Neusilin® the extraordinary excipient for solid dosage forms – Technical Newsletter

See the third issue of Fuji Chemical Industries Technical Newsletter. This issue focuses on achieving higher tablet hardness with pleasant mouth feel at good oral disintegranting (OD) times by addition of other common excipients.

Neusilin® has been rated as an excellent antacid in Japan and abroad. It is also widely used as excipient to improve the quality of drugs.

NEWSLETTER HIGHLIGHT

What is Neusilin ® US2?

Neusilin ®US2 is a fine ultra-light granule of magnesium aluminometasilicate, widely accepted as a multi-functional excipients that improves the quality of pharmaceuticals. Due to its large surface area and porous nature, US2 adsorbs high loads of oils or water, and can be mechanically compacted into high quality tablets.

Furthermore Fuji´s unique manufacturing expertise makes US2 neutral unlike traditional Magnesium aluminum silicates whose pH is alkaline. In this newsletter we introduce you to the best disintegrant combination with Neusilin ® US2 for tableting.

Disintegrants & Tabletting

Among excipients, disintegrants play an important role in disintegration and dissolution of tablets. This factor is critical for drug absorption in vivo. In order to give formulators the best choice of disintegrating agent in combination with Neusilin ® US2, eight of the most common disintegrants were and their ability to quickly disintegrate compressed tablets was evaluated.

Disintegrants Used in Tabletting

Formulation & Testing Methods

Neusilin ®US2 was compounded with 5% disintegrant and 1% magnesium stearate.

The mixture was then compressed into tablets of 11 mm. dia and 200 mg. weight in a rotary tableting machine.
Disintegration test was carried out as per JP. To measure the disintegration time, one tablet is placed in each tube in a basket rack assembly containing a total of six glass tubes.
Each tube was 7.75 cm. long, open at the top with a 1.8-2.2 mm. mesh attached at the bottom.
The assembly was positioned in a 1-liter beaker of water maintained at 37 C.
The basket rack was then moved up and down at a constant speed.

Disintegration times were calculated from the time taken for tablets to disintegrate to the point where all particles had passed through the mesh screen. The results are summarized in the below table.

The Results

Neusilin® the extraordinary excipient for solid dosage forms - by Fuji Chemical Industries_the result — Neusilin® the extraordinary excipient for solid dosage forms – by Fuji Chemical Industries_the result

See the full Pharmaceutical Technical Newsletter on “Issue 03 – Neusilin®” here:

(click the picture to download the technical newsletter)