Choice of glass packages for parenteral products.
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Drug Packaging↗
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Purchasing and inventory control--past, present, and future.
Factors that have affected hospital pharmacy purchasing and inventory control functions are discussed, and future trends are suggested. The concepts of the pharmacy and therapeutics committee and the hospital formulary system stemmed from early hospital pharmacy practice standards that were promulgated about the time drug products began to proliferate. Brand standardization, restricted drug-use policies, and selection of therapeutic alternates are among the approaches P & T committees have devised to hold down hospital drug costs; these efforts will expand. Brand-comparison advertising, use of various incentives to physicians and pharmacists, premarketing publicity about new products, improved product packaging, and support of research studies are among the promotional tactics pharmaceutical manufacturers have employed and are likely to expand. Government legislation and regulations that have had the effect of increasing the cost of drugs may be modified. Hospital pharmacists should monitor developments such as these to prepare themselves for the challenges in their purchasing and inventory control responsibilities.
Drug Industry↗
[Liquid storage media for vascular prosthesis of biological origins : their impact on biocompatibility (author's transl)].
Unlike synthetic arterial substitutes which are supplied as presterilized, dry-packaged products with potentially indefinite shelf lives, arterial prosthesis of modified biological origin must stored in less convenient liquid preservative media. These preservatives can affect the post-implantation performance and the biocompatibility of the devices. In order to identify the most suitable media, a modified "in vitro" cell culture test method was developed. It makes use of endothelial cells prepared from the aorta of chick embryo. In general, the prosthesis stored in liquid media had a disappointing performance from the point of view of neo-endothelium development and adhesion. Residual cytotoxicity was also noted for most of these currently used prosthesis storage and pre-surgical preparation protocols. Although devices stored in physiologic media showed adequate biocompatibility according to this cell culture test, it appears that neo endothelialization does not proceed concurrently with healing. Cellular development where present, adheres poorly to the substrate and cannot resist the shear forces of normal blood flow. Pre-implantation treatment of such prosthesis with cellular growth-promoting substances may enhance cell-prosthesis adhesion.
Animals↗
Sprotte needle introducers.
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Anesthesia, Spinal↗
A cost analysis of approved antiretroviral strategies in persons with advanced human immunodeficiency virus disease and zidovudine intolerance.
Treatment with zidovudine has been standard therapy for patients with advanced HIV infection, but intolerance is common. Previously, management of intolerance has consisted of symptomatic therapy, dose interruption/discontinuation, and, when appropriate, transfusion. The availability of new antiretroviral agents such as didanosine as well as adjunctive recombinant hematopoietic growth factors makes additional strategies possible for the zidovudine-intolerant patient. Because all of these agents are costly, we evaluated the cost implications of these various strategies for the management of zidovudine-intolerant individuals within a population of persons with advanced HIV disease. We performed a decision analysis using iterative algorithmic models of 1 year of antiretroviral care under various strategies. The real costs providing antiretroviral therapy were estimated by deflating medical center charges by specific Medi-Cal (Medicaid) charge-to-payment ratios. Clinical data were extracted from the medical literature, product package inserts, investigator updates, and personal communications. Sensitivity analysis was used to test the effect of error in the estimation of parameters. The models predict that a strategy of dose interruption and transfusion for zidovudine intolerance will provide an average of 46 weeks of therapy per year to the average patient at a cost of $5,555/year of therapy provided (1991 U.S. dollars). The models predict that a strategy of adding hematopoietic growth factors to the regimen of appropriate patients would increase the average amount of therapy provided to the average patient by 3 weeks (6%) and the costs attributable to therapy by 77% to $9,805/year of therapy provided.(ABSTRACT TRUNCATED AT 250 WORDS)
Acquired Immunodeficiency Syndrome↗
Current status of interactive multimedia education in medicine.
This article describes a subset of interactive medical education software that is representative of currently available products. Packages are now being produced with a variety of languages and "authoring" programs and have been distributed over CD-ROMs, floppy disks, and laser videodiscs. The developers and distributors include individuals, universities, pharmaceutical companies, publishers, and software companies. The target audiences are physicians, allied health workers, patients, and students. Software development is currently being encouraged by the recognition, on the part of several professional organizations, of the need to use computers in medical education.
