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Regulatory Update: The IPEC Novel Excipient Safety Evaluation ProcedureThe authors, representing the International Pharmaceutical Excipients Council, propose a new evaluation procedure, including tiered toxicology testing for excipients.
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Automated artwork generationThis article examines automated artwork generation, which enables pharma companies to generate validated artwork for their products' packaging. Automated artwork generation is based on a complete set of data stored in an artwork management system. It enables the dynamic assembly of artwork documents, accelerates traditional processes and significantly reduces costs.
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Comparing Different Granulation TechniquesGranulation is one of the most important unit operations in the production of pharmaceutical oral dosage forms. However, there are many different technologies each having different strengths and weaknesses. Most companies choose which one to use simply based on their own experience. This article introduces different processes, compares them objectively and offers unbiased advice on the merits of each system. It then looks at the implications of selection on two different applications.
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Milling Made Easy: Nanoindentation as a Predictor of Bulk PropertiesSize reduction of materials through comminution is employed in many industries, including agrochemicals, minerals, ceramics and pharmaceuticals. The reasons for particle size reduction depend on the industry in question. Within the pharmaceutical industry, a large percentage of products are formed from powders and undergo processing to improve dosage form properties. Particle size reduction prior to compacting to tablets can aid with dissolution and homogeneity. Such processing of powders is, in part, dependent on their mechanical properties and balancing these properties is crucial in achieving desired manufacturing performance. Generally, pilot-scale milling trials are run to determine the most effective and efficient mill and operating conditions for each material. These trials, however, require relatively large quantities of material as well as time, and are normally run in early development when sufficient material becomes available. Hence, it would be highly beneficial to identify a physical property..
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Rapid progress in pharma RFIDDrug companies have come to realize that spending heavily on creating new blockbuster drugs is risky and less cost-effective ...
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Credit crunch bites R&DA possible recession in the US and a global credit crunch are going to be major factors in the amount of money available as shareholders tighten their purse-strings.
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Applying Good Laboratory Practice RegulationsGood laboratory practice (GLP) regulations became effective in 1979 under 21 CFR Part 58 and apply to all non-clinical safety studies intended to support research permits or marketing authorizations. This article introduces some key elements regarding the application of GLP regulations as a quality system and how GLPs are perceived internationally.
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A Stability Program for the Distribution of Drug ProductsThe authors outline stability studies designed to evaluate the effect of temperature excursions on product quality that may occur during distribution.
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Using Ion Mobility Spectrometry for Cleaning Verification in Pharmaceutical ManufacturingThis article discusses the use of ion mobility spectrometry as an alternative to high-performance liquid chromatography to reduce the amount of time spent on the cleaning verification process.
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The Effect of Mill Type on Two Dry-Granulated Placebo FormulationsThe authors evaluate the effect of various mill types on particle-size distribution, flowability, tabletability, and compactibility.
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Effect of Formulation and Process Variables on Matrix Erosion and Drug Release from a Multiunit Erosion Matrix of a Poorly Soluble DrugBy optimizing formulation and process varibles, pellets can be prepared that can release a poorly soluble drug for 12-24 h following zero-order kinetics.
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Preparation and In Vitro Evaluation of Miconazole Nitrate-Loaded Topical LiposomesEntrapment of miconazole nitrate in liposomes was achieved after studying the effect of various process and formulation variables.
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CMO-grown Innovation and TechnologyToday's contract manufacturing organizations (CMOs) offer the latest in technology advanced equipment and innovative homegrown production processes.
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The Impact of 21 CFR Part 11 on Equipment Design for R&D ApplicationsThis article examines the application of 21 CFR Part 11 to those areas of research and development (R&D) where compliance is not strictly required and the response of R&D equipment vendors to the rule's requirements and customer needs. The case is presented that vendors must accept that understanding and meeting Part 11 requirements is now part of their business environment.
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Functionality Testing of a Multifunctional Directly Compressible Adjuvant Containing Lactose, Polyvinylpyrrolidone, and Croscarmellose SodiumThe authors review their study that aimed to develop a coprocessed, directly compressible, multipurpose adjuvant that could serve as a diluent and built-in disintegrant.
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21 CFR Part 11: Where Are We Now?FDA's revised guidance on 21 CFR Part 11 offers relief to the regulated industry by providing for enforcement discretion and suggesting a risk-based approach to compliance.
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Maintenance Qualification: Improving Compliance and Performance in Pharmaceutical ManufacturingThis article describes the approach to maintenance management that delivers enhanced compliance for direct impact GMP systems...
