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Monograph
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STARLAC^® lactose-starch compound - Introduction

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.

STARLAC^® lactose-starch compound - Monograph

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

STARLAC^® lactose-starch compound - Formulation Assistance

TYPICAL FORMULATION

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

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.

STARLAC^® lactose-starch compound - 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 submit your sample or other request here.

Request a sample

STARLAC^® lactose-starch compound - 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.

STARLAC^® lactose-starch compound - documentation

Technical brochures

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

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STARLAC®

STARLAC® lactose-starch compound - Introduction

STARLAC® lactose-starch compound - Monograph

STARLAC® lactose-starch compound - Formulation Assistance

STARLAC® lactose-starch compound - Sample Request

STARLAC® lactose-starch compound - Current packaging for this family of products