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MEGGLE lactose excipients support Continuous Manufacturing (CM)
The inherent product consistency of MEGGLE excipients enables the increasingly important production methodology of Continuous Manufacturing (CM).
In particular, the flexible properties of products such as MicroceLac 100, FlowLac 90 and Tablettose 80 enable Direct Compression (DC) techniques to be applied either in batch or continuous tablet production, as confirmed by successful trials of Continuous Manufacturing (CM) of Vitamin B2 tablets at powder integrated process specialists Glatt GmbH.
Continuous Manufacturing challenges
Continuous Manufacturing Technology continues to gain importance in pharmaceutical manufacturing, retaining familiar granulation and tableting processes but marrying them, with different methods for feeding and mixing of ingredients, combined with inline monitoring of the blend uniformity.
A proven continuous dry processing lines can consist of a primary feeding and blending unit, a roller compactor, a secondary feeding and blending unit for adding extragranular ingredients and a tablet press, along with a NIR instrument for measuring content of active ingredient in the powder blend.
The initial step of the CM process, feeding powders into a continuous blender, will require blending of at least four ingredients, including one or more APIs, filler/binder, a disintegrant, and a lubricant. Flow aids, anti-adherents, and additional dry binders may also need to be present.
Furthermore, dwell times in the blender in continuous manufacturing are more limited than those in batch processes.
A further aspect to be considered in terms of blending is the potential risk of over-lubrication, especially when magnesium stearate is used as a lubricant. This can cause a fall-off in finished tablet hardness and resilience. For this reason, it is better to add lubricant separately to the blend.
MEGGLE excipients for CM
This makes choice of excipient crucial for CM, with the ideal choice exhibiting co-processed, high functionality, easy flowing properties that can reduce total ingredient count and assist blending uniformity.
Examples of MEGGLE products that support continuous manufacturing process include:
- MicroceLac® 100: A co-processed 75% lactose and 25% microcrystalline cellulose (MCC) blend that is particularly suitable for use as diluent/binder in oral dosage formulations (ODT). Spray drying is used to combine lactose with MCC to provide synergistic effects, such as improved tablet hardness and adherence capacity, providing capability for CM in in direct compression (DC), due to superior flowability and compactibility.
- FlowLac® 90: A spray-dried suspension of fine milled alpha-lactose monohydrate crystals in a solution of lactose that forms amorphous, non-crystalline lactose in addition to crystalline lactose. This amorphous and stable content allows more consistent tabletting properties. FlowLac® 90 was developed to provide high flowability and compactibility, along with a particle size distribution (<32 µm: NMT 5%, <100 µm: 25-40%, <200 µm: NLT 85%) that makes it substantially dust-free.
- Tablettose® 80: Manufactured by a continuous spray agglomeration process, where water is used as the binder and is sprayed onto fluidized fine milled lactose particles, creating liquid bridges to form agglomerated lactose, Tablettose® is especially designed for DC, combining the flowability of coarse lactose crystals with the superior compressibility of fine milled lactose. MEGGLE’s Tablettose® 80 was the first available agglomerated alpha-lactose monohydrate of its kind, with agglomerates sized from <63 µm (NMT 20%) to 630 µm (NLT 97%). Other benefits include low hygroscopicity, excellent stability, superior blending characteristics and fast disintegration times.
MEGGLE products also support CM with excellent batch-to-batch consistency.