Nangenex Inc.

Zahony, Hungary

Nangenex Inc.

Zahony, Hungary
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Solymosi T.,Nangenex Inc. | Otvos Z.,Nangenex Inc. | Angi R.,Nangenex Inc. | Ordasi B.,Nangenex Inc. | And 9 more authors.
Cancer Chemotherapy and Pharmacology | Year: 2017

Purpose: Zytiga (abiraterone acetate, AA) is known to exhibit very low bioavailability and a significant positive food effect in men. The unfavorable pharmacokinetic properties are attributed to the inadequate and variable dissolution of the compound. Using a continuous flow precipitation technology, a novel AA formulation has been developed with improved solubility and dissolution characteristics. The current study was performed to evaluate the pharmacokinetics and safety of this novel formulation in healthy volunteers. Methods: The study was conducted in 11 healthy men aged 47–57 years. All subjects received 3 consecutive single doses of the novel formulation of AA (100 and 200 mg in the fasted state and 200 mg in the fed state). Data were compared with pharmacokinetic and safety data reported for 1000 mg Zytiga, the marketed drug. Results: The novel formulation of AA allows rapid absorption of the compound with tmax values within 1 hour. Based on AUC values, a ~250 mg dose of the novel formulation is predicted to give the same exposure as 1000 mg Zytiga in the fasted state. The significant positive food effect was also eliminated; actually, a slight, but statistically significant negative food effect was observed. Variability of exposure was significantly reduced when compared to Zytiga. AA administered in the novel formulation was well tolerated with no IMP-related safety AEs reported. Conclusion: The novel formulation might allow a 75% dose reduction with significant reduction of inter-individual variability. The negative food effect observed requires further investigations; however, elimination of the significant positive food effect could be adequate to negate the restriction of a food label. © 2017 Springer-Verlag GmbH Germany


Filipcsei G.,Nangenex Inc. | Sumaru K.,Japan National Institute of Advanced Industrial Science and Technology | Takagi T.,Japan National Institute of Advanced Industrial Science and Technology | Kanamori T.,Japan National Institute of Advanced Industrial Science and Technology | Zrinyi M.,Semmelweis University
Journal of Molecular Liquids | Year: 2014

Novel hydrogels that shrink in response to light irradiation and temperature change have been developed. Since any technical application of polymer gels critically depends on the response rate, therefore porous hydrogels have been prepared in order to accelerate the response reaction. Poly(N-isopropylacrylamide) gels were functionalized with photo-responsive spirobenzopyran and solvent/nonsolvent mixtures were used as swelling agent to introduce network heterogeneities during the gelation process. Both photo- and thermo-responsive properties of gels have been investigated and compared. The time dependence of bending deformation due to the asymmetric light irradiation as well as kinetics of shrinking has been measured. It was found that the fastest photo- and thermo-responsive shrinking was observed for loosely crosslinked porous hydrogels. Furthermore, it was confirmed that the highly cross-linked cylindrical gel rod with macroporous structure showed rapid bending deformation due to the asymmetric light irradiation. © 2013 Elsevier B.V.


Solymosi T.,Nangenex Inc. | Angi R.,Nangenex Inc. | Basa-Denes O.,Nangenex Inc. | Ranky S.,Nangenex Inc. | And 4 more authors.
European Journal of Pharmaceutics and Biopharmaceutics | Year: 2015

Abstract The oral bioavailability of Sirolimus is limited by poor dissolution of the compound in the gastrointestinal tract resulting in a low bioavailability and large inter-individual differences in blood levels. Several different formulation approaches were applied to overcome these disadvantageous pharmacokinetic properties including the marketed oral solution and a tablet form containing wet milled nanocrystals. These approaches deliver improved pharmacokinetics, yet, they share the characteristics of complex production method and composition. We have developed a nanostructured Sirolimus formulation prepared by the controlled continuous flow precipitation of the compound from its solution in the presence of stabilizers. We have shown that contrary to the batch production the process could be easily intensified and scaled up; apparently the uniformity of the precipitation is heavily dependent on the production parameters, most likely the mixing of the solvent and antisolvent. We compared the physicochemical and pharmacokinetic properties of the nanostructured formula with the marketed nanoformula. We found that our method produces particles in the size range of less than 100 nm. The solid form redispersed instantaneously in water and in biorelevant media. Both the solid form and the redispersed colloid solution showed excellent stability even in accelerated test conditions. The oral administration of the nanostructured formula resulted in faster absorption, higher exposure and higher trough concentrations when compared to the marked form. These advantageous properties could allow the development of solid oral Sirolimus formulae with lower strength and gel based topical delivery systems. © 2015 Elsevier B.V.


