Success of a wet granulation process depends on selection of appropriate excipients and choice of suitable process parameters which lead to excellent binding and compaction properties and flow.

This bulletin presents how standard crystallized mannitol in β-polymorphic form often lacks sufficient binding and tableting properties for use with wet granulation

Powder granulation is commonly used in the pharmaceutical industry to improve flowability and compactibility of powders. In this case our customer wanted to develop a new directcompression grade of excipient produced by granulation.

This bulletin presents the methodology of MEDELPHARM Science Lab to study the effects of granulation critical process parameters on product quality attributes.

In the early stages of drug development, APIs are often available in limited amount. However, scientists have to foresee the impact of compaction parameters on tablet attributes. In fact, tablet quality such as its hardness depends on several process parameters including the compression speed, pressure and profile used.

Compaction simulators, such as the STYL’One Nano, can easily explore compression dynamics and allow researchers to deeply understand their powder with only few grams of material. This avant-garde technology is key for fundamental material characterization and deep understanding of their product.

The goal of this bulletin is to dive into the V-shape compression cycle available on STYL’One Nano and to demonstrate its usefulness in powder characterization with real speed sensitivity practical examples.

During the development of a new drug, active materials are often available in small quantities for cost or process reasons. However, scientists have to understand their deformation behavior to design the best formulation possible and find suitable process parameters for production.

Compaction simulators, such as the STYL’One Nano, can easily explore compression dynamics and allow researchers to deeply understand their powder with only few grams of material. This premium technology is key for fundamental material characterization and deep understanding of your powder.

The goal of this bulletin is to dive into the Extended Dwell Time cycle available on STYL’One Nano and to demonstrate its usefulness in powder characterization with real practical examples.

Formulation development and technical transfer from lab to production can be challenging and requires a deep knowledge of your formulation.

The integrated and intuitive data analysis features drive formulators and scientists in their decision-making process with build-in graphs and reports to develop robust and scalable formulations. Knowledge management based on data leads to avoid tablet defects in production and guarantee high production output. This can be undertaken right from the development stage thanks to STYL’One compaction simulators.

Binders play a crucial role to ensure acceptable tablet hardness and low friability in direct compression and dry granulation processes. Among all dry binders, low molecular weight hydroxypropyl cellulose (HPC) is the most effective due to its outstanding plasticity. In addition to plasticity and molecular weight, the particle size of the binder can have a considerable effect on its binding capacity. Finer particles may fill the interstitial voids between large particles of the blend, and may exhibit increased toughness and therefore, result in harder tablets. The objective of this study was to evaluate the effect of different types and grades of plastic polymeric binders including HPC and microcrystalline cellulose (MCC) on tablet strength in direct compression and dry granulation processes.

Excipients, APIs or formulations can be processed in different ways, thus resulting in different properties. Research has been performed to improve powder properties including powder flow, powder density, particle size distribution and particle shape.

In the case of tableting, these improvements are crucial to guarantee optimal tablet properties, production yield and high production output. 

This case study illustrates how STYL’One Nano can be an efficient tool for scientists to demonstrate material properties, securing their formulation development and their product marketing.

The following data shows a comparison between conventional lubricants (stearic acid / magnesium stearate) and natural based lubricants (rice extract) or excipient premixes (cellulose/rice extract/oil/wax). By working with natural ingredients it would be possible to label your product cleaner than other chemical-sounding words.

The natural lubricant which was used for trials is a vegetable rice extract from RIBUS, a manufacturer of specialty ingredients. Nu-RICE® is a patented hypoallergenic extract from rice bran. This natural processing aid helps hydrate, lubricate and emulsify ingredients to create easier and faster processing.

This bulletin explains why you might experience differences between your target force and output force on your STYL’One Evo.

It also presents solutions to improve your system response and be as close as possible to your target force

This case study was presented by SKYEPHARMA during CSF Cambridge 2018 to highlight the development of multilayer and tab-in-tab dosage forms on STYL’One Evo while saving time and cost during the development phase.

Controlled release forms are more complex to design but very interesting to deliver a sustained API dose or a delayed pulse of API to the patient.