We recognize the importance of our customers’ requirements to develop robust formulations to provide bioavailable and stable drug products. Our range of complementary analytical tools is designed to save you time and money in selecting and advancing the optimal dosage form.
Our goal is to assist our customers in providing a range of analytical techniques that can be applied to study a wide range of delivery mechanisms:
- Orally inhaled and nasal drug products (OINDPs) - nasal sprays, dry powder inhalers, metered dose inhalers, nebulizers
- Oral solid dosage formulations - capsules, tablets for immediate release or extended release
- Topical semi-solid formulations - creams, gels
- Sterile liquid dosage formulations - ophthalmic, oral
- Injectables - intravenous, intramuscular, subcutaneous injectables
- Liposomes for drug delivery
- Semi-solid formulations for oral administration - syrups, suspensions
Our unique advantage comes from our expertise in the interoperability of the complementary methods available for particle size, particle shape, surface charge, rheological and chemical identification measurements.
Using the Malvern Panalytical formulation development toolset helps you assess the bioavailability, processability, stability and content uniformity of your chosen lead candidate formulation.
Orally Inhaled and Nasal Drug Products
OINDP formulation and device optimization
Already well-established for locally-acting pharmaceuticals, orally inhaled and nasal drug products (OINDPs) show great promise for the effective delivery of a variety of systemically-acting therapeutics. Patient acceptability, rapid absorption, gastro-intestinal tract avoidance, and the opportunity for product differentiation are just some of the driving factors.
How can characterization improve the performance of OINDPs?
For all OINDPs, the spray droplet or particle size delivered by the device is a critical-to-quality attribute, 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, or the rheological properties of liquid and suspension formulations also play an important role in defining efficacy of drug delivery and overall bioavailability.
Malvern Panalytical’s solutions for OINDPs include:
- Spraytec, enabling an understanding of the dispersion and delivery of OINDP product formulations through spray droplet and particle size analysis
- Morphologi, providing the ability to predict and control bioavailability by measuring component specific particle size and shape distributions for APIs within nasal spray, nebuliser and inhaler formulations
- Kinexus, enabling an understanding of the stability and atomization of suspension and liquid formulations by measuring rheological behavior
Oral Solid Dose Formulations
Measuring the critical material attributes of the active pharmaceutical ingredients and excipients used in oral solid dosage forms
Development and commercialization of solid oral dose formulations such as tablets, capsules and powders is a costly and time-consuming process. Accessing tools that help speed up the workflow and support the definition of a product’s design space are critical for success.
Malvern Panalytical’s analytical tool kit enables the critical material attributes (CMAs) such as particle size, particle shape and polymorphic form to be measured quickly and accurately for both active pharmaceutical ingredients (APIs) and functional excipients, supporting the product development lifecycle from chemical and formulation development right through to production quality control and batch release testing.
Many X-ray analysis tools have earned their place in today’s pharmaceutical development laboratories, especially in the areas of pre-formulation and formulation of solids. The non-destructive character of the analyses allows researchers to perform a multitude of process steps on the same sample without destroying its original structure. Our versatile XRD and XRF systems cover several important X-ray solutions for the full characterization of API’s (including cocrystals) and excipients in the drug development stages.
Topical semi-solid dosage forms
Accelerating formulation development of topical formulations
Topical semi-solid dosage forms are normally presented in the form of creams, gels, ointments or pastes. In addition to API, they may also contain emulsifiers, viscosity-increasing agents, antioxidants or stabilizing agents, depending on the desired therapeutic effect and the site of action or administration.
Topical formulations present many challenges related to bioavailability and stability. Control of critical material attributes such as particle size and viscosity are important to ensure formulation’s target profile is achieved. Malvern Panalytical has an array of technologies to help characterize these attributes. For example, Malvern Panalytical’s Morphologi G3-ID can help bioequivalence characterization through unambiguous particle size distribution measurement of the API in complex topical formulation matrices.
Ophthalmic suspensions and emulsions
Measuring physicochemical properties of ophthalmic formulations
Ophthalmic preparations are sterile, liquid or semi-solid preparations intended for application to the conjunctiva, the conjunctival sac or the eye lid.
Malvern Panalytical provides a suite of laboratory and in-process tools to characterize and measure critical attributes like particle size distribution, surface charge, viscosity and dispersibility, which ensure achieving a product’s target quality profile.
Characterization of parenteral preparations for intravenous, subcutaneous, and intramuscular injection
Parenteral formulations are sterile, pyrogen-free liquids, emulsions, suspensions or solid dosage forms, packed in either single dose or multi-dose containers, intended for administration by injection, infusion or implantation into the body.
Malvern Panalytical provides a suite of analytical tools to characterize and measure critical attributes such as particle or droplet size, density, foreign particulate matter count, viscosity, polymer molecular weight distributions, polymer conformation in support of product development and quality control.
Liposomes and micelles
Characterization of the particle size, zeta potential and rheological properties of liposomes
Liposomes are artificially-prepared spherical vesicles composed of a lipid bilayer. They are used in a wide range of industries, including the biopharmaceutical and consumer product sectors. Recent applications for liposomes have focused on their suitability for use as drug delivery vehicles, due to their ability to incorporate water-soluble materials in their aqueous volume, or oil-soluble materials in their lipid bilayer.
Malvern Panalytical’s range of easy to use particle size, zeta potential and rheological instrumentation can be used in the study of liposomes across a wide range of industries. The market-leading Zetasizer, NanoSight and Archimedes systems, combined with our industry and application knowledge, can be used to:
- Characterize the particle size, charge and concentration of liposomes
- Help predict the fate of the liposomes in vivo
- Monitor the association of charged liposomes with oppositely-charged molecules
- Study the phase transition temperature of liposomes
- Understand the influence of pH and other dispersant conditions on liposome charge using the optional MPT-2 autotitrator accessory
- Study the encapsulation of liquid-liquid systems
- Through the application of fluorescence-labeling, the ability to measure size and concentration of liposomes in biologically-relevant fluids
Excipients and coatings
Characterization of the molecular, particulate and rheological properties of pharmaceutical excipients
The performance of a formulation may be engineered by manipulating the physical and chemical properties of excipients and coatings. Excipients help define the bioavailability, release profile and stability of a formulation.
Malvern Panalytical provides a suite of analytical tools to characterize critical material attributes such as excipient particle size and shape, polymer molecular weight distributions, polymer conformation and the rheological properties of coatings and binders. In addition to quality control assessments, these tools aid in the selection of appropriate excipients based on the product’s target performance profile.