Lipid Screen
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Maximize Product Life Cycle Options and Success in Discovery/Development for Challenging Compounds The Problem Advances in computational chemistry and molecular biology are presenting extraordinary discovery opportunities; however, some of the challenges encountered in commercialization of new drugs are patient compliance issues presented by poorly water soluble and highly water soluble compounds. The Realistic Soultion - LipidScreen® Lipocine has a suite of proven technologies that it can bring to bear through its LipidScreen program to increase the chances of success with challenging compounds. LipidScreen is a fast and highly cost effective laboratory screening process that can provide the client with product strategies to overcome the issues presented with these challenging compounds. How The LipidScreen Program Works: Step 1: Confidential disclosure by client to Lipocine of information on active (MSDS, physical chemical characteristics, bio-availability experience, analytical methodology, etc.) and respective therapeutic expectations (dosing, potency, etc.). Step 2: Under confidentiality, Lipocine provides client with a proposal outlining the process, costs and timetables for providing prototype formulations for bio-availability testing. Cost depend on the scope of work and available information on the client active. Lipocine can work with microscale quantities, typically 1-50 g. Step 3: LipidScreen Feasibility Agreement signed. Step 4: Upon receipt of bulk active, Lipocine conducts preliminary screening of Lipocine technologies for the drug under investigation and develops formulation(s) for performance testing. Step 5: Supply formulation to client or third party for performance testing. Formulations can often be provided within 8 to 16 weeks of receipt of active. Step 6: Data review with client. Discuss next steps including Lipocine involvement (if any). Client benefits: • Identify/Maximize the "true" performance attributes of a drug. "True" value of your drug is often compromised by delivery inefficiencies. Lipocine's patented delivery enhancement technologies can enable you to maximize your drug's innate value with developable/commercializable product options through the LipidScreen program. • Assist in salvaging potential ‘winners' and shelving potential ‘losers'. By identifying the "true" potential of the drug with developable/commercializable formulation(s), LipidScreen enables focusing of resources onto the "most likely to succeed" candidates. • Minimize development iterations and time to commercialization. Traditional formulation approaches could lead to commercialization uncertainties and undo formulation and clinical development iterations for challenging drugs making product development resource intensive and inefficient. Lipocine technologies use excipients that are bio-acceptable and are unlikely to present problems from a regulatory acceptance standpoint. This can reduce development costs and maximize early revenue realization. • Proactively identify discovery/development opportunities and life cycle management options. The enhancement of therapeutic index, increase of patient compliance and exclusivity prolongation are part of the overall concept of life cycle management. Improving the delivery profile of poorly water soluble and highly water soluble with poor absorption potential compounds can be a highly effective and cost efficient strategy to accomplish life cycle management goals to expand and/or retain market share for your product. The screening output provided by LipidScreen allows the development of effective strategies for superior product line extensions. LipidScreen can identify opportunities early in the product life cycle to allow timely implementation. • Obtain an independent ‘proof of concept' assessment. Often, it is helpful to have an independent assessment regarding the potential success/failure for a problem compound from a group that has core competencies, database, and screening expertise to address specific delivery challenges. |
