RetaLac®
Premium co-processed Excipient
50 % milled alpha-lactose monohydrate and 50 % hypromellose (HPMC).
Co-processed excipients (CPEs) play a key role in modern pharmaceutical manufacturing by offering significantly improved functionality compared to conventional excipients. Through the physical combination of established substances – multifunctional particle systems are created with enhanced flowability, compactibility, and reduced sensitivity to lubricants. This leads to improved tablet uniformity and mechanical strength while reducing the need for additional formulation steps. Especially in direct compression, CPEs enable more efficient and robust tablet production, even with high drug loads or poorly compressible APIs. Since they are composed of pharmacopoeial-approved components, regulatory requirements are minimal, further increasing their appeal.
RetaLac® is a co-processed excipient of 50 % hypromellose (HPMC 2208) and 50 % milled alpha-lactose monohydrate, specifically designed for direct compression and dry granulation of modified release formulations.
While a binary composition, RetaLac® is monoparticulate in structure, having hypromellose and lactose in each particle. It is characterized by superior functional performance such as improved flow and blendability. Additionally, due to its monoparticulate structure, RetaLac® possesses both plastic and brittle fracture deformation characteristics, enhancing compactibility in direct compression (DC) compared to traditional wet granulation and physical admixtures of the parent ingredients.
API release is controlled predominantly by diffusion through the hydrophilic matrix, and is most robust in the range of pH 1.0 to 7.4. To minimize development time, API dissolution prediction as a function of tablet geometry is possible. This is aided by RetaLac®’s dramatic improvement in wettability compared to HPMC alone or in traditional wet granulations and simple admixtures.
Benefits
- Direct compression of modified release formulations
- Superior processability compared to corresponding wet granulated and physical admixture of parent ingredients
- Dissolution can be quantitatively predicted as a function of tablet geometry
- Drug release from hydrophilc matrix is governed by diffusion and is very robust within a pH range of 1.0–7.4
- RetaLac®, exhibiting monoparticulate structure, provides plastic deformation behavior and brittle fracture as well, which leads to overall improved compactibility
- Dramatic improvement in wettability compared to pure hypromellose
Areas of Application
- Capsule filling
- Direct compression (suitable for multi-layer and mini tablets as well)
- Dry granulation
- Preparation of aqueous HPMC formulations
- Extrusion, spheronization
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- Dry granulation
- Direct compression
- Roller compaction
- Co-processed Excipients
- Oral Solid Dose
- Multi-unit tablet
- Mini tablet
- Sustained release tablet
- Placebo tablet
- Low to medium dose DC formulation
- Extrusion-spheronization
- Capsule
- Tablet
12kg – Plastic drum with PE-EVOH-PE inliner
24 months
Wasserburg am Inn, Germany
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Typical particle size distribution
Typical Product Data
- x10: 61 µm, x50: 158 µm, x90: 337 µm
- Span [(x90-x10)/x50]: 1.74
- Density bulk: 0.267 g/ml
- Density tapped: 0.355 g/ml
- Hausner Ratio: 1.33
- Carr’s Index: 25 %
Specified Product Data
Particle size distribution
Sieve Method: Mechanical sieve shaker
- <32 µm: NMT 15%
- <250 µm: NLT 80%
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