User:Nsinghvi13/sandbox

= Auritec Pharmaceuticals = Auritec Pharmaceuticals, Inc. is a research and development (R&D) company, specializing in extended release drug delivery systems. The company is based from Santa Monica, California, USA, with its laboratory operations in Pasadena.

History
Auritec was founded in 2002 by Thomas J. Smith, MD. Dr. Smith was previously Medical Director and Chairman at Control Delivery Systems, Inc. (CDS), where he was the co-founder and PI on key patents. CDS, now Psivida Inc. (NASDQ - PSDV), is a successful device company specializing in ophthalmic extended release therapies. Since its inception, Auritec has received over $20 million in NIH funding to develop sustained-release formulation for a number of serious or life-threatening diseases. The company's IP portfolio includes 26 patent families, 31 granted patents and more than 80 patent applications worldwide.

Technologies
Auritec Pharmaceuticals owns three classes of patents in the field of sustained release delivery: ''Versa™ intravaginal rings and implants, The Plexis™ injectable sustained-release platform and Co-drug™ technologies. The Versa™ platform is Auritec’s flagship technology.''

Versa™
The Versa™ platform is covered by an extensive intellectual property library and is responsible for the two FDA approved drug delivery products – Vitrasert® and Retisert®. It is based on a core of solid drug, coated with a semi-permeable polymer. Water from tissue fluid diffuses into its core, leading to the dissolution of the drug, and resulting in a saturated solution within the polymer envelope. Drug in solution then diffuses out of the envelope based on the concentration difference between inside and outside. As the inside concentration remains saturated until virtually all of the drug is dissolved, and as the outside conditions are “sink,” the chemical potential which drives drug release is constant over the entire delivery period. This leads to pseudo-zero order release.

This platform is utilized for developing sustained release intravaginal rings and implants of a wide range of solubilities over the timescale of months to years. Versa™ technology have previously been used to develop FDA approved ganciclovir implants Vitrasert™ (NDA No. 020569) and Retisert™ (NDA No 021737)

Plexis™
Auritec’s Plexis™ technology 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. The technology comprises of an injectable depot made up of thousands of biodegradable “mini-implants.” The polymers chosen for the membrane are stable over the projected time of drug delivery and yet ultimately biodegradable.

Auritec is currently developing injectable sustained-release drug formulations using Plexis™ technology for the depot delivery of a broad range of indications, including the treatment of schizophrenia, Alzheimer’s, graft rejection, arthritis, macular edema, HIV and post-surgical pain.

Codrugs™
The Codrugs™ injectable platform is being developed for the oral delivery of a broad range of indications, including the treatment of Alzhemier’s and atherosclerosis.

Clinical Studies
Auritec has completed first-in-human clinical studies to assess tolerability and pharmacokinetics of acyclovir delivered via acyclovir intravaginal ring in six HIV-negative women with recurrent genital HSV. This first-in-human study demonstrated that an IVR could safely deliver mucosal levels of aciclovir similar to oral valaciclovir without systemic absorption.

Auritec has completed clinical trial to test the safety and PK of antiretroviral drug combinations (TDF, TDF-FTC) for the prophylaxis of HIV in 6 healthy women and demonstrated no significant safety concerns.