Lactose Spray Dried Monohydrate by Kerry

Excipients for direct tabletting, granulation, capsules, sachet filling and inhalation

Product Description

Lactose Overview

Lactose is a disaccharide of glucose and galactose obtained from the whey fraction of bovine milk. Depending on the temperatures used to crystallize and dry the lactose solution, it may be produced in either of two crystalline types: monohydrate or anhydrous.

In addition, the lactose disaccharide also has the ability to form two stable isomers known as alpha-lactose and beta-lactose. These two isomers differ in the orientation of the hydroxyl group in the glucose moiety. The monohydrate crystal in primarily the alpha-form, whereas the anhydrous crystal is primarily the beta-form (Zadow, 1984). At equilibrium in water at room temperature, both forms will be present as 62.3% beta-form and 37.7% alpha-form (Whittier, 1944).

Spray Dried Monohydrate

Spray dried grades by Kerry include Sheffield Lactose Monohydrate Spray Dried 315 and 316 Fast Flo®. Sheffield™ Spray Dried 316 Fast Flo® is ideal for direct compression and Sheffield™ Spray Dried 315 may be used in direct compression and also used in capsule filling, with 316 Fast Flo® designed for optimal flow through high speed tablet presses.

Advantages

Excellent tablet hardness at low compression forces
Eliminate wet granulation technology, reduce equipment and process validation
Fast dissolution and low friability
High flowability
Low color development

Products & Recommended Applications

General Physical and Chemical Characteristics

Product Description

Monohydrate Lactose is a disaccharide
obtained from the whey fraction of milk
and consists of one glucose and one
galactose moiety. Sheffield™ Monohydrate
Lactose Spray Dried is an optimal mixture
of crystalline alpha lactose and amorphous
lactose. It meets all requirements of the
National Formulary as well as the European
and Japanese Pharmacopeias.

Other Physical Characteristics

Free-flowing, non-hygroscopic powder. White
to creamy white in color, free of sediment and
with excellent stability. A 10% solution (in
boiling water) is clear to nearly colorless.

Packaging and Storage

Store in a cool, dry area with container closed
when not in use. A minimum shelf life of 18
months for spray dried 315 and 12 months for
316 Fast Flo®.

The standard packaging is a polyethylene
lined fiber drum with tamper evident seals.
The standard net weight for 315 is 95kg
and 316 Fast Flo® is 75kg. Products are also
available in 40kg drums or 25kg paper sacks
upon request.

Spray Dried Monohydrate by Kerry - General Physical and Chemical Characteristics

INTERESTED IN OTHER KERRY PRODUCTS?

SEMs (Scanning Electron Microscope Image)

See the full brochure on “Lactose Spray Dried Monohydrate Family by Kerry“ here

(click the picture to download the brochure)

Source: Kerry brochure “Lactose Spray Dried Monohydrate Family by Kerry”

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