Knowde Enhanced TDS
Identification & Functionality
- Chemical Name
- Pharma & Nutraceuticals Functions
- Technologies
- Composition
- Lactose - Starch
Features & Benefits
- Product Highlights
- Mixtures with high compressibility,superior diluition properties and fast disitegrating time. The purpose of the excipient is to aid processing during manufacture, enhance stability or bioavailability.
- Benefits
It's a unique product used as a filler for tablets and capsules: with
- Uniform drug distribution
- Content uniformity
- Better compressibility as it contains suitable proportion of fines
- Reduced weight variation
- And higher production rates.
- Choice of higher average weight
- Robust tablet with reduced friability
High bulk density makes this product suitable to formulate high tablet weight / Capsule fill weight in smaller die / capsule size respectively,
Applications & Uses
- Markets
- Applications
- Dosage Form
- Manufacturing Technology
- Application Fields
LS 004
Diluent - Disintegrant
ML 011
Diluent - Binder
SP 204
Designed for moisture sensitive APIs and where alkaline conditions are needed for stability purpose
SP 205
Designed for moisture sensitive and low bulk density and fluffy API’s formulations.
SP 206
Designed for moisture sensitive and low bulk density and fluffy API’s formulations
SR 300
Designed for modified release, matrix type of tablets
Properties
- Typical Properties
- Physico-Chemical Properties
- Microbiological Values
- Particle Size Distribution
| Value | Units | Test Method / Conditions | |
| Angle of reposel | 36.22 | º | — |
| Compressibility Index | 21.05 | % | — |
| Hausner's Ratio | 1.27 | — | — |
| LOD (105 OC-3h) | 2.3 | — | NMT 3.0% |
| PSD (Malvern mastersizer) D(10) | 34.1 | — | — |
| PSD (Malvern mastersizer) D(50) | 243 | — | — |
| PSD (Malvern mastersizer) D(90) | 583 | — | — |
| Tapped Density | 0.84 | — | — |
| Value | Units | Test Method / Conditions | |
| Loss on Drying | max. 3.0 | % | USP/NF / JP / Ph. EUR |
| Bulk Density | 0.5 – 1.0 | g/mL | USP/NF / JP / Ph. EUR |
| pH Value (2% Aqueous Suspension) | 4.0 – 8.0 | — | USP/NF / JP / Ph. EUR |
| Value | Units | Test Method / Conditions | |
| TAMC | max. 1000 | CFU/g | USP/NF / JP / Ph. EUR |
| TYMC | max. 100 | CFU/g | USP/NF / JP / Ph. EUR |
| E. Coli, Pseudomonas Aeruginosa | Negative in 10 g sample | — | USP/NF / JP / Ph. EUR |
| St. Aureus, Salmonella Species | Negative in 10 g sample | — | USP/NF / JP / Ph. EUR |
| Value | Units | Test Method / Conditions | |
| Particle Size | 300 - 500 | μm | Malvem Method |
Regulatory & Compliance
- Certifications & Compliance
- Grade