Orally Disintegrated Tablet Excipient Matrix
Introduction
PROSOLV® ODT G2 is a high functionality excipient for orally disintegrating tablet formulation, development and manufacture. It provides the functional performance needed for today's orally disintegrating tablet formulation challenges while delivering a creamy, smooth, cool mouth feel.
Composition
- Microcrystalline cellulose
- Colloidal silicon dioxide
- Mannitol
- Fructose
- Crospovidone
Physical Properties
- Free flowing, co-processed excipient
- White to nearly white in color
- Bulk density: 0.45 - 0.65 g/mL
- Average particle size: 40 – 80 µm
- Excellent flowability, leading to greater productivity Highly compactible
- Good mouth feel, resulting in excellent patient compliance
- Rapidly hydrating, allowing faster disintegration
Applications
PROSOLV® ODT G2 is used for the development and manufacture of orally disintegrating tablets, allowing the discrete and convenient administration of active ingredients without water, resulting in high patient compliance.
Benefits
- Simple to use
- Fast and freely flowing
- Smooth and creamy mouthfeel
- Superior compaction profile compared to other matrices
- Excellent blending characteristics for improved content uniformity
- Requires no additional binders or disintegrants Royalty-free
- License-free
- Faster time-to-market
- Directly compressible for simple manufacture
Specifications
Mass Flow Rate
Superior flow for high speed tabletting
In Vitro Tablet Disintegration
Consistent disintegration and quality placebo with 99.5 % PROSOLV ODT G
Packaging, Samples and Storage
Storage
Store in well closed container.
Protect from excessive heat and moisture.
Packaging
25 kg carton, double PE liner; Drums available upon request
Pallet Container
500 kg (cartons)
Sample Sizes
Available in 2 kg containers
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Example Formulation
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|---|---|---|---|
| Tablet Components | Amount per Tablet | ||
| Piroxicam | 10.00 | ||
| PROSOLV® ODT G2 | 88.75 | ||
| Cream Flavor | 0.25 | ||
| Vanilla Flavor | 0.25 | ||
| PRUV® Sodium Stearyl Fumarate | 0.75 | ||
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Example Formulation
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|---|---|---|---|
| Tablet Components | Amount per Tablet | ||
| Weight | 100.0 mg | ||
| Size | 0.2500II SC round | ||
| Hardness | 3.5 kP | ||
| Friability | 0.0 % | ||
| Disintegration Time (USP) | 27 sec | ||
| Weight Variation (%RSD) | 0.8 | ||
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Accelerated Stability
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|---|---|---|---|---|
| Characteristic | Initial | 6 month | ||
| Tablet Disintegration (sec, 4 kN) | 28 | 32 | ||
| % Moisture (Karl Fischer) | 0.72 | 0.9 | ||
| Tablet Hardness (KP, 4 kN force) | 4.2 | 4 | ||
| Assay for Sugars & Sugar Alcohol (%) | 4.8/66.5 | 4.8/66.2 | ||
| Presence of Impurity Peaks | neg | neg | ||
