OBJ Limited (ACN 056 482 636) Ground Floor, 284 Oxford Street, Leederville, Western Australia 6007 Phone: +61 9 9443 3011 Fax: +61 9 9443 3866 Email: [email protected] Tuesday, 6 December 2005 FOR IMMEDIATE RELEASE PRESENTATION TO THE AUSTRALASIAN PHARMACEUTICAL SCIENCE ASSOCIATION ANNUAL SCIENTIFIC MEETING ============================================== OBJ Limited (ASX:OBJ) is pleased to make available the materials to be presented by Sarika Namjoshi BSc(Hons) of Curtin University’s Drug Development Department to the annual scientific meeting of the Australasian Pharmaceutical Science Association. The invitation to present was extended jointly by the Australasian Pharmaceutical Science Association and the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists. The annual meeting commenced in Melbourne on 4 December 2005 and closes on 7 December 2005. - END - Background to the Announcement OBJ Limited is a drug delivery company, specializing in electronic “drug patch” technologies that allow drugs, vaccines, therapeutic agents and cosmetic compounds to be delivered more effectively and more efficiently through-the-skin. The OBJ Dermaportation system has been shown to manage and control the transdermal delivery of a broad range of drugs and therapeutic agents ranging from small difficult molecules such as Caffeine, through to large macro-globular proteins drugs such as vaccines. OBJ’s technology has been independently proven in both in-vitro and in-vivo studies and can manage a broader range of molecular sizes, structures and valencies than other active or passive drug delivery systems. OBJ has been successful in managing the through-the-skin delivery of drugs used in the inflammation, pain, cancer and cosmetic fields. OBJ’s technology is low cost, and can be incorporated into reusable drug patches, (as illustrated) disposable single use drug patches and in a range of packaging systems for OTC and retail use. Sustainable Benefits Low cost and controlled through-the-skin delivery of drugs, hormones, vitamins, vaccines, anti-bodies and anti-aging molecules has long been the desire of the pharmaceutical industry. It would provide economic, safety and efficacy benefits to the pharmacology, medical, veterinary and cosmetic industries. Side effects could be reduced by localized delivery and programmed delivery rates. Needle stick injuries and needle disposable problems could be eliminated while the reduction in the level of skill required for application could significantly reduce total cost of many health programmes. These clear commercial benefits may only be achievable if the skin’s natural barrier effect can be overcome. OBJ is the first company to create a broad spectrum through-the-skin delivery system that is kind to the skin, completely reversible, yet can handle drugs range from the small difficult molecules up to the largest and most complex proteins and anti-bodies. OBJ manages an extensive IP portfolio and prosecutes patent applications throughout the world. Independence of Results OBJ contracts its drug and technology testing programs to independent and respected organisations, such as Western Australian Biomedical Research Institute, Western Australian Institute for Medical Research, Curtin University of Technology and Murdoch University. The high level of independence and international accreditation means that the results attributable to OBJ’s proprietary technology can be published and presented at major medical and scientific conferences and forums. For more information: Jeffrey Edwards Phone: +61 9 944 33011 Mobile: 041 791 2211 E-mail: [email protected] HPLC ASSAY FOR HPLC ASSAY FOR 5–AMINOLEVULINIC ACID AMINOLEVULINIC ACID AND ITS APPLICATION TO AND ITS APPLICATION TO ASSESSMENT OF SKIN ASSESSMENT OF SKIN PENETRATION PENETRATION Sarika Namjoshi Sarika Namjoshi, Rima Caccetta, , Rima Caccetta, Jeff Edwards and Heather Benson Jeff Edwards and Heather Benson Structure of human skin Structure of human skin Background Transdermal Drug Delivery Transdermal Drug Delivery Painless and patient friendly Painless and patient friendly Avoid first pass metabolism: lower dose Avoid first pass