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Melissa Sandahl, Dustin Melton, Janet Tully, Mari Yang, Andres Garcia, Leo Trevino, Stuart Williams; Evaluation of Reproducibility and Uniformity of PRINT Implant Manufacturing. Invest. Ophthalmol. Vis. Sci. 2018;59(9):5671. doi: https://doi.org/.
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PRINT (Particle Replication in Non-wetting Templates) is a versatile manufacturing technology for the engineering and production of precisely sized and shaped drug particles from the nanometer to millimeter size range with high batch to batch reproducibility and dose uniformity. PRINT is compatible with a wide variety of drugs and excipients, including many classes of small molecules as well as biologics, and can be used in combination products with multiple APIs. Additionally, PRINT provides the ability to precisely manufacture small intraocular implants in the “hard to manufacture” range of 100 to 1000 microns. The reproducibility and uniformity of PRINT manufacturing was assessed using dexamethasone PLA/PLGA intravitreal implants.
Biodegradable dexamethasone PLA/PLGA implants were fabricated using proprietary PRINT technology. Three batches of a single dexamethasone PLA/PLGA formulation were prepared, with each batch producing four separate sheets of implant arrays and each array containing over 2,000 dosing units. A total of 12 arrays were evaluated for reproducibility and uniformity using mass and content uniformity and in vitro drug release rates. Dexamethasone content was measured by RP-HPLC and in vitro release was characterized in PBS/Triton X-100 at 37°C and measured by HPLC.
A high degree of mass and content uniformity was demonstrated with <6% RSD across all batches. Dexamethasone content per implant was within 85-115% of target dose for over 99% of samples tested. In vitro release rates showed minimal variability between batches, with <15% RSD between batch averages for drug released at each timepoint.
PRINT technology can be used to fabricate particles and implants using a variety of APIs and excipients. Here we manufactured fully biodegradable dexamethasone intraocular implants with uniform size, shape and dose. High reproducibility and uniformity of PRINT implant manufacturing was demonstrated across multiple batches of a single dexamethasone PLA/PLGA formulation.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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