MCC as Pharmaceutical Excipient for Drug Formulation
Microcrystalline Cellulose (MCC) is purified, partially depolymerized cellulose used by pharmaceutical customers around the world, CEOLUS™ offers superior performance and quality based on advanced particle design, production, and processing technologies at Asahi Kasei.
Asahi Kasei started MCC production in 1970. Since the 2000s, Asahi Kasei has been continuously developing MCC products that have unique performance which derives from our patented unique morphology design. The products have helped customers with technical challenges among several product development stages such as lab, scale-up, and production.
Asahi Kasei’s high functional excipients, CEOLUS™ KG & CEOLUS™ UF grades are distinct in terms of its application & provide greater flexibility to a scientist in designing a formulation. The high functional excipients also solve a range of tableting related issues namely capping, sticking & others. Other high functional excipients include MCC spheres CELPHERE™ used for drug layering and Pregelatinized corn starch PC-10.
|Grade||Features||Performance||Benefits for Customers|
|Rod-shaped particles||Super-compactability MCC||Facilitate high-dose formulation
Realize low pressure tableting
Lower tablet friability
Preventing sticking and capping
Suitable for roller compaction
Suitable for ODT, bilayer tablets, MUPS tablets
|Round shaped and Porous
Adsorption on the particle surface
|Improve poorly flowable formulations
Fast disintegration and dissolution with sufficient hardness
Prevent segregation and over-lubrication
Facilitate high speed tableting
|Well-balanced compactability and flowability||Optimized for tableting of poorly compactable and flowable formulations|
|CELPHERE™||100% MCC sphere
Narrow size distribution
|High Mechanical strength
Moderate water absorption
Stable particle property
|Tolerant with high stress and coating machine varieties
Yield improvement in coating
Stable storage stability
Suitable for controlled released formulations like MUPS
|PC-10||Partly pregelatinized starch with outer shell structure||High water retention capacity
Lower water-soluble content
pH independent disintegration
|Toler-Stabilizer for moisture sensitive API
Carrier for extracts
KG grade is fibrous morphology in nature with high L/D ratio and specialized in the performance of compactibility. It undergoes plastic deformation helping to eliminate Capping & Sticking issue.
UF grade is round shaped porous morphology creating a rough surface and superior in both flowability and compactibility, thus providing superior adsorption property eliminating segregation.
CELPHERE™ is 100% MCC spherical seed core. It’s tolerant to high stress and coating machine varieties solving issues like crushing and aggregation of pellets.
(1) What is the difference between alpha form MCC and beta form MCC?
MCC is made from alpha cellulose. Normally it is regarded as “alpha” form. “Beta form” is used to explain a needle shape particle morphology of MCC in order to differentiate it from conventional MCC in a certain situation.
(2) Are CEOLUS™ grades patented?
Yes, CEOLUS™ UF & KG grades are patented
(3) Where is production site of CEOLUS™?
Asahi Kasei currently manufactures CEOLUS™ in Miyazaki, Japan, and will build a second plant in Okayama, Japan.