The drug solubility specialist for solid dispersions, particle engineering and silica technologies
Almost half of currently marketed drug products, and around 90 % of those in clinical development are associated with poor drug solubility or permeability. A multitude of factors can affect drug solubility including molecular weight, lipophilicity, solid state, particle size or surface area, drug concentration and disintegration time of the oral solid dosage form. Evonik has decades of expertise in helping customers identify the right polymer, process technology and formulation solutions to successfully formulate APIs with poor solubility and thus increase their bioavailability.
EUDRAGIT® polymers have excellent characteristics to enhance drug solubility
Our EUDRAGIT® functional polymers have well defined processing characteristics that make them ideal to improve drug solubility and permeability. For spray drying, they are lightly soluble in common solvents and show excellent powder compressibility. For hot melt extrusion, they have excellent thermoplastic properties and broad miscibility with APIs and other excipients. All relevant down-streaming options including strand granulation and micropelletization are also available in our labs.
A broad portfolio of immediate and delayed release polymers to address poor drug solubility
A diverse range of EUDRAGIT® polymers are available to address your specific immediate or delayed release requirements for drugs with poor solubility. The portfolio can also be utilized to enhance drug solubility in parallel with achieving other functionality outcomes. For example, EUDRAGIT® FS 100 has been specifically designed to enhance drug solubility for drugs requiring site-specific delivery to the colon to treat localized diseases such as colon cancer and irritable bowel syndrome.
A solid dispersions leader to enhance drug solubility
Amorphous solid dispersions are widely recognized as one of the most important and fastest growing technologies to address poor drug solubility. However, stability and recrystallization of amorphous drug formulations can represent key challenges in drug solubility enhancement. EUDRAGIT® polymers serve as excellent carriers for amorphous solid dispersions due to their solubilizing and stabilizing capabilities. Furthermore, our extensive technical knowledge regarding the functionality, stability and API compatibility of EUDRAGIT® polymers make us well-positioned to help ensure your API dissolves at the molecular level for stable, solid solutions. In addition to hot melt extrusion and spray drying, our polymers also have a strong track record of performance for use with other technologies utilized with amorphous formulations including micro-precipitated bulk powders and fusion-based processes.
Superior drug particle engineering to address your specific drug solubility needs
In addition to solid dispersions, Evonik also has strong core competencies in other key areas to address poor drug solubility and low permeability, including particle engineering and silica technologies, and the development of formulations that enable rapid disintegration. We offer a superior range of drug particle engineering solutions including various crystal engineering methods and dry milling capabilities that can increase surface area, alter crystalline structure, or stabilize the amorphous state.
Best-in-class drug solubility services and predictive systems
To optimize bioavailability, enable higher drug loadings, improve stability and minimize development costs, it is of paramount importance to select the right processes and functional excipients at early development stages. That is why in addition to the strong drug solubility expertise available on our technical teams, we recommend the use of predictive tools such as MemFis®. Such systems can help to predict the best lead carrier excipient and process parameters for you to commence initial trials.
OTHER ORAL DOSAGE FORM APPLICATIONS
Drug solubility enhancement
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