No. Capsugel® Zephyr™ customized capsules, in both gelatin and hypromellose, are optimized to provide superior performance and compatibility between the capsule/device and capsule/formulation.The ability to customize a capsule, including the selection of the capsule polymer, has been an important element of successful product development for DPI.
The filling of the DPI capsule is done by automated equipment with a very accurate scale. As a typical inhalation formula is less than 40mg of powder, it is critical to obtain consistency in capsule weight to avoid variations in active drugs doses.
From a patient perspective, inhaling less than the required dose (usually 40mg) can be a concern. Patients, very often, double-check the DPI capsule to visually verify that they inhaled the entire contents of the capsule. Consequently, a transparent capsule plays an important role in patient compliance.
From a patient perspective, capsule-based DPI systems have several advantages such as portability, ease-of-use and, more importantly, patients can confirm that they have successfully taken their medicine by checking that the capsule is empty. Moreover, a capsule-based system is a simple, cost-effective and environmental-friendly solution.
There are two main differences between DPI capsules and standard capsules: microbial levels and lubricant levels. In order to avoid any risk of bacterial contamination during inhalation, the European pharmacopeia and the FDA require DPI suppliers to be compliant with a low level of microbes (EP 5.1.4 on microbiological requirements). Also, a lower level of lubricant is and keep a consistent level of applied residual powder in the DPI capsule (Lubricant <500 ppm).
With regard to the capsules, the critical parameters impacting the powder retention, and, thereby, dose emission, are the moisture level and the lubricant content. Our expertise with DPI capsules ensures the powder retention in our capsule remains consistent, resulting in a stable emitted dose over time.
With over 20 years’ experience and billions of capsules delivered for inhaled drug delivery systems, Capsugel® is well known for its world-class quality that helps ensure dose uniformity and reproducibility, as well as high performance machinability. Capsugel® partners with its customers to closely match specific requirements, and leverages a wide range of customization services for its DPI capsule portfolio: polymer options, moisture content, lubrication level, weight variation and puncturing improvement.
Capsugel® Zephyr™ DPI capsules have documented puncturing performance with major marketed devices such as Handihaler®, RPC Capsuhale® and RS01®, Twister®, Rotahaler®. We assist our customers in their choice of capsules to ensure that, when combined with a device, they provide optimum product performance.