Understanding the Need of Quality Excipients in Pharma Industry
July 9, 2018
How Excipients Affect Drug Quality in Pharmaceutical Industry
August 2, 2018
Microcrystalline cellulose is a pure, semi depolymerized cellulose synthesized from alpha cellulose (type Iβ). It is found on the earth in large quantity. It is obtained as a pulp from fibrous plant material, with mineral acids. The major source of MCC is wood. In woods, the cellulose chains are packed in layers by a polymer called lignin and hydrogen bonds. MCC is produced by using the spray drying method. It is manufactured by changing and controlling the spray drying conditions to obtain desired particle size and moisture content.
Direct Compression is the most favoured of all strategies for tableting as it spares both time and vitality. In this technique, tablets are compacted specifically from the powder mixes of dynamic fixings and reasonable excipients. Direct Compression is reasonable for moist and heats sensitive materials. This method has gained its ground because of economical technical approach. However, you cannot compromise on quality while desiring higher speed and lower costs. The important ingredient for the success of this method is the selection of suitable excipients.
The coveted properties of excipients for coordinate pressure are powder ease, great compressibility, low moisture affectability, and fast breaking down activity. A blend of at least two excipients with various attractive properties upgrades the assembling procedure as well as item execution. The nature of a conveyance framework is controlled by its assembling procedure and the execution of the measurements shape.
Following are the Reasons Is the Best Excipient Binder in Direct Compression Method
1) One of the important properties of MCC is plasticity which gets deformed during compression and maximizes the area of inter-particle bonding.
2) Another important property is the viscoelastic behaviour; it means the tabeltability of MCC increase with higher rotation speed machines and decreases if the rotations are decreased.
3) Because of low bulk density and broad particle size distribution, small amounts of MCC efficiently bind other materials.
4) MCC is highly porous, it promotes swelling and disintegration of MCC tablets.
5) Other properties include broad compatibility with APIs, physiological inertness, ease of handling, and security of supply.
Understanding Excipient Variability and Performance
Excipients play an important role in drug manufacturing. The potential impact of variability in API cannot be ruled out. However, the impact of variability of excipients also cannot be denied. Excipients improve manufacture quality, the performance of the drug product. QbD initiative gives a detailed understanding of the variability of API and Excipient variability on the performance and manufacturing of drug product. MCC also needs to meet the desired specification for quality and purity. Following are the critical material attributes of MCC
Potential Critical Material Attributes of Microcrystalline Cellulose
1) Moisture Content: MCC possess moisture in its pores which works as a lubricant, reduces frictional force, reduce tablet density and facilitate slippage. MCC also influences compaction properties, tensile strength, and viscoelastic properties.
2) Particle Size: Particle size generally does not have the impact on the tabetability of MCC. Variability in excipient particle size may impact not only tablet hardness, friability, and disintegration. Use of coarse MCC may improve flowability and reduce tablet weight.
3) Bulk Density: Excipients required for direct compression like MCC are generally spray dried, hence are porous and have low bulk density. It, therefore, results in improved tabeltablity, the better interlocking of particles, have higher dilution potential.
4) Specific Surface Area: The numerous hydrogen bonds between the large bonding surface areas of adjacent particles and to the mechanical interlocking of irregular particles of microcrystalline cellulose may positively impact its tabletability.
5) Degree Of Polymerization: No obvious correlation was found between the degree of polymerization (DP) of MCC and its tabletability. Scientists have shown that the origin of the raw materials and the production method more decisively influence the characteristics of MCC than DP.
6) Crystallinity: It has been reported that when a single method is selected, crystallinity does not vary much between various MCCs.
Conclusion
QbD is driving the pharmaceutical business to better comprehend the effect of material variability on the performance and manufacturability of new medication. DC stays one of the favoured procedures to create oral solid dosage forms. DC is straightforwardly affected by the material qualities, MCC is generally perceived as outstanding amongst other tablet diluents. It has been proved that moisture content; particle size, particle shape, bulk density and surface area do impact the tableting properties of MCC, i.e., tabletability and flowability. Since a criticality must be affirmed in a specific formulation and a given application, pharma companies and excipients providers need to cooperate with a specific end goal to advance excipients and procedures understanding.
