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MEGGLE launched Reta M® as first lactose-free co-processed excipient for modified release formulations
Wasserburg, Germany: – 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.
Reta M® enables shorter development times by making it possible to predict API dissolution as a function of tablet geometry, helped in part by dramatic improvement in wettability compared to HPMC alone or in traditional wet granulations and simple admixtures.
Sustained release and nutraceutical advantages
The new all-in-one excipient enables manufacture of sustained drug release tablets by direct compression. Other advantages include longer sustained drug release times (up to 13 hours), high drug loading capability (up to 50 % API load), a lactose-free formulation and the high quality associated with MEGGLE Wasserburg.
These characteristics also make Reta M® a highly significant product for the nutraceutical market, where is often necessary to avoid lactose-based excipients and emphasize sustained release, especially in products like Vitamin C, B2 and caffeine tablets.
Reta M® takes its place alongside RetaLac® in MEGGLE’s growing range of co-processed excipients for DC applications as the company’s first non-lactose product. It was developed and manufactured using the same spray-agglomeration technology as RetaLac®, which generates textured, highly structured particles with d50 in the range of many directly-compressible excipients, 100 µm to 200 µm, typically 125 µm. This produces almost white odorless powder, which is freely flowing and partially soluble in cold water.
The Reta M® blend comprises a 50/50 blend of K-type 2208 viscoelastic polymer hypromellose (hydroxypropyl methylcellulose or HPMC) with a nominal viscosity of 4000 mPa and Mannitol, the of sugar alcohol used as a medication and preferred as a sweetener in diabetic food for its resistance to absorption by the intestines.
The blend delivers very smooth release profiles (see Images) as well as a better compactibility profile, compared to physical admixtures. These enhanced predictability benefits allow accelerated development of new sustained release oral delivery formulations.
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 Excipients & Technology 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.
The company has introduced several pioneering products, notably Tablettose®, the world’s first agglomerated lactose for direct tableting, Cellactose® 80, a pioneering co-processed excipient based on cellulose-lactose for outstanding compression and flow properties and RetaLac®, the first direct compression co-processed excipient using a hypromellose-lactose base for sustained release formulations.
Further information at: https://www.meggle-pharma.com.
Reta M® uses spray agglomeration to produce a free-flowing powder with d50 particle size in the DC range at around 125 µm.
Co-processed Reta M® delivers a far more useful compactibility profile than physical ad-mixtures of HPMC/Mannitol
Reta M®’s potential for the nutraceuticals market is demonstrated in the smooth time release dissolution curves for Caffeine, Vitamin C and Vitamin B2 tablets