Sheffield Monohydrate 313
Lactose MonohydrateProduct Application: Capsule,Powder Blend,Tablet
Product Certification: Gluten-free,Kosher,Rennet free
Pharmaceutical Category: Bulking agent,Crystalline Monohydrate,Diluent,Filler
Sheffield Monohydrate 313 is recommended as an excipient, filler, diluent, and bulking agent in a wide variety of pharmaceutical tablets, capsules, powders, and other preparations. It also has applications as a nutrient and multifunctional ingredient in infant formulas, geriatric, dietetic and health foods and may be used as an ingredient in culture media.
Lactose is a disaccharide obtained from the whey fraction of milk consisting of one glucose and one galactose moiety. Sheffield Monohydrate 313 meets all requirements of the current National Formulary, the European Pharmacopeia, and the Japanese Pharmacopeia. All ingredients are certified rennet free.
Advantages of Sheffield Monohydrate 313
- Inert material, high purity, low colour
- Moisture stable – 4 year shelf life
- Physically and chemically stable
- High degree of crystallinity, low amorphous content
Particle Size Curves
Lactose clearly meets the criteria for an ideal excipient. It is chemically and physically inert to other excipients and active ingredients. Widely available worldwide, lactose is well characterized, easy to store, cost-effective and has low lot-to-lot variability (Bolhius and Lerk, 1973; Brittain, 1993). It is also suitable for both wet granulation and direct compression methods of tablet production. Typically, the crystalline grades are used in wet granulation and the spray dried forms are used in direct compression.
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 (Whiteman and Yarwood, 1988). Lactose is especially noted for its low hygroscopicity (Shukla and Price, 1991).