FDA

Abstract Sulfur and phosphorus are elements that can be found in various FDA-approved drugs, either as part of the active pharmaceutical ingredients (APIs) or as components of excipients (inactive ingredients). In this review we will explore the therapeutical use and the synthesis of the approved…
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Abstract Film-forming solution (FFS) implies a novel formulation strategy for liquid preparations for cutaneous application with numerous advantages in comparison with compendial dosage forms, including flexibility of composition (active pharmaceutical ingredient (API) solution in volatile and…
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Novel Carrier Systems for Targeted and Controlled Drug Delivery See the new book, edited by Awesh K. Yadav, Keerti Jain. Here the general concepts and new research results on targeted and controlled drug delivery are examined. Challenges and future directions in controlled drug delivery are…
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See an overview on Roquette´s low nitrite excipients and APIs and what they can do for your formulations: The Eye of the Storm Significant in its scope and serious in its potential consequences, nitrosamine formation will be remembered by the pharmaceutical industry as one of the most concerning…
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In this paper, the authors introduce a method that combines ion exchange chromatography with a easier-to-perform, simpler one-step post-column derivatization that is selective to nitrite and visible spectrophotometric detection to allow high sample loading volumes without affecting resolution.…
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Abstract This review describes the recent Food and Drug Administration (FDA)-approved drugs (in the year 2021) containing at least one halogen atom (covalently bound). The structures proposed throughout this work are grouped according to their therapeutical use. Their synthesis is presented as…
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Abstract The use of a process analytical technology has been demonstrated using near-infrared spectroscopy for continuous manufacturing of pharmaceutical formulations and is within the scope of the U.S. Food and Drug Administration's real-time release testing initiative. While effective for simple…
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Abstract Orally disintegrating granules (ODGs) are a pharmaceutical form commonly used for the administration of NSAIDs because of their easy assumption and fast dispersion. The development of ODGs is not easy for drugs like dexketoprofen trometamol (DXKT), which have a bitter and burning taste. In…
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Pharmaceutical 3D printing (3DP) has attracted significant interest over the past decade for its ability to produce personalised medicines on demand. However, current quality control (QC) requirements for traditional large-scale pharmaceutical manufacturing are irreconcilable with the production…
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FDA issued the ICH final guidance, Q13 Continuous Manufacturing of Drug Substances and Drug Products in March 2023. The document represents, according to FDA, a proactive step the FDA is taking to facilitate the pharmaceutical industry’s adoption of these advanced manufacturing technologies. FDA has…
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