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PubMed1981

Prescription drug products; patient package insert requirements--Food and Drug Administration. Final rule.

The Food and Drug Administration(FDA) is amending its patient package insert regulations to make the distribution requirements for patient package inserts for drug products in unit-of-use containers the same as the requirements for products in bulk containers. The agency is also amending its antibiotic drug regulations to permit manufacturers and distributors of antibiotics to make changes in labeling to comply with the patient package insert regulations without advance approval by FDA. This action will conform the requirements for implementing FDA's patient package insert regulations for antibiotics to the requirements currently applicable to the other drugs in the program.

Drug Labeling↗

PubMed2005

A new rate index for environmental monitoring of combined reuse/recycle packaging systems.

It is shown that the conventional recycling rate fails to reflect environmental performance for packaging flows with both recycle and reuse. The reuse rate, the total number of reuse trips and the reuse- lifetime are also shown to be inadequate. A new rate index defined in terms of the total amount of packaging material reaching the consumer is proposed. It reflects immediate improvements in environmental impact according to specific criteria and it reduces to the conventional rate for systems with only recycle. Albeit this shortcut environmental assessment is not entirely comprehensive and does not unveil a full sustainability profile, it may be useful for immediate packaging flow evaluation and policy implementation. For given packaging production technology it reveals a specific maximum level on recycling, below which environmental impacts from processing are limited or reduced, even if production level grows. Cleaner technologies in reprocessing of recycled materials may elevate this maximum level while still limiting or reducing environmental impacts.

Conservation of Natural Resources↗

PubMed1999

Evaluation of botulinal toxin production in packaged fresh-cut cantaloupe and honeydew melons.

The ability of Clostridium botulinum to produce toxin on cubed, packaged melons was investigated relative to microbial spoilage at various incubation temperatures and in different packaging systems. Freshly cut cubes (approximately 2.5 cm3) of cantaloupe and honeydew melons were surface inoculated with a 10 strain mixture of proteolytic and nonproteolytic spores of C. botulinum (10 to 15 cubes per package; approximately 100 total spores per package). To initially evaluate toxin production and spoilage in a passively modified atmosphere, melon cubes were loosely packaged in air in polyethylene pouches, sealed, and incubated at 7 or 15 degrees C for up to 21 days. At various sampling intervals, samples were tested for headspace oxygen and carbon dioxide levels, pH, presence of botulinal toxin, aerobic and anaerobic plate counts, and counts of yeasts and molds. During incubation, headspace oxygen levels decreased, headspace carbon dioxide levels increased, aerobic and anaerobic plate counts increased, and the pH remained constant or decreased slightly. Botulinal toxin was not detected in any cantaloupe samples or in honeydew samples incubated at 7 degrees C. Botulinal toxin was detected in some honeydew samples at 15 degrees C after 9 days of incubation, but the toxic honeydews were severely spoiled and considered organoleptically unacceptable. A similar second experiment was performed in which half of the melon cubes were treated with UV light to inactivate vegetative organisms before packaging, and these were incubated at 7, 15, or 27 degrees C. In this second experiment, toxin production occurred in the UV-treated samples at 15 degrees C with gross spoilage and at 27 degrees C with only marginal spoilage. These data indicate that inhibition of spoilage organisms with UV light could result in botulinal toxin formation in packaged melons before overt spoilage.

Bacteria, Aerobic↗

PubMed2001

Role of the UL25 gene product in packaging DNA into the herpes simplex virus capsid: location of UL25 product in the capsid and demonstration that it binds DNA.

Recent studies have suggested that the herpes simplex type 1 (HSV-1) UL25 gene product, a minor capsid protein, is required for encapsidation but not cleavage of replicated viral DNA. This study set out to investigate the potential interactions of UL25 protein with other virus proteins and determine what properties it has for playing a role in DNA encapsidation. The UL25 protein is found in 42 +/- 17 copies per B capsid and is present in both pentons and hexons. We introduced green fluorescent protein (GFP) as a fluorescent tag into the N terminus of UL25 protein to identify its location in HSV-1-infected cells and demonstrated the relocation of UL25 protein from the cytoplasm into the nucleus at the late stage of HSV-1 infection. To clarify the cause of this relocation, we analyzed the interactions of UL25 protein with other virus proteins. The UL25 protein associates with VP5 and VP19C of virus capsids, especially of the penton structures, and the association with VP19C causes its relocation into the nucleus. Gel mobility shift analysis shows that UL25 protein has the potential to bind DNA. Moreover, the amino-terminal one-third of the UL25 protein is particularly important in DNA binding and forms a homo-oligomer. In conclusion, the UL25 gene product forms a tight connection with the capsid being linked with VP5 and VP19C, and it may play a role in anchoring the genomic DNA.

