Disintegration Test Is Now Available at CD Formulation for Drug Analysis and Development

CD Formulation owns a cGMP-compliant laboratory and a team of experts. Together with state-of-the-art analytical instruments, the company is capable of conducting analytical process development and validation services for drug formulation projects. Recently, CD Formulation announced that it now offers the disintegration test, which is an important quality control (QC) test in drug analysis ever since its inception in the 1930s. “We have been recognized as a trustworthy service provider for custom pharmaceutical formulation projects for years. Our scientific team can provide valuable insights and tailor-made solutions to help customers conquer difficulties that arise from their drug development projects,” says the Marketing Chief of CD Formulation. Disintegration testing is very important for oral formulations. Such a test is carried out to evaluate how quickly a sample will break into smaller particles under standard conditions. Usually, drugs in the form of tablets, capsules, and enteric-coated tablets are required to conduct disintegration testing so as to obtain critical safety data on the in vivo bioavailability of drugs without the use of in vivo methods. At CD Formulation, solution, reagents, and techniques used for disintegration testing are in compliance with the regulations of the Pharmacopoeia, including European Pharmacopoeia (Ph. Eur.), United States Pharmacopoeia (USP), Japanese Pharmacopoeia (JP), Chinese Pharmacopoeia (ChP), etc. “Binders, lubricants, surfactant, and hardness are four factors that will influence disintegration testing. Our methods for disintegration test are test-tube method, sieve method with shaker, sieve method, pharmacopoeial method and many more,” further explains the Marketing Chief. It should be noted that despite disintegration being a prerequisite for acceptably rapid drug dissolution, complete disintegration does not necessarily imply complete dissolution of the active ingredient. With proper research performed, the use of the disintegration test can be expanded, for example, to serve as a release test surrogate in some instances. This will save significant costs for the QC departments of pharmaceutical companies. As always, CD Formulation is committed to developing tailor-made solutions to address customers’ specific challenges and problems. For more details about CD Formulation’s disintegration testing or any other type of drug analysis service, please visit: https://www.formulationbio.com/analytical.html or email us directly at contact@formulationbio.com.