Sheffield Bio-Science Pharmaceutical Excipient Experts

For more than 65 years, Sheffield has earned its reputation as a successful world-class pharmaceutical supplier that demonstrates excellence in consistent, high-yielding, customer-specific solutions for the biotech and pharmaceutical markets. Sheffield Bio-Science has a rich history of leadership in providing the highest-quality excipient solutions that exceed customer expectations every day.

As part of the Kerry Group, a $6 billion leader, Sheffield Bio-Science can provide global technical service, and regulatory and application support, whether this is in the development process or trouble-shooting commercial production challenges.

Monohydrate and anhydrous lactose NF

Sheffield Bio-Science manufactures both the monohydrate and anhydrous forms of lactose, which meet NF / JP / EP monographs in a variety of particle sizes and are produced at a fully compliant FDA registered drug establishment in Norwich, NY, US. Assuring further consumer safety, all ingredients are certified rennet free.

Our lactose is used in a wide variety of product applications, including:

• Direct compression – anhydrous milled and sieved lactose
• Wet granulation and capsules – monohydrate milled and sieved lactose
• Micronized drug carrier – inhalation milled and sieved lactose

Lactose anhydrous DT – direct tabletting

Sheffield brand anhydrous lactose, NF – direct tabletting is the original patented formulation that is the most outstanding and unique direct compression excipient available. It features exceptional tabletting properties and offers many distinct advantages over other direct compression products, including:

• Superior tablet hardness at low compaction pressures
• Low friability
• Excellent dissolution
• Moisture stability
• Minimal color development
• Direct reworking ability

Lactose anhydrous DT high velocity

Lactose anhydrous NF high velocity direct tabletting, commonly referred to as lactose DTHV, has been specifically developed as a faster flowing form of lactose for high-speed direct tabletting operations. It has superior flowability and improved tablet uniformity, while maintaining tablet hardness at low compaction pressures when compared with traditional direct tabletting anhydrous lactose. It also retains the fast disintegration properties of anhydrous lactose. Additional advantages are low friability, improved moisture stability, reduced color development and improved reworking.

Tabletting systems

Sheffield tabletting system ODT is designed for use in orally disintegrating tablets. It can be blended with a flavor and active, or a taste-masked active and then directly compressed into tablets. It can also be used for tablets where dissolution is an issue when using typical excipients such as lactose or MCC.

Sheffield tabletting systems DTFD and DTHV are designed for use in tablets where a hard tablet with fast dissolution is desired. They are specially processed lactose-based products priced similarly to that of MCC, but with a faster dissolution rate. The tablet hardness and friability are similar to that of pure lactose.

Tablet coating systems

SheffCoat coating systems are an alternative and cost-effective pharmaceutical line of clear and colored film coatings. Sheffield Bio-Science has created a one step, ready-to-use system to match your existing coating and color, while offering a full spectrum of best-in-class, cost-effective solutions.

SheffCoat coating systems are based on well-known, pharmaceutically-accepted polymers, pigments and plasticizers and formulated to be compatible with any coating equipment. Not only can we streamline your supply chain, but you will also benefit from innovative ways to improve cost, speed and quality of tabletting.

Flavor modulators

Kerry, through its business group Sheffield, has created functionally specific flavor modulation technology (fmt™) that is intended for use in the pharmaceutical market, particularly in the consumer-driven OTC segment. The flavor modulators can be used in both liquid and solid dosage forms, and work to improve consumer acceptance and patient compliance from the taste perspective.

Flavor modulation technology (fmt) is based on analytical and sensory findings of various components from natural sources. These flavor modulators provide the perception of sweetness and flavor enhancement to more effectively mask the bitter taste of an API. Kerry’s flavor modulation technology (fmt) leads to better overall flavor and sweetness perception to achieve a pleasant tasting drug delivery vehicle, which could not be achieved by simply overpowering the bitter API with flavor or sweeteners alone.

Kerry also has a standard collection of flavors for pharmaceutical applications. All the flavors in our standard collection have a DMF number.

Lactose for high-speed direct tabletting operations

Foremost™ brand 316 Fast Flo® lactose was specifically developed for use in high-speed direct tabletting operations. It contains a mixture of both crystalline and amorphous lactose. The special processing and particle size of the product aids in compressibility, flowability and disintegration, when compared with crystalline alpha monohydrate lactose.

Foremost Farms® USA and Sheffield have a strategic alliance for lactose marketing. Sheffield is a Kerry Group business. Sheffield manages the sales, marketing and distribution of Foremost Farms’ line of pharmaceutical lactose.