Cocrystals for pharma development
Cocrystal is an interesting crystalline structure for pharma development (bioavailabity, solubility). Dedicated investigations must be performed for identification : the so-called screening. Then further studies are necessary for an accurate description of the specific features (non-congruent solubility).
Polymorphism is a essential information !
According to ICH Q6A, polymorphism is described as: « The occurence of different crystalline forms of the same drug substance. This may include solvation or hydration products (also know as pseudopolymorphs) and amorphous forms. » Polymorphism is essential in pharma development for lead selection, solid form selection, regulatory affairs, IP, crystallization process development, robustness, and more.
OEL : 50 ng/m3
Holodiag’s analytical methods are apllicable to toxic samples down to 50 ng/m3. Thanks to laminar flow hood systems, HPAPIs, cytotoxic compounds and CMR substances can be handled with high security by our scientific team. Example of equipments under protection: • our Malvern Mastersizer 3000 for particle size distribution (Laser PSD) • our Dynamic Vapor Sorption […]
TGA and DSC are key thermal analyses for solid state characterization
Indeed, these analyses allow to get information about: • melting • (re)crystallization • stable/metastable phases • monotropy/nantiotropy • amorphous/Tg • hydrates/solvates • decomposition/degradation • temperature • enthalpy • stability • compatibility and more ! Holodiag owns a Mettler DSC 3+ and TGA-DSC 3+.
Challenging lyophilisate !
Drug products produced by lyophilization are typically amorphous and show higher dissolution rate and sulubility. However, undesired crystallization may occur, resulting in a lower dissolution rate or even undesirable particles. Holodiag performs specific investigations to identify crystalline particles, their origin in order to solve these situations.
BioFit Strasbourg 2022
Holodiag will attend as a visitor the new edition of BioFit based in Strasbourg this year ! See you there in three weeks !
CPhI Frankfurt 2022
Are you facing issues or are you looking for scientific discussions related to solid state characterization, polymorphism, crystallization processes ? Holodiag attends CPhI in Frankfurt as a visitor, can’t wait to meet you there !
About InfraRed
InfraRed is a well-known technique for molecular structure identification. It is also used to identify polymorphism in solid samples. Holodiag performs these analyses on high potent product down to 50 ng/m3.
PSD, a crucial parameter !
Particle size and shape are crucial parameters in the pharmaceutical industry because it influences many material properties. Consequences are numerous especially for filtration and drying steps. Holodiag provides advanced analytical services for PSD with a Mastersizer 3000 with both dry and liquid mode. Such a system is fully set and qualified under laminar flow hodd which […]
A multitude of samples can be analyzed by XRPD
Various formulations can be analyzed by XRPD to identify the crystal form of an API. Among classical ones, there are: • spray • suppository • capsule • transdermal patche • suspension • ointment • tablet • powder But also unexpected ones ! As: • flea collar • chew stick • IUD for cow • medicated […]
