Wednesday, December 1, 2010

SUPERCELL™ Tablet Coating Technology (SCT)

Revolutionary tablet coater that accurately deposits controlled amounts of coating materials on tablets - even if they are extremely hygroscopic or friable

Tablet coating technology in the pharmaceutical industry has remained fundamentally unchanged for the past 50 years. Until now.
Inconsistent and imperfect, this “standard” practice of tablet coating often delivers a non-homogenous product. Because the tablets are loaded in large rotating pans and vented for hot air drying, tablet edges can get grounded off, intagliations can get filled in by coating material, and edges and corners may not be coated with the same thickness as the tablet faces.
The inaccuracy of deposition of coating material limits the use of modified release coatings. In a laboratory setting, it is necessary to coat several kilograms of tablets at one time, making R&D of a tablet dosage form costly and difficult.
In addition, extremely hygroscopic tablets cannot be coated with current technology, nor can flat or other odd shapes be consistently coated. The process must be run slowly to prevent  "twinning," where two or more tablets stick together. Tablets may also be coated in a Wurster-type coating apparatus, but tablet attrition generally prevents all but the hardest tablets from being coated this way.
Breakthrough technology with small batch capabilities - SUPERCELL™ Coating Technology(SCT) from Niro Pharma Systems effectively solves all of these problems using a small, modular design. The tablets are coated in batches ranging from 30 to 120 grams, which linearly scale up to production capacities.
The tablets are coated with the coating spray in the same direction as the drying gas, resulting in a more efficient process. Due to SCT’s unique air distribution plate design, the tablets move quickly and predictably through the spray zone, receiving only a small amount of coating per pass, and therefore achieving higher coating accuracy. The process time is short, seconds or minutes as opposed to hours, and therefore gentler on the tablets. SUPERCELL™ Coating Technology allows for coating of friable tablets, as well as flat or highly oblong tablet shapes. Drying is very fast, making it possible to coat extremely hygroscopic tablets. The accuracy of deposition is great enough that Active Pharmaceutical Ingredients can be layered onto tablets, and uniform layers of taste masking or modified release coatings can be applied consecutively within a single continuous batch.

SUPERCELL™ Coating ProcessSCT's continuous small-batch capable coating process is predictable and efficient

The coating apparatus shown is described in US patent 6,209,479 and EP patent 1 140 366 and eqv.5,6. The apparatus consists of a processing chamber that sits on top of an air distribution plate (roto-nozzle). The roto-nozzle contains gas jets designed to accelerate the object through the coating zone. Additionally, the gas jets impart momentum such that the object is rotating as it passes through the coating zone. The spray zone is created by a low-momentum two-fluid nozzle beneath the gas distribution plate that atomizes the stream of coating solution into fine droplets. Tangentially located slots around the nozzle that mix high-pressure atomization gas with low-pressure processing gas muffle the energy from the two-fluid nozzle. The objects are loaded into the processing chamber and are coated co-currently with the drying gas. UNIQUE FEATURES OF SUPERCELL™ TABLET COATING TECHNOLOGY :
  • Continuous coating
  • Short processing time
  • No scale-up to parameters
  • Flexible modular design
  • R&D batch size (Minimum batch size of 30 grams)
  • Production capacity of 6 cells coats 200K tph of 120 mg tablets
  • Enhancing technology
  • Difficult-to-coat shapes
  • Friable tablets
  • Multi-layer coating
  • Enabling technology
  • “Low humidity process” suitable for moisture sensitive materials
  • Accuracy of coating (RSD less than 1% demonstrated)

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