Getting the choice for excipients is usually quite tough for any of the pharmaceutical manufacturing companies, and by now you must be well aware of their level of challenge in order to get an ideal tablet formulation. Today we are talking about how these may be considered by differences like MCC 102 with its variants and how what you make turns out from that manufacturing.
Assessing Your Choices
Think of it in terms of today's life. Choosing excipients is like selecting that good foundation for the building; everything else relies on it. When mulling over Microcrystalline Cellulose 101 vs 102, most manufacturers consider surface differences but overlook what it means for the needs of their specific formulation.
Science of Selection
Simply put, it is like baking bread: the flour you use will determine everything from what the loaf looks like to how well it rises. In the same way, that particle size of MCC 102 would help determine:
- Flow characteristics when during processing
- Compression behavior
- Final hardness of the tablet
- Dissolution properties
Real-Life Examples
A well-known generic drug manufacturer encountered this problem. The high-dose formulation had tablets which showed inconsistent hardness in the beginning. Once the company used a proper grade of microcrystalline cellulose powder, tablet hardness was now acceptable. Results: improved production efficiency and a 30 percent reduction in rejection rates.
Right Grade Selection
Here is a practical guide for selecting the correct grade
- Analyze your active ingredient
- Particle size distribution
- Moisture sensitivity
- Bulk density requirements
- Assess the Processing Conditions
- Direct Compression vs. Wet Granulation
- Equipment capabilities
- Production volume requirements
- Keep in Mind Ending Product Specifications
- Expected dissolution profile
- Required disintegration time
- Requirements for stability
General Mistakes to Avoid
After decades of working with pharmaceutical manufacturers, we have discovered quite a number of challenges that recur
- The flowing properties of powder don't get considered
- Moisture content is neglected
- Improper use of compression force
- Poor assessment of the blend's uniformity
Optimize Your Process
Tablet manufacturing is not all about the excipients; rather, it is a whole process optimization. Here are some of the relevant practical tips
- Trial in small scale
- Compress parameters
- Batch to batch variability
- Thorough quality control
What lies ahead
The pharmaceutical industry advances continuously, and excipient technologies keep on innovating. Stay tuned to the following:
- New grades and modifications
- Innovative processing techniques
- Advanced characterization techniques
- Regulatory scope
Expert Tips for Success
Based on much industry experience, here is a compilation of the most important recommendations:
- Trial different grades before conducting the main experiment
- Record environmental conditions during process
- Engage one source of raw materials
- Document all process parameters
Expectations
Keep in mind the following important points
- Review Certificate of Analysis
- Qualification of vendors
- Storage conditions
- Testing protocols
Selecting the right excipient grade is not only dependent on technical specifications but also on taking full cognizance of how such decisions will affect the various processes in your manufacturing plant. A systematic approach, taking into consideration all the parameters, can optimize the tablet formulation for consistent and quality results.
For personalized expert advice and assistance in achieving your manufacturing objectives, contact our technical experts to learn more about optimizing your tablet formulation.
In the end, it takes time, effort, and understanding to succeed in pharmaceutical manufacturing. Evaluating every option carefully increases the possibility of finding the best materials. However, against the tide of temptation, one must not shy away from reaching for expert advice.
Want to optimize your tablet manufacturing process? Contact RanQ Remedies for a consultation with our technical experts and discover how we can help you achieve superior formulation results.