Lactoses

. LACTOSES

Lactose clearly meets the criteria for an ideal excipient. It is chemically and physically inert to
other excipients and active ingredients. It is also suitable for both wet granulation and direct
compression methods of tablet production . Microlex® crystalline grades are used in wet
granulation and the spray dried forms are used in direct compression . In the direct
compression method of tablet production , dry ngredients are thoroughly mixed and then
compressed into tablets . This eliminates the drying steps associated with the wet granulator
method. It also reduces the higher costs involved in wet granulation including increased equipment,
labor, time, process validation and energy expenditure.

Crystalline Monohydrate		Anhydrous
Milled	Sieved	Milled
Microlex® LCM 80.m	Microlex® LCM 120.s	Microlex® LCA 60.m
Microlex® LCM 180.m	Microlex® LCM 180 .s	Microlex® LCA 120.m
Microlex® LCM 200.m	Microlex® LCM 220.s	Microlex® LCA 200.m

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 grarulation, the particle size is enhanced by aggregating the particle by roller compaction and then milling to the desired size.

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