Sudipta Roy,
- Assistant Professor Department of Pharmaceutics, Bengal College of Pharmaceutical Technology West Bengal India
Abstract
The quality and effectiveness of pharmaceutical tablets depend heavily on several factors influencing shear stress on tablet hardness and disintegration. These factors include formulation composition, wherein the selection and concentration of excipients and active ingredients affect how the tablet material responds to shear stress. Additionally, the compression force, speed, and duration during tablet compression are critical, impacting tablet hardness and disintegration properties. Tablet geometry and design, along with tablet press conditions, also contribute to variations in shear stress. Environmental factors and the use of lubricants further influence shear stress and tablet characteristics. It is essential to comprehend and regulate these factors to optimize tablet manufacturing processes and ensure the uniformity and durability of pharmaceutical tablets. In tablet manufacturing, optimizing performance requires systematic process monitoring and optimization. The tablet formulation is optimized through steps like API and excipient selection, pre-formulation studies, formulation development, and optimization studies. Shearing Stress Monitoring: To utilize inline sensors such as load cells or torque sensors for real-time monitoring throughout manufacturing. Tablet Hardness Monitoring: To evaluate tablet hardness during production using hardness testers, and adjust parameters as needed for consistency. Disintegration Testing: To conduct tests to assess disintegration performance, and correlate results with shearing stress levels for optimization. Process Optimization: To implement statistical process control (SPC) and root cause analysis to identify and address issues, optimizing parameters accordingly. Continuous Improvement: To foster a culture of ongoing optimization, promoting collaboration and updating SOPs based on insights gained from monitoring. Systematic monitoring and optimization are key to producing high-quality tablets consistently. Shearing stress significantly influences tablet manufacturing, affecting both disintegration and hardness. It compromises tablet structure, leading to delayed disintegration or surface defects. Shearing stress also consolidates particles, resulting in harder tablets, but excessive stress can lead to over-compression. To optimize manufacturing, control shearing stress by adjusting compression force, optimizing formulation and lubrication, modifying tooling design, and continuously monitoring parameters like clearance and press speed. Effective management of shearing stress ensures high-quality tablets with reliable performance.
Keywords: Shearing stress, disintegration, compression, hardness, shearing stress monitoring.
[This article belongs to Research & Reviews: A Journal of Pharmaceutical Science(rrjops)]
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Research & Reviews: A Journal of Pharmaceutical Science
| Volume | 15 |
| Issue | 02 |
| Received | April 19, 2024 |
| Accepted | May 9, 2024 |
| Published | July 18, 2024 |