PROSOLV® ODT G2

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

 

Example Formulation
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
Example Formulation
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
Accelerated Stability
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

Offering Advantages For:

  • Formulation Development
  • Manufacturing Ease
  • Business Simplicity
  • Patient Compliance