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Nano-E™: Nanoemulsion Drug Delivery System For Highly Insoluble Drugs LATITUDE Pharmaceuticals, Inc.’s Nanoemulsion Drug Delivery System (Nano-E™) is a versatile drug delivery platform for applications requiring a liquid formulation for highly insoluble small molecule, peptide, and protein drugs. Nano-E is being used in several NDA-stage and clinical-stage products. The Nano-E™ technology is the 505(b)(2)-enabling formulation behind two NDA-stage compounds that LATITUDE developed for its clients Key Advantages and Properties of Nano-E™ Technology • Highly versatile drug delivery platform for insoluble or soluble compounds • Small molecule and protein friendly • pH neutral, non-irritating, non-allergenic; clinically proven significant safety improvement for veinirritating drugs • For IV, IM, SC, IP, intra-thecal, intra-articular, ophthalmic, oral routes of delivery • IV bolus and infusion enabling • Up to 5% drug loading by weight • Tissue-friendly and wound compatible • Dilutable in standard IV diluents (e.g., D5W) • All components are GRAS listed and compendial grade (USP, NP, EP) • Does not contain co-solvents (e.g., Cremophor) or detergents (e.g., polysorbate) • PK profile bio-equivalent to solution formulations • RT stability demonstrated for 1.5-2 years • Filterable through 0.2 micron filters • Lyophilizable as needed • Simple and straightforward manufacturing • Manufacturing feasibility demonstrated for two NDA-stage drugs • Patent pending To learn how LATITUDE’s Nano-E DDS™ approach can optimize the therapeutic potential of your drug, please contact: Norman K. Orida, Vice President, Business Development LATITUDE Pharmaceuticals, Inc. 6364 Ferris Square San Diego, CA 92121 858-546-0924 ext 106 [email protected] 6364 Ferris Square Phone: 858.546.0924 www.latitudepharma.com San Diego, CA 92121 Fax: 858-546-0958 20121008 PG Depot™ Phospholipid Gel Depot Technology For Sustained Release (1-7 Days) LATITUDE Pharmaceuticals, Inc.’s Phospholipid Gel (PG) Depot™ technology is a versatile parenteral drug delivery platform for applications requiring the sustained release of small molecules, peptides, and proteins over 1-7 days. Key Advantages and Properties of the PG Depot™ • Sustained release for 1-7 days • Small molecule, peptide and protein compatible • Up to 20% drug loading by weight • Protein-friendly: provides >6 month RT stability • Enzyme-friendly: activity, stability uncompromised • Tissue-friendly and wound compatible • No collagen or other animal products • Components all GRAS listed and compendial grade (USP, NP, EP) Technology Manufacturing Cost of goods Drug Loading PG Depot Simple Low Liposomes Complex High ~5% • Single phase, ready-to-use format; no premixing prior to use • Injectable through fine needles • Dosing paradigm shift: from once or twice per day to once/week • Self administration-capable • Peakless or burst profile can be designed into final product • Simple and straightforward manufacturing • Autoclavable • ~$0.20-$2.00 vehicle cost/dose • Patent pending Burst ~15-20% Optional Unavoidable Premixing, Resuspen Req’d? RT Stable? No Yes Yes No Collagen Complex High <10% ? No No SABER™ ? High ~30% ? Yes No PLGA Complex High ~5% Unavoidable Yes No PLGA Microspheres Complex High ~5% Unavoidable Yes No 6364 Ferris Square Phone: 858.546.0924 www.latitudepharma.com San Diego, CA 92121 Fax: 858-546-0958 20121008 SC PG DepotPK @ 0.25 mg/kg PGBuprenorphine Depot™: Peakless Profile [Plasma] (ng/ml) (Right) A peakless PK profile engineered into the PG Depot™ to avoid Tmax issues. If desired, a burst release may be designed into the application. 1 0.9 0.8 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0 0 12 24 36 48 60 72 84 96 108 120 132 Time (in hours) Non-pain Response (%) 100 80 (Left) For the same API, the PG Depot™ can be adjusted to achieve longer or shorter efficacy. 