Co-processed Excipients

Enabling Efficient, Robust, and Scalable Tablet Formulations

The continued evolution of direct compression and continuous manufacturing in oral solid dosage forms has brought the spotlight back to excipients—not as inert fillers, but as functional formulation and manufacturing enablers. Among these, co-processed excipients (CPEs) have emerged as a key technology platform to address formulation complexity, process variability, and performance limitations.

Unlike physical blends, co-processed excipients are engineered systems where multiple excipients are physically co-processed (e.g., spray-dried, granulated, or co-milled) to generate synergistic properties such as: enhanced compressibility, flowability, low lubricant sensitivity, superior dilution potential, development simplicity and cost effectiveness.

Co-processed excipients

Enhancing Formulation Performance with Coprocessed Excipients (CPEs)

This blog focuses on specific examples of CPEs, and their role in formulation performance.

1. MCC-Based Coprocessed Excipients

Microcrystalline cellulose (MCC) is one of the most widely used fillers/binders in direct compression. However, its non-ideal poor flowability and sensitivity to moisture and lubricants limit its performance in certain formulations.

Example: CombiLac® (MCC + Lactose + Starch) offers enhanced compaction properties and superior flowability compared to a physical mixture of its individual components (alpha-lactose monohydrate, microcrystalline cellulose (MCC), and corn starch).

MicroceLac® (MCC + Lactose spray-dried) is a coprocessed excipient made from microcrystalline cellulose (MCC) and spray-dried lactose, designed specifically for direct compression tablet manufacturing. By combining the plastic deformation of MCC with the brittle fracture of lactose in a homogenous spray-dried particle, MicroceLac® simplifies formulation and improves tablet quality.

2. Lactose-Based Systems for Enhanced Compactability

Lactose, particularly spray-dried lactose (SDL), is often used for its taste and solubility. However, it lacks the compressibility needed for robust tablets at high throughput.

Example: Cellactose® 80 (MCC + SDL) This coprocessed excipient (75% lactose, 25% MCC) is produced via spray agglomeration. It combines the plasticity of MCC with the brittle fracture of SDL—leading to superior tablet strength, formulation robustness and uniformity.

3. Mannitol-Based Systems enabling Modified Release and DC

Mannitol is preferred for its non-hygroscopicity, cooling mouthfeel, and chemical inertness. However, it tends to have poor compressibility unless modified.

Examples: PEARLITOL® Flash (mannitol + starch) This is a co-processed mannitol-starch compound intended for fast disintegration and API release in orodispersible tablets (ODTs). It acts as a direct compression excipient with disintegrant properties, offering chemical inertness and consistent rapid disintegration time. It's suitable for swallowable and orally dispersible tablets.

PEARLITOL® CR-H (mannitol + HPMC) is a co-processed excipient designed for delivering hydrophilic matric tablets with optimal tablet manufacturability and reliable controlled release performance.

4. Hypromellose (HPMC) based co-processed excipients

HPMC (Hydroxypropyl Methylcellulose) is the predominant oral controlled release excipient for hydrophilic matrix tablets. Benecel™ HPMC DC is a direct compression (DC) grade of HPMC, which is silicified to simplify formulation and manufacturing of extended-release tablets without the need for wet or dry granulation. Benecel™ HPMC DC offers robust performance, especially in scale-up and high speed tablet manufacturing and regulatory acceptance across global markets.

5. High Functionality Fillers for Challenging APIs

High-functionality fillers are indispensable in modern tablet development – especially when working with challenging APIs. Their multifunctional properties not only simplify formulation strategies but also reduce development timelines and cost.

Example: MicroceLac® 100 (MCC + Lactose) is created by combining lactose and microcrystalline cellulose through spray drying. This excipient enables direct compression due to its excellent flowability and compactability.