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CHALLENGE:
The performance of drugs is mostly determined by the particle size, shape, and distribution of active pharmaceutical ingredients, which are important for drug formulations. For the purpose of formulation development and quality control, these characteristics must be measured accurately. Hence it is important to measure the height, diameter, and distribution of API particles in the sample.
SOLUTION:
To tackle the challenge of identifying API particle height ,diameter and distribution ,we implemented Atomic Force Microscopy (AFM) is a powerful tool that enables the measurement of API particles at the nanoscale it offers high-resolution and quantification of surface topography, making it ideal for analyzing API particles.
AFM micrographs of API is recorded at
Particle height and diameter values recorded from the 3×3 µm.
| Particle height | Particle diameter | ||||||
|---|---|---|---|---|---|---|---|
| Total number of particles | Average Height (nm) | Standard Deviation (nm) | RSD (%) | Total number of particles | Average Diameter (nm) | Standard Deviation (nm) | RSD (%) |
| 59 | 3.464 | 0.760 | 21.94 | 59 | 51.92 | 21.72 | 41.83 |
RESULT:
What We Attained
➢ API particle size distribution
➢ Height of the API Particle is recorded by AFM
➢ Identified API particle diameter .
➢ Microscopic image of API
Insight obtained from the study
➢ API Particle height and diameter
➢ Optimized Drug Performance
➢ Formulation Optimization
➢ Quality Control
➢ Stability Assessment
➢ Efficiency in Processing
➢ Regulatory Compliance
The outcomes of this project support our customers in measuring API particle height, diameter, and distribution using AFM . The results have had a significant positive impact on formulation development,efficient quality control, , regulatory compliance, and process enhancement, ensuring the production of pharmaceutical tablets that are safe, effective, and of high quality.