inhalation

The introduction of new routes of delivery combined with increasing research and development efforts, a competitive landscape, and a larger market for therapy, have resulted in many new market opportunities for drug delivery devices. In this precise case, advances in drug formulation and inhalation device design, are creating new opportunities for inhaled drug delivery as an alternative to oral and parental delivery methods.

The global market for asthma and chronic obstructive pulmonary disease (COPD) prescription drugs was valued at $34.9 billion in 2011. This figure is projected to reach $38 billion in 2012 and $47.1 billion in 2017, increasing at a fiveyear compound annual growth rate (CAGR) of 4.4%. (BCC  Research)

A growing focus on pediatric and geriatric markets around the world has forced pharmaceutical companies to develop more convenient drug formulations, thereby enhancing overall compliance.

Much of the interest in pulmonary delivery of systemic drug therapies is focused on chronic diseases and refractory conditions. Pulmonary delivery of drugs for the treatment of respiratory diseases stems from the fact that topical drug deposition to the infected lung gives a fast therapeutic effect and reduces side effects associated with key drugs.

Respiratory conditions such as asthma, chronic obstructive pulmonary, and emphysema disease are classical therapeutic areas of the pulmonary sector. However, recent technological advancements have applied the application of pulmonary delivery devices to the treatment of nonrespiratory conditions.

The inhalation systems market, comprising DPIs and MDIs, is forecast to grow by up to two digit percentage per year until 2016, especially in volumes. Key factors are driving growth, such as the increasing incidence of pulmonary diseases or an increasing awareness of the inherent benefits offered by the pulmonary route for systemic drug delivery.

DPI’s represent the most rapidly expanding field in pulmonary drug delivery as a result of perceived limitations in pMDI’s and nebulizers following advantages in their design and performance, including being very portable, patient friendly with ease of use and not requiring spacers.

BeyonDevices knows that the inhalation device is an important factor in achieving adequate delivery of inhaled products to the lungs, therefore a number of characteristics are important for device reliability, clinical efficacy and patient acceptance. With this in mind BeyonDevices devised a DPI platform with a focus on ease of use, flexible, inexpensive production and portability while considering an environment where the drug can maintain its stability and producing reproducible dose dosing.

By choosing a capsule format DPI, BeyonDevices efficiently addressed the issues concerning storage stability and protection against external agents, while ensuring consistency in dose delivery throughout the life of the inhaler. This also means that the powder formulation can change since it’s packed inside the capsule, without the need for any major change in the basic design of the DPI. For the pharmaceutical manufacturer this translates in rapid development ideal for combination products, simple and standard manufacturing process, cost-effective solutions and a process that is environmentally sustainable.

velocity magnitude

Contour of velocity magnitude inside BeyonDevices DPI.

A capsule based Dry Powder Inhaler (DPI) is a breath-actuated device that is triggered by the patient’s inspiratory fow to dispense a dry powder formulation and deliver the fne particle drug fraction to the lungs. Defnition of DPI geometry is critical in the development of effcient delivery devices. Assessment and optimization of the geometry has traditionally used empirical approaches however, simulation technologies are required to streamline the development as well as to gain substantial product understanding serving internal and external customers within their product development activities.

BeyonDevices’ objectives of using CFD includes computing the velocity field and pressure distribution inside the inhaler, evaluating the impact of the inlet shape in inhaler performance and assessing model performance as a function of different parameters regarding subsequent studies.