Good news - FACI magnesium stearate is activated!

FACI Magnesium Stearate

F20180001533

A

about 

FACI

Faci Asia Pacific Pte Ltd was established in 1999 and is located in Jurong Island, Singapore and is wholly owned by Faci SpA

The pharmaceutical excipients produced by the Singapore factory mainly include magnesium stearate, calcium stearate, sodium stearate, and zinc stearate

Product Regulatory Advantages

01100% plant origin

02Pharmaceuticalgrade, in line with national pharmacopoeia

Compliant with USP, EP, BP, JP, ChP

US FDA DMF No.

China CDE registration number F20180001533

03Completecertification

ISO, HACCP, Kosher, HALAL, RSPO

Production Process

It is produced by the international mainstream one-step reaction method.

Factors Affecting Formulations

01Relative content of stearic acid and palmitic acid

Pharmacopoeia: C18 > 40%, C16 + C18 >90%

High content of C18 - good lubrication effect - good flow of powder and good compressibility of tablet

The composition of stearic acid affects the crystal form of magnesium stearate

02Free fatty acid content 

Pharmacopoeia: <0.

Adverse reactions with tablet formulation ingredients

Limits depend on process and formulation stability studies

03Unreacted MgO

The reaction process of magnesium salts may reduce the lubricating effect;

Hydrophobic, potentially affecting mobility

04 Bulk density 

Differences in particle size and structure , as well as particle-particle interactions , determine differences in bulk density

Differences in bulk and compacted densities predict powder flowability

Affect tableting pressure

05Residual through 200 mesh sieve

Large particles reduce coating effectiveness

Large particles cause aggregation

06Appropriate particle size distribution range

Smaller particle size—larger specific surface area

But smaller particles require more coating, extending drug release time

Higher magnesium stearate content resulted in higher tablet friability

Narrower particle size distribution for smoother coating

Based on the characteristics of each component of the tablet, select the appropriate particle size distribution range

07Suitable specific surface area

Large specific surface area, more uniform coating and better fluidity

However, the larger the specific surface area, the lower the tablet hardness

Scan the code to get samples

Agency brand

JRS｜EVONIK｜MERCK

ACG｜INGREDION

FACI|OMYA