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PDA Journal of Pharmaceutical Science and Technology

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https://www.readbyqxmd.com/read/28928294/factors-affecting-reduction-of-reference-endotoxin-standard-activity-caused-by-chelating-agent-detergent-matrices-kinetic-analysis-of-low-endotoxin-recovery
#1
Masakazu Tsuchiya
Reduction of reference standard endotoxin (RSE) activity was kinetically analyzed under low endotoxin recovery (LER) conditions, and was considered as an apparent first-order reaction. Temperature, pH, and salt concentrations affected the rates of reduction of RSE activity. Temperature appeared to be the most important factor affecting LER. Components of LER matrices, such as citrate and polysorbate 20 showed similar LER effect at concentrations commonly used. Phosphate concentrations showed negative correlation against the half-life of RSE activity in solutions containing phosphate buffer and polysorbate 20...
September 19, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28928293/comparison-of-a-lyophilized-drug-product-to-other-solid-and-liquid-media-for-the-extraction-of-elastomeric-oligomers-from-a-butyl-rubber-stopper
#2
Steven A Zdravkovic
Lyophilization is commonly used to extend the shelf life of pharmaceutical products which are otherwise unstable when stored as a liquid formulation. However, the ability of a lyophilized drug, or other solid medium, to leach or extract substances from a pharmaceutical packaging material is not well characterized. To provide insight into this area of uncertainty, the extraction properties of a lyophilized drug product, the lyophilized drug product reconstituted in water, and several other solid and liquid media of varying polarity were determined using a glass vial with a butyl rubber stopper as a representative pharmaceutical packaging system...
September 19, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28928292/elastomer-change-out-justification-for-minimizing-the-removal-of-elastomers-in-order-to-prevent-cross-contamination-in-a-multiproduct-facility
#3
Michael Parks, Niamh O'Dwyer, Jeremy Bollinger, Alan Johnson, Brian Goss, Ned Wyman, Adeyma Arroyo, Joseph Wood, Derek Willison-Parry
The primary objective of any Biopharmaceutical Product Changeover (PCO) program is to employ control strategies before, during, and after the manufacturing process, as well as from the beginning of the lifecycle approach for the equipment and validation, which will minimize the opportunity for cross- contamination when switching between products. Evaluation of the need for an Elastomer Change Out (ECO) should be considered as a segment of an overall changeover assessment. Lifecycle systems (e.g. Preventive Maintenance (PM), Cleanability Coupon Testing, Good Engineering Practices, etc...
September 19, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28928291/inhibiting-sterilization-induced-oxidation-of-large-molecule-therapeutics-packaged-in-plastic-parenteral-vials
#4
Jeffrey R Vieregg, Steven J Martin, Adam P Breeland, Christopher M Weikart, Matthew V Tirrell
For many years, glass has been the default material for parenteral packaging, but the development of advanced plastics such as cyclic olefin polymers (COP) and the rapidly increasing importance of biologic drugs have provided new choices, as well as more stringent performance requirements. In particular, many biologics must be stored at non-neutral pH, where glass is susceptible to hydrolysis, metal extraction, and delamination. Plastic containers are not susceptible to these problems, but suffer from higher gas permeability and a propensity for sterilization-induced radical generation, heightening the risk of oxidative damage to sensitive drugs...
September 19, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28928290/enhancing-patient-safety-through-the-use-of-a-pharmaceutical-glass-designed-to-prevent-cracked-containers
#5
Robert A Schaut, Kyle C Hoff, Steven E DeMartino, William K Denson, Ronald L Verkleeren
An essential role of packaging material for the storage and delivery of drug products is to provide adequate protection against contamination and loss of sterility. This is especially important for parenteral containers, as lack of sterility or contamination can result in serious adverse events including death. Nonetheless, cracked parenteral containers are an important source of container integrity failures for injectable drugs and pose a serious risk for patients. Despite significant investments in inspection technology, each year many injectable drugs are investigated and recalled for sterility risks associated with cracked borosilicate containers...
September 19, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28819050/pda-pac-iam-2017-survey-on-post-approval-change-is-the-regulatory-environment-hindering-much-needed-innovation-in-the-pharma-industry
#6
Melissa Seymour
As part of the effort to identify, assess and address current barriers to PACs, the PDA administered a global, blinded, cross-functional survey to document industry experience with PACs in the current global regulatory environment, and to better understand the regulatory complexity and burden on the industry. The survey interrogated on specific points related to annual volume of PACs, reasons, time commitments/cycle time, impact of regional differences on change implementation, current use of tools (e.g. PACMPs), impact on supply chain complexity (e...
