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Pelletization, a popular oral drug delivery method in pharmaceuticals and nutraceuticals, offers numerous benefits. This article delves into the critical parameters for formulation development and technological consideration in pelletization, elucidating its significance in advancing pharmaceutical solutions.

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In the coming year, pharmaceutical innovation will be fueled by key trends throughout the quality sector.

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Lucy Zhou, Skin Lab Manager, discusses the importance and applications for utilizing in vitro Release Testing during development of generic topical drug compounds. Lucy discusses how IVRT can play a critical role by saving cost and time during product development and the techniques and applications for using in vitro testing to achieve desired product outcomes.

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This study reviews changes in in-country testing (registration testing, import testing) requirements and analyzes current trends. In the context of international harmonization of good practices and standards as well as the improved information exchange between national regulatory authorities, in-country testing is considered outdated and redundant in many cases.

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An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

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Basic principles of physiologically-based pharmacokinetic (PBPK) modeling and its impact in streamlining the drug development process are reviewed.

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Revolutionize pharmaceutical manufacturing through paperless manufacturing. By eliminating paper-based processes, you can quickly centralize your data, reduce cost and time, minimize errors, and release products faster. Even the simplest “paper on glass” digital systems enable streamlined workflows and can ensure real-time data access and seamless communication. Paperless facilities are a reality! Transform your operations today!

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Webinar Date/Time: Thu, Nov 7, 2024 9:00 AM PST (12:00 PM EST)

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An adulteration limit of 100 ?g/25cm? (4 ?g/cm?) was proposed for pilot-plant facilities. The dynamic changes in equipment, formulation, and residue determination made implementation of a constantly changing, calculated adulteration limit impractical. A single adulteration limit was simpler to communicate and document, making compliance achievable. The limit would be used only after it was determined to be lower than a health-based evaluation and a visual-cleanliness assessment.

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Industry should improve the standards on application of risk management tools in light of the cases of nitrosamine impurities.

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Testing the dissolution rates of a pharmaceutical formulation (also known as in vitro availability) aids drug quality control and is a compulsory requirement of the British, European and US pharmacopoeias.

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Extractables and leachables are a growing concern for pharmaceutical manufacturers and regulatory bodies.

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Smart manufacturing transforms management of tablet and capsule equipment and processes.

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Proper selection of normal flow filters leads to increased process efficiency from early phase product development through to full-scale biopharmaceutical production.

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Emerging new technologies and disruptive manufacturing concepts are providing new opportunities for pharmaceutical companies.

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Terminal sterilization of aseptically processed drug products is extremely important for patient safety. As such, it is a regulatory requirement that drug products that can withstand terminal sterilization be terminally sterilized. Overkill type sterilization cycles are not required for a drug manufacturer to make a terminal sterilization claim. Many different time and temperature combinations that are much more product friendly can be used to safely terminally sterilize drug products.

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Data integrity is crucial in unlocking novel data-based insights.

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Vetting a CMO for sterile injectable fill finish means more than capacity and equipment. This white paper from Jubilant HollisterStier discusses the range of factors to consider when outsourcing manufacturing for aseptically filled and terminally sterilized products.

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Sean Imlay, FG Clean Wipes, highlights the Saturix® Surface Cleaning System during INTERPHEX 2022. Watch this video to learn more about:

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Webinar Date/Time: Tue, Nov 12, 2024 9:00 AM EST

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Advanced manufacturing technologies are available, but challenges need to be addressed.

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This study aimed to develop a taste-masked drug resin complex using the ion exchange resin Kyron T-114.

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Challenges that can prevent sponsors realizing the full potential of managed access programs can be overcome by embracing a just-in-time manufacturing strategy.

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If you want to learn more about the physical characterization of your pharmaceutical powders, download this free e-book. You will find real measurement data that has been collected from a range of characterization methods, including particle, surface area and pore size analysis, powder rheology, and X-ray diffraction. Deepening your understanding of bulk particle properties is just the first step to get more predictable formulations and optimized processes.

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3D screen printing provides innovative drug development capabilities that are difficult or impossible to achieve with traditional methods, including complex multi-layered formulations, precision control over drug release profiles, and near-endless possibilities in the geometric shaping of dosage forms. In this article, learn how 3D screen printing offers unmatched flexibility to tailor formulations for specific therapeutic needs and redefines what’s possible in drug development and manufacturing.

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Regulations for mRNA products are evolving as the market for mRNA expands.