Freund Excipients Report No. NP-0-1712

Spherical bead core for capsule and tablet formulation

NONPAREILNONPAREIL is a spherical bead core with a narrow particle size distribution and highsphericity. It is an optimal core for controlled release formulation such asenteric release, sustained release and taste masking.
《Features》◆Film layer

High sphericity

Easy calculation of volume and surface dimension toAPI

control the film-thickness for API release.

◆NONPAREIL

Narrow particle size distribution

Particle size distribution is very narrow in the API layering process.
Layer thickness does not vary in the film layering process and the speed ofAPI release remain stable.

《Lineup》
3 types of NONPAREIL in different ingredients, grading and spherical size as neededin combination with API interaction.
The appropriate type can be chosen in combination with API interaction.

TypeNONPAREIL-103

NONPAREIL-105

NONPAREIL-108

Lactose andIngredient

Purified sucrose

Microcrystalline

D-mannitol

CelluloseCompendial

Lactose andPurified Sucrose
Spheres JPE

Grade

20-24 (710 - 850μm)（Particle24-32 (500 - 710μm)

size）

32-42 (355 - 500μm)

Microcrystalline
Cellulose Spheres JPE
50-83 (180 - 300μm)
150 (106 - 212μm)-1-D-Mannitol JP
Mannitol USP
32-42 (355 - 500μm)
200 (150 - 250μm)
100 (75 - 150μm)

NONPAREIL-103
Purified Sucrose Spheres JPE
Drug Master File“NONPAREIL-103” No. 16697
NONPAREIL-103 is a spherical granule which
consists solely of purified sucrose.
《Features》
Grade

20 - 24

24 - 32

32 - 42

Particle size

710 – 850μm

500 – 710μm

355 – 500μm

Loss on drying

not morethan 0.2%

not morethan 0.2%

not morethan 0.2%

Bulk density

0.88g/mL

0.87
g/mL

0.86
g/mL

Repose angle

30°30°32°

Friability

0.40%

0.20%

0.04%

Purified sucrose 100％
Granules have high hardness and wear- resistance.
Granules completely dissolveable in water.

Physical property

Little free water
No or very little influence in stability of API whichinteracts with water.
Suitable for layering on powder
Layering process efficient due to high sucrose
solubility in water.

NONPAREIL-105
JPE “Lactose and Microcrystalline Cellulose Spheres”
Drug Master File “NONPAREIL-105” No. 27536
NONPAREIL-105 are spherical granules made fromLactose Hydrage JP and Microcrystalline Cellulose JP.
200 μm《Features》
Mechanically durable forGrade50-83

150Particle size

300 – 180 μm

212 – 106 μm

Loss on drying

not morethan 5.0%

not morethan 5.0%

Bulk density

0.76
g/mL

0.73
g/mL

Repose angle

31°

33°

Friability

0.29%

0.18%

wearing-resistanceParticles have high hardness and excel inwear-resistance.
Less damage during the granulating/coating

Physical property

process for easier handling.
Sugar-free composition
Lower reactivity with API and low calories.

Low cohesiveness
Doees not clump during storage.

-2-NONPAREIL-108
D-mannitol JP
Mannitol USP
Drug Master File “NONPAREIL-108” No. 19954
NONPAREIL-108 is a spherical granuleconsisting of only D-mannitol.

Grade32 - 42

200100Particle size

355 – 500μm

150 – 250μm

75 – 150
μm

Loss on drying

not morethan 0.5%

not morethan 0.5%

not morethan 0.5%

Bulk density

0.77g/mL

0.72
g/mL

0.72
g/mL

Repose angle

31°

33°

37°

Friability

0.28%

0.12%

0.31%

100% D-mannitol
Chemically stable and low interaction withAPI due to less free water.
Completely soluble in water.
Available in small particle grades
100 and 200 grades are effective for capsuleminiaturizing, and for ensuring uniformity ofminute amounts of API.
100 grade is best recommended for core particles
in OD tablets.

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Physical property《Features》