STARLAC®

StarLac®
Innovative Lactose-starch compound for direct compression

Numerous pharmaceutical tablets contain lactose and starch, and these two excipients are generally recognized as traditional or classical excipients, long known and commonly used by formulators.

As part of our ongoing drive towards innovation, and in collaboration with the Meggle company,  Roquette has developed a novel starch-lactose compound, StarLac®. This has shown technical improvement and added value for the tablet producer, with an easier tableting development process, and a suitable combination of high compactability with fast disintegration.

DESCRIPTION Lactose / starch compound StarLac® is a spray-dried compound consisting of 85% alpha-lactose monohydrate (Ph. Eur./USP-NF) and 15% maize starch (Ph. Eur./USP-NF) dry matter. StarLac® is primarily designed for the Direct Compression and combines superior flowability with exceptional disintegration properties.   REGULATORY STATUS With respect to regulatory affairs StarLac® has to be considered as a pure physical mixture of alpha-lactose monohydrate (Ph. Eur./USP-NF) plus maize starch (Ph. Eur./USP-NF). The only adjuvant for the production of StarLac® is purified water which has no negative effect on the purity of the components.   PARTICLE SIZE < 32 µm  NMT 15% < 160 µm 35-65% < 250 µm NLT 80% Angle of repose*: NMT 30 Density poured*: 0.57 g/ml Density tapped*: 0.69 g/ml Hausner ratio* : 1.19 *Indicative values

BENEFITS Optimized disintegration properties Excellent tablet hardness yield due to the spray-drying process Excellent flowability providing high weight consistency at various tableting speeds High shear force resistancy Superior storage stability   APPLICATIONS All direct compression applications Low-dosage formulations Cores for coating Homeopathic formulations Fast dissolving tablets

TYPICAL FORMULATION

Roquette has developped a number of typical formulations to serve as basic guidelines for obtaining optimum performance from STARLAC® products.

• PH106ODT Orodispersible Acetylcysteine Tablets - Using Starlac^® Starch And Lactose Compound(PDF - 340 Ko)

 

APPLICATIONS LABORATORY SERVICES & SUPPORT Furthermore Roquette has long offered an integrated customer service for FORMULATION ASSISTANCE (see here presentation of Applications Laboratory Services & Support).

FORMULATION ASSISTANCE For special formulations requests, please contact us through our FORMULATION_ASSISTANCE form.

 

CURRENT PACKAGING FOR THIS FAMILY OF PRODUCTS:

• 25 kg bag

To check the immediate availability of these packaging formats or other special packaging, please contact us or your local Roquette representative for  further information.

QUALITY-RELATED DOCUMENTATION

 - Group quality policy
 - Group safety policy
 - Group environmental policy / S.M.E.
 - ISO certificate
 - GMO certificate

TECHNICAL BROCHURES

- STARLAC® – Lactose-starch compound for direct compression – 16 pages

 

SAMPLE REQUEST

Early formulation is important and we recognize the need for formulators to have representative material for initial testing. We can provide small non-commercial samples wherever you are in the world, with both the corresponding certificate of analysis and conformity and the material safety data sheet.

To obtain access to this service, please log in with your personal password and submit your sample or other request here.

More information

 

SAMPLE REQUEST

Early formulation is important and we recognize the need for formulators to have representative material for initial testing. We can provide small non-commercial samples wherever you are in the world, with both the corresponding certificate of analysis and conformity and the material safety data sheet.

To obtain access to this service, please log in with your personal password and submit your sample or other request here.

Sample request form