Repurposing Drugs for Inhaled or Intranasal Delivery Routes

Drug repurposing for inhaled or intranasal administration presents significant advantages for patients through improved speed and precision of treatment whilst offering an effective and rapid strategy for developing a new product whilst extending the intellectual property or taking advantage of an existing product’s generic status.

Orally inhaled or nasal drug products (OINDPs) can include those that have a local target such as hay fever treatments but can also be systemically targeted such as those to treat migraines or Parkinson’s disease. Administering via this route offers significant benefits over injected dosage forms, for example, with optimised delivery to lungs, a more rapid therapeutic effect can potentially be achieved.

Recently an increased interest in the delivery of vaccines and biologics by OINDP routes has driven innovation in this area. Respiratory vaccination is already present in the market with the nasal flu vaccine a popular option for vaccination programmes, and the covid-19 response has obviously increased focus in this area. Intranasal delivery, for example, provides significant advantages for product stability and needle-free, wide-scale distribution and administration, as well as potential pharmacological benefits in promoting a local mucosal response alongside a traditional systemic response by overcoming the challenges of first past metabolism.

One of the biggest challenges for drug repurposing projects is that many candidates may not yet be in a format suitable for delivery to the lungs. When designing new therapeutic candidates, it is important to evaluate the suitability of the formulation for the delivery platform and suitability for delivery to the target. The challenge of delivering biologics, for example, brings the significant development hurdles of formulation, device selection and analytical testing. Continual industry development opens up significant opportunities to deliver cost and time efficient programmes for the repurposing of existing drugs to greatly improve treatment options across a wide range of indications.

Strategic Drug Repurposing for Accelerated Development
Our expert team has worked on over 200 projects focused on repurposing of existing drug products for inhaled or intranasal delivery and based on this experience, we guide the specialist requirements for inhaled drug development from drug characterisation, formulation development, stability studies, and associated analytical support to support your internal resources where internal capacity is limited. Our GMP compliant facility is located in Melbourn, near Cambridge, UK, which is the largest GMP facility in Europe for OINDP development support.

Optimising Device and Formulation
Consideration of the combination of the drug and delivery system (e.g. pMDI, dry powder, nebuliser, nasal spray) is important. Our team effectively stewards the development process to ensure that the formulation and delivery system is optimised for delivery to the lung or nasal cavity while balancing the constraints posed by the drug characteristics, the need for a rapid response to the present critical need, and the longer-term viability of the marketed product.

With a track record of successful inhaled development programmes for both novel and generic products, we can draw on this experience to identify technologies and processes most likely to be appropriate for each drug, with its unique physical, chemical, biological, and pharmacological characteristics. This allows us to build and deploy tailored approaches for the particle engineering, formulation composition, manufacturing process, and analytical methodology to maximise success and maintain relevance and scalability from pre-clinical through to commercial release. We work across many modalities including small molecules, viral vector products, oligonucleotides, mRNA, recombinant and natural proteins, lipid nanoparticles or liposome-encapsulated products and so whatever your modality, we have the expertise ready to assist you.

With specialist capabilities in development support for inhaled biologics, our scientists deploy strategic programmes of orthogonal analytical methods which aim to fully characterise the biologic entity and to establish whether the device delivery mechanism (e.g. actuation through an inhaler) has adversely affected parameters including structure, purity (aggregation, degradation, etc) and the activity of the biologic drug in line with the ICH Q6B Guidance.

Leading OINDP Development Expertise
With over 30 years of experience in supporting our clients’ product development, we provide expert OINDP formulation development, drug repurposing expertise, product performance testing, in vitro bioequivalence studies, stability, CMC support for NDAs/ANDAs and clinical manufacturing services. Our OINDP development team provides method development and validation, inhalation product analysis, in vitro bioequivalence studies, comparator studies, device/excipient compatibility studies, ICH Stability Studies, Quality by Design (QbD), formulation development, clinical trials materials manufacturing and product characterisation studies.

Our Global Laboratory Network
Our global network of laboratories offers a comprehensive range of GMP analytical services to support product development and CMC activities including extractables and leachables, stability studies, elemental impurity analysis, and more. We can offer a range of flexible contracts that can help meet your needs when your existing testing capacity is stretched. Bringing quality and safety to life, we offer Total Quality Assurance expertise, helping you to navigate the challenges of development, regulatory submission, and production.