Pharmaceutical Solutions Brochure
16Pages

Micromeritics Predictive Materials Science Solutions for the Identification and systematic approach to development that begins Control of Critical Quality Attributes Quality by Design (QbD) is aand emphasizes product and process understanding with predefined objectives and process control, based on sound science and quality risk management. Achieving QbD requires an in-depth understanding of physicochemical properties that predict processability, in vivo, and in vitro performance. Early identification of Critical Quality Attributes (CQA) of excipients and active pharmaceutical ingredients...

Micromeritics Pharmaceutical Services- Material Sciences Contract Research Understanding physiochemical properties of drug substances, excipients and finished products is crucial. In today’s age of Process Analytical Technology (PAT) and Quality by Design (QbD), regulatory authorities look favorably upon drug developer partnerships with Contract Research Organizations (CROs) that have specific areas of expertise in material characterization. Backed by Micromeritics with 50 years of experience, Micromeritics Pharmaceutical Services can be trusted as your materials characterization solution...

Preformulations Preformulation is a multidisciplinary development of a drug candidate. Material characterization techniques play a key role in a QbD approach during preformulation activities by determining the physical and mechanical properties of APIs, excipients, and blends. This helps to ensure stability, bioavailability, and lot-to-lot consistency of materials while beginning to define your design space and overall control strategy. During this phase, research is directed to APIs and excipients, both as individual components and blends. Identification and evaluation through physical...

Micromeritics Material Science Solutions Material Characteristic Solubility, Bioavailability, Powder Flow, Compaction, Compression, Dissolution, Downstream Manufacturing Efficiencies Magnesium stearate as a lubricant in tablet production and its effective lubricity can be correlated to tablet ejection forces. Magnesium stearate batches with a smaller particle size distribution and larger surface area produces increased lubricity when compared with batches of larger particle size and smaller surface area. Bioavailability, Compaction, Powder Flow, Dissolution The principle used by Laser...

Formulations and Drug Delivery With physicochemical data derived from preformulation studies, the formulation scientist can leverage this information to assess initial compatibility of formulation components and begin activities surrounding process design. During this phase of the development, importance is placed on optimization of the formulation development of the final dosage form and process design. Also during this phase, consideration is given to factors affecting scale-up from bench top to pilot scale. In QbD, this phase is focused on providing a defined design space to meet FDA and...

Micromeritics Material Science Solutions Material Characteristic Bioavailability, Powder Flow, Compaction, Compression, Dissolution, Blend Uniformity, Protein Aggregation In a final crystallization step, particle size is a CQA (critical quality attribute) used to determine design space variables. Particle size distribution also has a direct impact on biologic material performance and processing. It can also be indicative of undesirable protein aggregation. Bioavailability, Compaction, Critical Element in Solid and Liquid Dispersion Processing Product morphology in addition to size has...

Process Design and Pilot Scale Up During this phase of development, emphasis is placed on evaluating options available to manufacture, purify, and characterize the final formulation by focusing on how Critical Quality Attributes (CQA) can impact Critical Process Parameters (CPP). Using the principles of QbD and experimental design, a design space with proven acceptable processing ranges is created that will produce a rugged, robust control strategy to meet established Quality Target Product Profiles and may allow for parametric (real-time) product release. Process Analytical Technology...

Micromeritics Material Science Solutions Example Material Characteristic Particle Size Powder Flow, Compaction, Compression, Blend Uniformity, Protein Aggregation. Fines Production API particles are of varying sizes and distribution and can potentially affect stability, solubility, and efficacy. PAT Compatible at line Bioavailability, Compaction, Critical Element in Solid and Liquid Dispersion Processing Product morphology in addition to size has a direct influence on solubility. Shape can be used as a PAT to define process end points and batch-to-batch variability. Fragmentation can...

Particle Size, Particle Shape, Zeta Potential The Particle Insight Dynamic Image / Particle Shape Analyzer is ideal for applications where the particle shape, not just the diameter, is critical information. For many years, particle size analyzers have rendered results with the assumption that all particles are spherical. However, not all particles are spherical. Particle shape information about raw materials enables manufacturers to control their process with a much higher level of sensitivity. • Three size range model options – 1 to 150 µm, 3 to 300 µm, and 10 to 800 µm • A camera with...

The NanoPlus Zeta Potential and Particle Size Analyzer is a unique instrument that utilizes photon correlation spectroscopy and electrophoretic light scattering techniques to determine particle size and zeta potential. The instrument is compact and easy to use with an extended analysis range, intuitive software, and multiple sample cells to fit the user’s application. • Measures particle size of samples suspended in liquids in the range of 0.1 nm to 12.3 µm with sample suspension concentrations from 0.00001% to 40% • Measures zeta potential of a sample suspension in the range of -500 mV to...