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Formulation of Modified Liquid-Solid Compact for Dissolution Enhancement of Raloxifene HydrochlorideThe purpose of this research was to formulate modified liquisolid compacts (MLSC) of RLX for improved dissolution in immediate-release tablet formulations.
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Inside USP: US Pharmacopeia Guideline for Pending MonographsUSP's guideline for pending monographs can speed up publication of monograhs and time to market.
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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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New Year, Same Challenges: Pharma’s Ongoing Struggle with FDA 483sThe authors examine common FDA 483 findings and outline strategies to address and prevent regulatory non-compliance.
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Using Modified QbD to Develop a Novel Pediatric Formulation of EzogabineThe epilepsy treatment, Potiga, has been used off-label to treat specific types of epilepsy in some children. However, it has never been formally evaluated in pediatric clinical trials. Using a modified QbD approach, the authors have developed a granular formulation suitable for use in clinical trials involving infants and children.
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Toxicology: Guaranteeing Drugs are Safe for PeopleAccelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.
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Enabling the Virtual Human Through Physiologically-based Pharmacokinetic ModelingBasic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed.
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Is There A Need For Stringent Regulations For Excipients?Excipients should be regulated to manage risk. Although, excipients are an integral part of a finished pharmaceutical product, the issue of regulation is complex.
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Inside USP: Metrology and USP DissolutionThe United States Pharmacopeia emphasizes mechanical calibration and a performance test to esnure integrity of the dissolution procedure.
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Patentability Considerations for Antibody-Related InventionsStringent patentability requirements present a challenge to obtaining broad-based antibody claims, so companies should develop a strategy based on multiple reinforcing layers of protection.
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The Marriage of RNA and Mass SpectrometryConsiderable efforts have been made over the years to resolve the key issues of stability and delivery of RNA-based therapeutics.
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From Isotope to Injection: Managing Risk and Compliance in Radiopharmaceutical DevelopmentWebinar Date/Time: Wed, Nov 12, 2025 11:00 AM EST
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Enhancing Patient-Centric Care Through Oral Liquid Drug Delivery FormulationsThe growing demand for liquid medicines is increasingly driven by the unique needs of several distinct patient groups, improving compliance in these demographics through flexible, palatable dosing options.
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Considerations for Method ValidationSusan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Shiri Hechter, senior lab operations manager for Nelson Laboratories, provide a simple approach to validating analytical methods.
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Launching And Commercializing BiosimilarsMany hurdles lie between a biosimilar and success on the market. In particular, there are three main questions that companies will be asking themselves.
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Enhancing Process Validation for Sterile Liquid and Freeze-Dried Forms: Part 1AFI representatives of the process validation working group explore and define key elements for an enhanced approach to process validation for sterile liquid and freeze-dried forms.
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At the Heart of Pharma: ESG has Arrived as a Central StrategyPharma supply chains are no longer hidden beyond the reach of ESG agendas, making it important for companies to accelerate adoption of new manufacturing processes and environmental technology
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Formulating to fight a global pandemicPartnering with Spark Global and Stanford University, startup CDMO, Bravado Pharmaceuticals, uses a creative approach to survive during the Covid pandemic.
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Thermogelling Matrix-Containing Platelet Lysate-Loaded Elastic Liposomes as a Potential Treatment of WoundsThe purpose of this article was to demonstrate the application of a new thermogelling matrix in the healing of wounds.
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DyadPalladate™ pre-catalysts: Cross-coupling made simpleThis technical brief will start by outlining the importance of cross-coupling catalysts in the industry. It will then weigh up the benefits of existing in situ and pre-formed catalysts. The remainder of the technical brief introduces Johnson Matthey’s DyadPalladateTM pre-catalysts as a cost-effective and greener alternative to traditional in situ systems.
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Formulation of Sustained-Release Ketorolac Tromethamine PelletsThe authors evaluated the effect of polymer composition on the drug-release profile and the effect of storage conditions on dissolution characteristics.
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Enabling the Virtual Human Through Physiologically-based Pharmacokinetic ModelingBasic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed.
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When Is It Appropriate to Outsource Bioanalysis Work to a CRO?When considering whether to outsource work to a CRO, there are a number of factors to assess, including the type of work that may be outsourced, regulatory considerations, and needs for the study.
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Public Trust in Medicine Quality as Public Health Challenges EmergePublic health challenges have highlighted the need for agility in maintaining the quality of medicines.
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Optimizing Quality by Design in Bulk Powders and Solid DosageCase studies on the manufacture of a bluk powder and the development of a tablet show the application of QbD principles.
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Navigating International PharmacovigilanceInternational pharmacovigilance for biotechs brings about a particular set of challenges, especially for small companies, which face the same rigour as large pharma companies.
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Development of Orally Disintegrating Tablets Based on a New ExcipientThe authors examine the effectiveness of an excipient comprised of mannitol, polyvinyl acetate, and crospovidone using model actives loperamide hydrogen chloride and caffeine.
