Nextstep Pharma

<body leftmargin="0" marginheight="0" marginwidth="0" topmargin="0"> <div align="left"> <strong><i>Nextstep Pharma</i></strong><i> - Pharmaceutical product development</i> <p><i>Nextstep Pharma is dedicated to the creation of new pharmaceutical products and formulations. We offer product definition and drug product development, and specialize in finding solutions that improve and speed-up development and production processes.</i></p> <p><strong><i>What Nextstep Pharma can do for you</i></strong></p> <p><i><b>Contact us:</b> When you need to have a new formulation or product; When you need other production technology; When you are annoyed by IP of competition. <b>And also:</b> When you want to work around existing IP; When you have insoluble compounds or insolvable formulation problems; When you want fast results. <b>We achieve/facilitate/speed-up:</b> Formulation of API’s; Formulation of generics; Development of drug products, medical devices, nutraceuticals.</i></p> <p><i><b>Product functionality:</b> better, easier, cheaper, smaller, faster, less side effects. <b>Technical means:</b> process, excipients, dosage form, active. <b>Intellectual property:</b> new patents, prior art, no infringing, inventive step.</i></p> <div align="left"> <p><i><b>Project Highlight - </b>Xechem Nigeria Ltd produces a phyto based drug for the treatment of sickle cell disease, Nicosan. Nextstep Pharma performed production balancing, de-bottlenecking, and redesign of critical production steps. Achievements: Doubling production without investments or costs; Design of adapted process facilitating 40-fold production with minimal investment.</i></p> </div> <p><i><b>THC Formulation - </b>Before starting Nextstep Pharma, Hubert Pellikaan developed a sublingual tablet containing THC (dronabinol USP). A unique formulation was developed to achieve very good solubility, bioavailability and pharmacokinetics. In fact the formulation works better than smoking. This product Namisol® is now in clinical development by Echo Pharmaceuticals. Namisol® may be supplied upon doctor declaration (the Netherlands only).</i></p> <p><strong><i>Services & Products</i></strong></p> <p><i><b>Product development </b>(contract service): Medical devices, Implants, Drug formulation (oral dosage forms, extended release, solubilisation etc), Work around patents/technology/regulatory.</i></p> <p><i><b>Formulation technology development</b> - Formulation of poorly soluble compounds: Current method achieves solubilisation of model compounds testosteron and griseofulvine; High excipient load facilitates low dosed API'i; (0-10 mg dose); Current research focuses on reducing excipient load to broaden the application; IP position is under investigation. Own product development: Nutriceuticals. A range of clinically effective products is being developed now; These products are based on clinical science, combined with decent pharmaceutical formulation technology; Two formulations of generics are currently being developed as a joint project with pharmaceutical companies. </i></p> <div align="left"> <p><i><b>Project Highlight - </b>Development of advanced implant system for aap Implantate AG (confidential). Product functionality specified by aap, from there Nextstep Pharma went through product definition phase and development work to (currently) upscaling and validation batches. Solving technical bottlenecks with other implant products.</i></p> </div> <p><i><b>Patents & IP - </b>Patent batabeses are used extensively as a source of knowledge, inspiration, technology etc. Old, ancient (!) and Japanese databases also yield very usefull approaches.</i></p> <p><strong><i>Approach</i></strong></p> <div align="left"> <p><i><b>Project forms for Product Definition - </b>Typically a product definition project looks like this: Phase 0 - You provide the aim or product! Phase I - A two day scouting phase where the subject is investigated by mining in scientific and patent literature. Normally many possibilities come up here. This phase is concluded by discussing the findings with the client and selecting strategies to proceed. Phase II - A three day phase where selected strategies are studied in more detail. This will result in several preliminary product designs. This phase is concluded by discussing the product designs and selecting the designs for a development project. Phase III - Putting together of a product development project.