Related Experiment Video
Updated: May 23, 2026

Solid Phase Synthesis of a Functionalized Bis-Peptide Using "Safety Catch" Methodology
Published on: May 15, 2012
Analytical characterization of an orally-delivered peptide pharmaceutical product
Wayne P Kelley1, Shujun Chen, Philip D Floyd
1Biopharmaceutical R&D, GlaxoSmithKline llc., King of Prussia, Pennsylvania 19406, United States.
Abstract:
The characterization of orally-delivered peptide pharmaceuticals presents several challenges to analytical methods in comparison to characterization of conventional small-molecule drugs. These challenges include the analysis and characterization of difficult-to-separate impurities, secondary structure, the amorphous solid-state form, and the integrity of enteric-coated drug delivery systems. This work presents the multidisciplinary analytical characterization of a parathyroid hormone (PTH) peptide active pharmaceutical ingredient (API) and an oral formulation of this API within enteric-coated sucrose spheres. The analysis of impurities and degradation products in API and formulated drug product was facilitated by the development of an ultrahigh-performance liquid chromatography (UHPLC) method for analysis by high-resolution mass spectrometry (MS). The use of UHPLC allowed for additional resolution needed to detect impurities and degradation products of interest. The secondary structure was probed using a combination of solution-state NMR, infrared, and circular dichroism spectroscopic methods. Solid-state NMR is used to detect amorphous API in a nondestructive manner directly within the coated sucrose sphere formulation. Fluorescence and Raman microscopy were used in conjunction with Raman mapping to show enteric coating integrity and observe the distribution of API beneath the enteric-coating on the sucrose spheres. The methods are combined in a multidisciplinary approach to characterize the quality of the enteric-coated peptide product.
More Related Videos
08:06Automated Acoustic Dispensing for the Serial Dilution of Peptide Agonists in Potency Determination Assays
Published on: November 10, 2016
12:02An Efficient Method for the Synthesis of Peptoids with Mixed Lysine-type/Arginine-type Monomers and Evaluation of Their Anti-leishmanial Activity
Published on: November 2, 2016
Related Concept Videos
Biopharmaceutical Factors Influencing Drug Product Design: Overview
Biopharmaceutics and Pharmacokinetics: Overview
Pharmaceutical Alternatives: Polymorphic Form-Related and Particle Size-Related Therapeutic Nonequivalence
Clinically Relevant Drug Product Specifications: Methods of Establishment
Factors Affecting Dissolution: Drug Permeability, Stability and Stereochemistry
Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules