To help pharmaceutical companies bring orally inhaled and nasal drug products (OINDPs) to market efficiently, scientific consultancy and contract research organisation (CRO), Broughton, has announced a new inhalation testing service.
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Inhaler for capsule and spray
The service builds on the company’s expertise in analytical testing and its in-depth understanding of aerosol and inhalation science while offering the added benefit to clients of working with a fully integrated testing, consulting, and compliance service provider.
The inhalation testing service is aimed at pharmaceutical companies, generic drug manufacturers looking to reformulate existing products for inhalation devices, and device manufacturers. It will focus on formulation and device testing for dry powder inhalers (DPIs), pressurised metered dose inhalers (pMDIs), soft mist inhalers (SMIs), nasal sprays, breath-actuated devices, and inhaled devices. The new inhalation testing service includes early-stage production characterisation and analysis, device selection and testing, small-scale manufacturing support, and manufacturing scale-up. Broughton has a fully integrated service with access to analytical method development and validation, on-site stability storage, extractables and leachables (E&L) testing, and toxicology support.
With their understanding of inhaled formulation systems and device compatibility, Broughton has a proven track record in aerosol science, inhaler development, the planning and execution of clinical programs, and successful regulatory filings. The company has now extended its operations to include technologies for pharmaceutical inhalation formulation testing and device verification.
“Inhaled medicines can deliver efficacy faster and at lower doses than other drug delivery routes and provide a huge opportunity to improve quality of life for respiratory disease sufferers,” said Chris Allen, CEO of Broughton. “As well as treating the hundreds of millions of people with asthma and COPD globally, there are new applications of inhaled medicines to explore. Interest in inhaled drugs has rocketed since the pandemic, and many pharmaceutical companies are developing novel products.
“Developing and commercialising a new inhaled drug product requires huge energy and deep scientific understanding, which is a level of resource and subject matter expertise that is difficult to maintain in-house,” continued Allen. “Working with Broughton is like having your own specialist respiratory scientific team. We can apply our technical knowledge of inhalation devices, aerosolisation, and formulation science, to give clients insight into how they can bring life-enhancing products to market efficiently and cost-effectively.”
The service covers formulation characterisation, pharmaceutical analysis and product characterisation, inhaled device evaluation, selection and testing, and chemistry, manufacturing and control (CMC).