Already used extensively for local activity, orally inhaled and nasal drug products (OINDPs) also show great promise for the effective systemic delivery of a variety of therapeutics. Patient acceptability, rapid absorption, gastro-intestinal tract avoidance, and the opportunity for product differentiation are just some of the driving factors.

When developing either inhalers or sprays, the development of formulation and device go hand-in-hand. Changes made for one will affect the other, and vice versa. As an example, the design and geometry of a spray nozzle affects the stress on the suspension and thereby the spray droplet distribution. Likewise, a change of excipient may affect the formulation viscosity and how efficiently it can be pumped through the spray nozzle – this is critical, as the droplet size distribution influences where the drug is deposited in the repsiratory tract and therefore also impacts its bioavailability and speed of action.

Malvern Panalytical’s physicochemical analysis solutions help you understand the impact of your formulation and process decisions on the final drug product, guiding you to success. 

Formulation excipient characterization & selection

When choosing your excipients, there are a number of considerations which may affect your formulation or even your final drug product. Excipients such as polymers are often used to modulate the viscosity of a suspension or solution. They can therefore often influence the ease of pumping or processing the suspension, and in nasal sprays or nebulizers can directly impact the spray droplet size distribution. The size distribution of drug carrier particles, such as lactose in dry powder inhalers, is critical for delivery of the drug to the lungs, and sometimes the shape of excipients and API particles can affect how they interact and flow during processing.     

Malvern Panalytical have several tools that are commonly used for the analysis of ingredients or raw materials from different suppliers and can also be applied to determine whether different batches are the same or show differences.  

Find out more about excipient characterization

Our solutions for excipient characterization and selection

Analyzing API stability across formulation and process development

API stability is critical for ensuring the delivery of a safe and efficacious dose of the drug, and there are many steps along the development and manufacturing route which can have an impact upon it. Amongst these are processing steps, where conditions could cause excipients to affect the API. Even storage of the final drug product before it reaches the patient could influence the API’s stability. As such, characterization of the API, together with potential formulation excipients, is critical for a good understanding of stability and how it might be affected by storage or processing stresses.

Accelerated degradation studies of API and excipients

X-ray powder diffraction provides a unique insight into changes in drug crystal form, crystallite size and morphology, as well as changes to the amorphous:crystalline ratios of API in the formulation during accelerated stress studies to assess or optimize formulation stability.  

Process development and process monitoring

Our physicochemical characterization tools are used to assess the stability of both APIs and excipients in a formulation, across processing conditions, to ensure that process parameters are controlled and optimized such that the final drug product meets the required Critical Quality Attributes (CQAs).  

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Comparability studies - to support process, formulation or material changes, and in vitro bioequivalence studies

In any process, changes may be needed.  Within the pharmaceutical industry, examples might include a change in the supplier of an excipient or API, a change of a piece of machinery, a move of a product between manufacturing sites, or a minor change in formulation composition. All of these changes must be controlled so that they don’t affect the final drug product. 

Malvern Panalytical’s physicochemical solutions are all regularly used to help with comparability assessment to check for changes in a product when there has been a change in the process used to create it. In addition, our technologies are also used to show in vitro bioequivalence between reference and test products when generics are being developed.  This testing can prove that the generic product and device combination delivers the same drug in the same manner as the innovator product, which can dramatically reduce the amount of clinical testing required and accelerate a generic pharmaceutical product’s route to market.

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Optimizing device and formulation performance

For all OINDPs, the spray droplet or particle size delivered by the device is a Critical Quality Attribute (CQA), directly influencing clinical efficacy. The correlation between spray size and in vivo deposition behavior makes spray particle size distribution measurement essential for all inhaled products during development, manufacture and QC. In addition, properties such as the API particle size within the dispersed aerosol also play an important role in defining the efficacy of drug delivery, as well as overall bioavailability.  This is critical for both innovator drug product development and generic drug product development, in preformulation studies to understand the reference drug characteristics, and especially for nasal sprays, to permit the use of in vitro bioequivalence studies.  Learn more about nasal spray, nebulizer, dry powder inhaler and metered dose inhaler drug-device characterization and optimization in the featured content.

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Expert solutions in orally inhaled and nasal drug product (oindp) formulation. Contact us to discuss your challenges.
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