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FAQ

Westpoint Pharmaceuticals DESU® Microcrystalline Cellulose (MCC) is categorized into three main series. Below is a breakdown of each grade and its optimal application scenarios for oral solid dosage formulations:

 

1. PH Series (Standard Pharm Grade MCC)

  • DESU® MCC PH-101: A fine powder grade featuring small particle size, high specific surface area, and excellent compressibility. It is highly versatile, suitable for wet granulation, dry granulation, and direct compression. Ideal for formulations like Levofloxacin Tablets, Atorvastatin Calcium Tablets, and Apixaban Tabletsespecially those with high API content requiring stringent moldability.
  •  DESU® MCC PH-102: The industry-standard workhorse. It offers a balanced profile of flowability and compressibility, making it the mainstream choice for direct tablet compression. Widely used in Amlodipine Besylate Tablets, it provides a wide processing window where hardness fluctuations have minimal impact on dissolution rates.
  •  DESU® MCC PH-112: An ultra-low moisture grade with Loss on Drying (LoD) of only 0.3%0.6%. It exhibits controlled moisture uptake even at 25℃/75% RH. Specifically designed for moisture-sensitive APIs such as Vildagliptin and Clopidogrel Bisulfate, compatible with direct compression and dry granulation.
  •  DESU® MCC PH-200: A large-particle grade offering superior flowability and stable bulk density. Optimized for high-speed tablet pressing, ensuring consistent tablet weight variation and hardness for formulations like Rosuvastatin Calcium Tablets.
  •  DESU® MCC PH-301 / DESU® MCC PH-302: High-density grades with bulk density increased by 36%43% compared to standard MCC. They provide exceptional flow and filling properties, solving formulation challenges for high-dose drugs (API >60%). DESU® MCC PH-301 is suited for small tablet diameters requiring high density, while DESU® MCC PH-302 is optimized for high-speed direct compression (e.g., Acarbose Tablets, Dapagliflozin Tablets).

 

2. High-Performance MCC

  •  DESU® MCC 802: Engineered with an optimal fiber aspect ratio, it achieves robust compaction at low compression forces (>5kN) and ensures rapid disintegration. It is specifically developed for Orally Disintegrating Tablets (ODT) and sensitive materials like enzymes, antibiotics, and coated granules.
  •  DESU® MCC 1000: Features an enhanced fiber aspect ratio and a high water absorption rate (up to 410%). It requires very low compression force (<4kN) for effective tableting and effectively inhibits liquid exudation. Perfect for the solidification of liquid-active pharmaceutical ingredients (APIs) such as Vitamin D and volatile oils.

 

3. Super-Flow MCC

  • DESU® MCC 702: Combines superior flow with high compressibility (Carr Index <30%, Angle of Repose <39°). Designed for ultra-high-speed production (>40,000 tablets/hour), it maintains a tablet weight RSD of <1% and friability of <0.2%, while ensuring stable disintegration even at high hardness levels.

 

All DESU® MCC grades are produced via WestPoint Pharmaceuticals proprietary spray-drying technology. This process allows for precise control over microstructure and physicochemical properties, ensuring performance parity with leading international brands. It provides a reliable raw material solution for the industrial-scale manufacturing of oral solid dosage forms.

WestPoint Pharmaceutical's DESU® MCC PH-101 features a fine particle size (D50 approx. 50μm), high specific surface area, and a water absorption rate of up to 310%. It is a core excipient designed to handle challenging tableting demands, offering excellent compatibility with Wet Granulation, Dry Granulation, and Direct Compression processes.

 

Performance Across Formulation Processes:

1. Wet Granulation Process

The fine particle size of DESU® MCC PH-101 allows it to form a more uniform granular structure when mixed with hydrophilic binders. It demonstrates outstanding compressibility. In the wet granulation of Atorvastatin Calcium Tablets, DESU® MCC PH-101 achieves a tablet hardness of 130N at a main compression force of only 12kN. As shown in Figure 1, its overall compactability surpasses that of comparable products from Asia, the US, and Europe. Furthermore, it offers superior disintegration performance, disintegrating in just ~2 minutes even at a hardness of 130Nsignificantly faster than the ~3 minutes required by European alternatives.

 Figure 1 Compressibility Curve of Different PH-101 in Atorvastatin Calcium Tablets

 

2. Dry Granulation Process

In applications like Apixaban Tablets utilizing dry granulation, the blend containing DESU® MCC PH-101 exhibits an Angle of Repose of only 38.1°. This is lower than competing products from Europe (40.6°) and the US (40.9°), indicating superior flow properties while maintaining excellent compressibility (see Table 1). The disintegration time curve remains smooth and linear relative to increasing hardness, ensuring stable disintegration even under high-hardness conditions. This provides a wide and forgiving Formulation Design Space.

Table 1 Comparison of Micromeritic Properties of PH-101 Total Mixed Powder from Different Sources

Final Blend Powder Angel of Repose Hausner Ratio
DESU 38.1° 1.32
European Product 40.6° 1.31
Asian Product 37.9° 1.33
US Product 40.9° 1.33

 

3. Direct Compression Process

DESU® MCC PH-101 exhibits significantly better compressibility at low pressures compared to PH-102 grades. At a main compression force of just 2kN, it achieves a hardness of 58N (compared to 48N for PH-102). This makes it ideal for formulations with a high API load or moisture-sensitive/brittle Active Pharmaceutical Ingredients (APIs) requiring low-pressure protection. In the direct compression of Levofloxacin Tablets, the tablet friability was only 0.10%, outperforming German (0.16%) and American (0.15%) competitors. Additionally, it ensures a more uniform dissolution profile with a smaller intra-batch RSD.

 

DESU® MCC PH-101 is manufactured using WestPoint Pharmaceutical's proprietary Spray-Drying Technology. This process allows for the precise control of microstructure and physicochemical properties, ensuring excellent batch-to-batch consistency. It serves as a reliable alternative to international brands, providing robust support for the development and large-scale manufacturing of Oral Solid Dosage (OSD) forms.