Particle Engineering Services
CritiTech uses both its Supercritical Precipitation and Spray Drying technologies to micronize its clients’ compounds. We are able to manipulate the technologies, under various conditions and with various solvents and solvent mixtures to attempt to achieve the client’s target particle size and distribution and work with clients to help develop potential formulations.
Stage 1 Compatibility Test (Supercritical Precipitation)
The client provides CritiTech with unprocessed drug to determine if it is compatible with our micronization process. This test can be performed in a minimal amount of time and at no cost. If compatible, we will move to a Proof of Concept Study.
Stage 2 Proof of Concept Study (Supercritical Precipitation and Spray Drying)
CritiTech will determine if its micronization process can reduce the particle size of the client’s drug. CritiTech will conduct multiple runs, adjusting the various operating parameters to achieve the desired result and will return both processed and unprocessed drug to the client for evaluation.
CritiTech can supply its clients with cGMP-grade API to support Phase I and II clinical trials. If the trials are successful, production will then be scaled up to manufacture sufficient quantities for Phase III clinical trials and commercialization. CritiTech can support its clients from the initial Proof of Concept Study through commercialization.
Stage 3 Optimization (Supercritical Precipitation and Spray Drying)
Following material evaluation by client, CritiTech will work with the client to develop a scope of work to reflect the ideal target drug profile. CritiTech will assist with the formulation development and evaluate the scalability and reproducibility. In addition, we will produce pre-clinical supplies.
Stage 4 Production (Supercritical Precipitation and Spray Drying)
In its cGMP facilities, CritiTech will provide processed drug for clinical trials through Phase II. We will also provide documentation to support the necessary regulatory filings and assist with scale up.
CritiTech possesses the following analytical capabilities to support the characterization of nanoparticulate particles:
- Particle Size Analysis
- Laser Diffraction
- Light Obscuration
- Residual Solvent Determination
- Gas Chromatography
- UV/Vis Spectroscopy
- Moisture Determination
- Karl Fischer Titration
- X-Ray Powder Diffraction
- Optical microscopy with digital image analysis
- Scanning Electron Microscopy
- Transmission Electron Microscopy
- Quantification and Purity
- HPLC (UV & PDA)
- UV/Vis Spectroscopy
- USP Apparatus 2
- Potentiometric Titration
- Optical Activity
- Stability Testing (in house Q1 – 2018) ICH Conditions
- Long Term
Advantages of CritiTech’s Nanoparticulate API Drug Production
- Pure drug dry powder after processing – no coatings or encapsulations
- No need to coat drug particles to prevent agglomeration
- High yields (>95%)
- Continuous processing
- Discrete fine particles with a narrow size range
- Inherently safe and environmentally friendly manufacturing process
- Completely closed system
- Reproducible and scalable process
- Smooth transition throughout CMC process
The client provides a few grams of unprocessed drug along with any safety information the client has about the drug. CritiTech then uses this material and information to process test batches of the client’s drug into nanoparticles. The client drug, processed into nanoparticles, is then returned to the client for additional testing. If the tests demonstrate that the client’s nanoparticle API has the desired benefits, CritiTech, through its formulation partners, can work with its clients to determine an optimal formulation.