Lactose Technical manual for oral solid dose – by Kerry

Kerry proudly presents their Lactose Technical manual 2025:

Kerry pharmaceutical grade lactose

The standard of comparison

For more than 75 years, we have earned our reputation for reliability and excellence in serving the biotech, pharmaceutical and nutrition markets by delivering unsurpassed product value, enhanced opportunities for supply chain consolidation, and new technology innovation.

We bring together our superior products with new innovative solutions and market-driving alternatives to help our customers succeed in today’s challenging global marketplace.

Customers benefit from our application expertise and vast global resources of a $6 billion global leader. We have the worldwide resources and global technical platform to deliver consistent, high quality products backed by unparalleled service, technical support and formulation customization capabilities.

At Kerry, we make it our business to exceed our customers’ expectations every day. We collaborate directly with pharmaceutical formulators in the development of new drugs and delivery systems.

We deliver the Industry’s most extensive Lactose product line in the Industry, including anhydrous, spray dried, monohydrate, and inhalation grades of lactose. The Sheffield™ Brand N.F. Anhydrous Direct Tableting (DT) lactose has been recognized since its original patent as the standard of comparison for anhydrous direct compression lactose excipients in the industry. This combined with Fast Flo® pharmaceutical-grade lactose product line, helps us provide customers with unsurpassed product value, greater opportunities for supply chain consolidation, and new technology innovation.We are the leading lactose provider in the world.

We prove it every day. Let us proveit to you.

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.At equilibrium in water at room temperature, both forms will be present as 62.3% beta-form and 37.7% alpha-form.

Manufacturing facilities

• FDA inspected facilities that adhereto the USP-NF general chapter 1078and the IPEC-PQG GMP guidelines
• IPEC member> Validated processes –complete traceability
• Kosher & Halal certified> Certified Animal Rennet –free raw materials
• Batch to batch consistency
• HEPA filtered pack room & conveying air
• Monohydrate and Anhydrous lines

Pharmaceutical excipients

Lactose clearly meets the criteria for anideal excipient. It is chemically and physically inert to other excipients and active ingredients. Widely available worldwide, lactose is well characterized, easy to store, cost-effectiveand has low lot-to-lot variability. It is alsosuitable for both wet granulation and direct compression methods of tablet production. Typically, the crystalline grades are used inwet granulation and the spray dried formsare used in direct compression.

Lactose has been used in pharmaceutical preparations since the early 1900s and it is one of the most widely used excipients for capsule and tablet formulations. Large-scale production of lactose in the United States commenced in the 1940s in part as a feedstock for antibiotic fermentation. In the 1950s, USP grade lactose became available for wet granulation methods of tablet production. Soon after, the direct compression method was developed in the mid-1960s, and the original Anhydrous Direct tableting (DT) Lactose was patented by Sheffield™ Products. The long history of manufacturing Sheffield™ Anhydrous DT products in a registered drug establishment assures our customers of consistent quality and functionality, as well as exceptional purity and corresponding low color.

In the direct compression method of tablet production, dry ingredients are thoroughly mixed and then compressed into tablets. This eliminates the drying steps associated with the wet granulation method. It also reduces the higher costs involved in wet granulation including increased equipment, labor, time, process validation and energy expenditure.

As a result, direct compression is both efficient and economical, well suited to the production of high quality tablets, which exhibit hardness, low friability and excellent dissolution rates. As an added benefit, direct compression can improve the physical and chemical stability of tablets as compared to wet granulation.

Lactose monohydrate is typically used for wet or dry granulation. During wet granulation, liquid binders or adhesives are added to the lactose and active mixture, usually by blending. The mixture is then dried and sized, and compressed into tablets. During dry granulation, the particle size is enhanced by aggregating the particles by roller compaction and then milling to the desired size.

Lactose has many desirable characteristics for use as a pharmaceutical excipient. It is both chemically and physically stable, and highly compatible with other excipients and ingredients. In addition, it is an all-natural product, which is available in a variety of physical forms. Lactose is especially noted for its low hygroscopicity.

3 different product groups:

1. Crystalline Monohydrate
2. Spray Dried Monohydrate
3. Anhydrous Lactose

1. Crystalline Monohydrate

Advantages 

• Inert material, high purity, low color
• Moisture stable – 3 year shelf life
• Physically and chemically stable
• Several off-the-shelf grades
• Milling & sieving capabilities
  (high flow grades available)
• Control of raw material – no supply issues
• High degree of crystallinity,
  low amorphous content

 

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 is crystalline alpha-monohydrate anomers. Sheffield™ brand meet 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. Soluble in water at 25°C (77°F) is 20g/100ml.

Packaging and storage

Store in cool, dry area with container closed when not in use. A minimum shelf life of 36 months is expected for unopened packages. The standard packaging is a polyethylene lined fiber drum with tamper evident seals. The standard net weight for Sheffield™ Monohydrate Lactose is 95kg, but Monohydrate Impalpable is 90kg. This product is also available in 100 lb drums or 25kg paper sacks upon request.

The standard net weight for Sheffield™ Monohydrate 310 is 95kg and 312 and 313 is 90kg. These products are also available in 40kg drums or 25kg paper sacks upon request.

Particle size curves

See the full technical brochure on Lactose Technical Manual Kerry 2025 here

(click the picture to download the brochure)

Source: Kerry technical brochure Lactose Technical Manual Kerry 2025

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