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 Process
SCT'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)