Description
Nonpareil seeds and Sugar Spheres are approximately spherical granules
(pellets) of a normal size range with a uniform diameter. They are
composed primarily of starch and sugar. Usually white in colour,
nonpareil seeds and Sugar Spheres can also be made available in
desired colours. They are practically inert, odourless and sweet
in taste. Nonpareils and Sugar Spheres are stable at ambient conditions.
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Specifications
| Appearance |
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White smooth spheres of normal size range |
| Moisture content (LOD) |
: |
Not more than 8% at 1050C for 1 hour |
| Friability |
: |
Not more than 0.5% |
| Microbial limit |
: |
Free from E. coli, P. aeruginosa, S. aureus and
Salmonella species; total aerobic count NMT 150/g |
| pH (1:1 aq. dispersion) |
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Between 5 and 7 |
| Heavy metals |
: |
10 ppm |
| Bulk density |
: |
Variable |
| Particle size distribution |
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10% oversize, 10% undersize |
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Typical Properties
Particle Size Distribution Nonpareil seeds and Sugar Spheres are of
a uniform diameter.
Following sizes are commercially available: |
US standard
sieve size range |
Size range
in mm |
Mean pellet
size in mm |
35 - 40 mesh |
425 - 500 |
463 |
30 - 35 mesh |
500 - 600 |
550 |
25 - 30 mesh |
600 - 710 |
655 |
20 - 25 mesh |
710
- 850 |
780 |
16 - 20 mesh |
850 - 1000 |
925 |
18 - 20 mesh |
850 - 1180 |
1015 |
14 - 18 mesh |
1000 - 1400 |
1200 |
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Nonpareil seeds and Sugar Spheres can also be made
available in size range(s) other than those mentioned above.
Density and Porosity
Bulk density: 0.68 - 0.73 g/ml
Pellet density: 1.30 - 1.45 g/ml
True density: 1.45 - 1.55 g/ml
Pellet porosity: 6 - 14%, depending upon the size of nonpareils; larger
pellets being more porous than the smaller ones. |
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Angle of Repose and Flowability
The angle of repose of nonpareil seeds and Sugar Spheres ranges
from 20.5o to 22.5o depending upon pellet size and density. Owing
to their spherical shape and smooth surface, nonpareils exhibit
excellent flow properties. |
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Pharmaceutical Applications of Nonpareil Seeds
and Sugar Spheres
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Capsule Formulations Nonpareil seeds and Sugar Spheres
are usually suitable for capsule formulations particularly multiparticulate
sustained release preparations. They are used as: |
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Starter seeds: for drug
layering or imbibition, which may or may not be coated subsequently
with a retarding material. |
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Filler or diluent: to
adjust capsule fill-weight of multiparticulate drug delivery
systems. |
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The major applications of the nonpareil seeds and
Sugar Spheres are their use as starter seeds for the manufacture
of drug loaded immediate-release of enteric/sustained-release pellets.
Drug(s) may be incorporated on nonpareil seeds or Sugar Spheres
by one of the following two techniques: |
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Surface layering |
| This may be done by layering the drug on the nonpareil
seeds or Sugar Spheres with or without the aid of a binder,
in one of the three ways - |
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- Drug solution layering.
- Drug suspension layering.
- Drug powder layering. |
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Imbibition |
Nonpareil seeds and Sugar Spheres are porous.
Drug from solutions can be imbibed in these pores.
Imbibition method is suitable for incorporation of following
categories of drugs in the nonpareil seeds or Sugar Spheres:
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- Low dose and potent drugs.
- Drugs having poor physicochemical stability e.g. vitamins.
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Drug loaded pellets (imbibed
or surface layered) may be subsequently coated to achieve a
specific purpose - |
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- Colour-coated for improving elegance and facilitating
product identification.
- Film-coated to improve drug stability.
- Enteric-coated.
- Coated with sustained release polymers or waxes. |
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Tablet Formulations
|
| Nonpareil seeds and Sugar Spheres can be used in tablet
products as excipient in one of the following two ways: |
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Directly compressible
tablet diluent
Nonpareil seeds and Sugar Spheres, preferably of size range
25-40 mesh, can be directly blended with active principles
and other excipients and compressed into tablets. Because
of their spherical shape and optimum density, nonpareil seeds
and Sugar Spheres provide good flow properties and compressibility
to the powder blend. |
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Directly compressible
dispersible tablet base
A special grade of nonpareil seeds has been designed to promote
rapid disintegration and homogenous dispersion of dispersible
tablets when they come in contact with water. Besides having
good flow properties and direct-compressibility, these seeds
comply with the compendial requirements for dispersible tablets.
A sample can be provided on request. Drug loaded and suitably
coated pellets can also be directly compressed into tablets
that have all the advantages of multiparticulate dosage forms.
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Grades of Nonpareil Seeds
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| Nonpareil seeds are available in following grades: |
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Nonpareil-CP
These are usual nonpareil seeds and suitable for processing
in coating pan and centrifugal granulator. |
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Nonpareil-FBP
These are specially formulated nonpareils having good mechanical
strength and very low friability and suitable for processing
in a fluid bed processor (where inter-particle and particle-equipment
attrition rates are very high) to prevent dust generation. |
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Customised Density Nonpareils
Segregation during mixing and capsule filling is a common problem
which can lead to content uniformity and weight uniformity problems
in the finished multiparticulate product. Segregation is often
due to differences in pellet density, surface morphology and
generation of electrostatic charges. Nonpareils can be tailored
to have the desired density, on request. |
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Storage
Nonpareil seeds and Sugar Spheres should be stored in a well-closed
container in a cool, dry place to prevent moisture exposure and
to avoid contamination. |
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Stability
Nonpareils and Sugar Spheres are stable under conditions of storage.
Avoid high temperature and storage of containers in sunlight. |
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Incompatibilities
None |
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Safety
Nonpareil seeds and Sugar Spheres are primarily composed of edible
food material- starch and sucrose. They are thus safe for human
consumption and are widely used in oral pharmaceutical formulations.
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Toxicological Information
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| Short term effects |
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None known. No hazard anticipated
incidental to industrial exposure. |
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| Eyes |
: |
None known. No hazard anticipated
incidental to industrial exposure. Mechanical irritant. May
cause scratching to eye surfaces. In case of contact with
eyes, rinse immediately and if discomfort persists, seek medical
attention. |
| Skin |
: |
None known. No hazard anticipated
incidental to industrial exposure. |
| Ingestion |
: |
None known. No hazard anticipated
incidental to industrial exposure. May be harmful if ingested
in great quantity. If swallowed in large quantities, immediately
seek medical attention. |
| Inhalation |
: |
None known. No hazard anticipated incidental to
industrial exposure. |
| Long term effects |
: |
No evidence of carcinogenic, mutagenic or teratogenic
effects. |
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Handling Precautions
Observe normal precautions appropriate to the circumstances and
quantity of material handled. Nonpareils and Sugar Spheres do not
generate significant dust during processing. However, it is advisable
to provide adequate ventilation or exhaust fans in areas where workers
are exposed to dusting. Cleaning procedures should minimise any
dust creation. Wear suitable protecting clothing, respirator/face
mask, protective gloves and safety goggles.
Homoeopathic Globules
On above basis, starch free higly porous homoeopathic globules of
various sizes can be prepared. |
