CLINICAL TRIALS
Double-blinding Capsules for Clinical Trials
How over-encapsulation can help tackle bias? During the preparation of clinical studies, the method for visually blinding dosage forms is a vital consideration. While many blinding options are available to sponsors, overencapsulation remains the most popular for many reasons, including better accessibility, efficacy, ease, shorter development time and cost. However, over-encapsulation involves a number of individual operations that can create a variety of complex situations if not managed effectively. From capsule colour and size selection to having a well-trained team dedicated to the manufacturing process, it is vital that companies take the time to make sure each part of the process is managed properly to curtail problems and provide an effective blind in the study.. Steve Rode, Manager Business Development, Capsules and Health Ingredients, Lonza Hideyasu Fujiwara, Business Development Manager, Lonza Capsules and Health Ingredients
C
apsules are tried, tested and trusted, but that is not to say that the method is simple or without innovation. Formulation considerations and patient-centricity have driven significant innovation by some businesses in the market. With the development of Hydroxypropyl Methylcellulose (HPMC) polymers, sponsors and manufacturers now have access to a capsule that is vegetarian and vegan-friendly and has a broader range of applications across different disease indications. Here, Stephen Rode, Manager Business Development in Lonza’s 38
P H A RM A F O C U S A S I A
ISSUE 40 - 2020
Capsules and Health Ingredients business division and Hideyasu Fujiwara, Ph.D., Business Development Manager, Lonza Capsules and Health Ingredients, Japan discusses the importance of capsule selection and process considerations for providing an effective blind as well as how HPMC-based capsules can further the use of capsules in clinical trials. Factors for effective blinding
Clinical studies are performed to evaluate the efficacy and safety of a trial drug in relation to a marketed comparator
product or a placebo. When blinding a drug product, the goal for investigators is relatively simple: to prevent patients’ ability to identify the blinded product.In a double-blinded trial, this goal is extended to include the trial staff. The design of the clinical study and characteristics of comparators, as well as advantages and disadvantages for each blinding approach, must be explored to determine the best blinding option. For clinical conditions in which exposure to the drug at the right time is a critical determinant of efficacy, and encapsulation is being used as a blinding
