Pharmaterials are delighted to announce GMP validation for solution calorimetry (Solcal).
For many years Pharmaterials have provided industry leading service in the quantification of amorphous content for inhalation API. As an extension of this service the instruments are now all being qualified to full GMP standards.
Mridul Majumder, Director of Physical Properties said: "In past, we have been successful of using this technique on numerous occasions and were able to generate reproducible results consistently. Now there is an ever increasing demand, driven by regulatory authorities, for GMP validated instruments and methods for the quantification of amorphous content in inhalation materials. To meet that demand we now have a GMP qualified instrument that can be used to test and release GMP material. This advance makes us even better placed to help our clients".
Professor Graham Buckton said "Pharmaterials has an MHRA inspected GMP manufacturing facility at Reading allowing us to make a variety of oral dosage forms, including Xcelodose powder in capsule. Our inhalation development facility includes particle engineering and material optimisation, micronisation, amorphous content determination, full formulation and analytical development for DPI and pMDI, and GMP manufacture. It is entirely fitting that the high quality materials science work is now being offered as a GMP service. We are delighted to have a comprehensive inhalation package to assist our customer base". |
