Sheffield Anhydrous DT
LactoseProduct Application: Direct tableting,Tablet
Product Certification: Rennet free
Pharmaceutical Category: Anhydrous Lactose,Direct compression
Sheffield Anhydrous DT, commonly referred to as Anhydrous Lactose Direct Tabletting, has been specifically designed for use in direct compression of tablets. Sheffield Anhydrous DT offers the following advantages over other direct compression forms of lactose: improved tablet hardness at low compaction pressures, low friability, good dissolution, improved moisture stability, reduced color development, and improved reworking.
Anhydrous Lactose is a disaccharide obtained from the whey fraction of milk, and consists of one glucose and one galactose moiety. Sheffield Anhydrous DT, commonly referred to as Anhydrous Lactose Direct Tabletting, has been specifically designed for use in direct compression of tablets. Anhydrous DT, commonly referred to as Anhydrous Lactose Direct Tabletting, is a crystalline mixture of beta and alpha anomers and meets all requirements of the National Formulary.
Particle Size Curves
Advantages of Direct Tableting Lactose
Sheffield Anhydrous DT offers the following advantages over other direct compression forms of lactose:
- Improved tablet hardness at low compaction pressures
- Low friability
- Good dissolution
- Improved moisture stability
- Reduced color development
- Improved reworking
Direct compression demands the use of excipients with strictly defined properties. Kerry has created excipients specifically to meet the requirements of the direct compression process: Sheffield™ Brand Anhydrous Lactose, N.F.-Direct tableting, and N.F.-Direct tableting High Velocity. The originally patented formulation, commonly referred to as Anhydrous DT, is one of the most outstanding and unique direct compression excipients available. Several other grades are now available to optimize tableting performance including Anhydrous DTHV, which has the same superior tableting properties as Sheffield Anhydrous DT but with exceptional flow.
Compaction Properties of Anhydrous DT
Tablet hardness versus compaction force profiles for lactose formulas are shown in the below figures. Analysis of the data concluded that Sheffield™ Brand Anhydrous DT forms harder tablets at lower compaction forces relative to the other products tested. Sheffield™ Brand Anhydrous DT also exhibited lower ejection forces at similar compaction forces. Lower ejection force profiles are desirable because they not only save energy, but also result in less wear on tablet press dies and less equipment maintenance.
Dissolution profiles for lactose formulas are shown in the below figure. Analysis of the data concluded that Sheffield™ Brand Anhydrous DT forms harder tablets that have similar dissolution profiles as lactose tablets with lower hardness values.
Numerous studies have been performed to examine the physical and chemical characteristics of Anhydrous DT (Brittian, 1991; Shangraw and Bowers, 1981; Whiteman and Yarwood, 1988). In one study, Sheffield™ Brand Anhydrous DT was compared to a different brand of anhydrous lactose, Lactose A, and to a spray dried monohydrate lactose, Lactose B. A variety of properties were compared in both a placebo and acetaminophen (APAP, 4-acetamidophenol, Sigma Chemical, St. Louis, MO) formulation.
Higher compaction profiles were obtained for Anhydrous DT for three APAP formulations as shown in the below figure. As the APAP concentration increased, tablet hardness decreased for all three products. Only the use of DT Grade resulted in suitable tablets at 20% APAP, where both Lactose A and B began capping. Even more significant is the fact that Anhydrous DT was the product capable of tablet formulation at 30% APAP.