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Lactose Monohydrate

1] Description:  White or almost white, odorless powder. Freely but slowly soluble in water, insoluble in alcohol.

Note: The monograph for lactose monohydrate is harmonized between Ph.Eur., USP/NF and JP.

Note: Browning of the product occurs when combined with amines (Kosky, K.T. et. al., Hammouda, Y. and Salakawy, S.A., and Severine, T. and Loidl, A.).
  

2] Physical Characteristics:

Water Content: 4.5 – 5.5%

LOD: <0.5%

Product Category: Crystalline, sieved

Typical Properties

 PrismaLac® 40*  Pharmatose® 50M Capsulac® 60* Pharmatose® 80M Sachelac® 80* Pharmatose® 90M

Typical Bulk Density (g/cc)

 0.45 0.80 0.56 0.77 0.64 0.76
Particle Size Specification NMT 10% < 200 microns

NLT 97% < 800 microns

 NMT 20% < 200 microns

NLT 80% < 400 microns

 NMT 10% < 100 microns

40-70% < 250 microns

NLT 97% < 630 microns

 NMT 20% < 100 microns

70-90% < 250 microns

NLT 95% <315 microns

 NMT 20% < 100 microns

NLT 98% < 400 microns

 NMT 10% < 63 microns

15-30% < 100 microns

55-80% <150 microns

100% < 315 microns
* Measured by mechanical sieve shaker

Product Category: Crystalline, sieved -- continued

Typical Properties

 Spherolac® 100*  Pharmatose® 100M Pharmatose® 110M Pharmatose® 125M

Typical Bulk Density (g/cc)

 0.68 0.75 0.73 0.68
Particle Size Specification NMT 10% < 200 microns

NLT 97% < 800 microns

 NMT 20% < 200 microns

NLT 80% < 400 microns

 NMT 10% < 100 microns

40-70% < 250 microns

NLT 97% < 630 microns

 NMT 40% < 45 microns

40-70% < 63 microns

NLT 90% < 100 microns

100% < 315 microns

* Measured by mechanical sieve shaker

Product Category: Crystalline, milled

Typical Properties

 Granulac® 70+  Pharmatose® 150M Granulac® 140+ Granulac® 200+

Typical Bulk Density (g/cc)

 0.72 0.58 0.66 0.53
Particle Size Specification 40-60% < 100 microns

NLT 95% < 400 microns

 NMT 50% < 45 microns

NLT 70% < 100 microns

NLT 85% < 150 microns 

100% < 250 microns

 NMT 40% < 32 microns

NLT 80% < 100 microns

 45-75% < 32 microns

NLT 90% < 100 microns

+Measured by Air Jet Sieve

Product Category: Crystalline, milled -- continued

Typical Properties

 Pharmatose® 200M Granulac® 230+ Pharmatose® 350M Pharmatose® 450M

Typical Bulk Density (g/cc)

 0.55 0.45 0.50 0.47
Particle Size Specification 50-60% < 45 microns

NLT 90% < 100 microns

100% < 250 microns

 NLT 90% < 63 microns NLT 60% < 45 microns 

NLT 96% < 100 microns

100% < 250 microns

 NLT 98% < 45 microns

NLT 98% < 63 microns

100% < 150 microns

+Measured by Air Jet Sieve

Category: Crystalline, milled -- continued

Typical Properties

 Pharmatose® 325M Sorbolac® 400+

Typical Bulk Density (g/cc)

 0.67 0.37
Particle Size Specification 5-10% < 32 microns

NLT 70% < 63 microns

100% < 100 microns

 NLT 97% < 32 microns

100% < 63 microns

+Measured by Air Jet Sieve

Product Category: Agglomerated 

Typical Properties

 Tablettose® 70* Tablettose® 80*

Typical Bulk Density (g/cc)

