MEGGLE’s first lactose-free co-processed excipient for modified release formulations: Reta M^®

Co-processing specialist MEGGLE Business Unit Excipients (MEGGLE) has developed Reta M^®. The first hypromellose/mannitol-based, co-processed excipient specifically designed for direct compression (DC) and dry granulation of modified release formulations for the pharmaceutical and nutraceutical market.

MEGGLE has been known as one of the key lactose excipient manufactures and pioneer of co-processed excipients for decades. In 2009 MEGGLE introduced RetaLac^® a combination of lactose monohydrate and hypromellose, tailored specifically to sustained drug release formulation, which can be easily produced by direct compression. Due to its ease of use and reliant performance, RetaLac^® has been very well received by the pharmaceutical industry. On the other hand nutritional industry has been missing out on the benefits of RetaLac^®, due to its reluctance to use lactose or lactose-based excipients. Therefore MEGGLE introduces its first lactose-free excipient, Reta M^®,  comprising 50 % Mannitol and 50 % hypromellose (K4M). Reta M^® easily enables sustained drug formulation through direct compression.

Powder characterization

Reta M^®’s PSD and bulk density are right in the range of providing free flow, good blending capabilities and compaction behavior. Its powder flow ranks as “Fair-aid not needed”. Co-processing two or more excipients generally improves the resulting excipient’s compactibiltiy over its physical ad-mixture. This effect can also be seen for Reta M^®. It shows a quite linear increase of tablet hardness as function of employed compaction pressure, which allows for reliable and better-to-predict product performance.

In order to achieve drug release in a sustained manner, MEGGLE has selected hypromellose K4M. MEGGLE has seen, the use of hypromellose grades, which provide higher viscosity does not necessarily lead to improvements in slowing down the drug release. In addition, the use of high-viscosity hypromellose compromise important excipient’s functional related characteristics, which has led to the decision to stick with hypromellose’s K4M type.

 

Application

• Tableting – Direct Compression, also for multi unit and mini tablets
• Tableting – Roller Compaction
• Preparation of aqueous HPMC-formulations (thickener)
• Spheronization, Extrusion

 

Benefits

• All-in-one excipient which enables manufacture of sustained drug release (time release) tablets by direct compression
• Prolonged drug release up to 13 hours
• High loading capability up to 50% drug load
• Pharmacopoeial quality
• Lactose-free

 

Packaging, storage, shelf-life

Reta M^® comes in a 15 kg carton box, while pharma-compliant polyethylene-inline is being used as primary packaging with a shelf life of 24 month.

 

More information about Reta M^®

 

About MEGGLE

Bavarian-based MEGGLE is one of the world’s experts in co-processing and powder technology.

From its roots as a dairy operation in the late 1880’s, 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 solid dosage forms and DPI applications, where they can deliver maximum performance.