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Products - NonPareil Seeds and Sugar Spheres

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.

 
Specifications

Appearance : 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) : Between 5 and 7
Heavy metals : 10 ppm
Bulk density : Variable
Particle size distribution : 10% oversize, 10% undersize
 
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
 
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.
 

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.

 
Pharmaceutical Applications of Nonpareil Seeds and Sugar Spheres

Capsule Formulations Nonpareil seeds and Sugar Spheres are usually suitable for capsule formulations particularly multiparticulate sustained release preparations. They are used as:

Starter seeds:  for drug layering or imbibition, which may or may not be coated subsequently with a retarding material.
Filler or diluent:  to adjust capsule fill-weight of multiparticulate drug delivery systems.
 

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:

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 -
  - Drug solution layering.
- Drug suspension layering.
- Drug powder layering.
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:
  - Low dose and potent drugs.
- Drugs having poor physicochemical stability e.g. vitamins.
Drug loaded pellets (imbibed or surface layered) may be subsequently coated to achieve a specific purpose -
  - Colour-coated for improving elegance and facilitating product identification.
- Film-coated to improve drug stability.
- Enteric-coated.
- Coated with sustained release polymers or waxes.
 
Tablet Formulations
Nonpareil seeds and Sugar Spheres can be used in tablet products as excipient in one of the following two ways:

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.

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.

 
 
Grades of Nonpareil Seeds

Nonpareil seeds are available in following grades:
Nonpareil-CP
These are usual nonpareil seeds and suitable for processing in coating pan and centrifugal granulator.
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.
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.
 
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.
 
Stability
Nonpareils and Sugar Spheres are stable under conditions of storage. Avoid high temperature and storage of containers in sunlight.
 
Incompatibilities
None
 
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.

 
 
Toxicological Information

Short term effects : None known. No hazard anticipated incidental to industrial exposure.
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.
 

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.