Manufacturing, Inhalation Drugs

Experts share best practices in designing, manufacturing, and scaling up dry powder inhaler and metered dose inhaler drug–device combination products for inhalation drug delivery.

When designing and manufacturing a pMDI or DPI combination drug-delivery device, the commercial stage should be kept in mind from the beginning of development.

FDA granted orphan drug designation for imatinib in AER-901 for the treatment of patients with pulmonary arterial hypertension.

The choice of delivery platform for inhaled drug products is contingent on API-related factors, as well as the development stage of the product.

Particle performance in a DPI can be optimized by fine-tuning the formulation and manufacturing process parameters.

Vectura will provide preclinical development services for Incannex’s inhaled drug product for the treatment of traumatic brain injury.

The expansion plans to increase Vectura’s DPI dosage form development, specifically its unit dose and multi-dose inhalers, and integrated device design and manufacturing for customer programs.

Creating an inhaled formulation is one way in which improved efficacy or added value can be achieved in projects to repurpose or reposition existing drugs.

The Ventofor Combi Fix will be brought into the Turkish market via Bilim’s development program, while the PowdAir Plus DPI is manufactured and commercialized by H&T Presspart under a patent license from Hovione.

Perrigo will be producing a limited amount of the generic inhaler medication but will accelerate production to meet future demands in collaboration with Catalent.

West Pharmaceutical Services will be showcasing various new pharmaceutical containment and closure offerings at Pharmapack from Feb. 5–6 in Paris, France.

Hovione Technology worked with Harro Höfliger on powder filling of blisters for the reusable Papillon DPI.

A simple, one-part DPI aims to make inhalation drug treatment more accessible and affordable.

Recipharm Inhalation Solutions is an integrated service for inhalation products.

The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates in inhaled drug products.

Particle engineering using jet milling or spray drying can be used to obtain appropriate particle characteristics for inhalation drug products.

Puncture and aerosolization tests measure the effectiveness of hard-shell capsules used in dry powder inhalers (DPIs) for inhaled drug products.

The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates.

A single-use DPI from Perlen Packaging, which offers lower-cost production and a more affordable device for emerging markets, won a 2017 CPhI Pharma Award.

Considerations in selecting a dosage form for drug delivery to the lungs.

Pulmonary drug delivery is becoming increasingly used. When developing pulmonary drugs, pharmaceutical chemists must consider drug absorption, control of particle size, suitable toxicology models, and patient compliance. The author reviews the issues specific to developing drugs designed for pulmonary delivery and considers how-with the right knowledge and expertise-these challenges can be overcome.

Successful development requires coordinating and aligning drug and device design, focusing on a complete drug delivery system that meets patients’ needs.

Follow guidelines for E&L studies of an orally inhaled and nasal drug product formulation in its delivery device.

The Intelligent Control Inhaler is an intuitive, fully-integrated device delivering accurate doses of medication to patients, while providing on-screen instructions for use and feedback to the patient and healthcare provider via an app.

Understanding the components of a reference marketed pMDI is needed to develop a generic pMDI.

Successful drug delivery via a dry powder inhaler is determined by the API physicochemical properties, the formulation composition and process, the device and operating conditions, the patient–device relationship, the environmental variables, and ultimately, patient compliance.

Advances in engineered particles and the subsequent reduction in the API mass required to achieve a therapeutic dose can lead to a reduction in side effects.

The role of add-on devices and how they affect drug delivery with a pressurized metered dose inhaler.

Experts discuss factors affecting drug delivery to the lungs and key considerations when developing inhalation formulations.

Products enable testing in accordance with methods described in new USP monograph.