Background Plasma rich in growth factors (PRGF-Endoret) is an autologous platelet enriched plasma that has been standardised for ophthalmic application. In the past years, PRGF-Endoret has been successfully used like an eye drop for the treatment of a wide range of ocular surface diseases, including dry eye, persistent corneal epithelial defects and ulcers. Current classification of autologous plasma derivatives such as human medicines imply that it has to meet all the requirements of ophthalmic preparations.
Purpose To assess the galenic properties of the PRGF eye drops and its compliance with European Pharmacopoeia requirements.
Material and methods Eye drops were obtained using the PRGF-Endoret ophthalmology kit. Briefly, blood was collected into 9 mL tubes, centrifuged at 580 g, plasma column was drawn off avoiding the buffy coat and incubated at 37°C with CaCl2. Supernatants were collected, filtered and aliquoted in single dose containers. Eye drops were kept fresh or stored at −20°C for 3 months. Aseptic process simulations (Media Fill) were performed using tryptic soy broth (TSB) to 6 batches. The samples were incubated for 14 days and inspected for microbial growth. A growth promotion test was done. Deliverable volume test was applied to 5 single dose containers. Oat-Water tightness test was done in two batches in duplicate with a toluidine solution and applying a vacuum for 10 min. pH and osmolarity were assessed in fresh samples and after freezing for 3 months.
Results In the media fill all units were negative for growth. In the growth promotion test, growth of all the microorganisms was clearly seen. The volume of each container was within the range of 95–110%. In the first batch, no toluidine was detected inside the vials or the caps. In the second batch, only one vial had a shadow of toluidine inside the cap. pH and osmolarity values were slightly modified after freezing. Eye drops were clear and free from particles.
Conclusion The PRGF-Endoret method was aseptic
The water tightness of the vials was correct, and the deliverable volume corresponded with the nominal volume. pH and osmolarity remained constant during the whole period. We can affirm that PRGF-Endoret meets the European Pharmacopoeia requirements and their galenic properties.
Conflict of interest:
Corporate sponsored research or other substantive relationships: EA is the scientific director of BTI, and GO and FM are scientists at BTI.
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