Apart from active ingredients, inactive excipients play a significant role in formulation development of pharmaceuticals. Pharmaceutical excipients are substances other than the pharmacologically active drug or prodrug, which are included in the manufacturing process or are contained in a finished pharmaceutical product dosage form. Although technically “inactive” from a therapeutic perspective, pharmaceutical excipients are critical and essential components of a modern drug product. In many products, excipients make up the bulk of the total dosage form.
Some excipients are used to keep the drug from being released too early in the assimilation process in places where it could damage tender tissue and create gastric irritation or upset the stomach. Other excipients can disintegrate quickly in aqueous/physiological medium releasing incorporated active pharmaceutical ingredients within seconds, and are used to protect the product’s stability so it will be at maximum effectiveness at the time of use. Excipients are also used to improve the product’s taste or look, which enhances patient compliance, especially in children.
The goal of this study was to demonstrate the importance of GPC in the analysis of commercially available pharmaceutical excipient materials. Herein, 7 pharmaceutical excipient polymers, namely Chitosan, hypromellose, polyacrylic acid, alginic acid, polycaprolactone, polyvinylpyrrolidone, and xanthan gum were analyzed by standardized Gel Permeation Chromatography (GPC), an analytical service offered at Jordi Labs.