MEGGLE lactose in OSD formulations

MEGGLE processed crystalline alpha-lactose monohydrate grades are highly valued for their chemical and physical stability and global availability in oral solid dose (OSD) pharmaceutical applications, providing versatile pill binder or filler properties in tableting.

In addition, alpha-lactose monohydrate grades can be tailored to function with differing physical properties for direct compression tableting, sachet or capsule filling.  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.

Lactose OSD applications

Pharmaceutical lactose plays an important role as tablet binder, carrier and filler and can be used in a wide field of industrial applications like traditional wet and dry granulation (roller compaction), direct compression (DC), or spheronization to form pellets to modify release characteristics.

Lactose may be used in spray-dried forms as filler or pill binder in direct compression (DC) tablet manufacture, being inherently able to form solid compacts under compression.

There is also need for lactose tablets as products in their own right as enzyme supplements for lactose intolerant people who have trouble digesting milk and other dairy products.

Lactose excipients used in tablets

High functionality pharmaceutical tablet excipients play an increasingly prominent role in modern oral solid dosage tablet formulations. Choice of precisely targeted lactose excipients allows manufacturers to overcome API deficiencies such as poor solubility, bioavailability or functional performance.

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

Pharma-grade lactose used in tablets plays valuable pharma roles as tablet binders, carriers and fillers and can be used in a wide field of supporting manufacturing applications like traditional wet and dry granulation (roller compaction), or direct compression (DC or DiCom) tableting.

The main targets for lactose monohydrates are still “classical” oral solid dosage forms like tablets or capsules for prescription, OTC medication, or nutritional use, while anhydrous lactose is particularly useful in DC applications, including co-processed tablet excipients for fast disintegration and sustained release.

Excipients used in tablet formulations include various lactose grades with ranges of defined physical attributes are important for handling crystallinity, density, particle morphology and particle size distribution (PSD).

Additionally, amorphous lactose, a mixture of α-, and ß-anomer, has been revealed as advantageous in introducing plasticity into spray-dried and other lactose grades.

Lactose grades for OSD use

Meggle’s lactose range comprises of different product groups with more than 20 specialty grades, covering all areas from solid dosage forms, dry powder inhalations and parenteral dosage forms. Their main excipient application areas are:

• Premium lactose grades for tableting: The highly tailored properties and consistent performance of MEGGLE lactose grades enable more rapid drug development and trouble-free manufacturing, with MEGGLE enhancing process understanding through quality by design (QbD) approaches, providing critical material attributes (CMA) data. The main MEGGLE lactose grades suitable for tablet excipient use are: GranuLac® 70, GranuLac® 80  GranuLac® 140, GranuLac® 200, GranuLac® 230, SorboLac® 400, Tablettose® 70, Tablettose® 80, Tablettose® 100, FlowLac® 90, FlowLac® 100, DuraLac® H, MicroceLac® 100, Cellactose® 80, StarLac®, RetaLac®, and CombiLac®
• Alpha lactose and anhydrous lactose for Direct Compression (DC): 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. MEGGLE’s lactose grades suitable for direct compression tableting are available under the trade names Tablettose® 70, Tablettose® 80, Tablettose® 100, FlowLac® 90, FlowLac® 100, DuraLac® H, MicroceLac® 100, Cellactose® 80, StarLac®, RetaLac®, CombiLac®
• Lactose grades optimised for capsule and sachet filling: Capsules and sachets are of special interest for early stage developments and clinical trials and also for patient-centric medicines for children and elderly, who may have impaired tablet-swallowing. Lactose has long been favoured or filling capsules for its limited interaction and is also stable with Hydroxypropylmethylcellulose (HMPC). Lactose grades for these applications are tailored for excellent flowability, narrow particle disc distribution (PSD), excellent blending properties, high storage stability and batch to batch consistency. They include PrismaLac® 40, CapsuLac® 60, SacheLac® 80 and SpheroLac® 100

Resources

Click on Lactose excipients for powdered lactose capsule fillings  for further information.
Click on Use of lactose excipients in tablet formulations  for further information.
Click on Lactose excipients for direct compression  for further information.
Click on MEGGLE Lactose Product Configurator for detailed product information and applications.