Our expertise
Milling-induced disordered (amorphous) material is highly energetic and a considerable portion of these particles significantly influence the cohesive and adhesive balance (CAB) of micronized particles.
This behaviour results in varying fine particle fraction (FPF), which ultimately affects dry powder inhaler (DPI) performance. Milled particles are also heterogeneous in nature, they differ in particle size, shape, surface area, and energetics.
These characteristics make it challenging to produce stable DPI products without a deep understanding of the physical properties of milled and un-milled samples, their behaviour and control over their processing. It is reasonable for the regulatory authorities (e.g. FDA, MHRA) to seek a suitable analytical method to quantify amorphous content and they may assign limits for amorphous content in batches that are to be used for commercial purposes. Hence, M2M Pharma is set up to be The Amorphous Content Determination Specialists by having its in-house technology coupled with decades of hands-on experience in handling 1000s of batches across 10s of APIs.
Highly Sensitive Specialised Techniques
TAM2277: Multi-Channel Solution Calorimeters
Solution Calorimetry: This measures the heat of solution upon dissolvation of solute into the solvent.
As crystalline materials exhibit crystal lattice arrangement and it would require higher energy (endothermic) to break its lattice but "Not" for amorphous materials as they don’t have long ordered crystal lattice arrangement (exothermic) and the difference between these two responses remained our key interest.
TAMIII: Perfusion, Solution & Other Calorimeters
Perfusion Calorimetry:
This measure change in power (µW) at a constant temperature and this change is related to wetting and drying response of solids under varying %RH or %RVP. Our perfusion calorimeter is attached to TAMIII. We have decades of experience in developing methods for various inhaled APIs.
DVS Advantage
This measure change in weight upon exposure to varying %RH at a constant temperature. We often use this technique for amorphous content determination by measuring recrystallisation (% weight loss) using either DI water or other organic solvents (e.g. Ethanol, n-Octane etc.).
We also use this for routine hygroscopicity measurement to predict storage condition for solid samples. Again, we have decades of experience in developing methods for various inhaled APIs.
Key Instrumentations:
BET-SSA & Pycnometer
BET-SSA: This measures surface area for solids. As we handle micronised batches, this technique is routinely used for measuring surface area.
Pycnometer is used for determining the true density of solids.
XRPD
This is a “gold standard” physical form identification technique. At M2M, we use this for phase identification, quantification, batch to batch variation, etc.
TGA & DSC
TGA: It measures % of weight change upon heating. This is routinely used for quantification of adsorbed and absorbed moisture and/or solvents, hydrate/solvate etc. It also provides an indication of melting and/or degradation temperature etc.
DSC: It measures change in power signal due to the endothermic and exothermic processes of solids upon heating. We routinely use this for determination of melting point temperature, glass transition temperature, crystallization temperature, solid state transitions.
MaSTERsizer 3000
M2M Pharma acquires Malvern Mastersizer 3000 that enables to measure particle sizes in dry and wet dispersion mediums. This adds additional value to our offerings as we now can micronise samples (e.g. to inhaled size <5microns) and measure sizes instantaneously along side amorphous content determination.
Chemical Imaging
Raman Spectroscopy
Raman Spectroscopy
Raman Spectroscopy
Raman Spectroscopy
Raman Spectroscopy
M2M Pharma now has its in-house RA802 from Renishaw for following application
- Advanced Raman chemical imaging
- Quantitative, non-destructive
- Identification of counterfeit medicines
- Size & content identification, distribution
- Analysis of tablets with uneven and/or rough surfaces
Raman Spectroscopy
Micro-mill & Microscope
Milling:
Particle size reduction technology using micro-mill is a very efficient way to obtain even micron sized particles in a continuous process. We can mill mg of sample at early stage of development to demonstrate reduction in particle size.
PLM:
Polarised light microscopy is used to get an indication on particle size and shape.