60 40 20 0 0 12 24 36 48 60 72 84 Time (h) Licensing and feasibility studies Latitude’s PG Depot™ technology is available to expand the product possibilities and intellectual property space for your compound. Please contact LATITUDE to discuss how the PG Depot™ technology may address the sustained-release needs for your API. We recommend a quick turnaround, low cost feasibility study to explore the PG Depot™ potential for your compound. For further information, please contact: Norman K. Orida, Vice President, Business Development 858-546-0924 ext 106 [email protected] 6364 Ferris Square Phone: 858.546.0924 www.latitudepharma.com San Diego, CA 92121 Fax: 858-546-0958 20121008 RFAP™ Matrix Powder Formulation for Extremely Insoluble Oral Drug Candidates Nearly half of new drug candidates in development are poorly soluble compounds. Of these, many are extremely insoluble and lack any appreciable water or oil solubility, making them unformulatable using conventional approaches. To overcome this high hurdle, LATITUDE Pharmaceuticals, Inc. is offering its new Rapidly-dissolving, Free-flowing Amorphous Particle (RFAP) Matrix formulation. This approach uses GRAS-listed materials to formulate particularly challenging compounds into a rapidly-dissolving yet highly stable matrix. In addition to its desirable pharmaceutical properties, the matrix is a fine, freely-flowing powder that is ideal for automated tableting. •• •• •• •• •• • Key Features of the RFAP Matrix: Greatly improves oral BA Applicable for drugs that are insoluble in oil, water, or both Rapid dissolution High drug loading (10-20%) Thermodynamically stable amorphous drug form Does not revert to crystal form (at least ~1.5 yrs) Simple manufacturing process Dose as a powder or in capsules Low cost of goods Automated tableting-capable Patent pending To learn how LATITUDE’s RFAP Matrix can help your drug development program, please contact: Norman K. Orida, Vice President, Business Development LATITUDE Pharmaceuticals, Inc. 6364 Ferris Square San Diego, CA 92121 858-546-0924 ext 106 [email protected] 6364 Ferris Square Phone: 858.546.0924 www.latitudepharma.com San Diego, CA 92121 Fax: 858-546-0958 20130502 24H™: 24 Hour Extended Release Tablet Technology LATITUDE Pharmaceuticals, Inc.’s 24H™ technology is a versatile oral drug delivery platform that provides the linear, sustained release of water-soluble and water-insoluble drugs from tablets for up to 24 hours. The 24H™ formulation is being utilized in several commercially launched and clinicalstage products. Key Advantages/Properties of the 24H™ System • Extended release for up to 24 hours • Compatible with many different APIs, including highly water soluble compounds • Up to 60-70% (w/w) drug loading • Near zero-order release kinetics; low burst • Simple and straightforward manufacturing • Low cost of materials • Components all GRAS listed and compendial grade (USP, NP, EP) • Patent pending (US Patent Application 20070020335 ) Case Study: 24H™-Based Glucosamine Extended Release Tablets PRODUCT OPPORTUNITY: Glucosamine is widely used in North America as a dietary supplement for cartilage repair and maintenance. It is highly water soluble and known to have a short elimination half-life. A daily dose in a range of 500 mg to 1500 mg has been recommended. Almost all currently available tablets of glucosamine are immediate release and release glucosamine rapidly over 1-2 hours, requiring 2-6 times-a-day dosing to maintain adequate levels. Glucosamine tablets are generally quite large, making them difficult to swallow, especially for the geriatric population. Solution: LATITUDE utilized the 24H™ System to develop a one dose/day tablet with typical vitamin tablet dimensions that continually releases glucosamine and chrondroitin over a 24 hour period with near-zero order kinetics (see graph). 