RETA M® by Meggle

MEGGLE’s first lactose-free co-processed excipient designed for direct compression

quadra is pleased to distribute MEGGLE’s first lactose-free co-processed excipient for modified release formulations: Reta M®

Co-processing specialist MEGGLE Excipients & Technology (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 one of the key lactose excipient manufactures and pioneer of co-processed excipients for decades.

In 2009 MEGGLE introduced the RetaLac® formulation, a combination of lactose monohydrate and hypromellose, is specifically tailored for sustained drug release formulations produced by using direct compression. Due to its ease of use and reliant performance, Retalac® was well received by the pharmaceutical industry.

The 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®,  comprised of 50 % Mannitol and 50 % hypromellose (K4M). Reta M® easily enables sustained drug formulations produced using direct compression.

Benefits

  • All-in-one excipient which enables manufacture of sustained drug release (time release) tablets by direct compression
  • 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

CHARACTERistics

Reta M®’s particle size distribution (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 compatibility 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.

Particle distribution chart for Reta M Co-processed
Compactability for Co-processed Reta M