Particle Engineering

Micronization and Nano-milling

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ASD via Hot Melt and Spray Drying

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Avoid a Tech Transfer

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We provide phase appropriate particle-engineering services
A customized and fit-for-purpose particle engineering service as part of our integrated drug substance and drug product offering. You can access:

  • Spray dryers
  • Hot-melt extrusion
  • Melt-spray congealing
  • Phase-appropriate particle size reduction processing

Each offering is in place to help advance your compound from concept to clinical and commercialization.

Particle size reduction to precise particle size distribution is in place for API milling across pin mill, hammer mill, jet mill and nano-mill processing at our NY sites,

Our particle engineering services using spray drying, hot-melt extrusion, or melt-spray-congealing are located at our Bend (US) site.

No more large pills or dosing uncertainties. Create compact, easy-to-swallow softgels delivering optimal drug protection and release without compromising on drug efficacy. 

By replacing outdated rotary die methods with advanced droplet-based flow, we craft spherical capsules ranging from 1 to 7mm—compact powerhouses yielding exceptional results.

Renejix Microgels stands out for their adaptability. By using top-tier shell excipients, our solution suits various fill formulations, tailored to the demands of diverse therapeutic compounds.

RENEJIX BENEFITS​

  • Improved Patient Experience: Seamless delivery helps patients struggling with swallowing, like pediatrics, geriatrics, and oncology cases. Embrace enhanced compliance and adherence, leaving behind administration struggles.
  • Effortless Dose Titration: Our sachets contain capsules for easy, uniform administration. Each holds an equivalent therapeutic dose, simplifying adjustments from the same production batch.
  • Optimal Dose Uniformity: Our technology ensures consistent dosing, minimizing variation across patients for potent compounds.
  • Exceptional Performance: Expect faster action, lower API doses, reduced side effects, and enhanced overall treatment performance.

Our technology limits abuse of the dose form by incorporating multistage levels of deterrence technology, preventing the manipulation of the product into an inhalable or injectable form, and rendering the recovered product unusable for further manipulation. In addition, the softgel dose form cannot be ground, blended, or crushed to create powder or microparticle form. Our lock technology therefore offers effective deterrence, preventing many common methods of abuse.

RENEJIX BENEFITS

  • Accessible technology enabling an effective and innovative abuse resistant product.
  • Multi-level abuse prevention technology incorporated into each capsule.
  • Product is a patient/consumer preferred Softgel dose form.
  • Rapid commercialization with Renejix’s development and manufacturing expertise.

Renejix has developed specific testing capabilities in the area of abuse-deterrent formulations per the recent regulatory guidelines. Specific assessment of abuse-deterrent formulations includes the following:

  • Hands-on experience with multiple therapeutic classes and extended/immediate release formulations
  • Physical manipulation studies including crushing and grinding techniques
  • Extraction/Solubility assessments
  • Specialized assessments of vaporization and syringeability/injectability
  • Comparison to marketed products
  • Initial assessment phase followed by protocol experiments
  • Studies conform to current regulatory guidelines
  • Documentation of results in final reports containing photographs and video

Small Molecules Particle Engineering Services

Solid Dispersion Technology

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Hot Melt Extrusion

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Bioavailability Enhancement

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Spray Dry Dispersion Technology

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Micronization and Jet Milling

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