Auritec expands for the development of a manufacturing facility to produce intravaginal rings

Santa Monica, CA. August 1, 2011

Auritec Pharmaceuticals, Inc. is pleased to announce the development of a 6000 ft² manufacturing facility, funded by the NIH, for the production of intravaginal rings.  The purpose of this facility will be to scale intravaginal ring production from laboratory prototypes to small-scale manufacture.  It is expected that this facility will be fully functional by March 2012.  Capabilities of the facility will include:

Core production (tableting): GlobePharma MTCM-1 manual tablet compression machine for initial formulation development using identical B tooling to that in the production tablet presses; Riva Single-station Minipress 6-ton tablet press with B tooling for core production at up to 6000 cores h^-1.

Pod production (core coating): Vector MFL.01 Micro fluid-bed spray coater for PLA and PVA coating of cores in batches of 20-600 g (1000-30,000 cores) in Würster mode and 100-600 g (5,000 – 30,000 cores) in top-spray mode; dedicated curing oven.

Injection molding: custom laboratory-scale liquid silicone resin (LSR) injection molding system including single-cavity molds for production of R&D lots of silicone ring blanks for human and sheep, macaque, and in vitro studies. Morgan Press G-55T thermoplastic injection molding system for R&D and short-run production of thermoplastic ring blanks (EVA and polyurethane – alternative materials to LSR).

Assembly: Class 100,000 clean-room (175 ft²) with workbenches for manual IVR assembly and packaging; adhesive dispensing system for semi-automated silicone backfilling during assembly; 5x-50x inspection microscope.

Analytical and QA/QC: USP Type II dissolution apparatus (6 systems); custom low-volume flow-through dissolution apparatus for IVR release evaluation; Complete analytical facilities are located at Oak Crest Institute of Science (adjacent to manufacturing facility), including HPLC, HPLC-MS, and HPLC-MS/MS; GC-MS; NMR; spectroscopy (UV-visible and FTIR absorption, fluorescence); particle size analysis (light-scattering); and fluorescence microscopy.

About Auritec Pharmaceuticals

Auritec Pharmaceuticals, Inc. based in Santa Monica and Pasadena, CA, is a R&D company specializing in innovative, extended release drug delivery systems.  Auritec was founded by Thomas J. Smith, MD, who has been granted 9 INDs and 2 NDAs throughout his pharmaceutical career in sustained release drug delivery. Dr Smith is joined on Auritec's management team by Gary Ransom, a seasoned international business executive, who focuses on strategy, marketing and business development.

Auritec’s Plexis™ technology is an innovative, polymer-based, proprietary platform technology for sustained release of drugs given by injection.  Plexis™ combines a membrane based, diffusion-driven release mechanism with drug particle sizing large enough to allow high drug loading, but small enough to be injected.  Plexis™ combines the benefits of linearization of release with those of injectability.

Auritec’s Versa™ technology is an implantable drug delivery platform that is responsible for two FDA approved products.  It is based on a core of solid drug, coated with a semi-permeable polymer.

Auritec has developed a novel approach to extended release drug delivery with implications so far for indications including schizophrenia, Parkinson’s Disease, arthritis, herpes and HIV/AIDS. Auritec’s primary objective is to develop and test the use of its Plexis and Versa platforms in a wide range of drug classes, and subsequently license the technology to key partners to continue development, trials and eventual commercialization. Auritec has been previously funded by numerous NIH grants and their IP estate includes worldwide granted and pending patents.