Audiovisual Aids↗
[Encasing evaluation: studies of dust retention and water permeability].
The use of allergenproof mattress casings for those allergic to house-dust mite is a vital component of therapeutic concepts concerning the avoidance of allergens. Encasings of different materials are available from a variety of manufacturers on the German market. The goal of this study was to investigate different encasing materials to test for their impermeability to dust and permeability to water vapour ("breathability"). Material samples from nine different manufacturers as well as one additional samples were tested by two independent institutes. The samples were coded with serial numbers and the product names and manufacturers were unknown to the testers. The degree to which particles could penetrate the materials (as a measure of dust penetration) was tested in two series of experiments using the naturally available ambient air and fine coaldust. A thermo-regulation model ("skin model") was used to test the materials for water vapour permeability. The results of three of the nine samples tested for particle penetration have to be considered unsatisfactory due to the number and size of the particles allowed to enter. Overall an additional synthetic layer appears to improve the materials capacity to prevent dust penetration. The water vapour permeability of three of the nine samples of encasing material must be classified as unsatisfactory with the consequence of possible sleep disturbance. From an allergological point of view, minimal particle penetration is an essential criteria. On the other hand, low water vapour transport properties can diminish the patients willingness to comply. The present study cannot be substituted for a clinical study of effectiveness but nonetheless reveals, in some cases, considerable differences in the physical properties of the various materials. It would be desirable for the individual product packaging to feature a declaration of the relevant test data, thus providing decision-making for those buying or prescribing.
Allergens↗
Overproduction and purification of the products of bacteriophage T3 genes 18 and 19, two genes involved in DNA packaging.
The products of gene 18 (gp18) and gene 19 (gp19) of bacteriophage T3 are noncapsid proteins involved in DNA packaging. A restriction fragment containing gene 18 or 19 was cloned into the plasmid vector pNT45 under the control of the inducible leftward promoter (PL) of phage lambda. Induction of transcription of gene 18 or 19 by derepression of the PL promoter led to the synthesis of a high level of gp18 or gp19. By using complementation of T3 DNA packaging in vitro as an assay, gp18 and gp19 were purified to near homogeneity. The overall yields of gp18 and gp19 were 1.4 mg and 0.35 mg, respectively, from 1 g wet wt cells. Addition of gp18 to the in vitro DNA packaging system resulted in increased phage production with increasing amounts of gp18 until 10% of the DNA was packaged into infectious phage particles. In contrast, addition of gp19 to the packaging system initially caused an increase in phage production, but increasing amounts of gp19 inhibited DNA packaging.
Cloning, Molecular↗
Mutations of RNA and protein sequences involved in human immunodeficiency virus type 1 packaging result in production of noninfectious virus.
To identify RNA and protein sequences involved in packaging of human immunodeficiency virus type 1 (HIV-1), various mutations were introduced into the viral genome. Portions of the human immunodeficiency virus type 1 genome between the first splice donor site and the gag initiation codon were deleted to investigate the RNA packaging site (psi). Point mutations that alter cysteine residues in one or both zinc finger motifs of p7, a cleavage product of the gag precursor, were created to study the role of the gag zinc fingers in packaging. The psi site mutants and the gag mutants exhibited similar phenotypes. Cells transfected with the mutant genomes, while expressing normal levels of human immunodeficiency virus type 1 RNA and proteins, produced viral particles that were normal in protein content but lacked detectable viral RNA. These mutant virions were unable to productively infect cells. The combination of human immunodeficiency virus type 1 packaging mutations should minimize fortuitous assembly of infectious virus and may provide a means to produce noninfectious particles for candidate vaccines.
Amino Acid Sequence↗
The effect of modified atmospheres and packaging on patulin production in apples.
