Professional Documents
Culture Documents
PROSOLV ODT G2
Orally Disintegrating Tablet Matrix
MP
I CO O N E
LT
NT
MU
Formulation Development
Manufacturing Ease
Business Simplicity
Patient Compliance
PROSOLV ® ODT G2
Orally Disintegrating Excipient Matrix
Composition:
Benefits
• Microcrystalline cellulose
• Colloidal silicon dioxide • Simple to use
• Mannitol • Fast and freely flowing
• Fructose • Smooth and creamy mouthfeel
• Crospovidone • Superior compaction profile compared to other
matrices
• Excellent blending characteristics for improved
Physical Properties content uniformity
• Requires no additional binders or disintegrants
• Free flowing, co-processed excipient • Royalty-free
• White to nearly white in color • License-free
• Bulk density: 0.45 – 0.65 g/mL • Faster time-to-market
• Average particle size: 40 – 80 µm • Directly compressible for simple manufacture
• Excellent flowability, leading to greater productivity
• Highly compactible
• Good mouth feel, resulting in excellent patient
compliance
• Rapidly hydrating, allowing faster disintegration
2
Benefit your Customers and Operations with PROSOLV ® ODT G2
5.00
Cream Flavor 0.25
4.00
Vanilla Flavor 0.25
3.00
PRUV ® Sodium Stearyl Fumarate 0.75
2.00
1.00
Tablet Components Amount per Tablet
0.00
0 4 6 8 9 10
Weight 100.0 mg
Aperature [mm] II
Size 0.2500 SC round
Superior flow for high speed tabletting Hardness 3.5 kP
Friability 0.0 %
Disintegration Time (USP) 27 sec
In Vitro Tablet Disintegration Weight Variation (%RSD) 0.8
60
50
40
Characteristic Initial 6 month
30
Tablet Disintegration (sec, 4 kN) 28 32
20
% Moisture (Karl Fischer) 0.72 0.9
10
Tablet Hardness (KP, 4 kN force) 4.2 4
0
0 1 2 3 4 5 6 7 8 9
Assay for Sugars & Sugar Alcohol (%) 4.8/66.5 4.8/66.2
Hardness [kP]
Presence of Impurity Peaks neg neg
Consistent disintegration and quality
Storage conditions: 40 °C / 70 % r.h. according to
Placebo with 99.5 % PROSOLV ® ODT G2
the ICH Q1A guideline
Pallet-container
500 kg (cartons) Disclaimer:
The information provided in this brochure is based on thorough research and
is believed to be completely reliable. Application suggestions are given to assist
Sample Sizes our customers, but are for guidance only. Circumstances in which our material
Available in 2 kg containers is used vary and are beyond our control. Therefore, we cannot
assume any responsibility for risks or liabilities, which may result
from the use of this technical advice.
3
Pharmaceutical Contract Pharma
www.project-pharmaceutics.com www.celonic.com
Customers’ Needs
Convenience
Outsourcing
Total Cost Savings
Animal Health
Global Services
Nutraceuticals
Innovation
5142_GB_V8_0.01604PDF
System
Solution
Supplier
www.jrspharma.com