MEGGLE pharma excipients

MEGGLE are specialists in co-processing lactose to produce improved and sophisticated pharmaceutical excipients that can be used as tablet binders, aids to flowability or other characteristics needed to support ease of production and ultimate product quality.

The wide range of MEGGLE excipients include co-processed excipients that are innovative, superior products exhibiting unique functional characteristics that cannot achieved through simple blending.

What is an excipient?

A pharma excipient can be defined as any substance other than the active ingredient to be included in a drug delivery system, particularly in tableting to aid powder flowability, compressibility or product characteristics, such as tablet binding, or hardness.

The purpose of excipients is to aid processing during manufacture, enhance stability or bioavailability, assist product identification or in some other way enhance overall safety and effectiveness of the product in storage or use.

Pharmeuropa defines a co-processed excipient as “any combination of two or more excipients obtained by physical co-processing that does not lead to the formation of covalent bonds.”

This means that co-processed excipients have functionalities that are not achievable through mere sample blending.

Co-processed pharma excipients

In all pharma excipients, the combination of ingredients is designed to maximize performance and functionality. That combination can either be achieved by adding specific ingredients into the powder mix or use a single co-processed excipient in which two or more substances are blended.

Co-processed excipients can be produced using a variety of processes such as, dry and wet granulation, extrusion, or spray-drying.

The pharmaceutical industry first started co-processing excipients from the late 1980s, with early examples including co-processed microcrystalline cellulose and calcium carbonate, introduced in 1988. MEGGLE was an early pioneer of co-processing with its Cellactose® cellulose and lactose mix introduced in 1990.

MEGGLE co-processed excipients

MEGGLE offers five principal brands of co-processed excipients intended for direct compression (DC) tableting applications. All combine ingredients that are recognized under international pharmacopeias and well-established for use in the pharmaceutical industry.

• RetaLac®: the first hypromellose/lactose-based, co-processed excipient specifically designed for sustained release DC and dry granulation formulations. RetaLac® is binary in composition but monoparticulate in structure, having hypromellose and lactose in each particle. It is characterized by superior functional performance such as improved flow and blendability. API controlled release is predominately achieved by diffusion through the hydrophilic matrix, and is most robust in the range of pH 1 to 7.4. For example, with Vitamin C in a sustained release excipient formulation, use of RetaLac® makes it possible to achieve a simplified sustained release of Vitamin C in excess of 80% after eight hours. RetaLac®’s dramatic improvement in wettability compared to hydroxypropyl methylcellulose (HPMC) alone or traditional wet granulations and simple admixtures, makes it possible to predict API dissolution as a function of tablet geometry.
• Reta M®: MEGGLE’s latest co-processed excipient is similar to RetaLac® in applications and benefits but replaces the lactose component with mannitol to suit lactose-free formulations. This pioneering hypromellose/mannitol-based excipient is specifically designed for direct compression (DC) and dry granulation of modified release pharmaceutical and nutraceutical tablets and 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.
• Cellactose^®: The MEGGLE Cellactose^® range combines 75% alpha-lactose monohydrate with 25% cellulose powder as functional excipients for oral solid dosage forms, using co-spray drying to integrate the ingredients into a monoparticulate structure with narrow particle size distribution (PSD), while retaining their individual chemical identities. Cellactose® 80 was developed to offer the compaction and flow properties necessary for DC tableting or sachet filling.
• MicroceLac^®: uses co-spray drying to combine 75% alpha-lactose monohydrate and 25% microcrystalline cellulose (MCC) into a monoparticulate system having brittle fracture and plastic deformation compaction mechanisms, with individual particles that retain their distinctive chemical identities. MicroceLac® 100 maximizes formulation development flexibility, providing the compaction and flow properties desired for DC tableting that may also be applied to other formulation development approaches such as dry granulation and capsule filling.
• StarLac^®: combines 85% alpha-lactose monohydrate and 15% maize starch (corn starch) as functional excipients used in oral solid dosage forms. To establish synergistic functional performance, such as enhanced compactibility and faster tablet disintegration, lactose and starch are co-spray-dried to form a monoparticulate system. StarLac® provides compaction and lubricant insensitivity characteristics desired for DC, and the hydration properties desired for rapid API release.
• CombiLac®: A high-functionality integrated, co-processed ready-to-use excipient, specifically designed to ease oral solid dosage form development and manufacture by combining 70 % alpha-lactose monohydrate, 20 % microcrystalline cellulose (MCC) and 10 % white, native corn starch into a monoparticulate structure that is not separable by physical means. CombiLac®. is the co-processed excipient of choice for applications where robust, time saving development of frequently used formulation ingredients is the top priority, since the ternary combination reduces requirement for raw material testing during production, and shows improved compaction properties compared to an equivalent admixture of individual ingredients.

Resources

Click on Cellactose® 80 to download product information.
Click on RetaLac®  to download product information.
Click on Reta M®  to download product information.
Click on MicroceLac® 100  to download product information.
Click on StarLac®  to download product information.
Click on CombiLac®  to download product information.