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Mabitab1500 is a new partially pregelatinized maize starch designed for pharmaceutical use. It has been developed as a filler for two-piece hard gelatin capsules. Mabitab1500 is a free-flowing and self-disintegrating powder with high bulk density, making it most suitable for this application. Excellent flow properties and bulk density allow homogenous filling of capsules. It is made from native starch by simple and unique physical modification which ensures rapid disintegration and drug release. Mabitab1500 particles action is well suitable for rapid disintegration and release of the drug from the pharmaceutical preparation. Mabitab1500 is superior starch excipient over Native Starch by virtue of its flow property and disintegration property.
Wet Granulation : Mabitab1500 is partially soluble in cold water. It can therefore be employed as a binder-disintegrant in wet granulation, It improves hardness and disintegration time of the tablets. Use level about 15% is recommended in wet granulation tableting
Capsule Filler: Mabitab1500 is cost-effective filler and disintegration aid for hard gelatin capsules. Its physicochemical properties (Flow Property) are well suited to the requirements of an ideal capsule filler. The Mabitab1500 production process results in an appropriate density for this application. compared to native maize starch,
|Description||White or almost white, fine, granular powder, practically insoluble in water, in acetone, in ethanol, in toluene, in dilute acids and in 50 g/l solution of sodium hydroxide|
|Identification||Ph Eur, USPNF|
|pH||4.5 to7 ( Ph Eur, USPNF )|
|Residue on Ignition||max 0.5% ( Ph Eur, USPNF )|
|Loss on Drying||Max 14% ( Ph Eur, USPNF )|
|Heavy Metals||Max. 10 ppm|
|Loose Bulk Density||0.50 to 0.60 g/cm3|
|Tapped Bulk Density||0.60 to 0.70 g/cm3|
|SULPHUR DIOXIDE||Max. 50 ppm|
|Oxidising Substances||Negative ( Ph Eur, USPNF )|
|Organic Volatile Impurities||USP|
|Retention on 40 mesh
Retention on 200 mesh
|Total Aerobic Microbial Count
Total Molds and Yeast Count
|max. 1000 cfu/gm ( Ph. Eur /USP)
Max. 100 cfu/gm (Ph. Eur / USP)
|E. Coli Salmonella||absent (Pharma Eur/ USP)
absent (Pharma Eur/ USP)