Orally inhaled and nasal drug product (OINDP) formulation
Physicochemical analysis of nasal sprays, nebulizers, dry powder inhalers and metered dose inhalers
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.
Accelerating the Development of Orally Inhaled and Nasal Drug Products (OINDPs)
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Watch nowFormulation 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
OMNISEC
Characterize polymer excipients to find the right formulation conditions for your drug products
Mastersizer 3000
Monitor the particle size and particle size distribution of API and excipients to ensure they meed formulation requirements
Morphologi 4-ID
Understand particle shape and particle size changes to excipients and API, and investigate the chemical composition of different particle populations in your sample to monitor how API and excipients interact.
Analyzing API stability across formulation and process development
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).
Featured Content
Automatic condensation-free combined temperature-humidity control for XRD studies
Application note
Focus on Pharma - XRD Masterclass 2: In situ Stability Studies
Recorded webinar
Crystallite size determination of a pharmaceutical compound by Rietveld analysis
Application note
Crystallinity determination - Quantification of low amounts of amorphous material in a crystalline matrix and vice versa
Application note
Focus on Pharma - Solid Form Analysis: Targeting your Methods
Recorded webinar
The influence of electrostatic stabilisation in apolar suspension formulations.
Application note
Focus on Pharma: Particle Sizing – Advance your Analysis
Recorded Webinar
Featured products
Aeris
Powering the next generation of XRD research
Empyrean range
Multipurpose X-ray diffractometers for your analytical needs
Epsilon 1 Pharma
Pharmaceutical catalyst analysis at the push of a button
Epsilon 4
Fast and accurate at-line elemental analysis
Mastersizer 3000
Delivering the data you need for outcomes you can trust
Morphologi 4-ID
Rapid, automated, component-specific particle characterization in a single,...
Zetasizer Pro
High performance, versatile and robust
Zetasizer Ultra
World’s most advanced light scattering system
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.
Featured Content
Component specific particle sizing in orally inhaled and nasal drug products (OINDPs)
Recorded webinar
Supporting dry powder inhaler formulation development using component-specific particle characterization
Application note
In vitro bioequivalence studies for a metered dose inhaler formulation using the Morphologi automated particle imaging system
Application note
Rapid Generic Pharmaceutical Product Development
Recorded webinar
Achieving Bioequivalence in Generic Formulations by Characterizing Particle Size, Shape & Chemical Identity
Recorded webinar
Featured solutions
Mastersizer 3000
Delivering the data you need for outcomes you can trust
Spraytec
Spray particle and spray droplet size measurement
Morphologi 4-ID
Rapid, automated, component-specific particle characterization in a single,...
Empyrean range
Multipurpose X-ray diffractometers for your analytical needs
Aeris
Powering the next generation of XRD research
Zetasizer Pro
High performance, versatile and robust
Zetasizer Ultra
World’s most advanced light scattering system
OMNISEC
The world’s most advanced multi-detector GPC/SEC system
Optimizing device and formulation performance
Featured Content
Inhaler and nebuliser characterization
Recorded webinar
Laser diffraction and imaging - complementary techniques for nasal spray development
Recorded webinar
Consistency of Delivery is Key in Nasal Spray Treatments
Article
Enhancing the in vitro assessment of nasal sprays
Article
