Solving the problem of drug disposal

Transcription

1 Solving the problem of drug disposal

2 Summary Why We Exist Who We Are To prevent the diversion of prescription opioids and to reinforce safe disposal of all medications through education and awareness A group of committed scientists and entrepreneurs who want to help solve the opioid abuse epidemic by establishing the gold standard for medication disposal What We Do How We Do It When Is It Available? Provide a unique cross-linking technology that is added to water which safely renders medications unusable and inconsumable. This is accomplished by using a proprietary blend of powders, which are a safe blend of chemical polymers listed by the FDA as safe and biodegradable By sharing with the consumer a technology that s as easy as adding a sweetener packet to iced tea or a flower food packet to a vase of flowers September 2017

3 Worst Drug epidemic in American History! Market is lacking non-toxic consumer facing medications disposal methods. Problem Purpose Raising awareness by highlighting safe and simple to use consumer facing medication disposal alternatives that captures unused medications in a non-toxic viscous environment, rendering it inaccessible removing it from the ecosystem of misuse, abuse & diversion. Goal Expand pharmacy services and educating patients with defined programs that mirror diabetes and hearth health initiatives, targeting the importance of proper medication disposal, through safe and cost-effective solutions.

4 Abuse Deterrent Experience John W. Holaday, Ph.D., is scientist with decades of experience in neuroscience, oncology and immunology. Dr. Holaday was the former CEO of QRxPharma Limited (QRX-ASX) and the co-founder of Medicis (MRX- NYSE) and served at the Walter Reed Army Institute of Research as Captain, US Army and Chair of Neuropharmacology Brand. Dr. Holaday holds a BS and MS from the University of Alabama, and PhD from the University of California, San Francisco School of Medicine. Edward Rudnic, Ph.D., is a scientist and pharmaceutical executive with an extensive background in the biopharmaceutical industry. Dr. Rudnic was founder, chairman and CEO of MiddleBrook Pharmaceuticals (Nasdaq: MBRK, previously Advancis; Nasdaq: AVNC) and was Sr. VP, Development and Technical Operations for Shire Laboratories, where he was the lead inventor of Carbatrol and co-inventor of Adderall XR. Dr. Rudnic has been named lead inventor or co-inventor of 54 issued U.S. patents and numerous related international patents. Dr. Rudnic holds a BS in Pharmacy, a MS in Pharmaceutics and a PhD in pharmaceutical Sciences from the University of Rhode Island. Marcus Schestopol, is a pharmaceutical development chemical engineer with over 15 years of experience in pharmaceutical CMC product development. Marcus received his Chemistry degree from Emory University and his Chemical Engineering degree from the Georgia Institute of Technology.

5 The Solution: DisposeRx TM 1: Open vial 2: Add warm tap water until vial is 2/3 full 3: Add DisposeRx Powder & shake for ~30 seconds, contents solidifies in <10 min. Pills + DisposeRx + Water = 100% effectiveness Proprietary, patented technology made of solidifying cross-linking chemical polymers to sequester all medications All materials used in DisposeRx are safe and listed in the FDA s Inactive Ingredient Database. DisposeRx crosslinking polymers are found in foods, oral drug products, are safe to ingest if accidentally exposed, and environmentally-friendly. Video Link:

6 DisposeRx Sequestration DisposeRx formulated testing Biodegradable matrix DisposeRx formulated its products to be compliant with evolving recommended governmental standards including DEA guidelines (Dec. 21, 2012, 21 CFR Subpart C, ). According to the DEA the method of destruction shall be consistent with the purpose of rendering all controlled substances to a non-retrievable state in order to prevent diversion of any such substance to illicit purposes and to protect the public health and safety.

7 Product Review At DisposeRx, our team is focused on stopping the opioid epidemic at the home medicine cabinet, preventing the cycle of environmental pollution, addiction, overdose and death. DisposeRx was designed especially for site-of-use disposal (the action of sequestering pharmaceutical ingredients within the vial in which the prescription was dispensed), uniquely capturing prescription drugs within the prescription vial, users are empowered with a best-in-class drug disposal solution. The disruptive cross-linking polymer blend, embraces safe and easy to understand user directions, providing the only prescription drug disposal solution which permanently captures drugs in a non-divertible and biodegradable gel. Our biodegradable solid is manufactured with components that are safe enough to be eaten. The disposal composition material, when combined with water and medicaments, forms a gel substance of high viscosity that it is not easily pourable, transferable, or mixable, and remains in the container in which it is formed. DisposeRx is able to provide homes and communities with a process where they can effortlessly be a part of the solution, breaking the chain of illicit prescription drug access and curbing our nation s opioid epidemic.

8 Extraction Data Data for all solvent extraction conditions are presented in this section. The mean percent (w/w) of Oxycodone recovered from the filtrate during each duplicate analyses was calculated and graphed. Specifically, the percent recovery of Oxycodone relative to the initial quantity of Oxycodone added was calculated (see Figure 1). Note: 40 tablets of 5 mg Oxycodone HCl equates to: 200 mg (0.200 g) Oxycodone HCl and mg ( g) Oxycodone free base. All results are reported as free base. A range of 0 8% of Oxycodone was recovered from filtrates across all conditions; this equates to approximately mg ( g) of Oxycodone. Gel after settling for minutes after mixing Test Product with water; white tablet particulate evident

9 Solvent Extraction Sample ID Oxycodone Added (mg) Filtrate Recovered (ml) Average Filtrate Recovered (ml) Oxycodone Recovered (mg) LC-MS/MS value (mcg/ml) Pre-filtration Mass (g) % Oxycodone Recovered Relative to Initial Oxycodone Added Average % Oxycodone Recovered Relative to Initial Oxycodone Added % Oxycodone Recovered Relative to Pre-filtration Mass Average % Oxycodone Recovered Relative to Pre-filtration Mass 1A B A B A % B A B A % % 5B % 6A % % 6B % 7A % % 7B % When considering the disposal of critical drugs of abuse including opioids (e.g. Oxycodone), it is essential that these substances are discarded in such a way that drug abusers are unable to access the material for abuse purposes. The DisposeRx product possesses multiple deterrence mechanisms which render the resulting material less amenable to abuse; these include the formation of a gelatinous mass upon mixing with pharmaceuticals, and the production of highly viscous solutions upon extracting the material with common household solvents. Sample preparation, Solvent extraction, Filtration and Quantitation data collected during study.

10 Thank you Wm Simpson, President 135 West Illinois Ave., Suite 1 Southern Pines, NC T/ (844) E/ wsimpson@disposerx.com