MEGGLE Pharmaceutical grade lactose – Made in Germany

MEGGLE can offer high functionality pharmaceutical-grade lactose excipients for all kind of applications, including powder blends for tableting, sachets, capsules and dry powder inhalation. Recently, these have included increasing focus on continuous manufacturing (CM) applications.

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

MEGGLE lactose portfolio

This portfolio is based on MEGGLE’s more than 70 years’ experience as a lactose manufacturer, with partners and customers in more than 110 countries. Its offers include:

• Precisely tailored products developed in application labs all over the world
• High quality products manufactured in German production facilities operating to the highest standards and Excipact certified for GMP
• Flexible packaging options, and highly responsive customer service delivered via a global cGDP Distributor Network

Uses of lactose

Lactose excipients are used as fillers or filler-binders in production of pharmaceutical tablets and capsules. They are also useful as carriers in dry-powder inhalation (DPI) formulations and in infant formulas or even freeze-dried products.

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.

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

Types of excipients

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 pharma excipient lactose grades suitable for tableting 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®
• Tailored lactose grades for wet and dry granulation: The GranuLac® product line is dedicated to granulation processes with functionality tailored to allow most stable process and also enabling continuous production. MEGGLE’s lactose grades suitable for granulation include GranuLac® 70, GranuLac® 80 GranuLac® 140, GranuLac® 200, GranuLac® 230, and  SorboLac® 400
• Alpha lactose and anhydrous lactose for Direct Compression (DC): MEGGLE offers one of the world’s most comprehensive portfolios of agglomerated 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 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 gelatin 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
• Customized grades for Direct Powder Inhaler (DPI) applications: Customization of MEGGLE lactose grades is especially important when it comes to the inhalation route, where lactose plays a predominant role as carrier for the active pharmaceutical ingredient (API) facilitating its delivery to the lower part of lung. MEGGLE´s lactose grades suitable for DPI are produced via crystallization and subsequent sieving, milling or micronization and include InhaLac® 70, InhaLac® 120, InhaLac® 140, InhaLac® 150, InhaLac® 160, InhaLac® 230, InhaLac® 251, InhaLac® 300, InhaLac® 400 and InhaLac® 500.

Application & processing of pharmaceutical lactose

Lactose disaccharide, also called “milk sugar”; occurs naturally as a simple carbohydrate in mammalian milk. Chemically, the lactose molecule is composed of bonded molecules of D-galactose and D-glucose. It can exist in either alpha lactose and beta isomeric forms (a-lactose or b-lactose).

In the pharmaceutical industry, lactose is one of the oldest and still widely used filler and diluent in tablets and capsules, due to its inherent advantages like low hygroscopicity, water solubility, and compatibility with active ingredients, coupled with excellent physical and chemical stability.

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, agglomeration, 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.

Resources

Click on MEGGLE Lactose Product Configurator for detailed product information and applications
Click on Premium lactose for reliable-tableting  for further information
Click on GranuLac: tailored for perfect granulation for further information
Click on Comprehensive portfolio for DC Direct Compression for further information
Click on Successful powder preparation for capsule and sachet filling for further information
Click on Highest quality for DPI dry powder inhalation for further information
Click on MEGGLE Lactose Sales to contact distribution partner
Click on Contact MEGGLE to contact company directly