MCC SANAQ® S – Solving direct compression formulation problems

Formulating tablets in the pharmaceutical industry often involves a delicate balancing act between powder flowability, compressibility, content uniformity, and final tablet properties.

Trying to get the balance right becomes especially challenging when working with high API loads or low-dose formulations, where precision and performance are critical.

This is particularly often when tableting is through Direct Compression process, and where traditional excipients may not have enough compressibility or flowability characteristics needed.

Maintaining Quality

Conventional excipients frequently fall short when trying to achieve free flowing and easily compressible powders, leading to inefficiencies and quality control issues. These can include weight variations, sticking issues, or tablet capping that compromise both manufacturability and assured dose delivery.

Uneven powder flows are also problematic, leading to batch rejections and costly production delays. Worse still, oversized tablets caused by inefficient drug loading can compromise patient safety and end-user satisfaction, as well as regulatory compliance.

Rising demand for high-quality, scalable formulations have emphasized industry needs for more reliable and multi-functional excipients. For direct compression applications, these need to exhibit not only ideal flowability and compressibility properties to ensure good tablet strength, but also stability under direct compression so as not to degrade the API.

These considerations also argue for the use of a highly multifunctional excipient, since the more diverse types of powders are involved, the more complicated the formulation and production processes are likely to become.

High performance

Pharmatrans MCC SANAQ® S meets these needs with a groundbreaking next generation co-processed excipient that combines silicified MCC microcrystalline cellulose and CSD colloidal silicon dioxide to deliver a high-performance, multifunctional platform for modern tablet formulations.

The combination of MCC and CSD makes MCC SANAQ® S easy to use in formulations, with highly advantageous compaction and flowability characteristics. Additionally, it exhibits brittle fracture and plastic deformation characteristics, giving it superior binding properties, along with extremely high stability under compression.

The product is obtained by a spray drying process, giving it greater homogeneity, a much narrower PSD particle size distribution, and up to five-fold increase in surface area comparing with MCC. The increased surface area enabled by CSD coating of the MCC particles enables superior flow and increased compaction and results in improved content uniformity and stability in the formulation, even for low dosage formulations or for micronized APIs.

MCC S SANAQ® shows a 30-50% compaction increase compared to traditional MCC. When used for direct compression, it can replace granulations, while significantly reducing the number of required excipients used, for example:

• 30-50% less MCC & binders needed
• 25%-50% less lubricant
• 35-50% less disintegrants
• No need for Dibasic Calcium Bibasic Phosphate
• No need for additional glidants

Solving problems

MCC SANAQ® S solves pharmaceutical formulation problems on multiple levels:

• Enhanced Powder Flowability: Adding CSD significantly improves the flow characteristics of MCC SANAQ® S, a critical advantage for high-speed, automated tableting.
• Superior Compressibility: The synergistic interaction between MCC and CSD enables stronger, more cohesive tablets with reduced friability, even at lower compression forces.
• Improved lubrication efficiency to combat sticking issues in tablet presses.
• Optimum Content Uniformity: MCC SANAQ® S provides excellent homogeneity, making it ideal for low-dose APIs where uniform distribution is essential.
• Higher Drug Loading Capacity: MCC SANAQ® S can support API loads up to 50%, enabling smaller, more patient-friendly tablets without compromising integrity or dissolution.
• Direct Compression Ready: Optimized particle design ensures MCC SANAQ® S is suitable for direct compression, cutting down processing steps, significantly reducing the number of required excipients and therefore overall manufacturing costs for more cost-effective tablet production.

In summary, the free-flowing nature of MCC SANAQ® S promotes easier mixing and filling in compression processes while its multiple functions as binder, disintegrant, lubricant, and glidant and its suitability for DICOM applications allows manufacturers to reduce number of powders in development and process steps in production for increased overall efficiency.

Pharmatrans Advantages

MCC SANAQ® S is available in a range of variants (see Resources) that allow manufacturers to precisely tailor their formulations to meet the demands of challenging APIs and demanding high speed manufacturing conditions.

Variants include:

• MCC SANAQ®S 101: best in class binder.
• MCC SANAQ®S 102: optimum balance between flow properties and compaction.
• MCC SANAQ®S 102 HD: ideal choice for rapid disintegration.
• MCC SANAQ®S 102 LM: another rapid disintegration formulation but with lower moisture content (< 3%).

MCC SANAQ® S benefits

Across the range, MCC SANAQ® S delivers a series of key benefits:

• Enhanced performance: With MCC SANAQ® S, formulators gain a robust, scalable solution from a single excipient that boosts tablet quality, improves process reliability, and enhances patient compliance.
• Consistency: Manufacturers can rely on uniform performance across every batch, with MCC SANAQ® S ensuring consistent quality, making it a reliable partner in for trouble-free production.
• Cost Efficiency: MCC SANAQ® S enables reduced waste, fewer defects, and lower maintenance costs, translating into significant savings and higher profitability.
• Faster to market: MCC SANAQ® S is the formulator’s friend when it comes to a multifunctional excipient that is easier to use and enables more rapid tablet development, easier scale-up, and accelerated regulatory market approval.

Across a range of applications, from developing mass market generics to innovative blockbuster therapies, this is a leading-edge excipient that brings science, efficiency, and performance to the tableting process.

Discover how Pharmatrans SANAQ® can elevate your formulations. Contact our team today to learn more about MCC SANAQ® S and solve your pharmaceutical formulation problems.

Resources

Click on MCC SANAQ® S specifications for detailed data.
Click on MCC SANAQ® S variants  for further information.