Micro-dosed capsule filling and dry powder inhalation are key innovation topics at Aenova
Dry powder inhalation using a DPI device (dry powder inhaler) is becoming more and more important for patient care in view of the worldwide increase in lung and respiratory diseases. The need for therapeutics for bronchial asthma and COPD (chronic obstructive pulmonary disease), for example, is also rising worldwide. Many of the therapies need to be used by patients for life, which underscores the need to make DPI cost-effectively available and easy for patients to use.
The galenic formulation of the active ingredients is particularly challenging, as the inhalable aerosol particles must have an aerodynamic diameter of 1 to 5 µm over the entire shelf life of the product in order to ensure adequate pulmonary mobility. For this purpose, Aenova has a state-of-the-art DPI capsule production and proven expertise from development to commercial production.
With state-of-the-art micro-dosing technology, Aenova ensures full scalability for DPI capsule products (flexible batch sizes from 0.5 kg to commercial sizes). In addition, there are product-specific analysis options according to EP / USP as well as specific blistering and combination packaging solutions.
Together with the customer, Aenova creates a purposeful concept phase and a product design precisely tailored to the requirements - including analytical method development, ICH stability testing, development and validation of the manufacturing process to obtain a safe and stable effect of the drug product.
The modern high-speed capsule filling machine at the Aenova site in Münster is suitable for product dosing in the range of 5 mg to 50 mg per capsule and is equipped with 100% control, which enables in-process control of each individual capsule and ensures the highest quality of the final low-dose product. If required, additional modular dosing units can be integrated to combine also different dosage forms, e.g. pellets and powder, tablets and pellets and other variants.
"We are very proud to be able to offer such a comprehensive service from development to commercial production in the field of dry powder inhalation and micro-dosed capsule filling of highly potent active ingredients," says Dr. Gereon Rau, Team Lead - Capsule Technologies at Aenova. "Our innovative solutions and reliable production and delivery capabilities are of benefit to our customers in the pharmaceutical industry and, last but not least, to patients with respiratory diseases worldwide."