August 17, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28819049/a-comparison-of-protein-stability-in-prefillable-syringes-made-of-glass-and-plastic
#7
Lloyd Waxman, Vinod D Vilivalam
The development of protein therapeutics requires stabilization of these labile molecules during shipment and storage. Biologics, particularly monoclonal antibodies, are frequently packaged at high concentration in prefillable syringes traditionally made of glass. However, some biologics are unstable in glass due to sensitivity to silicone oil, tungsten, glue or metal ions. Syringes made from the plastic cyclic olefin polymer, Daikyo Crystal Zenith® (CZ), with a Flurotec-laminated piston have none of these issues...
August 17, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28819048/development-of-methods-for-recovering-endotoxins-from-surfaces-and-from-air-in-production-environment-of-injectable-drugs
#8
Fiammetta Frucci, Annalaura Carducci, Giulia Davini, Marco Macchia, Simone Bertini, Sandra Vecchiani, Stefano Ceccanti
The aim of this work is to develop and validate methods for quantify endotoxins on surfaces and in the air of manufacturing environment of injectable drugs, in order to use them for evaluate the quality of the process and the risk for the products processed therein. The method for recovering endotoxins from surfaces was a direct method which provides sampling surfaces by swabbing and extraction of endotoxins from the swabs with an appropriate diluent; while the method for airborne endotoxins provides an air active sampling on a glass fiber filter (GFF) and endotoxins extraction with an appropriate diluent...
August 17, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28733334/application-of-recombinant-factor-c-reagent-for-the-detection-of-bacterial-endotoxins-in-pharmaceutical-products
#9
Jay S Bolden, Kelly R Smith
Recombinant Factor C (rFC) is non-animal derived reagent used to detect bacterial endotoxins in pharmaceutical products. Despite the fact that the reagent was first commercially available nearly 15 years ago, the broad use of rFC in pharmaceutical industry has long been lagging, presumably due to historical single source supplier concerns and the lack of inclusion in worldwide pharmacopeias. Commercial rFC reagents are now available from multiple manufacturers, thus single sourcing is no longer an issue. We report here the successful validation of several pharmaceutical products by an end-point florescence-based endotoxin method using the rFC reagent...
July 20, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28733333/method-development-for-container-closure-integrity-evaluation-via-headspace-gas-ingress-by-using-frequency-modulation-spectroscopy
#10
Ken G Victor, Lauren Levac, Michael Timmins, James Veale
USP <1207.1> Section 3.5 states that "A deterministic leak test method having the ability to detect leaks at the product's maximum allowable leakage limit is preferred when establishing the inherent integrity of a container-closure system." Ideally, container closure integrity (CCI) of parenteral packaging would be evaluated by measuring a physical property that is sensitive to the presence of any package defect that breaches package integrity by increasing its leakage above its maximum allowable leakage limit (MALL)...
July 20, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28733332/demonstration-of-the-maintaining-the-validated-state-of-a-system-used-to-generate-water-for-injection-by-thermocompression
#11
Alberto Leyva, Iriac Bisquet, Tania de la Cruz, Leoner Del Arco, Joel Ríos, Rodolfo Valdés, Sonny Robles, Fabian Ugarte, Manuel Montané
Water for injection is used in multiple applications in Biopharmaceutical industry. Regarding this, several methods have been use to generate water with this high quality. Within them, the thermos-compression distillation method has been widely employed. Though, reports on the maintenance of the qualification and validation status of thermo-compression systems used for water for injection generation are non-existent in the scientific literature. Therefore, this paper sought to give evidences on continue process verification of a system used for water for injection generation during two years analyzing the level of conductivity, nitrate, total organic carbon (TOC), endotoxins and microbiology in 1284 water samples...
July 20, 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28747538/complexing-agents-and-ph-influence-on-chemical-durability-of-type-i-molded-glass-containers
#12
Alberto Biavati, Michele Poncini, Arianna Ferrarini, Nicola Favaro, Martina Scarpa, Marta Vallotto
Among the factors that affect the glass surface chemical durability, pH and complexing agents present in aqueous solution have the main role. Glass surface attack can be also related to the delamination issue causing glass particles' appearance in the pharmaceutical preparation. A few methods to check for glass containers delamination propensity and some control guidelines have been proposed. The present study emphasizes the possible synergy between a few complexing agents with pH on borosilicate glass chemical durability...