Animals↗

PubMed1995

Determination of benzoic and sorbic acids in packaged vegetable products. Comparative evaluation of methods.

Three analytical methods for determining sorbic and benzoic acids in various packaged vegetable products were evaluated, with special attention being paid to green olives. Two of these methods used a simple, isocratic, reversed-phase HPLC technique for separating and detecting the preservatives, but differed in the preparation of the sample (extraction with 60% methanol or steam distillation). The third method was based on separation by steam distillation and determination of the acids in the distillate by spectrophotometry. For the olives, while this method proved to be excellent (total error < 25%) for high concentrations (> 100 ppm), the HPLC methods were more efficient for the whole range of concentrations studied (5-500 ppm). Both HPLC methods had detection limits of approximately 1 ppm for the two preservatives. With other sample matrices (tomatoes, cucumbers, caperberries, silver-skinned onions and hot peppers), the three methods proved to be excellent for high concentrations of preservatives (500 ppm), but at low levels (20 ppm), the spectrophotometric method and the HPLC method with extraction by 60% methanol proved to be unacceptable (total error > 50%) in some cases.

Benzoates↗

PubMedDate not supplied

Evaluation of a commercial process for collection and cooling of beef offals by a temperature function integration technique.

The hygienic adequacy of a commercial process for the collection and cooling of beef offals was assessed by a temperature function integration technique. The diverse operations for collection of offals were inspected. The rates of product movement through those operations, and the temperatures of products at the time of their being packed, were determined. From that information, four of the nine product types were selected for examination of their temperature histories during the assembly and cooling of the cartoned products. The products selected encompassed product at near-body and near-air-ambient temperatures at the time of packaging, product in the largest and smallest cartons used in the process, and product with relatively short and long residence times in an unchilled carton stack assembly area. Twenty-one temperature histories were collected for each of the products, and the possible proliferation of an indicator organism, Escherichia coli, calculated for each temperature history. The results were assessed against a temperature function integration criterion derived from studies of beef carcass and cartoned meat cooling processes. Products packaged at near-ambient temperature readily met with the criterion, but products packed at near-body temperatures did not comply. The latter non-compliance was extreme for product packaged in large cartons. However, the principal cause of non-compliance was identified as highly variable cooling conditions in the carton freezing facility. A brief survey of air speeds and temperatures within that facility indicated means by which product cooling could be better controlled.

Animals↗

PubMed1997

Enhancement of retroviral production from packaging cell lines expressing the human immunodeficiency type 1 VPU gene.

The HIV-1 Vpu protein stimulates virus production by enhancing the release of viral particles from infected cells. Interestingly, Vpu was also shown to enhance the release of capsids produced by gag gene contructs of other retroviruses that lack a Vpu-like activity. To investigate the effect of Vpu expression on viral particle production in retroviral packaging cell line, we developed the Damp-VpuP cell line in which vpu expression is under the control of the tetracycline-responsive promoter. Retroviral production was measured by dosage of virion-associated reverse transcriptase activity, by capsid protein immuno-detection in cell-free supernatants and by evaluating the transfer of antibiotic resistance to target cells. Induction of the Damp-VpuP cell line caused a 40-fold increase in the titer of infectious virus-like particles when compared with control cell lines. This increase in viral titer was not the result of a clonal effect nor was it a consequence of high selective pressure but rather the effect of a Vpu-mediated enhancement of viral particle production. Similar results using the third generation psi CRIP packaging cell line confirmed these findings. Constitutive expression of vpu caused a 13-fold increase in viral titer in this packaging cell line. These results indicate that the expression of HIV-1 vpu in retroviral packaging cell lines can significantly improve the titers of infectious retroviral particles.

Animals↗

PubMed2005

Lactobacillus oligofermentans sp. nov., associated with spoilage of modified-atmosphere-packaged poultry products.

