By MEDELPHARM S.A.S
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MEDELPHARM: The science of characterizing powders and tablets
As international specialists in innovative technologies and services for powder processing, MEDELPHARM is dedicated to helping its customers get the very most from their powders for tableting, through expert materials characterization.
MEDELPHARM delivers this on two levels: through the simulation and data collection capabilities of its research focused STYL’One compaction simulator and Analis software, backed by a suite of expert materials characterization services, delivered by the MEDELPHARM Science Lab.
Types of characterization
Effective formulation for tableting requires two types of capability that together form the definition of characterization:
- Powder characterization: Quantifying the properties of the powders to be used (including APIs and excipients) for true density, flowability and particle size distribution, their behaviors under compaction (measured to USP<1062> US Pharmacopeia guidelines), early development assessment: optimization of compression forces, speed, lubrication and tooling choices, suitability for full scale-up and troubleshooting issues like sticking, capping, lamination, and hardness loss.
- Tablet characterization: Assessing the properties of the prototype tablet, including appearance, tablet defects, weight consistency, physical dimensions, hardness (breaking force), friability, disintegration, dissolution and content uniformity. These tests must quantify variables according to European Pharmacopoeia guidelines, including Uniformity of mass (Ph.Eur. 2.9.5), Disintegration (Ph.Eur. 2.9.1), and Friability (Ph.Eur. 2.9.7).
Characterization and Formulation Services
Alongside its instruments and distribution services, MEDELPHARM offers the capabilities of its Science Lab: a team of scientists fully dedicated to support customer R&D In solid dosage forms that now supports more than 100 companies in various industries, including pharmaceuticals, veterinary medicines, cosmetics, chemistry, and detergents.
The laboratory benefits from a team of experienced formulators and compaction specialists, backed by a suite of the most advanced research technology. The laboratory capabilities extend from early API characterization, through formulation development, all the way to production optimization and troubleshooting. In addition, its Science Lab can also produce marketing samples and prototypes for complex oral solid dosage forms like minitablets, multilayer or tab-in-tab.
The Science Lab capabilities include powder characterization, tablet characterization, formulation screening, roller compaction feasibility studies, rotary press simulation (scale-up support), particle size and particle shape measurement, milling and flowability tests. With the dry granulation module, it also has the ability to target specific solid fractions and determine key process parameters.
MEDELPHARM’s powder characterization scientists use relevant powder flow and image analysis methodology from Granutools (assessing angles of repose, Carr Index and tap density) and QICPIC (assessing particle morphology and size).
This expert support can help to overcome product development and production challenges.
Characterization on STYL’One tableting instruments
Powder characterization and tablet development can also be performed on MEDELPHARM compaction simulators that are equipped with data analytical features, empowered by highly capable software, such as Alix® or Analis®, which enables the STYL’One Nano and STYL’One Evo laboratory R&D presses to become complete research environments that can characterize powders.
These ‘smart’ tablet presses can measure accurate force and displacement and determine parameters such as compressibility, compactibility, tabletability, solid fraction, elastic recovery, ejection force and stress, compression energies, radial die wall pressure and detachment stress. Tests performed at the development stage allow researchers to generate full characterization and datasets from small powder samples in just a few moments.
Pharmaceutical Powder Characterization
Accurate characterization of powders is vital to the tablet manufacturing process in seeking to predict how the powders that comprise active ingredients and excipients will behave and respond to direct compression.
The challenge in development is to refine and adjust formulations to ensure process control and optimized tablet characteristics, particularly for hardness, friability, disintegration and dissolution.
Variability in excipients or APIs could be a main challenge and affect processing, blending, tableting output. Characterizing variabilities of material in particle size or shape, compression and flow behavior is critical to ensure a robust process.
Characterization and Formulation knowledge sharing
The MySTYL’One networking and knowledge sharing community (see Resources) provides a real bonus for all users of STYL’One, STYLCAM, Alix and Analis software platforms in the form of dedicated access to a wide powder characterization research community including academics, industrial experts and researchers who as specialized in different types of characterization.
Through MEDELPHARM’s links with universities, MySTYL’One also includes many posters and publications on various subjects, including materials characterization.
Click on MEDELPHARM high-precision tableting instruments and powder characterization for further information.
Click on MEDELPHARM Science Lab to learn more about the lab’s work and characterization resources.