6364 Ferris Square Phone: 858.546.0924 www.latitudepharma.com San Diego, CA 92121 Fax: 858-546-0958 20121008 Near-zero order kinetics in vitro release profile of 24H™ glucosamine/chondritin (LPI Extra Strength G750mg/C600mg) compared to other extended release glucosamine products. Licensing and feasibility studies Latitude’s 24H™ technology is available to expand the product possibilities and intellectual property space for your compound. Please contact LATITUDE to discuss how the 24H™ technology may address the extendedrelease needs for your API. We recommend a quick turnaround, low cost feasibility study to explore the 24H™ potential for your compound. For further information, please contact: Norman K. Orida, Vice President, Business Development LATITUDE Pharmaceuticals, Inc. 6364 Ferris Square San Diego, CA 92121 858-546-0924 ext 106 6364 Ferris Square Phone: 858.546.0924 www.latitudepharma.com San Diego, CA 92121 Fax: 858-546-0958 20121008 MiniSpheres™ Oral Drug Delivery Platform for High & Bulky Dose Drugs MiniSpheres™ are LATITUDE Pharmaceuticals Inc.’s new oral drug delivery technology especially suited for high/bulky dose and/or sustained release applications. MiniSpheres™ are tiny spherical pellets (~0.5 to 1.5 mm diameter) that can be dispensed in a packet or a bottle. Unlike bulky tablets, MiniSpheres™ are very easy to swallow – even in large quantities – because of their small, spherical, smooth shape. For oral dosing, the pellets may be sprinkled on food or mixed with water or flavored liquids to form a drinkable oral suspension, which may be ideal for pediatric applications and for patients with swallowing difficulties. Multigram dosing is possible with this approach. For low-dose drugs, the MiniSpheres™ may be dispensed in capsules. Despite their small size, MiniSpheres™ can provide a sustained release profile – up to 24 hours in vitro – even for highly water-soluble drugs. The release profile is adjustable to meet most any dosing requirements. If needed, the taste-masking agents may be incorporated during their production. Key Features of MiniSpheres™: Ideal for high dose (>1-2 grams) drugs Applicable for insoluble and highly water soluble drugs, nutraceuticals, and vitamins Converts multiple dosing/day to complianceenhancing once/day format Simple manufacturing process Manufacturable using conventional equipment Low cost of goods Patent pending To learn how LATITUDE’s MiniSpheres™ can optimize the therapeutic potential of your drug, please contact: Norman K. Orida, Vice President, Business Development 858-546-0924 ext 106 [email protected] 6364 Ferris Square Phone: 858.546.0924 www.latitudepharma.com San Diego, CA 92121 Fax: 858-546-0958 20121008 RTT Rapid Tox Template Formulations LATITUDE Pharmaceuticals, Inc. is now offering a Rapid Tox Template (RTT) Formulation Service to help drug developers maximize oral drug exposure and identify potential toxicity of poorly soluble drug candidates in animal studies. Key Advantages/Properties of RTTs: • • • • • • • • • Proven track records for significantly improving oral bioavailability (up to 16-fold enhancement) for a large number and variety of insoluble compounds. Extremely well tolerated vehicle (MTD >7.5g/kg in dogs). Composed of naturally occurring oils and lipids; do not contain large amounts of organic co-solvents or toxic detergents. May be dosed by oral gavage or filled into capsules. Up to 10% drug load, as permitted by drug solubility. The RTT-formulated compounds are provided with strength (in mg/g or % wt) information. An optional HPLC assay to confirm strength and purity or stability test is available. Each RTT-formulated compound is individually packaged and labeled. Instructions for use/storage are also provided. Minimal API requirements (~200 mg). HPLC method development and in vivo tox evaluation services are also available. For further information, please contact: Norman K. Orida, Vice President, Business Development LATITUDE Pharmaceuticals, Inc. 6364 Ferris Square San Diego, CA 92121 858-546-0924 ext 106 [email protected] 6364 Ferris Square Phone: 858.546.0924 www.latitudepharma.com San Diego, CA 92121 Fax: 858.546.0958 20090924