HiSORAD
HSR-D03

News & Topics

  • Poster presentation at the 12th PBP World Meeting on May 14, 2021 Read more
  • We published an article on Drug Development & Delivery Read more
  • Applicability of ODTs with Daicel's excipient to continuous manufacturing process Read more
  • Pediatric preparation with DAICEL's excipients Read more

NEW GENERATION

Directly Compressible Excipient for Orally Disintegrating Tablets

HiSORAD HSR-D03

Product Features

  • HiSORAD is a state-of-the-art co-processed excipient for orally disintegrating tablets designed to have well-balanced property between oral disintegration time and tablet hardness.
  • Composed of three compendial grade excipients, D-Mannitol, Microcrystalline cellulose and Croscarmellose sodium.
  • Regulatory status: US-DMF filed
  • Before

  • After

Characteristics

  • Excellent compactability
  • Well-balanced tablet property between OD time and hardness
  • High API loading capacity
  • Simple composition

How to use

HiSORAD is developed for direct compression by conventional manufacturing and packaging machineries.
HiSORAD consists of excipients that have already been chosen and processed to design ODTs. In the simplest case,
manufacturers only need to mix HiSORAD with APIs and lubricants before tableting.
As it helps in the formulation of ODTs, HiSORAD can be a time-saving tool for manufacturers.

Powder Properties

Item Typical Value
Mean Particle Size*1 106 μm
Density*2 Loose   0.35 g/cm3
Tapped   0.49 g/cm3
Angle of Repose*2 41°
Orifice Diameter*3 6.3 mm
Water Content 2.4 wt%

Measurement methods
*1 Dry laser diffraction/light scattering instrument
*2 Powder tester
*3 Orifice diameter measurement instrument

Tablet Properties (Placebo)

  • High tablet hardness possible even at relatively low compression forces.
    HiSORAD is expected to be suitable for poorly compressible APIs.
  • Placebo tablet with HiSORAD draws water rapidly and disintegrates within 20 seconds.
Composition :
HSR-D03(99%)+Sodium Stearyl Fumarate (1%)
Tablet Shape :
200 mg, φ8 mm, Flat-bevelled edge
Tableting Condition :
Rotary-press, 20 rpm, Open-Feeder
Hardness :
Measured by electronic hardness tester (Avg. of n=10)
Disintegration Time :
Measured by JP general test method (Avg. of n=6)
Oral Disintegration Time (in vivo) :
Measured 3 times by 3 adults (Avg. of n=9)