Insights, Strategies, and Practical Suggestions on Pre-formulation Studies for Pharmaceuticals
In a recent statement, the US-based CRO company CD Formulation re-demonstrated its competence in drug development and announced that it now offers industry-leading insights, strategies, and practical suggestions on pre-formulation studies for drug developers worldwide.
The past decade has witnessed a boom of new chemical entities development in the hope of bringing more therapies to diseases hard to cure. The timeline segment after the discovery of a potential chemical hit and before the start of human clinical studies is often referred to as drug pre-formulation stages by scientists.
“The role of pre-formulation studies is of utmost significance to the drug development process. A deep and thorough understanding of drug products is required, including different parameters such as the toxicology, pharmacokinetics, and physicochemical properties of drug chemicals,” said the Marketing Chief of CD Formulation. “Meanwhile, formulation researchers also work very closely with the analytical scientist to identify stability issues, which will decide whether a chemical candidate will be approved or abandoned at later stages.”
Challenges pop out throughout the pre-formulation stage regarding the enhancement of solubility, the choice of the most appropriate excipients, the best volumes to be administered, and many other fields. Through the intelligent use of CRO services, the burden can be eased.
Currently, CD Formulation is capable of conducting the following pre-formulation services for pharmaceutical companies: Crystallinity Determination, Amorphous Content Determination, Hygroscopicity Evaluation, Particle Size Analysis, Moisture Content Determination, Solubility Analysis, LogP/LogD/pKa Analysis, Stability Analysis, API-Excipient Compatibility, API Physical & Chemical Characterization, Dissolution Rate Test, Solid State Characterization of APIs, Powder Flowability Test, Forced Degradation Studies, Drug Formulation and Packaging Compatibility, Determination of Contact Angle of Pharmaceutical Excipients, and Long-Term Accelerated Shelf-Life Testing.
Among them, excipient compatibility studies, physical/chemical characterization, and solubility studies are the three typical preformulation studies that are most extensively carried out. Please visit https://www.formulationbio.com/preformulation.html to learn more.
About
Being innovative and science-driven, CD Formulation is at the forefront of contract research and always applies the latest science and technology to the pharmaceutical industry. All of its CRO services are carried out in concerted efforts to advance the global medical business. Up till now, a comprehensive range of drug pre-formulation, formulation, and analytical services are readily available at CD Formulation.