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Monitoring of phase transformations during processing of solid dosage formsWhen a dosage form or an API is introduced to the gastrointestinal tract, or dissolution media mimicking it, a transformation from a metastable to a more stable form with lower solubility and bioavailability is possible.
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Ensuring a culture of qualityThe concept of quality should not only apply to the manufacture of the media - it should also continue throughout the product's lifetime of usage.
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The Role of 21 CFR Part 11 in the LaboratoryThe benefits of using computers and electronic records are proven in most fields of modern-day work, none more so than in laboratories. The opportunities for automation have improved productivity; the computational abilities have increased the accuracy of scientific data and allowed previously difficult or impossible analytical techniques to become routine affairs. This, in turn, has led to huge advances in drug discovery and in the chemical, biochemical and physical analysis of drugs and patients.
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Scaling Manufacturing Processes Using Single-Use TechnologiesAlthough new single-use technologies offer the flexibility needed to overcome several challenges in ATMP production, there are many considerations and hurdles manufacturers must be aware of when scaling.
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Fixed-Oil Excipient Monographs: Development of USP Fixed-Oil Reference StandardsThis article summarizes the development and modernization of the United States Pharmacopeia-National Formulary (USP-NF) fixed-oil excipient monographs. This article contains bonus online-exclusive material.
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Developing nanoparticle drug carriersNanoparticulate drug carriers include a class of particles made of polymers or lipids that - because of their size and chemical composition -permit systemic and local treatment.
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The Use of Acrylic Resins for Improved Aqueous Enteric CoatingRecent technology improvements have made acrylics the preferred system for the aqueous enteric coating of tablets
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From data to knowledge: the challenge in bioprocess developmentIn biomanufacturing, multiple sensors provide a wealth of data that could be used to enhance process understanding and assist in performance improvement. This article looks at how to move from a data-rich environment to one where the data are translated to useful information that leads to knowledge and, ultimately, process improvements.
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The Squeeze in Contract ManufacturingThe demand for CGMP production of biopharmaceuticals is at an all-time high.
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Cultivating ComplianceThe authors discuss how companies facing ever-evolving regulatory requirements can address and assess compliance risk in their operating practices.
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Cultivating ComplianceThe authors discuss how companies facing ever-evolving regulatory requirements can address and assess compliance risk in their operating practices.
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Controlling the Release of Highly Dosed and Highly Soluble DrugsThe authors formulated bupropion hydrochloride tablets with various grades of methacrylic copolymers and analyzed the properties of the resulting dosage forms. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."
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Outsourcing clinical trials: growth continuesThe CRO market is experiencing two-tiered growth: firstly from pharmaceutical companies seeking to lower fixed costs by outsourcing clinical research to CROs; and secondly, from biotechnology and specialty pharmaceutical companies that lack the infrastructure to conduct trials.
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Alcami Grows Contract Manufacturing and Laboratory Business 20% With Waters PartnershipRead a compelling, detailed Case Study about how an innovation partnership with Waters Corporation enhanced Alcami’s capacity, efficiency, and compliance-readiness for their pharmaceutical manufacturing and analytical services to differentiate their offerings and drive business growth.
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How to Engage in a Strategic Outsourcing RelationshipCarefully crafted outsourcing arrangements allow companies to become powerful partners in the quest for market share.
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The extrusion and spheronization of chitosanChitosan is of pharmaceutical interest because of its positive attributes with respect to toxicity, biocompatibility and bioavailability.
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Particle design using fluidized hot melt granulationFluidized hot melt granulation (FHMG) is an emerging technique combining the advantages of both dry and wet granulation methods, and represents an innovative continuous granulation process capable of mixing and agglomerating excipients and active pharmaceutical ingredients (APIs) to produce uniform blends of particles suitable for use in the manufacture of pharmaceutically elegant solid dosage forms.
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From data to knowledge: the challenge in bioprocess developmentIn biomanufacturing, multiple sensors provide a wealth of data that could be used to enhance process understanding and assist in performance improvement. This article looks at how to move from a data-rich environment to one where the data are translated to useful information that leads to knowledge and, ultimately, process improvements.
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Scale-up trials of foam-granulation technology — high shearThe authors evaluate the scalability of foam-granulation technology using continuous foam addition in high-shear granulation equipment at the laboratory, pilot and manufacturing scales. Immediate- and controlled-release model formulations were used. Continuous and batch addition of foam were compared for the controlled-release model formulation at the manufacturing scale, and physical testing was performed on the granules and finished tablets.
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Mefenamic acid: new polymorph or crystal defect?Mefenamic acid has variable bioavailability and tabletting issues because of its hydrophobic nature and poor material characteristics. Recrystallization of mefenamic acid was performed from three different solvent–solvent mixtures under differing conditions. The crystals obtained were screened for the existence of new crystal properties or polymorphic forms, then characterized further.
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Risk-Based Intermediate Precision Studies for Analytical Procedure ValidationValidation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.
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A Raman spectroscopic method to monitor magnesium stearate in blends and tabletsA new Raman spectroscopic method to detect magnesium stearate in powder blends and tablets is described. High-volume pharmaceutical manufacturing requires the use of lubricants to facilitate tablet ejection from compressing machines. However, lubricants may also bring a number of undesired problems that have been widely documented in pharmaceutical scientific literature. New analytical methods are needed to understand lubrication and provide process knowledge in support of FDA's process analytical technology initiative. The detection of magnesium stearate in lactose, mannitol, corn starch and other commercially important excipients is reported. The Raman spectroscopic method has a detection limit of about 0.1% (w/w) based on the 2848 cm-1 band that corresponds to the symmetric stretch of the methylene group in magnesium stearate.
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Manual versus Automated Actuation of Nasal Sprays: Applications for Droplet SizingAutomated actuation of nasal sprays removes operator bias during measurement of particle size, spray-plume geometry, and delivered dose.
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The Validation and Implementation of a Chromatography Data SystemThis article describes the approach used to upgrade a chromatography data system. The upgrade was required to meet the current regulatory requirements for good laboratory and good manufacturing practice. Compliance with 21 CFR Part 11 for electronic records and electronic signatures was also a major consideration. The procedures used for this project followed the software development life cycle (SDLC) and involved the co-ordination of personnel from the software vendor, the user department, information technology and quality assurance.
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PAT — a team effortThe biggest benefit of PAT and the current FDA initiatives may be in allowing pharmaceutical scientists to use their technical capabilities to improve pharmaceutical processes.
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The Use of Acrylic Resins for Improved Aqueous Enteric CoatingRecent technology improvements have made acrylics the preferred system for the aqueous enteric coating of tablets
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Avoiding pitfalls in scaling up biopharmaceutical productionThe scale-up of manufacturing processes to clinical production can be complicated and expensive, with many issues to consider. This article describes some of the common and less obvious pitfalls encountered by biopharmaceutical companies when scaling up protein production processes, and how to avoid them.
