Stability is a critical factor in drug formulation, with implications for product quality, lifecycle management, and ...
Drug formulation is becoming increasingly complex. Poorly soluble APIs, personalized medicines, and advanced oral dosage forms require production methods that are scalable, reproducible, and precise.
Biofrontera Inc. Announces Patent Approval and Inclusion of Ameluz® Formulation in FDA's Orange Book
Biofrontera Inc. announced that it has received patent approval for a revised formulation of its Ameluz® nanoemulsion gel, which is now listed in the FDA's Orange Book, ensuring patent protection ...
Hot-melt extrusion (HME) has emerged as a game-changer in modern drug development—a solvent-free approach that transforms difficult compounds into effective medicines. This guide breaks down the ...
CAMBRIDGE, MA -- About 60 percent of drugs on the market have hydrophobic molecules as their active ingredients. These drugs, which are not soluble in water, can be difficult to formulate into tablets ...
In June 2020, FDA had opened a public docket to solicit comments on the listing of patent information in the Orange Book, specifically seeking feedback on the types of patents currently listed in the ...
Intrepid Labs’ Valiant platform uses AI and robotics to cut drug formulation timelines from months to days Over $11M USD total raised to-date; latest round led by AVANT BIO TORONTO--(BUSINESS ...
Researchers develop an oil-based gel formula suitable for metered dosages of medication. There are many reasons why someone might find it difficult to swallow solid medications like pills and tablets.
To optimize the final formulation for a drug, it must meet many criteria beyond producing a safe and effective product. For example, it must be stable and amenable to various manufacturing steps, such ...
Expertise in CMC (chemistry, manufacturing, and control) ensures the appropriate manufacture of a pharmaceutical or biologic by coordinating material characterization, formulation development, and ...
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