Espheres EM

Espheres EM

ESPHERES EM (Microcrystalline Cellulose Spheres)

MCC (Micro Crystalline Cellulose) spheres are hard free flowing spherical masses prepared principally using MCC and Espheres EM are available containing 100% MCC also.

The ingredients used are having GRAS status and are compliant to monographs of all the recognized pharmacopoeias.

Important Features of Espheres EM

  • Uniform sphere size

  • Low friability

  • Insoluble in water

  • Uniform and consistent loading

  • Cost effective

  • Availability in a wide size range

General Physico-chemical Characteristics

  • Appearance
  • White to off white hard free flowing spherical pellets
  • Loss on Drying
  • Not more than 7% w/w
  • pH
  • 5 to 7.5 (2% aqueous dispersion)
  • Solubility
  • Insoluble in water
  • Microbial Enumeration Test
  • Complies with pharmacopoeial requirements
  • Pathogens
  • Absent

Storage conditions

Protect from excessive temperature moisture and freezing.

Re-evaluation Date - 36 months from the date of manufacture.

Application

These spheres can be used as an inert base for modified release formulations promoting consistency and uniformity of release profile thus ensuring a uniform therapeutic response.

Particle Sizes (U.S. Standard Sieve) Available

#20 – #30, #30 – #40 and #40 – #60

  • Other intermediate sizes can be considered on request.

  • Size considerations - Not less than 90% pass through the coarser sieve size and not more than 10% passes the finer sieve. These sizes are stated on the label.

For more details about ESPHERES™ products, please contact us at info@idealcures.co.in