Search Results

Nextar is pleased to announce positive pre-clinical acute toxicity results for our proprietary BTLS delivery technology, which facilitates targeted delivery of versatile drugs into the brain. These results present a significant milestone in the clinical development of our pipeline of proprietary novel brain therapies. Furthermore, these results add substantial value to Nextar's ability to commercialize and partner with other pharmaceutical companies looking to develop brain and CNS targeted therapeutics. Nextar's proprietary BTLS drug-delivery platform is a liposomal vehicle combined with a unique Targeter that allows molecules to cross the Blood-Brain Barrier, thus enabling brain-specific delivery of versatile therapeutic agents. Read more about our platform's advantages .

Dr Orna Dreazen, CEO of Nextar and former General Director of the Israeli Laboratory Accreditation Authority (ISRAC), gave a webinar presentation on medicinal formulation development essentials. Dr Dreazen focused on the proper planning of the development process while keeping the end in mind, by performing risk management for the various stages of the drug life cycle, from drug development to commercial production. Thanks to all the participants in the webinar. Watch the webinar (in Hebrew) or download the pdf presentation (in English): Formulation Development Essentials Presentation:

Recently, Nextar's subsidiary (Nextage Therapeutics, TASE:NXTG) announced that they had completed the development of a unique formulation which allows targeted delivery of CBD and other cannabinoids to the brain. This formulation is an adaptation of the technology developed by Nextar and provides a solution for the main challenge in treating brain-diseases: efficient delivery of drugs through the Blood-Brain Barrier (BBB). Okay ... but we know that CBD reaches the brain without the utilization of special technologies. So why fix something that is not broken? The main challenge is targeting Cannabinoids treatment only to the brain The use of cannabinoids for medical purposes has become increasingly common in recent years, and patients can choose between different routes of administration based on the required medical treatment and their personal needs. There are a few routes for administration of cannabinoids into the body, each has its pros and cons. Most of them (all but topical administration) result in systemic exposure. This none-specific exposure poses several challenges: 1. Unwanted side effects The endocannabinoid system is an endogenous system. The endocannabinoid receptors are the most abundant receptors in the human body. Hence, APIs from cannabis and/or cannabis-based treatments will be non- specifically bound to the relevant receptors in the body in addition to the brain. While at times, this type of interaction can be beneficial, it may also cause undesired side-effects when targeting the brain. 2. Administration of excessive cannabinoids dosages The blood-brain barrier is a protective layer which prevents the entry of chemicals and pathogens to the most vital and sensitive organ in the body. It is a known fact that cannabinoids can cross the blood-brain barrier and thereby reach the brain. The challenge arises when cannabinoids are exposed systemically, as only a small part of the administered dosage finds its way into the brain while the rest gets systemically dispersed. With the capability of specifically targeting the brain, it is possible to reach therapeutic levels at the brain using lower cannabinoids concentrations. This will result in minimizing unwanted side effect, prolonging the effect in the brain, minimize possible organ damage, and possibly reduce the product cost. 3. Cannabinoids accumulation in tissues and organs Although the use of cannabinoids is considered safe, during research done by GW Pharmaceuticals on patients treated with Epidiolex® (Cannabidiol) it was noted that a significant percentage of the patients (16%) had shown an increase in liver enzymes. This observation indicates that although their product is designed to affect the brain in the treatment of Lennox-Gastaut syndrome or Dravet syndrome, it still might cause undesired liver activity and possible damage. Another example of unwanted accumulation of cannabinoids in body tissues is in mother's milk. Studies have shown residues of THC at least six days after administration. Thus, mothers in need of medical cannabinoids treatment are facing two choices: avoid breastfeeding or discontinue the treatment. Accumulation of cannabinoids in the body might also affect the endocannabinoids tone and enhance malfunctions. Therefore, by using a targeted brain delivery technology, these types of accumulation of cannabinoids in tissues and organs are reduced, and possible damage to body organs minimized. Although the endocannabinoid system challenge is unique to cannabinoids, the latter two challenges exist for most drugs designed to treat brain-related diseases. The apparent need for the improvement of therapies for brain-diseases treatment led Nextar and Nextage to invest and further develop unique technology for targeted treatment of the brain-related diseases. This technology provides a solution for the main challenge in treating brain-diseases: efficient delivery of drugs through the Blood-Brain Barrier (BBB). Want to learn more about our drug delivery system and how it works? The second part of this article will be published soon. Subscribe here for updates on new blog posts.

