®
PROSOLV ODT G2
Orally Disintegrating Tablet Matrix
MP
I CO O N E
LT
NT
MU
A Tasteful New Design
in Solid Dosage Forms
Offering Advantages for:
Formulation Development
Manufacturing Ease
Business Simplicity
Patient Compliance
PROSOLV ® ODT G2
Orally Disintegrating Excipient Matrix
What is PROSOLV ® ODT G2 ?
PROSOLV ® ODT G2 is a high functionality excipient for Applications
orally disintegrating tablet formulation, development, and
manufacture. It provides the functional performance PROSOLV ® ODT G2 is used for the development and
needed for today's orally disintegrating tablet formulation manufacture of orally disintegrating tablets, allowing
challenges and offers a creamy, smooth, cool mouth the discrete and convenient administration of active
feel. ingredients without water, resulting in high patient
compliance.
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
PROSOLV ® ODT G2 matrix
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Benefit your Customers and Operations with PROSOLV ® ODT G2
Mass Flow Rate Example Formulation
8.00
Tablet Components Amount per Tablet
7.00 PROSOLV ® ODT G2
Piroxicam 10.00
6.00
PROSOLV ® ODT G2 88.75
Mass Flow Rate [g*s-1]
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
PROSOLV ® ODT G2 Accelerated Stability
Disintegration Time (sec.)
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
Packaging, Samples and Storage
Storage
Store in well closed container.
Protect from excessive heat and moisture. Case Studies
Case studies and formulation examples are available
Packaging
upon request. Please contact your sales rep for more
25 kg carton, double PE liner;
Drums available upon request information or visit www.jrspharma.com.
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.
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