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.
Counterfeit drug products and their potentially fatal outcomes are in the news nearly every week. The market for counterfeit versions of drug products such as potency l pills and heparin is booming ...
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The US Drug Supply Chain Security Act (DSCSA) officially went into effect last November, and the European Union’s Falsified Medicines Directive (FMD) goes into effect in February 2019. While these ...
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Recent FDA regulations and guidances have simplified the notification procedure pharmaceutical companies must follow when making certain changes to equipment, technology, and processes. The agency now...
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With many grinding mills—including roller mills, rotor mills, hammer mills, air-classifier mills, and fluidized-bed opposed-jet mills—successfully achieving the desired production throughput depends ...
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Cetirizine dihydrochloride is a second-generation antihistamine that is used to treat hay fever, allergies, angioedema, and urticaria (hives). As an H1 antagonist, cetirizine relieves the symptoms of ...
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Bottles are one of the most common packaging forms for over-the-counter solid oral dosage medications and nutritional supplements. Tablets, capsules, and softgels are all commonly sold as bottled ...
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Orally disintegrating tablets (ODTs are not just another fancy dosage form; they address a very important component of treatment success: compliance. This is especially true for pediatric and ...
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Sometimes simple dosing with API powder in a bottle or capsule for a clinical Phase I study can be acceptable, and it may be quicker to use API powder in either a capsule or a bottle than to develop a...
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In recent years, continuous powder mixing has attracted pharmaceutical processing, which has traditionally been a batch-based industry. However, while continuous processing is widely used in bulk ...
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The final rule of the FDA’s Dietary Supplement GMP Regulation 21 CFR Part 111.30(c) requires dietary supplement manufacturers to “routinely calibrate, inspect, or check the equipment to ensure proper ...
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Tablet compression tooling is a significant investment. production costs compared to the cost of a tablet press or fluid-bed dryer, tablet manufacturers typically buy many sets of tooling over a drug ...
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With today’s global pharmaceutical supply chain, setting United States Pharmacopeia–National Formulary (USP– NF) compendial specifications for excipients is becoming increasingly complicated. This is ...
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Pharmaceutical and nutraceutical production personnel often struggle to achieve the same tablet hardness as that achieved during R&D and sometimes fail to reach even the specified minimum hardness. ...
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Nearly every company that manufactures tablets has had to deal with a sticking problem during compression. Despite the problem’s ubiquitous nature, cross-functional collaborations to discuss sticking ...
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Tablets come in many shapes and sizes, and tablet formulations have a range of physical characteristics and tableting properties, such as abrasiveness, corrosiveness, lubricity, and compressibility. ...
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