Unidentified lactic acid bacterium (LAB) isolates which had mainly been detected in spoiled, marinated, modified atmosphere packaged (MAP) broiler meat products during two previous studies, were identified and analyzed for their phenotypic properties and the capability to produce biogenic amines. To establish the taxonomic position of these isolates, 16S rRNA gene sequence analysis, numerical analysis of ribopatterns, and DNA-DNA hybridization experiments were done. Unexpectedly for a meat-spoilage-associated LAB, the strains utilized glucose very weakly. According to the API 50 CHL test, arabinose and xylose were the only carbohydrates strongly fermented. None of the six strains tested for production of histamine, tyramine, tryptamine, phenylethylamine, putrescine, and cadaverine were able to produce these main meat-associated biogenic amines in vitro. The polyphasic taxonomy approach showed that these strains represent a new Lactobacillus species. The six isolates sequenced for the 16S rRNA encoding genes shared the highest similarity (95.0 to 96.3%) with the sequence of the Lactobacillus durianis type strain. In the phylogenetic tree, these isolates formed a distinct cluster within the Lactobacillus reuteri group, which also includes L. durianis. Numerical analyses of HindIII-EcoRI ribotypes placed all isolates together in a cluster with seven subclusters well separated from the L. reuteri group reference strains. The DNA-DNA hybridization levels between Lactobacillus sp. nov. isolates varied from 67 to 96%, and low hybridization levels (3 to 15%) were obtained with the L. durianis type strain confirming that these isolates belong to the same species different from L. durianis. The name Lactobacillus oligofermentans sp. nov. is proposed, with strain LMG 22743T (also known as DSM 15707T or AMKR18T) as the type strain.

Animals↗

PubMed2000

Effects of deceptive packaging and product involvement on purchase intention: an elaboration likelihood model perspective.

From an Elaboration Likelihood Model perspective, it was hypothesized that postexposure awareness of deceptive packaging claims would have a greater negative effect on scores for purchase intention by consumers lowly involved rather than highly involved with a product (n = 40). Undergraduates who were classified as either highly or lowly (ns = 20 and 20) involved with M&Ms examined either a deceptive or non-deceptive package design for M&Ms candy and were subsequently informed of the deception employed in the packaging before finally rating their intention to purchase. As anticipated, highly deceived subjects who were low in involvement rated intention to purchase lower than their highly involved peers. Overall, the results attest to the robustness of the model and suggest that the model has implications beyond advertising effects and into packaging effects.

Attitude↗

PubMed1999

Predicted and observed growth and toxigenesis by Clostridium botulinum type E in vacuum-packaged fishery product challenge tests.

The observed growth and toxigenesis by Clostridium botulinum type E in vacuum-packaged unprocessed, raw pickled and cold-smoked rainbow trout stored at slightly abusive temperatures were compared to predictions generated by two currently available predictive microbiological programs, Food MicroModel and Pathogen Modelling Program. In unprocessed fish there was only a 2 log increase in type E cell count at the time the toxicity first occurred after 2 weeks storage at 8 degrees C. Neither growth or toxin production was observed in raw pickled fish with a NaCl concentration of 6.7% (w/v) during 6 weeks storage at 6 degrees C. In cold-smoked fish with a NaCl level of 3.2% (w/v) toxic samples were detected after 3 and 4 weeks storage at 8 degrees C and 4 degrees C, respectively, without any increase in type E count. Both models were hampered by limitations to controlling environmental factors set by the programs which also had an adverse effect on the reliability of predictions. Most predictions generated by the models were inconsistent with the results observed in the challenge studies. In certain situations, the models seemed to be 'fail-safe', in that, the growth rate predicted from the model was faster or a predicted time to toxicity shorter than that which actually occurred in the food. In other situations, the predictions showed the product to be safe when it was not. The results demonstrate the need for further development and rigorous validation of the models before they are accepted for wider use by inspecting officials and the food industry.

Animals↗

PubMed2006

Role of broiler carcasses and processing plant air in contamination of modified-atmosphere-packaged broiler products with psychrotrophic lactic acid bacteria.

Some psychrotrophic lactic acid bacteria (LAB) are specific meat spoilage organisms in modified-atmosphere-packaged (MAP), cold-stored meat products. To determine if incoming broilers or the production plant environment is a source of spoilage LAB, a total of 86, 122, and 447 LAB isolates from broiler carcasses, production plant air, and MAP broiler products, respectively, were characterized using a library of HindIII restriction fragment length polymorphism (RFLP) patterns of the 16 and 23S rRNA genes as operational taxonomic units in numerical analyses. Six hundred thirteen LAB isolates from the total of 655 clustered in 29 groups considered to be species specific. Sixty-four percent of product isolates clustered either with Carnobacterium divergens or with Carnobacterium maltaromaticum type strains. The third major product-associated cluster (17% of isolates) was formed by unknown LAB. Representative strains from these three clusters were analyzed for the phylogeny of their 16S rRNA genes. This analysis verified that the two largest RFLP clusters consisted of carnobacteria and showed that the unknown LAB group consisted of Lactococcus spp. No product-associated LAB were detected in broiler carcasses sampled at the beginning of slaughter, whereas carnobacteria and lactococci, along with some other specific meat spoilage LAB, were recovered from processing plant air at many sites. This study reveals that incoming broiler chickens are not major sources of psychrotrophic spoilage LAB, whereas the detection of these organisms from the air of the processing environment highlights the role of processing facilities as sources of LAB contamination.