Heltovics G.,Nangenex Inc. | Otvos Zs.,Nangenex Inc. | Filipcsei G.,Nangenex Inc. | Darvas F.,Nangenex Inc.
Nanotechnology 2010: Bio Sensors, Instruments, Medical, Environment and Energy - Technical Proceedings of the 2010 NSTI Nanotechnology Conference and Expo, NSTI-Nanotech 2010 | Year: 2010

Nanotechnology provides new innovative solutions for original as well as generic applications in a wide variety of industries including pharmaceuticals, cosmetics, foods, nutraceuticals and home care. Nanoformulation is the reduction of particles size down to below 200 nm. This size reduction below 200 nm by using continuous flow nano precipitation technology led to 100s fold higher solubility and 103-4 fold increased drug concentration in a stable colloid solution. In the paper we will discuss the perspectives and pharmacokinetic benefits of the nanostructured active molecules over the parent active molecules. The bioavailability of reference and nanostructured drug was determined after oral administration (30 mg/kg) in fasted state at Sprague-Dawley rats. Nanosized drug had an AUC15-360min value of 6412 μg·min/ml while this value after reference treatment was 940.1 μg-min/ml. The ratio of the two AUC values (AUC 15-360min(nanosized)/AUC15-360min(reference)) was 6.82.


Angi R.,Nangenex Inc. | Solymosi T.,Nangenex Inc. | Otvos Z.,Nangenex Inc. | Ordasi B.,Nangenex Inc. | And 4 more authors.
European Journal of Pharmaceutics and Biopharmaceutics | Year: 2014

The oral bioavailability of Aprepitant is limited by poor dissolution of the compound in the gastrointestinal tract which is more prominent in the fasted state resulting in significant positive food effect. Due to the low aqueous solubility of the active substance the product development has been focused on decreasing the particle size of the active compound down to the submicron range in order to overcome this disadvantageous pharmacokinetic property. The marketed drug consisting of wet-milled nanocrystals exhibits significantly higher oral bioavailability in the fasted state and reduced food effect when compared to the unformulated compound. We have developed a novel process for the production of a nanostructured Aprepitant formulation in which the generation of the nanosized particles takes place at molecular level. The process relies on controlled continuous flow precipitation of the compound from its solution in the presence of stabilizers. The precise control of the production parameters (mixing geometry, flow rates, temperature, etc.) allows to tailor the physicochemical properties and biological performance of the active compound. We have prepared a novel nanostructured Aprepitant formulation using this method and compared its physicochemical and pharmacokinetic properties with the reference compound and the marketed nanoformula. We found that our method produces a stable amorphous solid form comprising novel nanostructured particles having a particle size of less than 100 nm with instantaneous redispersibility characteristics and improved apparent solubility and permeability. In vivo beagle dog pharmacokinetic studies showed that the novel formula exhibited greatly improved pharmacokinetic characteristics when compared to the reference compound, while serum blood concentrations for the nanostructured formula and the wet-milled formula were similar. The marked food effect observed for the reference compound was practically eliminated by our formulation method. These results indicate that the novel continuous flow precipitation technology is a suitable tool to prepare nanostructured formulations with similar, or even superior in vitro and in vivo characteristics when compared to the industrial standard milling technology. © 2013 Elsevier B.V. All rights reserved.


Trademark
Nangenex Inc. | Date: 2013-12-02

Medicines, chemical preparations for medical purposes; dietetic supplements for medical purposes; nutritional supplements, foodstuffs for microorganisms; diagnostic preparations. Diagnostic instruments, observation instruments, measuring instruments, precision measuring apparatus, electronic measuring devices, electronic monitoring apparatus, signalling instruments, regulating instruments; laboratory instruments. Pharmaceutical research-development; scientific laboratory services; research and development of new products for others.


Trademark
Nangenex Inc. | Date: 2014-04-15

Medicines for humans; chemical preparations for medical purposes; food substances adapted for medical use; nutritional supplements; nutritive substances for microorganisms; diagnostic preparations for medical purposes. Medical research and development; scientific laboratory services; research and development of new product for others.


PubMed | Druggability Technologies Holdings Ltd. and Nangenex Inc.
Type: | Journal: European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V | Year: 2015

The oral bioavailability of Sirolimus is limited by poor dissolution of the compound in the gastrointestinal tract resulting in a low bioavailability and large inter-individual differences in blood levels. Several different formulation approaches were applied to overcome these disadvantageous pharmacokinetic properties including the marketed oral solution and a tablet form containing wet milled nanocrystals. These approaches deliver improved pharmacokinetics, yet, they share the characteristics of complex production method and composition. We have developed a nanostructured Sirolimus formulation prepared by the controlled continuous flow precipitation of the compound from its solution in the presence of stabilizers. We have shown that contrary to the batch production the process could be easily intensified and scaled up; apparently the uniformity of the precipitation is heavily dependent on the production parameters, most likely the mixing of the solvent and antisolvent. We compared the physicochemical and pharmacokinetic properties of the nanostructured formula with the marketed nanoformula. We found that our method produces particles in the size range of less than 100nm. The solid form redispersed instantaneously in water and in biorelevant media. Both the solid form and the redispersed colloid solution showed excellent stability even in accelerated test conditions. The oral administration of the nanostructured formula resulted in faster absorption, higher exposure and higher trough concentrations when compared to the marked form. These advantageous properties could allow the development of solid oral Sirolimus formulae with lower strength and gel based topical delivery systems.

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