Ibuprofen DC100 for direct compression

Ibuprofen DC100 for direct compression as an enhanced powdered active ingredient assisting simplified production of superior oral Ibuprofen formulations. Thereby, this DC-grade is made of 100% active without the need of further excipients. Performance in compression is simply reached through transformations of the physical form.

This improved physical form of Ibuprofen can be incorporated into designed formulations, both for increasing process simplicity or for enhancing the efficiency of coating and layering properties.

Ibuprofen applications

Rising market demand drives the need for improved ibuprofen formulations. This nonsteroidal anti-inflammatory drug (NSAID) treats pain, especially headaches. It also reduces fever and inflammation.

Manufacturers market ibuprofen in diverse dosage forms. Patients receive it intravenously or orally. Oral formats include tablets, sachets, capsules, and stick packs. These products offer dissolution profiles from immediate release to controlled release.

Key challenges in ibuprofen OSD formulations include effective taste masking. Formulators must also address poor compression and limited compaction properties in tablet manufacturing.

Compression of Ibuprofen demands sophisticated treatment of the drug to achieve compressibility. Long compression cycles are critical as the product tends to stick after a while due to the low melting point and especially with using low compression forces leads to manufacturing problems.

Ibuprofen DC100 as a solution

Ibuprofen DC100 complies with European Pharmacopoeia (Ph. Eur.) specifications. It consists of spherically shaped particles made from 100% Ibuprofen drug substance. A patented granulation process forms the particles. The formulation contains no added excipients.

Ibuprofen DC100 offers a uniquely direct compressible form of Ibuprofen. Its engineered shape and surface structure create distinctive performance attributes. The particles feature a smooth surface and low porosity. They deliver good flow properties and high mechanical stability. The material shows a uniform particle size distribution between 200 µm and 500 µm.

This allows an easy substitution in Ibuprofen formulations while keeping the registered composition in the outer phase. Furthermore, process steps in tableting are reduced from eight (including sieving, granulating with internal and outer excipients, blending, compression, and  cleaning) to just four (sieving, blending, compression, tableting).

Simplified formulations

Granulated Ibuprofen DC100 has a granule size in the range between approximately 200 μm and 500 μm with a bulk density of 0.5 g/ml to 0.7 g/ml. It satisfies regulations following Ph. Eur.  With a 100% API concentration the granulated Ibuprofen easily substitutes for conventional Ibuprofen in formulations that can provide either immediate or extended drug release profiles.

Thus, Ibuprofen DC100 can replace conventional ibuprofen grades with only minor regulatory adjustments. The formulation contains no additional excipients, which simplifies variation procedures.

Ibuprofen DC100 supports direct compression for tablets. Manufacturers can also use it in sachets and stick pack applications.

Its high drug load gives formulators maximum flexibility. They can optimize tablet size, adjust release profiles, and implement effective taste-masking strategies.