formulation Development anlaytical Development test Articles Preparation Preclinical trials Bioanalytical testing manufacturing scale up Analytical method validation manufacturing Stability testing clinical trials Test Articles Preparation Non-clinical studies (also known as preclinical trials) are usually composed of two types of experiments: in-vitro (experiment conducted in a laboratory tube/dish on cells, microorganisms, etc.) and in-vivo (experiments in/on a living organism). The data gained from these studies is then used to assess the safety of the product for human use. Preparation of a drug prototype, commonly referred to as "test articles", is required for both types of experiments. ​ The non-clinical phase begins very early in the development process of a drug, with the final formulation usually still unknown. Test articles prepared at such an early stage are frequently composed of a simple mixture of the active ingredient (API) with a generic media (i.e., cream, solution, etc.). As the development process progresses, the test articles should resemble the intended clinical material, and therefore the preparation procedure should be similar to the future manufacturing process . Using the final formulation in preclinical trials can establish a safety profile that will pave the way to first-in-man trials. ​ Tip from our scientists The characteristics of the formulation compounds may vary between different manufacturers due to diverse synthesis processes, equipment, chemical substances, etc. Those differences may affect the types and levels of impurities and contaminations found in the formulation which in turn may affect the physical, chemical, and microbial characteristics of the drug. ​ Using the same compounds for both test articles preparation and Clinical Trial Material (CTM) production can provide accurate information on drug safety and effectiveness. Therefore, it is recommended that manufacturers of raw materials will be chosen prior to test articles preparation. Previous stage Next stage Services for you Preparation of test articles for pre-clinical efficacy/toxicity studies. ​ Bioanalysis of tissues and body fluids such as plasma, serum, urine, vitreous fluid, CSF, and cerebral fluid. Development and validation of bioanalytical methods for quantitation of active drugs, natural compounds, and metabolites. ​ GLP testing and documentation. ​ Formulation development of innovative drugs- New Chemical Entity (NCE), cytotoxics, and biologicals. ​ Formulation development of injectables, topical creams, ophthalmic solutions, suspensions, emulsions, foams. ​ Reformulation, repositioning, repurposing of generic drugs. ​ Improvement of solubility and bioavailability. ​ Taste masking. ​ Contact Us

Your Development Journey I'm interactive manufacturing GMP stage Read More > Analytical method validation GMP stage Read More > manufacturing scale up R&D stage Read More > Preclinical trials clinical trials Stability Testing GMP stage Read More > test Articles Preparation R&D stage Read More > anlaytical Development R&D stage Read More > formulation Development R&D stage Read More > Bioanalytical testing GLP stage Read More >

Chemistry Services Rapid development of new drug candidates Custom synthesis is required for new drug candidates' development as well as for identifying impurities, degradation products of known drugs and analogs. Our experienced chemists can help you fulfill your needs and aims through robust and streamlined processes. Preparative separation is available for purification of synthesized molecules and related substances. Services for you Synthetic processes for the preparation of lab-scale quantities of: New Chemical Entities (NCE) Active Pharmaceutical Ingredients (API) Pro-drugs Analogs Intermediates Impurities Metabolites Degradation products Reference standards ​ Compound optimization using structure-based drug design. ​ Custom synthesis of small libraries based on scaffolds to improve pharmacological or pharmaceutical properties. ​ Synthesis of analogs for structure-activity relationship (SAR) studies . ​ Contact Us