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MEGGLE lactose advantages in pharma applications
MEGGLE has unrivalled expertise in processing lactose for the pharmaceutical industry, using crystallization, spray drying, sieving, milling and micronization to optimize the characteristics and functional performance of lactose particles to specific pharma uses as excipients.
MEGGLE’s very wide range of lactose (monohydrate and anhydrous) powder grades support the whole range of pharmaceutical applications, including wet and dry granulation, direct compression tableting, capsule or sachet filling and dry powder inhalation.
What is lactose?
Lactose, also called ‘milk sugar; occurs naturally as a simple carbohydrate in mammalian milk. Lactose is obtained from cow milk, where it makes up between 2% and 8% of milk by weight.
Lactose is the disaccharide of simple sugars. Chemically, lactose is composed of molecules of D-galactose and D-glucose. It can exist in either alpha and beta isomeric forms (a-lactose or b-lactose).
Functions of lactose
Principal lactose uses are as excipients (filler or filler-binder) in production of pharmaceutical tablets and capsules. They are also useful as carrier for active pharmaceutical ingredients in dry-powder inhalation (DPI).
The chemical and physical stability of crystalline lactose monohydrate powder makes it highly suitable for oral pharmaceutical applications, with versatile properties for binding or filling, compressibility and global availability.
Lactose may also be used in lactose anhydrous or spray-dried forms as filler-binders in direct compression (DC) tablet manufacture, being inherently able to form solid compacts under compression.
Lactose is derived from the whey (milk plasma) as the liquid remaining after milk is curdled and strained, for example in the production of cheese. Lactose accounts for the majority of solids found in whey, which can be purified by crystallisation.
Pharma lactose is produced from the permeate of whey that has been filtrated for all major proteins, with the protein fraction then available for use in nutritional products. Meanwhile the whey permeate can be evaporated to 60–65% solids and crystallized while cooling into a lactose powder. Some lactose manufacturers worldwide use an isolation process based on dilution of whey with ethanol.
Pharmaceutical-grade lactose is highly pure lactose specifically produced to meet identity and purity standards defined by the lactose monographs of the various pharmacopoeia, including the United States Pharmacopoeia/National Formulary (USP-NF) and European Pharmacopeia (Ph. Eur.) with Calf Rennet Free derivation preferred for pharmaceutical applications.
MEGGLE’s wide range of lactose monohydrates possess all the particular characteristics most beneficial to pharmaceutical use, very high purity, low protein residue, excellent functionality, and specially modified forms for direct compression, powdered filling or inhalation applications.
The generic reasons why lactose uses are so widespread in the pharma industry include high solubility, bland taste, low hygroscopicity; generally, non-reactive compatibility with active ingredients, high physical and chemical stability; and low cost.
The excellent flowability of sieved and milled lactose grades make them superior to gelatin for capsule filling on some applications, especially where high speed capsule filling machines are to be used.
Furthermore, the narrow PSD and excellent blending properties make lactose-based formulations suitable for a range of applications, even in conjunction with very fine or micronized active pharmaceutical ingredients (APIs).
Crystalline lactose monohydrate grades have a long tradition in pharmaceutical applications due to their chemical and physical stability, in oral pharmaceutical applications, versatile binder-filler properties, and global availability.
In addition, lactose grades can be tailored to function with differing physical properties for direct compression, sachet or capsule filling or direct inhalation formulations. These characteristics can be determined by bulk density, particle size distribution (PSD) and flowability that are in turn products of the production process: sieved, milled or micronized.
MEGGLE’s expertise in sieving, milling, spray-drying, agglomeration, co-processing or micronizing during production make it one of the worlds’ leading lactose suppliers, with finely optimized products that open up multiple opportunities to improve functional performance.
Further advantages of MEGGLE’s lactose grades include high stability in storage, high batch-to-batch consistency, the high quality delivered by ultra-modern production facilities and the in-depth product expertise accumulated over more than 60 years of manufacturing.
Click on MEGGLE lactose product configurator for detailed product information and applications.
Structure of the alpha-lactose molecule
SpheroLac® 100 microscopic image