Atmosphere↗

PubMed1980

Food and Drug Administration--Prescription drug products; patient package inserts requirements. Final rule.

The Food and Drug Administration [FDA] adopts final regulations establishing requirements and procedures for the preparation and distribution of patient package inserts for prescription drugs for human use. The package inserts will inform the patient about the drug product. This action is intended to promote the safe and effective use of prescription drug products by patients and to ensure that patients have the opportunity to be informed of the benefits and risks involved in the use of prescription drug products. The agency intends to apply the regulations to 10 drugs or drug classes during an initial implementation program. Further evaluation of the costs and benefits of the program will guide the agency in deciding whether to extend, revise, or defer these requirements.

Drug Labeling↗

PubMed2006

Putting the genie back in the bottle? Availability and presentation of oral artemisinin compounds at retail pharmacies in urban Dar-es-Salaam.

BACKGROUND: Recently global health advocates have called for the introduction of artemisinin-containing antimalarial combination therapies to help curb the impact of drug-resistant malaria in Africa. Retail trade in artemisinin monotherapies could undermine efforts to restrict this class of medicines to more theoretically sound combination treatments. METHODS: This paper describes a systematic search for artemisinin-containing products at a random sample of licensed pharmacies in Dar-es-Salaam, Tanzania in July 2005. RESULTS: Nineteen different artemisinin-containing oral pharmaceutical products, including one co-formulated product, one co-packaged product, and 17 monotherapies were identified. All but one of the products were legally registered and samples of each product were obtained without a prescription. Packaging and labeling of the products seldom included local language or illustrated instructions for low-literate clients. Packaging and inserts compared reasonably well with standards recommended by the national regulatory authority with some important exceptions. Dosing instructions were inconsistent, and most recommended inadequate doses based on international standards. None of the monotherapy products mentioned potential benefits of combining the treatment with another antimalarial drug. CONCLUSION: The findings confirm the widespread availability of artemisinin monotherapies that led the World Health Organization to call for the voluntary withdrawal of these drugs in malaria-endemic countries. As the global public health community gathers resources to deploy artemisinin-containing combination therapies in Africa, planners should be mindful that these drugs will coexist with artemisinin monotherapies in an already well-established market place. In particular, regulatory authorities should be incorporated urgently into the process of planning for rational deployment of artemisinin-containing antimalarial combination therapies.

Administration, Oral↗

PubMed2000

Nonproteolytic Clostridium botulinum toxigenesis in cooked turkey stored under modified atmospheres.

The ability of nonproteolytic Clostridium botulinum type B spores to grow and produce toxin in cooked, uncured turkey packaged under modified atmospheres was investigated at refrigeration and mild to moderate abuse temperatures. Cook-in-bag turkey breast was carved into small chunks, surface-inoculated with a mixture of nonproteolytic C. botulinum type B spores, packaged in O2-impermeable bags under two modified atmospheres (100% N2 and 30% CO2:70% N2), and stored at 4, 10, and 15 degrees C. Samples were analyzed for botulinal toxin and indigenous microorganisms, as well as subjected to sensory evaluation, on days 0, 7, 14, 28, 42, and 60. Given sufficient incubation time, nonproteolytic C. botulinum type B grew and produced toxin in all temperature and modified atmosphere treatment combinations. At moderate temperature abuse (15 degrees C), toxin was detected by day 7, independent of packaging atmosphere. At mild temperature abuse (10 degrees C), toxin was detected by day 14, also independent of packaging atmosphere. At refrigeration temperature (4 degrees C), toxin was detected by day 14 in product packaged under 100% N2 and by day 28 in product packaged under 30% CO2:70% N2. Reduced storage temperature significantly delayed toxin production and extended the period of sensory acceptability of cooked turkey, but even strict refrigeration did not prevent growth and toxigenesis by nonproteolytic C. botulinum. At all three storage temperatures, toxin detection preceded or coincided with development of sensory characteristics of spoilage, demonstrating the potential for consumption of toxic product when spoilage-signaling sensory cues are absent.