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Milling Made Easy: Nanoindentation as a Predictor of Bulk PropertiesSize reduction of materials through comminution is employed in many industries, including agrochemicals, minerals, ceramics and pharmaceuticals. The reasons for particle size reduction depend on the industry in question. Within the pharmaceutical industry, a large percentage of products are formed from powders and undergo processing to improve dosage form properties. Particle size reduction prior to compacting to tablets can aid with dissolution and homogeneity. Such processing of powders is, in part, dependent on their mechanical properties and balancing these properties is crucial in achieving desired manufacturing performance. Generally, pilot-scale milling trials are run to determine the most effective and efficient mill and operating conditions for each material. These trials, however, require relatively large quantities of material as well as time, and are normally run in early development when sufficient material becomes available. Hence, it would be highly beneficial to identify a physical property..
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Terahertz applications for the analysis of solid dosage formsThis article investigates pharmaceutical applications of terahertz technology, specifically using techniques for solid dosage form analysis such as pulsed spectroscopy (to generate physical information and detect API changes) and pulsed imaging (to locate formulation impurities, and regulate tablet coating quality and thickness).
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Design and Implementation of Electronic Batch Recording SystemsPaper batch records have been used for decades to record procedures, the type and quantity of each material used, and the status of each step in the manufacturing process for both pharmaceuticals and medical devices. Although paper batch records are less complicated to implement than their electronic counterparts, and the controls required for data recording and archival are well understood, a paper batch record system is laborious to maintain and prone to human error, which increases the compliance risk. Additionally, batch records have become bulky and more time consuming to prepare and review, particularly as manufacturing operations become increasingly complicated. Advances in technology and science have created a more competitive climate in life science industries than ever before, causing the need for manufacturers to reduce costs and time-to-market, and improve their ability to satisfy the compliance requirements of US Food and Drug Administration (FDA) regulations. The use of electronic batch recording systems (EBRS) and electronic batch records (EBR) offers one solution.
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Toyopearl Toyoscreen — For the Fast Identification of the Optimal ResinTosoh has developed a new product - Toyopearl Toyoscreen that allows fast identification of the optimal resin for your sample. You can develop the optimal conditions for the separation in addition to the determination of the dynamic binding capacity. All the resins prepacked in these columns are real process resins concerning particle size. Results on the small columns can be scaled up to production.
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Defining the Similarity of Dissolution Profiles Using Hotelling's T2 StatisticThis article describes a method for assessing the similarity of dissolution profiles using Hotelling's T2 statistic. The method applies a covariance structure that accounts for the heterogeneity of variance and correlation across time points. Comparing the method with the f2 criterion recommended in FDA's guidance on dissolution testing, the performance of the two methods was assessed on real examples, and simulation studies were also done to compare the method's performance with that of the f2 criterion.
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Superdisintegrants for Solid Dispersion To Produce Rapidly Disintegrating Tenoxicam Tablets via Camphor SublimationThe authors examine the effects of three superdisintegrants on the dissolution and absorption of tenoxicam from solid-dispersion formulations.
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Implementing Total Organic Carbon Analysis for Cleaning ValidationTotal organic carbon (TOC) analysis is a fast and effective analytical technique for cleaning validation. Understanding the various types of TOC technologies is essential for choosing the best solution.
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The influence of monoglycerides, mixtures and derivatives on the formation of pellets by extrusion/spheronizationThe previous studies on the incorporation of glyceryl monostearate into pellets by extrusion/spheronization has been extended to include a range of grades of this material plus a mixed medium chain partial glyceride and two glycerol esters of hydrogenated natural glycerides as described in this article.
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Handling Challenging Powders in Tableting OperationsTests evaluated commercial rotary tablet presses to see how effectively they deal with problems such as poor flow, overlubrication, and capping.
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Process Analytical Technology: A First-Birthday Standardization UpdateThe author describes the efforts of the standards committees to establish guidelines for PAT implementation and the impact of the guidelines on the industry.
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Formulation Development of a Nucleotide PhosphoramidateA small-volume parenteral formulation of NB1011, an enzyme-catalyzed therapeutic activation compound, was successfully developed for intravenous administration.
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Novel Acrylate Adhesives for Transdermal Drug DeliveryThe authors discuss the solubility and adhesive performances of adhesives that incorporate monomers such as hydroxyethyl acrylate or pyrrolidonoethyl acrylate.
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Packaging and Counterfeit PharmaceuticalsThere can be little argument that packaging is at the forefront of the fight against counterfeit drugs, which currently costs the industry between 6-10% of the value of pharmaceutical sales. According to IMS Health, the figure is approximately $22 billion from global pharmaceutical sales of $364 billion. To set this in context, counterfeiting of all goods costs $200-400 billion annually, claims the Global Anti-Counterfeiting Group. According to the the US Pharmaceutical Manufacturers Association, it can take an average of $250 million and 10 years to legally develop and market a drug, but it is possible for a counterfeiter to 'reproduce' a product within a couple of months for as little as $250000.
