Your partner in direct compression expertise

Represented in South Africa by Amchem, Meggle’s direct compression (DC) lactose offering extends beyond products, manufacture and supply to technical expertise, process and development consultancy. DC is the most accessible form of oral dosage production, involving the fewest process stages and quickest production. The choice of ideal DC excipient is defined by a range of factors, including:

• the need for particle engineered DC excipients to ensure correct flow and compression characteristics

• consideration of active ingredient dosage levels, with DC occupying a ‘sweet spot’ between 0.5 and 50mg

• compatibility with other ingredients with a ‘classic’ DC powder mixture usually containing a binder and a lubricant and sometimes a disintegrant and glidant.

Generally, the selection of pharmaceutical excipients for DC is more critical than for granulation, or wet granulation in particular. Few traditional excipients combine the functional characteristics, specifically powder flow and compactibility required for robust DC. This makes modifying traditional excipients a necessity.

DC excipients

Meggle offers more than 50 different lactosebased excipients suitable for DC, under a range of brands, including Tablettose, FlowLac, DuraLac, Cellactose, MicroceLac, StarLac, CombiLac, RetaLac, and InhaLac. These brands cover the following eight main categories:

• sieved, milled or micronised lactose for dc

• agglomerated lactose

• co-processed monoparticulate lactose and cellulose

• integrated, lactose-based, coprocessed excipient

• alpha-lactose monohydrate and microcrystalline cellulose

• fine milled alpha-lactose monohydrate crystals

• crystalline alpha-lactose monohydrate

• co-processed hypromellose lactose for direct compression

• alpha-lactose monohydrate and maize starch.

Milled lactose

Sieved, milled or micronised lactose is ideal for optimum granulation, for use with limited flowability compounds that demand granulation before tabletting. Because of its good compression and blending properties, lactose is the most frequently used excipient for granulation. Meggle’s GranuLac and SorboLac both offer small particle size distributions, supporting a range of applications including wet granulation, dry compression, premixes, triturations, fermentation and flavour off-set.

These formulations offer the following convincing advantages:

• good compactibility

• ideal blending properties

• narrow particle size distribution

• long lasting storage stability

• high batch-to-batch consistency.

In addition, Meggle’s milled lactose formulations include the InhaLac range of sieved, milled or micronised pharmaceutical lactose, particularly suited to dry powder inhalation drug delivery applications.

Agglomerated lactose

The Tablettose range from Meggle is manufactured using a continuous spray agglomeration process, where water is used as the binder and sprayed onto fluidised fine milled lactose particles, creating liquid bridges to form agglomerated lactose.

Tablettose is purpose-designed for DC, combining the flowability of coarse lactose crystals and the high compressibility of fine milled lactose.

Featuring a broad range of particle size distributions, Tablettose offers a range of benefits including very good flowability and compactibility, low hygroscopicity, excellent stability, superior blending characteristics and rapid disintegration. As a result, it supports a wide range of useful applications, including low-dose DC formulations, capsule and sachet filling, effervescent tablets, artificial sweeteners and orally disintegrating tablets.

Co-processed monoparticulate lactose and cellulose

Alpha-lactose monohydrate and cellulose powder are functional excipients used in oral solid dosage forms. Both are naturally derived and well-established for use in the pharma industry.

In an effort to create synergistic functional performance, such as improved compactability and mixing characteristics, Meggle uses co-spray drying to integrate alpha-lactose monohydrate and cellulose powder into a monoparticulate system.

Cellactose 80 was developed to provide the flow and compaction properties necessary for direct compression tabletting, comprising 75 percent alpha-lactose monohydrate and 25 percent powdered cellulose, both maintaining their individual chemical identities.

Although it’s designed for direct compression tabletting, Cellactose 80 can be used in other formulation applications such as dry granulation and capsule filling. In comparison to a corresponding physical blend of the individual components, Cellactose 80 provides improved compactability, superior flowability and increased adherence capacity, which reduces segregation tendencies typical of simple powder blends, making it ideal for low-dose formulations.