Malvern has a wide range of characterization technologies that can be used to accelerate the drug development process. From tools that can run reliably and unattended, to systems that provide information on several key attributes in a single analysis, such as particle size, shape, and chemical identity or molecular weight, size and concentration.
Malvern's instruments are deployed across the pharmaceutical discovery, development and manufacturing enterprise. Work-flow efficiencies may be achieved when these tools are used in conjunction with each other.
Malvern is focused on providing well designed, innovative analytical instruments, which follow the QbD (Quality by Design) ethos, in all fields from drug discovery to pharmaceutical manufacturing.
We understand what is involved in the development and manufacture of a drug product and the requirements to measure the Critical Material Attributes and Critical Quality Attributes (CQAs) affecting the Critical Process Parameters (CPP) in the manufacturing process.
Drug discovery tools
High throughput screening of large libraries of chemical compounds is the dominant technique used in early stage drug discovery. Dynamic Light Scattering is the perfect tool. Being able to measure very small particle size at low concentrations.
Molecule Optimization with laser diffraction
In order to monitor efficacy of the suspension accurately, administering trial drug candidates in this form requires accurate, repeatable and validatable control of the active ingredient's particle size, often on limited sample volumes. Laser Diffraction is the best tool to meet these pre-formulation requirements. This technique provides particle size distribution of nano-scale material while also having a wide dynamic range.
Chemical Development for drug delivery
When characterizing bioavailability or bioequivalence of nasally administered drugs, in support of (New Drug Application) NDAs or (Abbreviated New Drug Application) ANDAs, for nasal aerosols and sprays, the United States Food and Drug Administration (FDA) recommends several tests. In cases where the active components are suspensions, one important attribute is the drug particle size distribution. A laser diffraction system fit for this purpose must be able to rapidly measure obscuration in addition to changes in droplet size distribution and span, in realtime over the life of a single actuation from the drug delivery device.
Formulation Development of drugs
The size of a liposomal vesicle plays a pivotal role in the pharmacokinetic and pharmacodynamics attributes of chemotherapeutic drugs, whereby the liposome acts as a carrier of the drug to the site of action and Dynamic Light Scattering can be a good technique. Triple-Detection Size Exclusion Chromatography (TD-SEC) can accurately characterize polymer excipient molecular size and weight and avoid incorrect determination. The conditions of a tablet coating process can be simulated using a rotational rheometer system. The viscosity of the liquid coating is measured initially under low stress conditions to quantify its full structure, then at high shear rates to simulate spraying, and again at low stress conditions to assess the viscosity rebuild with time.
Online particle analysis for drug manufacturing
Granulation can improve the ease of handling of powder blends and prevents the segregation of fine constituents, improving consistency in subsequent process steps, principally tableting. To improve the efficiency of the milling operation, and to deliver more consistent milled particle sizes, on-line particle-size analysis is a solution for continuous milling monitoring and control. In addition, measurements made by the on-line analyzer can control the process through a closed loop with the mill's programmable logic controller (PLC).
Founded in the late 1960s, Malvern Instruments understands that when a customer chooses to invest in a product, customer is making a serious financial commitment. We take this seriously, and strive to ensure that the customer is reminded with every interaction with us that they have made an excellent decision, and that they will receive exceptional and personalized support for the many years they will have our equipment.
Malvern Instruments Ltd.
Enigma business park
Malvern, Worcs. UK, WR14 1XZ
Tel: +44 (0)1684 892 456
Fax: +44 (0)1684 892 789