 0.53 0.55
Particle Size Specification NMT 6% < 63 microns

40 - 75% < 200 microns

NLT 98% < 500 microns

 NMT 20% < 63 microns

40 -75% < 180 microns

NLT 85% < 400 microns

NLT 97% < 630 microns

* Measured by mechanical sieve shaker

Product Category: Spray-Dried

Typical Properties

 FlowLac® 100+ Pharmatose® DCL 11

Typical Bulk Density (g/cc)

 0.60 0.62
Particle Size Specification NMT 10% < 32 microns

25 - 40% < 100 microns

NLT 85% < 200 microns

 NMT 15% < 45 microns

30 -60% < 100 microns

NLT 98% < 250 microns

+Measured by Air Jet Sieve

 


3] Applications: 

Wet granulation Crystalline, milled products like GranuLac® 70, 140, 200, 230; and Pharmatose® 150M, 200M, 350M, 450M
Powder Blends, Capsule/Sachets Crystalline products like PrismaLac®  40, Capsulac®  60, Sachelose®  80, Pharmatose®  150M, 200M, 350M, and 450M; 

Spray-dried products like FlowLac®  100 provide excellent flow properties, and Pharmatose DCL-11

Agglomerated products like Tablettose® 70/80
Direct compression Agglomerated products like Tablettose® 70/80, combine the flowability of coarse lactose crystals with the good flow properties of milled lactose. Highly stable and non-hygroscopic. High surface area provides easy water intrusion for fast tablet dissolution. White appearance leads to absolutely white tablets.

Spray-dried products like FlowLac®100 provide superior flowability with exceptional hardness yield. Useful for low-dose formulations. Good water solubility leads to fast tablet disintegration. Porous surface provides an adhesion of actives leading to high content uniformity

Crystalline products like Pharmatose 50M, 80M, 90M, 100M, 110M and 125M

Spray-Dried products like Pharmatose DCL-11
Effervescent Tablets Tablettose® 70/80,  FlowLac®100
Spheronization Crystalline, sieved products like Spherolac® 100
Chewable Tablets Spray dried products like FlowLac®100 provide pleasant taste and mouth feel. Good water solubility leads to fast tablet disintegration. Porous surface of the particles provides an adhesion of actives leading to high content uniformity
Dry Powder Inhalers and Blend Premixes Crystalline, milled products with superior surface area like Pharmatose® 325M and Sorbolac® 400 
   
Sweetener Tablettose® 70/80, Highly stable and non-hygroscopic. Ideal for table-top sweeteners due to its particle-structure, whiteness, and sugar like appearance

4] Suppliers:

Need a supplier? Submit in Excipients Express!!!

 

 

5] References:

Kosky, K.T., Duvall, R.N., Troup, A.E., Pyles, J.W. (1965) Factors involved in the 

          Browning of Spray-dried Lactose, J Pharm Sci, 54:4, 549-554.
  

Hammouda, Y. and Salakawy, S.A., (1971) Non-enzymatic Browning in 

          Solid-dosage Forms: Lactose-induced Discoloration of Neomycin Tablets, 

          Pharmazie, 26:10, 636-640.
  

Severine, T. and Loidl, A. (1976) Formation of Pyridone Derivates from Maltose 

          and Lactose. XII. Investigations on the Maillard-reaction, Z Lebensm Unters 

          Forsch, 161:2, 119-124.

FlowLacâ 100 Technical Brochure, Meggle GMBH

Lactose Monohydrate Technical Brochure, Meggle GMBH

 

Pharmatoseâ 50M, 80M, 90M, 100M, 110M, 125M, Lactose Monohydrate NF – Crystalline, 

          Product Bulletin rev. 4/99, CHR Hansen
 

Pharmatoseâ 150M, 200M, 350M, 450M, Lactose Monohydrate NF – milled, 

          Product Bulletin rev. 4/99, CHR Hansen
 
Pharmatoseâ DCL 11, Lactose Monohydrate NF – Spray Dried, 

          Product Bulletin rev. 4/99, CHR Hansen

Tablettoseâ 70/80 Technical Brochure, Meggle GMBH

Pformulate/lactoserev1/09/14/2002