As the basic human needs, drugs are not administered to patients as pure compounds, they are formulated into drug products. However, recently an FDA review on the approval stats, states that most products fail in clinical studies at phase-II stage as well as phase-III stage possibly due to inefficacy of drug (B55%), toxicity issues (30%), commercial reasons (5%), operational hurdles (5%), and unknown errors (5%). Therefore, in order to save research costs and ensure the production of qualified dosage forms, before developing these main dosage forms, it is essential that certain fundamental, physical and chemical properties of the drug molecule and other properties of the drug powder are determined.
Preformulation is an investigation of physical and chemical properties of a drug substance when used alone or combined with excipients. Early prediction of these properties will generate information useful to the formulator in developing stable and safe dosage forms with good bioavailability.
Fig.1 General preformulation approaches for tablet production. (Lee B J, 2010)
At CD Formulation , our preformulation services are equipped with advanced instrumentation, and our research team not only have the expertise to handle the most complex formulations, but also have a depth of experience in the pharmaceutical industry and contract service organisations. CD Formulation can offer tailored and rational preformulation development.
|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|
|Long-Term Accelerated Shelf-Life Testing|