metabolism: lower dose and reduced side and reduced side-effects effects Controlled release: better control of Controlled release: better control of symptoms, extended dosing intervals and symptoms, extended dosing intervals and reduced side reduced side-effects effects Major limitation: skin permeability Major limitation: skin permeability – few few TDD applications currently available TDD applications currently available Skin Penetration Enhancement Skin Penetration Enhancement Optimize physicochemical characteristics Optimize physicochemical characteristics of the drug and/or formulation of the drug and/or formulation Chemical penetration enhancers Chemical penetration enhancers Physical penetration enhancers Physical penetration enhancers Iontophoresis Iontophoresis Electroporation Electroporation Sonophoresis/phonophoresis Sonophoresis/phonophoresis Dermaportation Dermaportation 5 Aminolevulinic acid (ALA) 5 Aminolevulinic acid (ALA) ALA is a delta amino acid ALA is a delta amino acid It is hydrophilic and zwitterionic at It is hydrophilic and zwitterionic at physiological pH physiological pH Used with PDT in the treatment of BCC. Used with PDT in the treatment of BCC. It is converted into PpIX, precursor of heme It is converted into PpIX, precursor of heme Exogenous administration of ALA results Exogenous administration of ALA results in PpIX accumulation in PpIX accumulation Light activation (PDT) causes destruction Light activation (PDT) causes destruction of tumours of tumours Skin permeability of ALA through skin Skin permeability of ALA through skin lesions is poor lesions is poor AIM AIM To assess the impact of Dermaportation on To assess the impact of Dermaportation on the transdermal delivery of ALA the transdermal delivery of ALA HPLC Method Development HPLC Method Development ALA does not contain a chromophore therefore ALA does not contain a chromophore therefore cannot be detected by UV cannot be detected by UV Fluorescence derivitization for developing a HPLC Fluorescence derivitization for developing a HPLC assay. assay. -100 0 100 200 300 400 500 600 700 0 2 4 6 8 10 12 Concentration (µg/mL) Peak area Methods 0 500 1000 1500 2000 2500 3000 3500 0 10 20 30 40 50 60 Concentration (µg/mL) Peak area Standard curve after derivatization at 1000C Standard curve after derivatization with Fluorescamine at room temperature R2 = 0.9475 R2 = 0.9993 HPLC Assay For ALA Detection HPLC Assay For ALA Detection Amine group of ALA targeted by Amine group of ALA targeted by Fluorescamine Fluorescamine Linearity Linearity R2 = 0.9993 = 0.9993 Limits of detection (LOD) = 120 ng mL Limits of detection (LOD) = 120 ng mL−1 Limit of quantification (LOQ) = 400 Limit of quantification (LOQ) = 400 ng ng mL mL−1 Accuracy = 99.4% Accuracy = 99.4% Dermaportation Dermaportation – in vitro in vitro diffusion diffusion protocol protocol Donor Phase Membrane Dermaportation Receptor phase Sampling arm Dermaportation Dermaportation vs vs passive diffusion of passive diffusion of ALA across human epidermis ALA across human epidermis (mean (mean ± sem sem) 0.0 2000.0 4000.0 6000.0 8000.0 10000.0 12000.0 0 60 120 180 240 Time (min) Cumulative amt ALA (ug/cm2) Dermaportation Passive Dermaportation: ALA flux and Dermaportation: ALA flux and Enhancement ratios (ER) Enhancement ratios (ER) 3.82 3.82 76.57 76.57 Dermaportation Dermaportation 0.006 0.006 0.12 0.12 Passive Passive Permeability Permeability coefficient (cm.h coefficient (cm.h-1) Flux during Flux during Dermaportation Dermaportation (µg.cm g.cm-2.h) .h) Conclusions Conclusions The HPLC method developed was The HPLC method developed was accurate and sensitive accurate and sensitive Dermaportation enhanced the Dermaportation enhanced the transdermal delivery of ALA as transdermal delivery of ALA as compared to passive diffusion compared to passive diffusion Dermaportation has potential as a skin Dermaportation has potential as a skin penetration enhancement technology penetration enhancement technology – further evaluation with small and large further evaluation with small and large molecules molecules
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