Drug development is a complex and multi-stage process aimed to discover, develop, and bring safe and effective new drugs to market. Each stage demands rigorous scientific evaluation and strict regulatory compliance to ensure the safety and efficacy of the drugs. A key step of drug development is formulation development, which focuses on transforming the active pharmaceutical ingredient (API) into a safe, stable, and user-friendly dosage form. This involves selecting suitable excipients and carriers to enhance the drug's physicochemical properties, designing and producing appropriate dosage forms (such as tablets, capsules, injections, and sustained-release systems) to improve stability, dissolution behavior and bioavailability, and refining the manufacturing process to ensure consistent quality and scalable production.
In the process of formulation development, precise pharmaceutical analytical instruments are employed to thoroughly evaluate the physicochemical characteristics, purity, stability, and release profile of drugs to ensure the safety and effectiveness of the formulation. High-performance liquid chromatography (HPLC) remains the standard technique for quantitatively separating active compounds and impurities. Dissolution testers simulate physiological conditions to measure drug release kinetics, providing essential data for formulation optimization. Injection site simulators are valuable for ranking formulations and screening excipients during the development process. Particle size analyzers are essential for solid dosage forms and nanomedicine, providing accurate measurements of particle size and distribution, which significantly impact dissolution rate and bioavailability. Differential scanning calorimeters (DSC) can be used to study the thermal properties of drugs and excipients to ensure the physical stability of the formulation. Additionally, instruments such as infrared spectrometers and UV-visible spectrophotometers are frequently used to study drug–excipient interactions and analyze the physical state of formulations.
Amerigo Scientific offers a comprehensive range of pharmaceutical analytical instruments specifically designed to support the efficient development, optimization, and quality assessment of pharmaceutical formulations.
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