API Particle Size Distributuion In the Tablet

CHALLENGE:

Achieving uniform particle size distribution of API in tablet formulations is essential for consistent dosage and effective treatment. Variability in particle size can lead to dosage inconsistencies and affect the performance of the medication. The challenge was to precisely analyse and optimize the API particle size distribution to enhance the quality and reliability of the tablets.

SOLUTION:

To tackle the challenge of API particle size distribution, we implemented Raman spectroscopy, a powerful analytical technique that provides detailed insights into the distribution and characteristics of API particles. The solution involved in the following

➢ Raman Mapping of API
➢ Analysis of API Particle Size Distribution
➢ Excipients Raman spectra
➢ Tablet Examination

Raman spectra of Input API

RESULT:

What We Attained
➢ Raman spectra of the API.
➢ API particle size distribution in its powder form.
➢ Raman spectra of the excipients.
➢ API particle size distribution on the marketed tablets

Insight obtained from the study
➢ API Uniformity
➢ Formulation Optimization
➢ Quality Control
➢ Bioavailability Considerations
➢ Manufacturing Process Validation
➢ Stability Assessment
➢ Efficiency in Processing
➢ Regulatory Compliance

The outcome of the project
The outcomes of this project support our customers in achieving consistent dosage and optimizing formulations by precisely analyzing API particle size distribution in tablets. Additionally, these results contribute to efficient quality control, formulation optimization, regulatory compliance, and process enhancement, ensuring the production of pharmaceutical tablets that are safe, effective, and of high quality.