Ibuprofen DC100 – a grade for direct compression
Ibuprofen as a popular drug
Before discussing the Ibuprofen DC100 grade for direct compression, it is important to first examine why improvements in Ibuprofen formulations are desirable. Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is commonly used to treat pain—such as headaches—fever, and inflammation. The drug is administered in various dosage forms, with oral and intravenous routes being the most common. Oral administration, in particular, supports multiple dosage forms, including tablets, sachets, and stick packs. These formulations can be designed to achieve specific drug dissolution profiles, ranging from immediate release to modified or controlled release.
The main issue with Ibuprofen
Oral dosage forms of Ibuprofen face several challenges. For sachets or stick packs, effective taste masking is crucial to ensure high patient compliance. In the case of tablets, however, manufacturing can be particularly difficult because Ibuprofen is hard to process. Its low compression and compaction properties present the main obstacles during formulation.
Compressing Ibuprofen requires careful handling to achieve sufficient compressibility. Long compression cycles are often necessary, as the drug tends to stick over time due to its low melting point. These issues are especially pronounced when low compression forces are applied. In a subsequent section, we will examine how these challenges can result in rough or even defective tablet surfaces.
Expert’s opinion
Ibuprofen DC100 (Ph. Eur.) can simplify the production process of your oral Ibuprofen formulation with great advances. Use the improved physical form of Ibuprofen in your designed formulation for increasing the process simplicity or turning the efficiency of coating and layering properties.
Solution: Ibuprofen for direct compression
Ibuprofen DC100, designed for direct compression, is produced through patented granulation processes and consists of 100% pure active ingredient without additional excipients. This composition allows it to be easily substituted into existing Ibuprofen formulations while maintaining the registered composition in the outer phase. Moreover, tableting processes are simplified: whereas conventional Ibuprofen typically requires multiple steps—such as sieving, granulating with internal and external excipients, blending, compression, and cleaning—Ibuprofen DC100 reduces the number of process steps significantly (Figure 1).
Figure 1: Exemplary process with conventional Ibuprofen: 8 steps required.
Driving the process with the granulated Ibuprofen DC100, the process steps reduce by 50% and result in 4 steps, such as sieving, blending, compression (Figure 2). The main process steps include the mixing with internal and outer excipients which cannot be avoided.
Figure 2: Exemplary process with granulated Ibuprofen DC100: 4 steps remaining – Ibuprofen for direct compression.
Simplifying complex formulations
Granulated Ibuprofen DC100 has a particle size ranging from approximately 200 µm to 500 µm and a bulk density of 0.5–0.7 g/mL, fully meeting Ph. Eur. requirements. With a drug concentration of 100%, Ibuprofen DC100 can easily replace conventional Ibuprofen in existing formulations. This substitution allows pharmaceutical products to maintain immediate or extended-release profiles, and because no additional excipients are required, only minor regulatory adjustments are needed.
Ibuprofen DC100 is suitable not only for tablets but also for sachets and stick packs. Its granules facilitate straightforward taste-masking, improving patient compliance. The high drug concentration also offers maximum flexibility in designing dosage forms—such as tablet size and release characteristics—supporting better adherence and overall patient satisfaction.
Find your solution
See how Ibuprofen DC100 can simplify your production process. Study the technical information or request a sample for your lab testing.
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