperature in a high vacuum. This method is also used for dehydrating pharmaceutical and food products.	Lyophilization,Drying, Freeze,Dryings, Freeze,Freeze Dryings,Lyophilizations
D012900	Smallpox Vaccine	A VACCINIA VIRUS vaccine used for immunization against SMALLPOX. It is now recommended only for laboratory workers exposed to SMALLPOX VIRUS. Certain countries continue to vaccinate those in the military service. Rare complications most often associated with older generation smallpox vaccines include VACCINIA, secondary bacterial infections, and ENCEPHALOMYELITIS. Because MONKEYPOX VIRUS and SMALLPOX VIRUS are both ORTHOPOXVIRUS and are closely related smallpox vaccines provide effective CROSS-PROTECTION against MPOX (MONKEYPOX) (https://www.cdc.gov/poxvirus/monkeypox/clinicians/smallpox-vaccine.html).	Monkey Pox Vaccine,Monkeypox Vaccine,Monkeypox and Smallpox Vaccine,Mpox Vaccine,Mpox and Smallpox Vaccine,Small Pox Vaccine,Smallpox and Monkeypox Vaccine,Smallpox and Mpox Vaccine,Vaccinia Vaccine,Vaccine, Monkey Pox,Vaccine, Monkeypox,Vaccine, Mpox,Vaccine, Small Pox,Vaccine, Smallpox,Vaccine, Vaccinia
D013696	Temperature	The property of objects that determines the direction of heat flow when they are placed in direct thermal contact. The temperature is the energy of microscopic motions (vibrational and translational) of the particles of atoms.	Temperatures
D014867	Water	A clear, odorless, tasteless liquid that is essential for most animal and plant life and is an excellent solvent for many substances. The chemical formula is hydrogen oxide (H2O). (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)	Hydrogen Oxide