Microcrystalline Cellulose PH 101

Product Overview

Microcrystalline Cellulose PH 101 is a high-purity pharmaceutical-grade excipient derived from purified cellulose. It is widely used in solid oral dosage formulations as a multifunctional diluent and binder, particularly where good compactibility and tablet mechanical strength are required.

PH 101 is characterized by a relatively fine particle-size distribution and excellent compactibility. Its particle structure provides a high surface area for interparticle contact during compression, supporting effective particle bonding and the formation of strong, coherent tablets.

PH 101 is particularly suitable for direct-compression formulations and can also be used in other tablet manufacturing processes depending on the overall formulation design.

Key Characteristics

  • Pharmaceutical-grade Microcrystalline Cellulose
  • Relatively fine particle-size distribution
  • Excellent compactibility
  • Effective binding performance
  • High surface area
  • Good compression characteristics
  • White, odorless and chemically stable powder
  • Suitable for solid oral dosage formulations

Functional Properties

Excellent Compactibility

PH 101 exhibits excellent compactibility under compression. The relatively fine particles provide substantial contact between particles, facilitating the formation of strong interparticle bonds.

This property makes PH 101 suitable for formulations where tablet mechanical strength and structural integrity are important.

Binding Function

Microcrystalline Cellulose PH 101 provides effective binding functionality and can contribute significantly to tablet strength and integrity.

It can be particularly useful in formulations where adequate tablet hardness and resistance to mechanical stress are required.

Diluent / Filler Function

PH 101 can be used as a pharmaceutical diluent or filler to provide bulk and improve the physical structure of solid dosage formulations.

Compression Performance

The relatively fine particle size and favorable deformation characteristics of PH 101 support efficient compaction during tablet compression.

Its performance makes it a commonly selected MCC grade for direct-compression formulations.

Pharmaceutical Applications

Microcrystalline Cellulose PH 101 can be used in a variety of pharmaceutical formulations, including:

  • Immediate-release tablets
  • Direct-compression tablets
  • Conventional compressed tablets
  • Chewable tablets
  • Capsule formulations
  • Solid oral dosage forms
  • Formulations requiring high compactibility
  • Formulations requiring effective binding functionality

Direct Compression

PH 101 is particularly suitable for direct-compression applications where good compactibility and binding performance are required.

During compression, the particles form strong interparticle bonds, helping produce tablets with good mechanical integrity.

The suitability of PH 101 for a specific formulation depends on the API characteristics, excipient combination, compression force, tooling and manufacturing process.

 

Particle Size and Its Importance

The relatively fine particle-size distribution of PH 101 contributes to its high surface area and favorable particle-to-particle contact during compression.

This can support:

  • Strong particle bonding
  • Effective compaction
  • Good tablet mechanical strength
  • Consistent tablet formation
  • Efficient binding performance

Particle size should be evaluated together with other parameters such as moisture content, bulk density, particle morphology, flow properties and formulation composition.

Tablet Performance

PH 101 can contribute to:

  • Good tablet hardness
  • Improved mechanical integrity
  • Resistance to mechanical stress
  • Consistent tablet formation
  • Effective binding
  • Good compact structure

Final tablet hardness, friability, disintegration and dissolution are formulation-dependent properties and should be established through appropriate development and testing.

 

Formulation Considerations

PH 101 may be particularly appropriate when a formulation requires:

  • High compactibility
  • Effective binding
  • Strong tablet structure
  • Fine-particle MCC characteristics
  • Reliable compression behavior
  • Good mechanical integrity

 

Quality and Regulatory Considerations

For pharmaceutical applications, Microcrystalline Cellulose PH 101 should comply with the applicable pharmaceutical specification and relevant pharmacopoeial or customer requirements.

Typical quality-control parameters may include:

  • Identification
  • Cellulose content / assay
  • Loss on drying
  • Residue on ignition
  • pH
  • Water-soluble substances
  • Ether-soluble substances
  • Elemental impurities, where applicable
  • Microbial quality
  • Particle-size distribution
  • Bulk density
  • Other customer-specific requirements

The final product specification should be established according to the applicable pharmacopoeial requirements and the manufacturer's approved technical specification.

Storage and Handling

Store in tightly closed packaging in a clean, dry and well-ventilated environment. Protect the material from excessive moisture, direct sunlight and contamination.

Specific storage conditions, shelf life and packaging requirements should be defined according to the approved product specification and technical documentation.