Microbiological purity testing of semisolid topical preparations. 1986

L Turakka, and T Ojanen, and T Prittinen

The reliability of the poured plate method for purity testing of three different creams and an anhydrous ointment was studied. The ability of some nonionic surfactants to elute the microbes from the semisolid preparations to water phase and possible detrimental effects of these surfactants on the microbes was especially investigated. The method was used to test the effect of preparation temperature and of storage on the number of microbes in creams. Nonionic surfactants studied did not generally harm the bacteria. Variation was, however, found between different bacterial species and even bacterial strains. The surfactants studied eluted bacteria quantitatively from the water-containing creams but not from the water-free ointment. The concentration needed for quantitative elution of microbes was dependent on the surfactant used, being lower for Brij 58 than for Tween 80. Heating of the phases up to 60 or 70 degrees C for a short time during the preparation of the creams does not ensure the microbial purity of the preparation. In creams made at 80 degrees C, however, all the bacteria had died, only the spores of B. subtilis survived this temperature. After two months storage at 5 degrees C, all microbes tested were still detected in creams. There were, however, differences in survival of different microbes. None of the bacteria multiplied during the storage, but decreased slightly in number.

UI MeSH Term Description Entries
D009824 Ointments Semisolid preparations used topically for protective emollient effects or as a vehicle for local administration of medications. Ointment bases are various mixtures of fats, waxes, animal and plant oils and solid and liquid hydrocarbons. Ointment,Paste,Pastes,Salve,Unguent,Salves,Skin Ointment,Unguents,Ointment, Skin
D004340 Drug Contamination The presence of organisms, or any foreign material that makes a drug preparation impure. Drug Adulteration,Drug Contamination, Chemical,Drug Contamination, Microbial,Drug Contamination, Physical,Drug Impurity,Adulteration, Drug,Chemical Drug Contamination,Chemical Drug Contaminations,Contamination, Chemical Drug,Contamination, Drug,Contamination, Microbial Drug,Contamination, Physical Drug,Contaminations, Chemical Drug,Contaminations, Microbial Drug,Contaminations, Physical Drug,Drug Adulterations,Drug Contaminations,Drug Contaminations, Chemical,Drug Contaminations, Microbial,Drug Contaminations, Physical,Drug Impurities,Impurity, Drug,Microbial Drug Contamination,Microbial Drug Contaminations,Physical Drug Contamination,Physical Drug Contaminations
D005079 Excipients Usually inert substances added to a prescription in order to provide suitable consistency to the dosage form. These include binders, matrix, base or diluent in pills, tablets, creams, salves, etc. Excipient,Stabilizing Agent,Stabilizing Agents,Suspending Agent,Suspending Agents,Agent, Stabilizing,Agent, Suspending,Agents, Stabilizing,Agents, Suspending
D001419 Bacteria One of the three domains of life (the others being Eukarya and ARCHAEA), also called Eubacteria. They are unicellular prokaryotic microorganisms which generally possess rigid cell walls, multiply by cell division, and exhibit three principal forms: round or coccal, rodlike or bacillary, and spiral or spirochetal. Bacteria can be classified by their response to OXYGEN: aerobic, anaerobic, or facultatively anaerobic; by the mode by which they obtain their energy: chemotrophy (via chemical reaction) or PHOTOTROPHY (via light reaction); for chemotrophs by their source of chemical energy: CHEMOLITHOTROPHY (from inorganic compounds) or chemoorganotrophy (from organic compounds); and by their source for CARBON; NITROGEN; etc.; HETEROTROPHY (from organic sources) or AUTOTROPHY (from CARBON DIOXIDE). They can also be classified by whether or not they stain (based on the structure of their CELL WALLS) with CRYSTAL VIOLET dye: gram-negative or gram-positive. Eubacteria
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

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