Excipient Screening

Excipient Screening

Excipients represent the inactive components of a pharmaceutical dosage form, which are intentionally incorporated into a formulation to function as stabilizer, synergist, and other specific roles. Since they directly contact with the active pharmaceutical ingredients, an ideal excipient is, therefore, have no or at least indistinctive adverse effect on the critical quality attributes of the actives, such as the stability and bioavailability.

Excipient Screening

Application of excipients

  • Enhancing certain physicochemical properties of active ingredients such as solubility
  • Exerting favorable effect on the pharmacokinetics and bioavailability of drug products
  • Acting as a stabilizer to maintain the API’s crystal forms and the pH/osmolarity of liquid products
  • Ensuring the quality and safety of the formulations through acting as antioxidants
  • Preventing aggregation or dissociation, especially for those biopharmaceutical products such as the protein, peptide, vaccines and polysaccharide actives
  • Alleviating the immunogenic responses of certain active ingredients
  • Other effects such as acting as emulsifying agents, aerosol propellants, tablet binders, etc.

Our Services

Given the increasing emergence of functional categories of excipients, selection of the most suitable excipients is becoming more time-consuming and complex. Through a variety of top-notch analytical methods and techniques such as physicochemical testing, thermal investigation and some surface energy analytical tools, we are able to offer our customers the most appropriate strategy and valuable information in a cost-effective way. For supporting your screening services, BOC Sciences will simplify the excipient selection process by various aspects:

  • Physicochemical characterization of powders such as the particle size, shape, surface energy, and surface area density
  • Loose density and vibrational density determination
  • Mechanical properties test of excipients
  • Comprehensive analysis of the flow properties, moisture content and hygroscopicity
  • Stability investigation under the ICH condition (high-humidity, photostability, and high-temperature)
  • Excipient compatibility assays including drug-excipient and excipient-excipient compatibility investigation
  • A wide range of instrumentations including IGC (Inverse Gas Chromatography), DFT (Density Functional Theory), TGA, DSC (Differential Scanning Calorimetry), and MDSC (Modulated Differential Scanning Calorimetry)

Why Choose BOC Sciences?

BOC Sciences has extensive professional knowledge in analyzing a broad range of excipients no matter derived from natural sources, synthesized chemically, or semisynthetic chemistry. BOC Sciences will provide you with a full range of analysis reports related to how the tested excipients impact the stability, binding properties, compaction, compression, and other properties of the active ingredients. Additionally, our team of highly trained experts work collaboratively with you to find out the most cost-effective and fundamentally appropriate excipients for supporting your formulation development.

References

  1. Katdare, A., & Chaubal, M. (Eds.). (2006). Excipient development for pharmaceutical, biotechnology, and drug delivery systems. CRC Press.
  2. Baldrick, P. (2000). Pharmaceutical excipient development: the need for preclinical guidance. Regulatory toxicology and pharmacology32(2), 210-218.
Quote Request
Verification code