</i></p> <p><i><b>Contract forms - </b> 1. Phase I + phase II of product definition as a package. 2. Hourly rate. 3. Reduced hourly rate + milestones, success fee’s or royalties. 4. Fixed result fixed price. 5. Your suggestion</i></p> </div> <p><i><b>Project Highlight - </b>PHILIPS Healthcare and Devices. Philips as a technology driven company strong in medical applications is actively developing drug delivery device technology. Nextstep Pharma performs business development activities on confidential device development.</i></p> <p><i><b>Available methods - </b>Through an extensive scientific and business network, many necessary techniques and skills are accessible. Analytics: All regular pharmacopeial methods, including dissolution testing but also less common methods like laser diffraction, ICP-MS, NMR, AES, and typical protein analytics like CD etc. Processing: Drying by evaporation, freeze drying, spray drying, spray freeze drying, SCF drying. Mixing, granulation, spray granulation, (spray) coating. </i></p> <p><strong><i>Projects</i></strong></p> <p><i><b>PHILIPS Healthcare and Devices - </b>Philips as a technology driven company strong in medical applications is actively developing drug delivery device technology. Nextstep Pharma performs business development activities on confidential device development. <b>THC Formulation</b> - Before starting Nextstep Pharma BV, Hubert Pellikaan developed a sublingual tablet containing THC (dronabinol USP ). A unique formulation was developed to achieve very good solubility, bioavailability and pharmacokinetics. In fact the formulation works better than smoking. This product - Namisol® - is now in clinical development by Echo Pharmaceuticals BV Weesp the Netherlands Namisol may be supplied upon doctor declaration (in the Netherlands only). <b>Martin Biggs Associates</b> - Several confidential projects were done with the aim to maintain and/or improve functionality without infringing competitor IP. The combination of the technical imput from Nextstep Pharma with the legal and regulatory view of MBA is outstanding. <b>Xechem Nigeria Ltd</b> - Xechem Nigeria Ltd produces a phyto based drug for the treatment of sickle cell disease, Nicosan. Nextstep Pharma performed production balancing, de-bottlenecking, and redesign of critical production steps. Achievements: Doubling production without investments or costs; Design of adapted process facilitating 40 fold production with minimal investment. <b>Aap Implantate AG</b> - Development of advanced implant systems (confidential). Solving technical bottle necks with other implant products. Product functionality specified by aap. From there Nextstep Pharma went through product definition phase and development work to (currently) upscaling and validation batches.</i></p> <p><i><b>Product Development</b> - Nextstep Pharma also has several projects running for own product development. At this time, a range of clinically effective nutriceutical products is being developed. These products are based on clinical science, combined with decent pharmaceutical formulation technology. Two formulations of generics are currently being developed as a joint project with pharmaceutical companies.</i></p> <p><i><b>Client talk</b> - I am delighted to confirm that Nextstep Pharma has provided both cost effective and practical solutions on several Pharma manufacturing and development projects on which I have commissioned them. Nextstep Pharma has the ability to successfully deal with both normal and phyto pharmaceuticals. Regards, Martin Biggs.</i></p> <p><strong><i>Company</i></strong></p> <p><i><b>Why?</b> Nextstep Pharma is dedicated to the creation of new and/or better pharmaceutical products and formulations. This is were our competence contributes the most value. Besides that, we simply can't resist the challange! <b>How?