Journal of parenteral science and technology : a publication of the Parenteral Drug Association最新文献

The stability of cefazolin 1 g in metronidazole 500 mg/100 mL at 8 degrees C was studied for use as an IV admixture. The commercially available injection of cefazolin sodium 1 g vial was diluted to 5 mL with 0.9% sodium chloride injection and added to metronidazole 500 mg/100 mL. Following dilution of 2 mL to 100 mL with water, 1-mL aliquots were transferred to glass vials, refrigerated at 8 degrees, and assayed for cefazolin and metronidazole concentration at 0, 1, 2, 4, 8, 12, 24, 36, 48, and 72 hours after preparation. The concentration of cefazolin and metronidazole was determined by a stability-indicating high-performance liquid chromatographic method. The range of concentration was determined to be within 5% of the 0-hour mean concentration. Over the 72-hour period, the mean concentration of cefazolin at all assay times was within 98.4 to 101.0% of the initial concentration. The mean concentration of metronidazole at each assay time was 96.9 to 104.9% of the initial concentration. Cefazolin sodium 10 mg/mL and metronidazole 5 mg/mL, prepared by adding reconstituted cefazolin to a glass bottle of metronidazole ready-to-use solution, were stable for 72 hours when stored at 8 degrees C.

The objective of this study was to characterize the effect on particle size and stability of oil-in-water emulsion formulations caused by the addition of polyhydroxy alcohols. Stable soybean oil and hexadecane emulsions were prepared containing increasing amounts of propylene glycol (PG) and glycerol (GLY). A nonionic emulsifier system consisting of Tween 80 and Span 80 was used to achieve optimal stability. Particle size was found to decrease as the level of PG or GLY increased. A three-fold particle size reduction was obtained at a PG level of 40% w/w and at a GLY level of 70% w/w. The particle size of soybean oil emulsions decreased from about 4.8 microns to about 1.7 microns. The particle size of hexadecane emulsions decreased from about 2.7 microns to less than 1 micron. The increase in emulsion viscosity was found to be proportional to the amount of polyhydroxy alcohols added to the formulation. The particle size and creaming stability of the emulsions were found to improve with increasing PG or GLY concentration.

The mechanical properties of frozen mannitol, L-iditol, dulcitol, and sorbitol solutions were measured as a function of temperature during warming (after freezing) using a thermal mechanical analyzer (TMA). The mannitol sample first underwent a contractive phase starting at 30 degrees C and ending at -25 degrees C. This was followed by an initially rapid, then less rapid expansive phase which continued until melting occurred. These events provide direct evidence that mannitol solutions undergo an expansion during warming after "fast" freezing and also corroborate the vial breakage observed when mannitol solutions are frozen and thawed or freeze-dried in glass vials. Of the other stereoisomers studied, only dulcitol had an expansive phase although at a slower rate than mannitol. Its solution was found to cause vial breakage also but only at fill volumes higher than mannitol fill volumes. TMA is a useful technique for studying dimensional changes in the frozen state, with important implications for solving vial breakage problems in freeze-drying.

Today's demand for higher quality products can be satisfied through a comprehensive quality assurance system (Total Quality System, "Worldwide Quality Standard") using the latest state of the art measuring technologies. Totally automated state of the art glass vial manufacturing begins once the glass tubes are loaded into the machine and ends with the finished product in the packaging machine, all without human contact. This standard is achieved by measuring dimensions with SPC (statistical process control) and 100% inspection of the products. These systems complement each other and give the machine operator instant data in an overview format. To achieve the visual requirements forma vitrum developed the FVC90 control line. This optical surface inspection device controls online and without contact 100% of the products for cosmetic defects as small as 50 microns. It can detect and eject defects such as dirt, scratches, chips, air-lines, loose glass particles, cracks, etc. The sensitivity of the system can be adjusted and is fixed based on client needs. An important quality assurance technique is the checking of dimensions at the production machine with a Vision System. With this system deviations are instantly recognized and corrections can be made immediately, thus assuring that glass products can be run on the high-speed filling machines for which they are designed. These computer assisted inspection systems are key in producing the highest quality pharmaceutical glassware in the 90's.

The purpose of this presentation is to describe the theoretical relations for the dispersal of airborne contaminants and to illustrate the validity of these equations occurring during factual situations, where a number of observations on air movements in open unidirectional air flow units supplied with HEPA-filters are described. In factual situations the aerodynamic system which governs the dispersion of contaminants in reality is always very complicated that risk situations must be mapped and assessed empirically. The presence of a person can give risk to wakes that may be stable or unstable. The unstable situations are in most cases caused by the influence of arms and hands. As part of the microbiological assessment of aseptic processes carried out in clean zones, it is important to investigate that such vortices do not occur in the clean working areas. As the level of airborne contaminants in the operational environment may have an effect on the level of product contamination, the microbiological assessment of aseptic processes is important. A system is described for microbiological assessment in unidirectional air flow units by using visual illustrative methods and particle challenge tests (measured by particle counter) for the dispersion and/or induction of particles.