Dry-Powder Inhalation Capsule Portfolio
Capsugel® Zephyr™ is Lonza’s customizable dry-powder inhalation capsule portfolio that is optimized to provide superior performance and compatibility between the capsule/device and capsule/formulation.
Our dry-powder inhalation capsule portfolio offers:
Lonza partners with its customers to closely match specific requirements and leverages a wide range of customization services for its DPI capsule portfolio. To ensure optimal performance for the required device, Lonza:
Given patient convenience and compatibility with a range of formulations and doses, capsule-based dry-powder inhalation (DPI) technology is becoming the specialists preferred DPI drug delivery platform for respiratory and systemic applications.
OVER 3+ BILLION DPI DOSES DELIVERED WORLDWIDE
At Lonza, we provide expertise in spray dry processing and jet-milling for optimized particle engineering – which is crucial to successful respiratory product design. Lonza has facilities that are recognized for spray-dried dispersion technology and particle engineering with fast-track programs for new chemical entities. From common to very complex inhalation development, our scientists can select a lactose-free, spray-dried dispersion-based approach based on the API characteristics and target product profile – from large to small molecules.
The Capsugel® brand offers more than 20 years experience and billions of capsules delivered for inhaled drug delivery systems. The Capsugel® portfolio of DPI capsules is well known for its world-class quality that helps ensure dose uniformity and reproducibility, as well as high-performance machinability.
We have developed customized capsule solutions for a number of drugs that have become the gold standard in the treatment of major respiratory diseases. Global supply chain, security of supply and technical and regulatory support accompany every capsule sold. Customized DPI capsules and encapsulation are core competencies, with dedicated equipment in place for efficient, phase-appropriate capsule filling.
Step 1: Product Target Profile |
Project synopsis: Reference product, targeted market, regulatory route |
Targeted patients: Characteristics and needs |
Device selections supports characterization |
Step 2: Setting DPI Capsule Specifications |
Active principle ingredient (API) profiling: Formulation approach discussion |
Support to QbD approach: On critical capsule parameters |
Rapid supply of R&D capsule quantities: For preliminary test |
Step 3: Support throughout validation and dossier filling |
Capsule branding: Color matching, custom color and print development |
Rapid supply of customized DPI capsules : For validation / clinical batches |
QA & regulatory support: Required statements for dossier filling, support on questions from agencies |
Water Activity Testing |
Device Compatibility Testing |
Powder Retention with Standard Lactose Blend |
Impact of storage condition on performance |