MEGGLE Pharmaceutical lactose grades

MEGGLE can offer high functionality pharmaceutical-grade lactose excipients for a very wide range of pharma applications, including powder blends for tableting, sachets, capsules and dry powder inhalation. These lactose-based excipients can be used as fillers or filler-binders in production of pharmaceutical tablets and capsules but are also useful as diluents in dry-powder inhalation (DPI) formulations and in baby nutrition formulas or freeze-dried products.

The MEGGLE portfolio of excipients is one of the complete offered by any lactose manufacturer, allowing the choice of precisely targeted excipients to overcome production challenges and overcome API deficiencies such as poor solubility, bioavailability or functional performance.

The right alpha lactose monohydrate to meet any demand

Lactose fulfils numerous applications within the pharma industry, where it is highly appreciated for its convenient handling, long shelf life, formulation neutrality, and its ideal suitability to filling and dilution roles.

The MEGGLE lactose excipients portfolio is based on MEGGLE’s more than 70 years’ experience as a lactose manufacturer, deriving pharma grade lactose from whey, a byproduct of cheese production.

Lactose occurs in different forms, with crystalline, thermodynamically most stable alpha-lactose monohydrate (“tomahawk-shaped” crystals) and lactose anhydrous (“kite-like” crystals) as the most frequently used polymorphs.

The chemical and physical stability of crystalline lactose monohydrate powdered lactose makes it highly suitable for oral pharmaceutical applications, with versatile properties for binding or filling, compressibility and global availability.

MEGGLE uses crystallization, spray drying, sieving, milling and micronization to process a very wide range of lactose monohydrate powder grades for the pharmaceutical industry to support the whole spectrum of lactose pharmaceutical applications, including wet and dry granulation, direct compression tableting, capsule or sachet filling and dry powder inhalation.

MEGGLE’s anhydrous lactose grade for direct compression: DuraLac® H”

MEGGLE’s anhydrous lactose grade for direct compression: DuraLac® H, was developed especially for direct compression processes, where it exhibits excellent compactibility, good flowability, relatively low hygroscopicity (water sorption above 70 % relative humidity), and high storage stability, making it an ideal excipient choice for formulations requiring low water content, such as low to medium dose DC formulations, dry granulation roller compaction and slugging, and capsule or sachet filling.

DuraLac® H is produced by roller-drying a lactose solution at high temperature to form anhydrous beta-lactose and alpha-lactose crystals at levels approximating 80 % and 20 %, respectively.

During anhydrous lactose crystallization, no water is incorporated in the crystal lattice. Subsequent to roller-drying, anhydrous lactose is milled and sieved to the desired particle size distribution, optimizing powder flow and compactibility. DuraLac® H complies with the monograph Lactose, anhydrous“ (Ph. Eur., USP-NF and JP). Because DuraLac® H deforms by brittle fracture during compaction, it is well suited for directly compressed and dry granulated formulations.

DuraLac® H anhydrous lactose complies with the current harmonized USP-NF, Ph. Eur., and JP monographs and is manufactured to cGMP standards at MEGGLE’s state-of-the-art, pharma-dedicated production facilities at Le Sueur, Minnesota, USA, producing milled alpha-lactose monohydrate and anhydrous lactose. MEGGLE has been an EXCiPACT™-certified excipient lactose manufacturer and supplier since 2014 and is also a member of IPEC (International Pharmaceutical Excipients Council).

Powder compressibility

During compaction, DuraLac® H fragments, exposing clean surfaces having numerous binding sites. This provides the functional performance needed to produce robust tablets in direct compression and granules having desired characteristics for highspeed tableting and capsule filling processes. Thus tablets made with DuraLac® H achieve higher hardness yield than compacts produced from agglomerated alpha-lactose monohydrate (DC grade).

MEGGLE offers one of the world’s most comprehensive portfolios of granulated and spray dried alpha-lactose and anhydrous lactose for DC applications, including co-processed excipients for fast disintegration and sustained release.

Other MEGGLE’s lactose grades suitable for direct compression are available under the trade names Tablettose® 70, Tablettose® 80, Tablettose® 100, FlowLac® 90, FlowLac® 100, MicroceLac® 100, Cellactose® 80, StarLac®, RetaLac®, and CombiLac®.

Resources

Click on MEGGLE: Expert in Excipients to download brochure.
Click on Lactose: The ideal excipient for further information.
Click on Technical brochure DuraLac® H to access download.
Click on MEGGLE anhydrous lactose applications for further information.