Animals↗

PubMed1996

Environmental Assessment of Packaging: The Consumer Point of View

When marketing environmentally responsible packaged products, the producer is confronted with consumer beliefs concerning the environmental friendliness of packaging materials. When making environmentally conscious packaging decisions, these consumer beliefs should be taken into account alongside the technical guidelines. Dutch consumer perceptions of the environmental friendliness of packaged products are reported and compared with the results of a life-cycle analysis assessment. It is shown that consumers judge environmental friendliness mainly from material and returnability. Furthermore, the consumer perception of the environmental friendliness of packaging material is based on the postconsumption waste, whereas the environmental effects of production are ignored. From the consumer beliefs concerning environmental friendliness implications are deduced for packaging policy and for environmental policy.KEY WORDS: Consumer behavior; Environment; Food; Packaging; Perception; Waste

Journal Article↗

PubMed2003

The rheology of liquids: a comparison of clinicians' subjective impressions and objective measurement.

Texture-modified diets are commonly prescribed for patients with dysphagia; it is therefore important to demonstrate that clinicians form accurate impressions of the rheological (flow) properties of the items that they recommend for their clients. We explored the correlation between objective rheological measurement and clinicians' subjective impressions of liquid consistency, rated on the bases of product labeling and sampling. Ten liquids, ranging from thin through nectar-thick and honey-thick to spoon-thick consistencies, were selected for study. Rheological analysis was conducted using a CarriMed CSL Controlled Stress Rheometer. Fifty speech-language pathologists ranked the liquids in order of perceived viscosity, based on their interpretation of the product packaging and label. Product nomenclature proved insufficient to accurately represent the consistency class to which each liquid belonged. A second group of 16 speech-language pathologists rated the perceived relative viscosity and density of nectar-thick and honey-thick juice items in blinded two-point discrimination tests of stirring-resistance, oral manipulation, and vessel weight. Physical sampling of these two products enabled clinicians to reliably perceive relative viscosity and density differences between the nectar- and honey-thick items.

Deglutition Disorders↗

PubMed1988

Bacteriophage lambda DNA packaging. The product of the FI gene promotes the incorporation of the prohead to the DNA-terminase complex.

Lambda DNA packaging in vitro can be examined in stages. In a first step, lambda DNA interacts with terminase to form a DNA-enzyme complex, called complex I. Upon addition of proheads, in a second step, a ternary complex, complex II, containing DNA, terminase and the prohead is formed. Finally, upon addition of the rest of the morphogenetic components, complete phages are assembled. We have investigated the effect of the FI gene product (gpFI) in these reactions and found that a stimulation in phage yield is observed when gpFI is included early in the reaction, at the time when DNA, terminase and proheads interact to form complex II. Measurements of complex II formation revealed that gpFI stimulated the rate of formation of this intermediate. gpFI was further shown to stimulate the addition of proheads to preformed complexes I to give complex II, but the protein did not stimulate complex I formation.

Bacteriophage lambda↗

PubMed1998

GFP:HIV-1 protease production and packaging with a T4 phage expression-packaging processing system.

A bacteriophage T4-derived protein expression, packaging and processing system was used to create recombinant phage that encode, produce and package a protein composed of human HIV-1 protease fused to green fluorescent protein (GFP). The fusion protein is targeted within the phage capsid by an N-terminal capsid targeting sequence (CTS), which is cleaved through proteolysis by the viral scaffold protease P21. The fusion protein is designated CTS [symbol see text] GFP:PR. The [symbol see text] symbol indicates the linkage peptide sequence leu(ile)-N-glu that is cleaved by the T4 head morphogenetic proteinase gp21 during head maturation. The fusion protein is fluorescent and has protease activity as detected by the appearance of the expected substrate cleavage product on a Western blot. CTS [symbol see text] GFP:PR packaging occurs at about 200 molecules per phage particle. The CTS [symbol see text] GFP:PR fusion protein, when protected within the phage capsid, has been maintained stably for over 16 months at 4 degrees C. Production and storage of fusion protein within the phage circumvents problems of toxicity and solubility encountered with E. coli expression systems. Because recombinant phage inhibit host proteolytic enzymes, foreign proteins are stabilized. This phage system packages and processes the fusion protein by means of the CTS. Proteins can be purified from the phage to give high yields of soluble, proteolytically processed protein. The T4 phage packaging system provides a novel means of identification, purification and long-term storage of toxic proteins whose folding and DNA-directed activities can be studied readily in vivo.

Bacteriophage T4↗