MEGGLE lactose monohydrate powders

MEGGLE has unrivalled expertise in crystallizing, formulating and processing alpha-lactose monohydrate particles to optimize their physical characteristics and functional performance for specific applications.

This has resulted in a very wide range of MEGGLE lactose monohydrate powders that support the whole range of pharmaceutical applications, including wet and dry granulation, direct compression tableting, capsule or sachet filling and dry powder inhalation.

Lactose monohydrate properties

Over decades, alpha-lactose monohydrate has become well-established for pharmaceutical applications. The chemical and physical stability of crystalline lactose monohydrate powder makes it highly suitable for oral pharmaceutical tableting, sachet and capsule applications, with versatile properties for binding or filling, compressibility and global availability.

Lactose (C₁₂H₂₂O₁₁) is a naturally occurring milk sugar disaccharide composed of one galactose and one glucose molecule. In the pharmaceutical industry, lactose is used in crystalline a-lactose monohydrate form as an excipient filler or binder to help form tablets as well as a diluent powder for capsule fillings or dry powder inhalation (DPI) applications. Lactose may also be used in lactose anhydrous or spray-dried forms.

Lactose monohydrate exhibits a number of general properties that make it ideal for use as an excipient. These include:

• Excellent compactibility
• Low hygroscopicity
• Compatibility with a wide range of active pharmaceutical ingredients (APIs) and other excipients
• High physical and chemical stability
• Water solubility
• Cost effectiveness
• Availability
• No bitter taste

Lactose monohydrate parameters

Lactose monohydrate ‘flowability’ defines the intrinsic ability of a powder to flow evenly through orifices and into enclosed spaces. Flowability can be assessed on the index of 4 to 40 defined by Dr. A. Gioia at the Dow Pharmaceutical Research Labs in Milan, using the Hanson FlowRatex® tool to measure the ability of powder to flow through disk apertures of increasing diameter. Flowability can also be quantified on the Hausner Ratio or Carr Index.

Flowability is affected both by lactose monohydrate processing, by differences in morphology and by particle size distribution (PSD).

MEGGLE Lactose monohydrate products

MEGGLE offers a very wide range of lactose monohydrate grades with differing physical properties in respect of particle size distribution (PSD), bulk density, and the flowability which is so important in defining how lactose monohydrate-based powders will behave in tableting and filling processes.

MEGGLE’s lactose monohydrate brands are defined by their area of application (granulations, direct compression tableting, powders preparations for capsule/sachet filling and DPI), cross referenced against production process or format (milled, agglomerated, spray dried, anhydrous, co-processed, sieved or micronized).

This results in a total of 14 MEGGLE lactose monohydrate brands, covering 26 distinct products. Together these build into a complete framework or grid that covers the whole range of applications, formats and grades.

These can be tabulated as follows:

Resources

Click on MEGGLE lactose monohydrate products to download Competencies Brochure.
Click on MEGGLE Products Configurator to browse all lactose monohydrate grades.