FDA

Abstract The recent advancement of 3D-printed drugs is an emerging technology that has the potential for effective and safe oral delivery of personalized treatment regimens to patients, replacing the current “one size fits all” philosophy. The objective of this literature review is to highlight the…
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Abstract Nitrosamine impurities have garnered recent attention due to their presence in pharmaceuticals and their mutagenic risks. Recent studies have emphasized controlling impurities and suggest ways to mitigate the further formation of nitrosamines by the addition of antioxidants to tablets and…
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Abstract The integration of Process Analytical Technology (PAT) into pharmaceutical process development has become a critical focus since the issuance of FDA PAT guidance in 2004. While PAT applications for blend uniformity (BU) and content uniformity (CU) are well-established, their utilization in…
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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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