</b> We recognize the fact that products are more important then technology. Products can create turnover. Technology can do this only through a product. Technology however, can solve any problem on the way to a new product. It can clear the way around IP, regulatory issues, drawbacks, etc. And most of the problems can be solved with existing technology. <b>Where?</b> Many projects are carried out at Nextstep Pharma and at the client's facilities. Often the client's staff is involved, especially when it comes to analytics and production. For specialized methods Nextstep Pharma can rely on the expertise from within it's own network of specialists, who can be subcontracted for this purpose.</i></p> <p><i><b>Your contact</b> - Your contact at Nextstep Pharma is founder and director Hubert Pellikaan, MSc MBA.</i></p> <p><i><b>Expertise network</b> - Nextstep Pharma has a network of dedicated specialists in various fields: Analytical; Intellectual Property (IP); Super Critical Fluid technology; Advanced drying technology; Phyto pharmaceuticals; Registration files, regulatory; Medical devices; GMP manufacturing; Protein/peptide delivery; Inhalation; And more. </i></p> <p><strong><i>Publications</i></strong></p> <p><i>Water as modifier of the DMSO-CO2 phase behaviour: new approach for polymer micronization using the PCA proces. Y. Perez de Diego, H.C. Pellikaan, F.E. Wubbolts, M. Wiggenhorn, G. Borchard, G.J. Witkamp, P.J. Jansens. Proceedings of the 9th Meeting on Supercritical Fluids, Trieste, Italy (2004). • Production of L-PLA microparticles below and above the mixture critical pressure of the system DCM-CO2. Y. Perez de Diego, H.C. Pellikaan, F.E. Wubbolts, G.J. Witkamp, P.J. Jansens. Proceedings of the 9th Meeting on Supercritical Fluids, Trieste, Italy (2004). • Operating regimes and mechanism of particle formation during the precipitation of polymers using the PCA process, J. Y. Perez de Diego, H.C. Pellikaan, F.E. Wubbolts, G.J. Witkamp, P.J. Jansens. Supercritical Fluids 35, 147-156 (2005). • Opening new operating windows for polymer and protein micronisation using the PCA process J. of Supercritical Fluids 36. Y. Perez de Diego, H.C. Pellikaan, F.E. Wubbolts, G. Borchard, G.J. Witkamp, P.J. Jansens. 216-224 (2006). • Nozzle construction for particle formation using super critical anti solvent precipitation. H.C. Pellikaan, F.E. Wubbolts. Proceedings of the 6th Meeting on Supercritical Fluids, Versailles (April 2003). • Microparticles prepared in supercritical fluids as inhalable drug delivery system. H.C. Pellikaan, P.J. Smits, G. Borchard, M. Wiggenhorn, H. Yuasa. Proceedings of the 6th Meeting on Supercritical Fluids, Versailles (April 2003) • Intratracheal administration of insulin dry powder formulation using N-trimethyl chitosan as an absorption enhancer. M. Amidi, H. Pellikaan, W. Hennink, D. Crommelin, W. Jiskoot. Proceedings of the 5th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology, Geneva (2006). • Application of Near- and Supercritical Fluids to Dry Aqueous Liposomal Formulations. M. Wiggenhorn, H.C. Pellikaan, G. Winter. Proceedings of the 5th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology, Geneva (2006). • Preparation and physicochemical characterization of supercritically dried insulin-loaded microparticles for pumonary delivery. M. Amidi, H.C. Pellikaan, A.H. de Boer, D.J.A. Crommelin, W.E. Hennink, W. Jiskoot. EJ of Pharmaceutics and Biopharmaceutics 68, 191–200, (2008). • Diphteria toxoid-containing microparticulate powder formulations for pulmonary vaccination: preparation, characterisation and evaluation in guinea pigs. M. Amidi, H.C. Pellikaan, A.H. de Boer, D.J.A. Crommelin, W.E. Hennink, G. Kersten, W. Jiskoot. Vaccine 25, 6818-6829, (2007).</i></p> <p><strong><i>Patents</i></strong></p> <div align="left"> <p><i>WO 2004006893 A1 Method for particle precipitation using near-critical and supercritical antisolvents. • WO 2003086606 A1, EP 1494796 Process for small particle formation by controlled nucleation and precipitation. • WO 02/102947, EP 1468135 A Method of Processing Lipid Materials in gases. • US2006157091 A1 Device for treating pieces of a substrate at high pressure with a supercritical or near-critical treatment medium, piece by piece or in batches. • EP 05026983.6 Process for stabilisation and drying of liposomes and lipid drug delivery systems. • Cannabinoid formulations: 2 patents filed in september 2006.