Multilayer tablets are a popular fixed-dose combination (FDC) offering a range of release profiles for effective drug delivery. Multilayer tablet technology solves challenges to API consistency, allowing manufacturers to develop formulations from incompatible ingredients while optimizing the release profile for immediate release and controlled release.

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Multi-layer tablets coating

Multi-layer tablets compaction

Multi-layer tablets drying

Multi-layer tablets inspection

Multi-layer tablets pressing

Multi-layer tablets packing

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Use accurate weight-dosing systems and excipients to avoid delamination

Tablet sequencing is vital to achieving the correct lamination in the inner layer of the capping. Multi-layer technology relies on the accuracy of weight-dosing systems to counter delamination.

An inadequate ratio of the layer sizes presents an additional challenge to layering. The target ratio is 1:1, but API incompatibility and separate formulation mixtures impact the sizing of layers. Compressibility, flowability, and particle size distribution are crucial to controlling the weight and size of different layers.

Reduce cross-contamination with gluing pills technology to ensure adhesion between layers

Gluing pills technology (GPT) uses a binding agent to attach both layers after they’ve been individually compacted. The binding process safeguards against cross-contamination and ensures both tablet layers do not interact with one another.

Cross-contamination is a significant risk in formulation design when active pharmaceutical ingredients are exposed to other materials.

Superdisintegrants facilitate repeat-action of multilayer tablets

A tablet-within-tablet design makes multilayer formulations a good solution for repeat-action products. But their pharmacological effectiveness depends on the correct disintegration ability of the outer tablet.

Traditionally, starches and clays have been used as disintegrants by attracting water into the tablet. However, these may occupy up to a fifth of the weight of the final tablet. Specially developed disintegrants like Crospividone, Croscarmellose Sodium and Sodium Starch Glycote offer higher effectiveness at a lower concentration. These three make up the main categories of superdisintegrants.

Multilayer tablet technology is ideal for polypharmacy in single dose form

Polypharmacy is a growing area of interest in medication. It finds an effective solution in multilayer tablets by administering a minimum of 5 medicines at regular intervals.

Formulas designed for this purpose may include high-potency active pharmaceutical ingredients (HPAPI) with smaller but more powerful concentrations of materials. Multilayer tablet technology combines these complex formulations to manufacture more efficacious pharmaceutical products.