| SPRAYSPHERES ™
This division is manufacturing “Neutral pellets”,
destined fpr pharmaceutical use, in compliance with BP, EP
& USP.
We offer the following standard products:
| Sugar
Spheres |
Common
name |
Availability |
Specifications |
| Sprayspheres
™- MS |
Microcrystalline
Cellulose Spheres |
Spherical
Particles |
Pdf
format |
| Sprayspheres
™- SS |
Microcrystalline
Cellulose Spheres with sucrose |
Spherical
Particles |
Pdf
format |
| Sprayspheres
™- SP |
Microcrystalline
Cellulose Spheres with cationic polymers |
Spherical
Particles |
Pdf
format |
• Sample kits are also available.
Contact Us for
more information on how we can help you.
Applications :
SPRAYSPHERES ™ are used by Pharma &
Food manufacturers specializing in Modified Release formulation,
health Care and Pharmaceutical industries producing ORAL CONTROLLED
drug formulations.
Sugar Spheres/ MCC Spheres/ Speciality Spheres Products
are :
• Neutral micro granules based on sucrose, Corn Starch
& MCC for pharmaceutical use,
• Available in standard & special sizes from #12/16
upto # 60/80
• Other sizes available upon request.
SPRAYSPHERES ™- MS (Microcrystalline Cellulose
Spheres)
Have been developed using microcrystalline cellulose (MCC)
as base.
MCC complying with Ph.Eur. Its manufacturing is in accordance
with cGMP.
General Properties:
• Nearly white hard, uniform and spherical particles.
• Very law friability level.
• Insoluble in water, absolute ethanol, acetone.
Particle size specifications:
• Minimum of 96%(w/w) of Sprayspheres™ –MS
are between the lower and the upper limits of the size stated
on the label.
• The Sprayspheres™ MS selection is obtained y
decreasing size by sieving method.
Sizes in mesh
| 60/80 |
40/60 |
| 30/40 |
20/30 |
| 16/20 |
12/16 |
Applications :
• Used as cores to be coated in the manufacture of
dry pharmaceutical forms. It enables greater accuracy
and consistency in drug layering and coating.
• Suitable for non-carcinogenic products.
• Adopted to controlled release or sustained- release
formulations Sprayspheres™- MS make it easy
to produce spherical micro granules which has
the most suitable size and dissolution profile to each
specific purpose.
Product Specification :
| Sr.
No. |
TESTS |
Specifications |
| 1 |
Appearance |
Hard,
brittle, free flowing, spherical masses ranging
generally in size from 1 to 60 mesh . Usually white,
but may be coloured. |
| 2 |
Solubility |
Solubility
in water varies according to sugar to starch / MCC
ratio |
| 3 |
Identification |
Thin,
cloudy mucilage is formed |
| 4 |
Specific
optical rotation |
Not
less than +41° and not more than +61°, determined
on a portion of the filtrate obtained in the Identification
test, corresponding to not less than 62.5% and
not more than 91.5% of sucrose (C12H22O11), calculated
on the dried basis. |
| 5 |
Loss
on drying |
NMT
4% |
| 6 |
Residue
on ignition |
NMT
0.25% |
| 7 |
Heavy
metals |
NMT
5 µg/gm |
| 8 |
Organic
volatile impurity |
Meets
the requirement |
| 9 |
Particle
Size |
Not
less than 90% of it passes the coarser sieve size
stated in the labeling; all of it passes the next
coarser sieve size listed in Table 1 of the general
chapter. Not more than 10% passes the finer
sieve size stated in the labeling. |
| 10 |
Microbial
Limit Test |
The
Spheres meet the requirements of the tests for absence
of Salmonella species, Escherichia coli, Staphylococcus
aureus, and Pseudomonas aeruginosa, and the total
aerobic microbial count does not exceed 100
cfu per g. |
| 11 |
Sucrose
content |
62.5%
to 91.5% |
3) Sprayspheres™ – SP : specialty Product
Sprayspheres™ SP is based of sugar spheres and microcrystalline
spheres coated with cationic polymers.
Sizes in mesh
| 60/80 |
40/60 |
| 30/40 |
20/30 |
| 16/20 |
12/16 |
Applications :
• Suitable for very low/ high dosages forms and for
drugs with a low therapeutic margin.
• Filler for Dispersible Tablets.
• Used as cores to be coated in the manufacture of highly
hygroscopic / soluble drugs / unstable drugs.
• Using Sprayspheres™ – SP products are
interesting into a transfer strategy of
capsules with pellets to tablets.
Product Specification :
| Sr.
No. |
TESTS |
Specifications |
| 1 |
Appearance |
Hard,
brittle, free flowing, spherical masses ranging
generally in size from 1 to 60 mesh . Usually white,
but may be coloured. |
| 2 |
Solubility |
Solubility
in water varies according to sugar to starch / MCC
ratio |
| 3 |
Identification |
Identification
for Starch / MCC & Cationic polymer |
| 4 |
Specific
optical rotation |
Not
less than +41° and not more than +61°, determined
on a portion of the filtrate obtained in the Identification
test, corresponding to not less than 62.5% and
not more than 91.5% of sucrose (C12H22O11), calculated
on the dried basis. |
| 5 |
Loss
on drying |
NMT
4% |
| 6 |
Residue
on ignition |
NMT
0.25% |
| 7 |
Heavy
metals |
NMT
5 µg/gm |
| 8 |
Organic
volatile impurity |
Meets
the requirement |
| 9 |
Particle
Size |
Not
less than 90% of it passes the coarser sieve size
stated in the labeling; all of it passes the next
coarser sieve size listed in Table 1 of the general
chapter. Not more than 10% passes the finer
sieve size stated in the labeling. |
| 10 |
Microbial
Limit Test |
The
Spheres meet the requirements of the tests for absence
of Salmonella species, Escherichia coli, Staphylococcus
aureus, and Pseudomonas aeruginosa, and the total
aerobic microbial count does not exceed 100
cfu per g. |
| 11 |
Sucrose
content |
62.5%
to 91.5% |
* All intermediate SPRAYSPHERS™ – SS/ MS/ Sp
sizes are available on request .
|
