LUBRISTAR – Innovation, Quality & Competence in Excipients by Gangwal

Gangwal Healthcare Pvt. Ltd., part of the prestigious Gangwal Group, has been a pioneer in the Pharmaceutical industry since 1987. Driven by the sense of social wellbeing and the steely determination to make a difference through technology and expertise, Gangwal Healthcare continues to be at the forefront of Pharmaceuticals, Nutraceuticals and Personal Care sectors in India. Nutraceutical industry globally, is a fastest growing market. As per the recent reports, India has remained 2% of the global nutraceutical industry of USD 400 billion and has potential to be a USD 50 billion by 2025 and USD100 billion by 2030. Our people are our core asset. Their vision, their ideas, their formulations, all connected at the core of Gangwal’s success. The team turn our formulations into reality. A reality that has made Gangwal’s name synonyms with INNOVATION & QUALITY

Lubristar – Sodium stearyl fumarate (SSF)

Hydrophilic lubricant

Lubristar – Sodium stearyl fumarate (SSF) used in the manufacturing of tablets, capsules and other dosage forms. Due to its high hydrophilicity, it is used for high performance formulations, where other lubricant (i.e., magnesium stearate) fail to provide adequate stability, hardness, content uniformity, disintegration and dissolution rate.

Lubristar is used similarly as magnesium stearate with a same lubrication efficiency. However, due to less hardness, and insufficient tablets stability provided by conventional lubricating agents, SSF is very effective.

Lubristar has good compatibility with APIs and a perfect lubricant for high-performance formulations. It is used in various application such as wet granulation, dry granulation, and direct compression. Some of the properties of Lubristar include anti-adherent, hydrophilic, control particle size, less sensitivity to blending time, high consistency compared to magnesium stearate.

Marketed formulations with Sodium stearyl fumarate

Structural Formula

Functional Category

Lubristar is an hydrophilic, tablet lubricant, useful in situations where other lubricant (i.e., magnesium stearate) fail to provide adequate stability, hardness, uniformity, disintegration and dissolution rate.

Physical properties of Lubristar

• White fine powder
• Good lubrication properties
• Uniform particle size distribution

Sodium stearyl fumarate is used as a lubricant in tablet and capsule formulations at 0.5–2.0% w/w concentration.

Physical properties

Particle size (by Malvern)

Particle size distribution of Lubristar is a key factor for optimal tableting results. Particle size on disintegration time is very well documented. Reduced particle sizes are directly linked with higher disintegration times.

Direct compression study

To provide more flexibility and reduce blending sensitivity associated with lubricants, direct compression
TM study carried out to check the effects of addition of Lubristar compared to available marketed SSF in
different ratios.

Model formulation

Tablets were composed of 650 mg Paracetamol, 2% of binder, 2% of disintegrant and variable contents (1
or 2% w/w) of lubricant (SSF). Microcrystalline cellulose used as filler.

Blending

2-step addition method was followed: The components (except the lubricant) were blended for 10 min.,
followed by addition of lubricant and further 2 min. of blending

 

See the full technical brochure on LUBRISTAR here

(click the picture to download the brochure)

Source: Gangwal technical brochure LUBRISTAR 

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