July 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28747537/john-sculley-s-noble-cause-disruptive-innovation-to-transform-healthcare
#13
EDITORIAL
Govind Rao
No abstract text is available yet for this article.
July 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28416646/increasing-patient-safety-by-closing-the-sterile-production-gap-part-3-moist-heat-resistance-of-bioburden
#14
REVIEW
James P Agalloco
Terminal sterilization is considered the preferred means for the production of sterile drug products, as it affords enhanced safety for the patient because the formulation is sterilized in its sealed, final container. Despite the obvious patient benefits, the use of terminal sterilization is artificially constrained by unreasonable expectations for the minimum time-temperature process to be used. The core misunderstanding with terminal sterilization is the notion that destruction of a high population of a resistant biological indicator microorganism is required...
July 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28416645/performance-stability-of-silicone-oxide-coated-plastic-parenteral-vials
#15
Christopher M Weikart, Carlo G Pantano, Jeff R Shallenberger
A new packaging system was developed for parenteral pharmaceuticals that combines the best attributes of plastic and glass without their respective drawbacks. This technological advancement is based on the synergy between high-precision injection-molded plastics and plasma coating technology. The result is a shatter-resistant, optically clear, low-particulate, and chemically durable packaging system. The demand for this product is driven by the expanding market, regulatory constraints, and product recalls for injectable drugs and biologics packaged in traditional glass materials...
July 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28416644/evaluation-of-different-estimation-methods-for-accuracy-and-precision-in-biological-assay-validation
#16
REVIEW
Binbing Yu, Harry Yang
Biological assays (bioassays) are procedures to estimate the potency of a substance by studying its effects on living organisms, tissues, and cells. Bioassays are essential tools for gaining insight into biologic systems and processes including, for example, the development of new drugs and monitoring environmental pollutants. Two of the most important parameters of bioassay performance are relative accuracy (bias) and precision. Although general strategies and formulas are provided in USP<1033>, a comprehensive understanding of the definitions of bias and precision remain elusive...
July 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28196916/historical-review-of-glasses-used-for-parenteral-packaging
#17
REVIEW
Robert A Schaut, W Porter Weeks
Glass has long been used for packaging precious liquids, in particular pharmaceuticals. Its unique combination of hermeticity, transparency, strength, and chemical durability make it the optimal material for such an important role. Today's life-saving drugs are stored in borosilicate glasses, which evolved from applications in microscope optics and thermometers. As the glass compositions improved, so did the methods used to shape them and the tests used to characterize them. While all of these advances improved the quality of the glass container and its ability to protect the contents, problems still exist such as delamination, cracks, and glass particulates...
July 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28089965/increasing-patient-safety-by-closing-the-sterile-production-gap-part-2-implementation
#18
REVIEW
James P Agalloco
Terminal sterilization is considered the preferred means for the production of sterile drug products because it affords enhanced safety for the patient as the formulation is filled into its final container, sealed, and sterilized. Despite the obvious patient benefits, the use of terminal sterilization is artificially constrained by unreasonable expectations for the minimum time-temperature process to be used. The core misunderstanding with terminal sterilization is a fixation that destruction of a high concentration of a resistant biological indicator is required...
July 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28089964/increasing-patient-safety-by-closing-the-sterile-production-gap-part-1-introduction
#19
REVIEW
James P Agalloco
Terminal sterilization is considered the preferred means for the production of sterile drug products because it affords enhanced safety for the patient as the formulation is filled into its final container, sealed, and sterilized. Despite the obvious patient benefits, the use of terminal sterilization is artificially constrained by unreasonable expectations for the minimum time-temperature process to be used. The core misunderstanding with terminal sterilization is a fixation that destruction of a high population of a resistant biological indicator is required...
July 2017: PDA Journal of Pharmaceutical Science and Technology
https://www.readbyqxmd.com/read/28624777/a-novel-lack-of-fit-assessment-as-a-system-suitability-test-for-potency-assays
#20
Ruojia Li, Weiguo Cai, Marcel Zocher
Bioassay data analysis is used to determine the potency of protein therapeutics. To properly determine potency, the experimental data need to be fitted to a model that adequately describes the observed dose-response relationship. Typical models include 4-parameter logistic curve fits (Healy (5)), 5-parameter logistic curve fits (Prentice (6)) or parallel line analysis (Finney (7)). Lack-of-Fit (LOF) assessment can be used as a measure of potency assay system suitability to ensure appropriate closeness of the chosen model fit to the experimental data...
June 16, 2017: PDA Journal of Pharmaceutical Science and Technology
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