Over-Encapsulation: Techniques And Challenges Of Blinding Clinical Trial Material

Over-encapsulation is the most widely used method of blinding supplies in clinical studies, which are larger, more complex, and spread through more countries than ever before. This article reviews techniques for successful over-encapsulation and suggests solutions to common problems.

Methods of blinding the dosage forms used in CTMs range from deprinting or debossing the comparator or manufacturing an identical placebo to milling the tablets and filling them into capsules. But over-encapsulation is the most common approach. Over-encapsulation places the product or products(e.g.,tablets, caplets, capsules) into an opaque capsule that prevents investigators and subjects from identifying which capsules hold the active medication and which hold the placebo or comparator product. The method removes bias and allows you to perform comparator studies without manufacturing matching placebo samples.