Delves into all aspects of R&D and manufacturing of all oral solid dose (OSD) forms. Tracks industry trends. Relays latest applied research relevant to OSDs. Provides “how to” information for the latest techniques in formulation/excipients, tablet manufacturing, capsule filling and other aspects of the process—including logistics like supply-chain management.
Driven by persistent supply chain disruptions, shifting trade dynamics, evolving customer expectations and the accelerating growth of the nutraceutical sector, the pharma ecosystem is rewiring where —...
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Although not a routine manufacturing step, granulation plays a central role in determining the quality, consistency and performance of modern OSD products. This article explores how granulation can ...
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Scaling up a tablet coating process from work performed with a small-scale unit to a full-scale production plant raises critical questions: Which controls and product attributes must remain unchanged,...
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Ensuring the quality of finished products not only requires in-house quality control processes but also a robust supplier qualification process. Establishing a supplier qualification program is one of...
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The FDA deadline to meet nitrosamine control guidance is upon us. Here’s a review of past nitrosamine-related regulatory actions — and lessons learned.
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More than an ambition or just another formulation strategy, patient-centric drug design is the future of pharma. As emerging technologies make gathering and implementing user feedback simpler than ...
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While colors are up for interpretation, science generally is not. Health misinformation has always existed, but took centerstage during the pandemic when social media quickly became a powerful tool ...
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The first federal ban on a synthetic color due to the outdated Delaney Clause has inked a line in the sand — and crossing it could push the industry past the threshold of science-driven formulation ...
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Speed-to-market, efficiency, flexibility, quality. These aren’t just buzzwords — they’re critical goals every pharma manufacturer must achieve to bring new therapies to patients. The challenge lies in...
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Successfully navigating scale-up challenges in suppository drug products demands proactive regulatory planning, robust quality control approaches and cross-functional collaboration during technology ...
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Integrating spray dried dispersions with controlled release technologies offers a promising pathway to simultaneously address solubility limitations and the advantages of controlled release. The ...
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As we edge past the midpoint of 2025, the U.S. oral solid dose sector has already put up some regulatory wins. Here’s a closer look at this year's OSD approvals.
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Beyond Rule of Five compounds were once considered unlikely to demonstrate oral bioavailability. This article examines what bRo5 drugs are, how they are formulated, and the modern manufacturing ...
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As the pharmaceutical pipeline shifts increasingly toward low-solubility, low permeability compounds — especially in therapeutic areas such as oncology and antivirals — the need for practical, phase-...
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The U.S. government is currently investigating an ongoing antidumping and countervailing duty action looking into hard empty capsules from major trading partners.
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