By MEGGLE Excipients
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Bavarian-based MEGGLE Wasserburg is one of the world’s foremost experts in lactose and its applications in pharmaceuticals.
From its roots as a dairy operation in the late 1880s, MEGGLE has become one of the world’s leading manufacturers of pharmaceutical lactose, supplying the pharma market segment with a broad-based and unique lactose product portfolio.
MEGGLE Business Unit Excipients has harnessed outstanding product quality and intelligent innovation to become a global leader in the manufacture of lactose-based excipients, focusing on products for direct tableting and dry powder inhalation.
A multidisciplinary team of committed and highly qualified people allows MEGGLE clients to benefit from pioneering experience and innovative drive in industrial milk and whey processing. The company constantly strives to develop high-tech, functional products for implementation in customer applications, where they can deliver maximum performance.
Products & Services
MEGGLE Business Unit Excipients focuses on production of pharmaceutical grade lactose and lactose-based excipients for tableting and dry powder inhalation applications with on-going commitment to developing innovative functional products that enable drug development at ease. It supplies products for three main application areas: tableting, powder preparation such as capsules and sachets and dry powder inhalation.
MEGGLE tableting products are developed for granulation and direct compression processes.
Granulation products consist of milled GranuLac® and SorboLac® powders, which are available in various grades with regard to particle size distribution, density, and specific surface. Therefore, performance parameters such as tablet hardness, disintegration time, and powder blend homogeneity can be designed to various specific needs.
Direct Compression (DC) products include the agglomerated Tablettose® and spray-dried FlowLac® range as well as anhydrous lactose and co-processed excipients.
- Agglomerated Tablettose® combines the good flowability of coarse lactose and goodcompactability of fine milled lactose.
- Spray-dried FlowLac® allows for non-varying tableting properties, excellent flowability and extraordinary compactability.
- Anhydrous DuraLac® H 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%, well-suited for directly compressed and dry granulated formulations (roller compaction, slugging).
- Co-processed products have demonstrated functional improvement, offering better flow, compaction, and hydration characteristics, which streamline manufacturing processes and improving cost efficiencies. Co-processed products like Cellactose® and MicroceLac® that combine lactose and cellulose synergistically to improve tablet hardness and API-adherence, StarLac® combining alpha-lactose monohydrate with maize starch for enhanced compactability and faster tablet disintegration and CombiLac® that combines alpha-lactose monohydrate, microcrystalline cellulose (MCC) and white corn starch into a monoparticulate structure for improved compaction, minimal tablet friability and rapid tablet disintegration for effective API release.
- Sustained release RetaLac® powder, comprising equal parts of hypromellose (HPMC) and milled alpha-lactose monohydrate in textured, highly structured particles. RetaLac® allows for the production of hydrophilic sustained release matrix system by direct compression, which, by industry standards, is unparalleled and only available from MEGGLE.
Powder Preparation products
Narrow classification of randomly sized lactose crystals results in coarse sieved grades, which show particle size and shape-dependent powder flow for increased production speeds. MEGGLE´s sieved alpha-lactose monohydrate grades; PrismaLac® 40 , CapsuLac® 60 , SacheLac® 80 and SpheroLac®100; are mainly monocrystals with some agglomerates, exceptionally suited to permit and optimize applications (capsules and sachets) where powder flow is important.
Dry Powder Inhalation products
MEGGLE has developed a specialty lactose grade, InhaLac®, to meet the challenges associated with dry powder inhalation (DPI). With our tightly controlled production process different high quality sieved and milled grades are obtained, providing a range of particle sizes with excellently defined product characteristics. Due to the consistent product quality the InhaLac® product family can be used safely in DPI formulations for improved inhaler performance and facilitated powder handling during production.
Apart from direct manufacturing of a broad range of off-the-shelf products, MEGGLE Business Unit Excipients also offers Application Management services and customized products for pharmaceutical industry development.
History and organization
MEGGLE traces its origins to a dairy operation founded in 1887 in the town of Wasserburg, near Munich. During the 1950s, MEGGLE established Business Unit Excipients, manufacturing lactose-based products to international pharmacopeia standards. MEGGLE began providing the pharmaceutical market with broad range of pharma-grade lactose-based products, supported by a strong multi-disciplinary workforce with deep experience of industrial milk and whey processing along with dry powder characteristics and tableting technologies.
The company took a further significant step forward in the mid-1970s when it pioneered the first lactose for direct compression, Tablettose®. In the late 1980s, MEGGLE created its first co-processed excipient, Cellactose® and during the following decade extended its Direct Compression range of products for tableting.
At the start of the new millennium MEGGLE introduced the new InhaLac® range of lactose-based excipients for Dry-Powder-Inhalers and in 2009 introduced RetaLac® co-processed excipients for modified release formulations. Since 2012, the company has also pioneered DuraLac® anhydrous lactose and CombiLac®, the world’s first triple, co-processed excipient.
MEGGLE’s main production sites are in Wasserburg and at Le Sueur, Minnesota, USA, with regional offices in Singapore, Shanghai, Tokyo, New York and Sao Paolo, Brazil, supported by a worldwide network of some 65 local agents.
For all its expansion and world scale operations, MEGGLE remains a wholly family-owned business with strict ethical values and high standards that places performance and partnership with customers at the core of its success.
Quality, Regulatory and Standards
MEGGLE ’s products and processes are quality compliant with key International Standards DIN EN ISO 9001 (Quality Management), DIN EN ISO 14001 (Energy Management) and DIN EN ISO 50001 (Environmental Management). Its products comply with Ph.Eur., USP-NF, JP and CN monograph requirements.
MEGGLE is also a member of the EXCiPACT™ international excipients certification scheme recently introduced by the European Fine Chemical Group (EFCG), International Pharmaceutical Excipients Councils (IPEC) for Europe and the Americas, European Association of Chemical Distributors (FECC), and the Pharmaceutical Quality Group (PQG). EXCiPACT certification combines GMP and GDP standards for excipients with Certifying Body quality system definition/qualification process and Auditor Competency definition, training course, exam, and registration process.
MEGGLE quality is rigorously enforced by robust internal quality management processes complying with all relevant pharmaceutical Industry regulations, backed up by regular internal and external Audit and inspection by clients’ authorities.