</i></p> </div> <p><i><b>Special requests</b> - If you would like to recieve a full copy of a publication or patent from the list at this page, please send your request, including your contact information, to: [e-mailaddress].</i></p> <p><i><b>Credits:</b> website design and production: Beelders (<a href="http://www.beelders.nl">http://www.beelders.nl</a>)</i></p> <p><i><b>Copyrights</b> - Nextstep Pharma has the right to change any information contained in its web pages without notice. Nextstep Pharma holds all copyrights to the contents of this website and downloads. All other intellectual property rights are reserved. Visitors may not modify, copy, reproduce, distribute, sell or publish any information obtained from this website. The use of this website and download of it, and the operations of these terms and conditions, shall be governed by the laws of The Netherlands. The courts in The Netherlands shall have exclusive jurisdiction over any dispute arising out of the use of this website.<br>© 2010, Nextstep Pharma B.V., Utrecht, The Netherlands. All rights reserved.</i></p> <p><i><b>Disclaimer - </b>The information, offered on this website by Nextstep Pharma B.V. is intended to be useful and informative and for personal use of the visitor. Although the information has been composed with care, Nextstep Pharma does not represent or warrant its accuracy. It is not intended to provide the basis for any evaluation or decision. The web pages are provided "as is" without warranty of any kind. Nextstep Pharma will not be responsible for the direct or indirect consequences of reliance upon any information contained in this website or for any omission. Nextstep Pharma assumes no responsibility for the contents of any other website to which the Nextstep Pharma website has links.</i></p> <p><i><b>Key words:</b> </i><i>implant, orthopaedics, medical device, drug delivery, phase behaviour, micronization, pca process, sas process, pgss process, gas process, proceedings of the 9th meeting on supercritical fluids, pla, l-pla, dl-pla, plga, polyactive, chitosan, alginate, pectin, hyaluronic acid, collagen, gelatin, inulin, dextran, microparticles, nanoparticles, mixture critical pressure, precipitation of polymers, supercritical fluids, nozzle construction, particle formation, inhalable drug delivery system, intratracheal administration of insulin, dry powder formulation n-trimethyl chitosan, world meeting on pharmaceutics biopharmaceutics and pharmaceutical technology, supercritical fluids, liposomal, liposomes, liposome, supercritically dried supercritical drying, pumonary delivery, diphteria toxoid, microparticulate, pulmonary vaccination, vaccine, supercritical antisolvents, cannabinoid formulation, cannabis thc d9-thc cbd d9-thca thca, echo pharmaceuticals, namisol, poorly soluble compounds, hydrophobic compounds, solid solution, solid dispersion, aap implantate, aap biomaterials, schwarz pharma, tu delft process&energy, uu, utrecht university, xechem, nicosan, niprid, farmalyse, emcm, bactimm, fame holding, implant development, nutriceutical, nutraceutical, health supplement, voedingssupplement, alfa liponzuur, alfa lipoic acid, l-carnitine tartraat, vitaminb-12, yuliv boosters for body and mind, iason-g, iason collagen fleece, rebasol, philips healthcare and devices, martin biggs, cees van der hoeven, marcel boekhoorn, klaas riepma, albert van der veen, hans verkerk, christopher bush, michel van bruggen, geert wijnhoven, toine pieters, yohana perez de diego, frank wubbolts, bas vermeulen, johan bender, michael wiggenhorn, gerrit borchard, geert jan witkamp, peter jansens, peter jan smits, hiroshi yuasa, maryam amidi, wim hennink, daan crommelin, wim jiskoot, gerhard winter, herman vromans, anne de boer, gideon kersten, johan bender, elvira dingeldein, oliver bielenstein, noes de vries, peter york, michel perrut, gerard hofland, robert swift, melville oniyide ireti</i></p> <p><i><b>Links:</b> <a href="http://www.woonfraudeadviseurs.nl">www.woonfraudeadviseurs.nl</a>, <a href="http://www.wijsgerigepraktijk.nl">http://www.wijsgerigepraktijk.nl</a></i></p> <p></p> </div> </body>