This study was undertaken to determine the effectiveness of modified atmospheres and packaging materials on the growth of Penicillium expansum and patulin production in apples. Granny Smith apples were surface sterilized with 76% ethanol and inoculated with 0.1 ml of a 1.1 x 10(7) spore/ml P. expansum spore suspension. The apples were packaged either in polyethylene (PE) or polypropylene (PP) and treated with three different gas combinations, viz., 58% CO2/42% N2, 48% CO2/52% N2, and 88% CO2/12% N2, and were then incubated for 14 days at 25 degrees C. Fungal growth was monitored every 2 to 4 days by measuring radial growth from the point of inoculation. After the 14th day, apples were pulped, and patulin was extracted, purified, and quantified by high-performance liquid chromatography. PP did not inhibit fungal growth in any of the atmospheres tested, and it only inhibited patulin production in atmospheric gas and 58% CO2/42% N2. PE was very effective and inhibited fungal growth by four- or fivefold, depending on the modified atmosphere. Patulin production in PE-packaged apples was almost completely inhibited by all three gas combinations. Gas chromatographic analysis of the PE-packaged samples before and after the incubation period showed that CO2 levels dropped and N2 levels increased for all of the atmospheres tested. Our studies showed conclusively that PE is an excellent packaging material for the storage of apples since it inhibited the growth of P. expansum, thereby allowing <3.2 microg/ml of patulin to be produced, regardless of gaseous environment.
Carbon Dioxide↗
Strategy for determining extractables from rubber packaging materials in drug products.
The migration of substances from rubber packaging materials into drug products can be significant with certain packaging materials in contact with organic solvent systems. Recommendations for testing drug products for leachables are continually evolving to address new developments. Testing packaging materials using simulated solvents is not always an acceptable protocol for the pharmaceutical industry. We describe a rational strategy for evaluation of the drug product for packaging extractables. A profile of the extractables from rubber packaging materials was made with a range of organic solvents and stress conditions to provide information on substances to target in the drug product. The drug product was evaluated to determine if the matrix would cause interferences that might inhibit detection of the found extractables. Analytical methods were selected based on these findings. The procedures were validated according to FDA guidelines. A stability program using time and storage conditions as variables provided information for acceptance criteria. This same strategy can be used on other types of pharmaceuticals and packaging materials.
Drug Packaging↗
Interaction of ionising radiation and acidulants on the growth of the microflora of a vacuum-packaged chilled meat product.
Microbiological effects of gamma irradiation dose of 2 kGy, with and without reduction of pH to 5.3-5.2, have been investigated with a vacuum-packaged, minced meat product prepared from pork and beef with spices and cereal fillings. Either glucono-delta-lactone or ascorbic acid were used as acidulants. Experimental batches were stored at 0-2 degrees C for 4 weeks. Effect of temperature abuse condition was also studied by transferring packages for one week to 10 degrees C after 2-week holding at 0-2 degrees C. The irradiation caused two decimal reduction of the aerobic viable cell count determined after incubation at room temperature and four decimal reduction in the Enterobacteriaceae count. Lactic acid bacteria appeared to be more radiation resistant and became the dominant component of the microflora during storage. Combination of pH-reduction and irradiation prevented growth of Enterobacteriaceae even at 10 degrees C incubation.
Animals↗
Streptococcus parauberis associated with modified atmosphere packaged broiler meat products and air samples from a poultry meat processing plant.
Lactic acid bacteria (LAB) isolated from marinated or non-marinated, modified atmosphere packaged (MAP) broiler leg products and air samples of a large-scale broiler meat processing plant were identified and analyzed for their phenotypic properties. Previously, these strains had been found to be coccal LAB. However, the use of a 16 and 23S rRNA gene RFLP database had not resulted in species identification because none of the typically meat-associated LAB type strains had clustered together with these strains in the numerical analysis of the RFLP patterns. To establish the taxonomic position of these isolates, 16S rRNA gene sequence analysis, numerical analysis of ribopatterns, and DNA-DNA hybridization experiments were done. The 16S rRNA gene sequences of three isolates possessed the highest similarities (over 99%) with the sequence of S. parauberis type strain. However, in the numerical analysis of HindIII ribopatterns, the type strain did not cluster together with these isolates. Reassociation values between S. parauberis type or reference strain and the strains studied varied from 82 to 97%, confirming that these strains belong to S. parauberis. Unexpectedly, most of the broiler meat-originating strains studied for their phenotypical properties did not utilize lactose at all and the same strains fermented also galactose very weakly, properties considered atypical for S. parauberis. This is, to our knowledge, the first report of lactose negative S. parauberis strains and also the first report associating S. parauberis with broiler slaughter and meat products.
