Monitor Dissolution In Pharmaceutical Development Using Uv Spectroscopy

INTRODUCTION

In the pharmaceutical industry, UV spectroscopy is used in drug dissolution testing, which is a critical analytical task for solid oral dosage forms. This testing is performed at different stages of drug development to evaluate the release behavior of new formulations, ensure manufacturing consistency, and help predict the in vivo absorption of the drug after administration. Dissolution testing has been an essential tool for decades in the assessment of drug release from solid oral dosage forms, such as tablets and capsules, during pharmaceutical development. The test can be implemented on disrupted solutions of solid tablets upon exposure to the medium fluid. Dissolution testing is also applied to solutions synthesized by mimicking processes in the human gastrointestinal tract. This application note will reveal the methodology and the recommended device in the sections below.

METHODOLOGY

To understand well how the application can trace the dissolution of drugs in a biofluid, measurements were presented using UV setup on both calibration and samples. The dissolution expressed by UV absorption profiles administers kinetic ability and time to respond to the drug when entering the body via monitoring distinct absorption characteristics of substance structures in the real-time investigation. The action of dissolution performed perfectly how changing of drug’s concentration in the body’s fluid. The collected data was also used to build the database including calibration and validation to support the next step to determine precision.

Figure 1a illustrates the UV absorption spectrum of dissolved naproxen sodium solution with two character absorption peaks of 272 nm and 329 nm and Figure 1b illustrates collected absorption points at 329 nm in real-time.  The dissolution profiles reflect a correct tendency of Lambert-Beer law via the absorption of the dissolution increased over time, meaning dissolved concentration decreased over the period.

Figure 1. a) Absorption spectrum of naproxen sodium; b) Dissolution profiles (absorbance vs real-time) of a naproxen sodium tablet before and after correction. The gray curve shows the absorbance of a naproxen sodium reference standard solution collected every half hour.

Furthermore, the assessment of the consistency in dissolution profiles according to FDA standards, conducted at a 95% confidence level, is illustrated in Figure 2, which represents the nonlinear fitting of experimental kinetic data and calibration data.

Figure 2. Representative nonlinear fitting of experimental kinetic data and calibration data.

RECOMMENDED DEVICE

The system will measure the absorbance of the solution at multiple time points with a portable USB4000 UV/Vis spectrophotometer (Ocean Optics, Inc., Largo, FL). This spectroscopy has a wide wavelength range from 200 nm to 1100 nm, which covers the survey range of 250 – 350 nm, and a high-sensitive detector using a 3648-element linear silicon CCD array with optical resolution under 0.5 nm. This is also one of the considerations for the final choice because it can be easy to detect a small change of concentration via absorption display. In addition, high-speed acquisition capabilities with an integration time of 4 ms – 20 ms could decrease the wait time of users.

Similarly, thanks to striking features, a DH-2000-BAL light source (Ocean Optics, Inc., Largo, FL) covers a wide spectral range. The combination of deuterium-tungsten halogen light sources provides a single optical path from 200-2500 nm.

CONCLUSION

UV Spectroscopy plays an important role in supervising the dissolution for the determination of pharmaceutical formulations. By accurately measuring drug concentration in dissolution media, UV spectroscopy enables researchers to assess the performance of drug formulations and optimize their properties for enhanced efficacy. This method is simple and more sensitive and could handle research in lab studies, and even in manufacturing conditions.