Air Microbiology↗
An implementation of the HACCP system in the production of food-packaging material.
The Hazard Analysis Critical Control Point (HACCP) system according to the Codex Alimentarius model was applied to the processes of five paper and paperboard mills and four plants further converting paper or board intended for contact with foodstuffs. The generalised flow diagrams of the processes are presented. Each of the overall processes contained 40-150 process steps. Normally three to five sessions with HACCP teams and additional private negotiations were needed for each mill or plant. Hazards leading to critical control points (CCPs) were microbiological (handling/storage, circulation water, starch, process environment) and physical (process environment) in mills, and microbiological (storage, lacquers or glues, packaging and process environment), chemical (printing) and physical (storage of products, packaging and process environment) in plants. Specifications, critical limits (e.g., based on different kinds of reports and instructions), monitoring methods (microbiological and visual) and frequency, responsibilities and corrective actions of the processes are presented. Most of the improvements focused on improving the process environment. In five cases, hygiene training was included in the implementation of the HACCP system.
Food Packaging↗
Bulk packages of injectable products.
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Drug Labeling↗
Human immunodeficiency virus type 1 Vif is efficiently packaged into virions during productive but not chronic infection.
Packaging of the human immunodeficiency virus type 1 Vif protein into virus particles is mediated through an interaction with viral genomic RNA and results in the association of Vif with the nucleoprotein complex. Despite the specificity of this process, calculations of the amount of Vif packaged have produced vastly different results. Here, we compared the efficiency of packaging of Vif into virions derived from acutely and chronically infected H9 cells. We found that Vif was efficiently packaged into virions from acutely infected cells (60 to 100 copies per virion), while packaging into virions from chronically infected H9 cells was near the limit of detection (four to six copies of Vif per virion). Superinfection by an exogenous Vif-defective virus did not rescue packaging of endogenous Vif expressed in the chronically infected culture. In contrast, exogenous Vif expressed by superinfection of wild-type virus was readily packaged (30 to 40 copies per virion). Biochemical analyses suggest that the differences in the relative packaging efficiencies were not due to gross differences in the steady-state distribution of Vif in chronically or acutely infected cells but are likely due to differences in the relative rates of de novo synthesis of Vif. Despite its low packaging efficiency, endogenously expressed Vif was sufficient to direct the production of viruses with almost wild-type infectivity. The results from our study provide novel insights into the biochemical properties of Vif and offer an explanation for the reported differences regarding Vif packaging.
Amino Acid Sequence↗
[EXAMINATION OF THE BASIC PRINCIPLES OF A LEGISLATION RELATIVE TO THE PACKAGING OF FOOD PRODUCTS IN PLASTIC MATERIALS].
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Belgium↗
Application of sorption--desorption moisture transfer modeling to the study of chemical stability of a moisture sensitive drug product in different packaging configurations.
The sorption--desorption moisture transfer (SDMT) model was used to predict the effect of desiccant quantity, tablet quantity and tablet initial moisture content on the relative humidity inside high density polyethylene (HDPE) bottles containing a moisture sensitive drug product, roxifiban tablets. The effect of these variables on the stability of roxifiban tablets in the HDPE bottles was also evaluated. There was a good correlation between the calculated relative humidity values inside the package and stability results. Tablet degradant concentration increased with the increase in the relative humidity calculated by the SDMT model. Desiccant quantity was the most important factor in controlling degradation rate, which decreased as the quantity of desiccant in the bottle was increased. For a given desiccant quantity, degradation rate increased with an increase in the weight of tablets in the bottle. The inclusion of a desiccant in the package significantly reduced the effect of initial tablet moisture content on stability. Nevertheless, the effect of initial moisture content was still discernible. This study demonstrated the practical utility of the SDMT model in understanding the correlation between packaging variables and the stability of a moisture sensitive product.
Adsorption↗