FMXIN001 comprises naloxone microspheres (5-30 μM) and lactose particles (40–240 μM). Upon in vitro testing, naloxone deposits mainly to the middle turbinates region and the upper part of the nasal cavity of a nasal cast. In human subjects, FMXIN001 produced significantly higher exposure at the initial time points of 4, 10, and 30 min, post-administration, compared to Narcan®. Both treatments were safe and well tolerated. FMXIN001, powder-based spray, results in similar overall exposure to Narcan®, but with more rapid absorption in the first 30 min. Conclusions

FORMULEX is meticulously formulated to express a pH of 6 when made up with tap water. Hydroponic growers no longer need to worry about pH. Rzasa Lynn R, Galinkin J. Naloxone dosage for opioid reversal: current evidence and clinical implications. Therapeutic Advances in Drug Safety. 2018;9(1):63–88.

Exclusive hydroponics offers straight to your inbox.

Dilute 5ml of concentrated solution per litre of water and mix well. Spray thoroughly onto plants, ensuring that the leaves are thoroughly coated. For safety reasons, avoid spraying near or onto your grow lighting. Concentrations of unconjugated naloxone were measured by LC MS/MS from plasma samples collected over an 8-h interval after dosing in each period. The PK variables C max, AUC 0-8h, AUC inf, AUC 0-4min, AUC 0-10min, AUC 10-30min, T max, K el, and T half were calculated using a noncompartmental approach. Djupesland PG, Skretting A. Nasal deposition and clearance in man: comparison of a bidirectional powder device and a traditional liquid spray pump. Journal of Aerosol Medicine and Pulmonary Drug Delivery. 2012;25(5):280–9. Lin Y-W, Wong J, Qu L, Chan H-K, Zhou Q. Powder production and particle engineering for dry powder inhaler formulations. CPD. 2015;21(27):3902–16.

The naloxone administration in our pivotal study was generally well-tolerated by the healthy subjects. No serious adverse events (SAEs) were reported and none of the AEs had a significant impact on the safety of the subjects or on the integrity of the study results. No effect of the treatment was recorded on the sense of smell by validated smell test [ 18, 19]. Within 45 min from collection, whole blood samples were centrifuged at approximately 4°C for approximately 10 min at 3000 rpm for plasma separation. Within 45 min from centrifugation, plasma was aliquoted into 2 aliquots pending total naloxone analysis and stored at −25 ± 10°C. The bioanalysis of unconjugated naloxone in the plasma samples was performed using a validated LC-MS/MS method. Bioanalytical Method If you are a brand owner, manufacturer, regulatory person or on R&D team and works with the large number of health and dietary supplement products you’ll probably value any tool that:

Quality: Gives you accurate information about what are regulatory requirement for formula, , claims and label compliance as per the FSSAI. Quality of regulatory service is not known and consistent. All steps are performed manually, have a chance of lapses in analysis hence prone to human error.Formulex with the help of it’s proprietary algorithm provide 100% accurate reports every time as per the laid guidelines by the FSSAI. Determine the plant's grow pot diameter. Compare this to the size of the opening of your chosen decorative pot and ensure it is big enough to insert the plant's grow pot through the opening (see diagram below). In each period, 17 samples (10 ml) were collected by direct venipuncture or from an indwelling cannula, placed in an arm vein as follows: prior to dosing (0-h) and at 0.033, 0.067, 0.1, 0.133, 0.167, 0.25, 0.333, 0.416, 0.5, 0.75, 1, 2, 3, 4, 6, and 8 h after drug administration. The pre-dose sample was collected within 60 min prior to dosing. The samples were maintained in an ice-water bath throughout sample collection and until further processing.

A pilot study and a pivotal clinical study were performed in 14 and 42 healthy volunteers, respectively, according to a similar protocol. The primary objective in both studies was to evaluate the comparative bioavailability of naloxone between FMXIN001 Naloxone Microspheres Powder 4 mg for Nasal Application (Nasus Pharma, Israel) and Narcan® (naloxone HCl) NASAL SPRAY 4 mg (Adapt Pharma, Inc., USA) after a single-dose in healthy subjects under fasted conditions. The secondary objective was to evaluate the safety and tolerability of the study treatments (NCT04713709). The pilot study results (see on-line resource Fig. S3 and Table S.II) supported progression to the pivotal study, described here. FMXIN001 naloxone powder was manufactured and loaded into the Aptar Unit dose powder devices, by Formulex Pharma Innovations (Israel). Optimization of Excipient Amount Dunne RB. Prescribing naloxone for opioid overdose intervention. Pain Management. 2018;8(3):197–208. FORMULEX is complete. It is designed for hydroponic applications where every nutrient element must be supplied in solution.For hydroculture plants use the size tip to select a decorative pot that will accommodate the waterproof liner recommended for the plant in the hydro kit. Large items are sent via a standard 48L (48 hour large) service. Large items take from 2 working days to arrive. Jain MS, Lohare GB, Bari MM, Chavan RB, Barhate SD, Shah CB. Spray drying in pharmaceutical industry: a review. Research Journal of Pharmaceutical Dosage Forms and Technology. 2012;4:74–9. Formulex has a buffered pH and generally requires no pH correction once in solution. It is exceptionally versatile and simple to use. It is an excellent nutrient for soil grown plants and perhaps the ultimate fertiliser for all house plants. Liners come in various sizes to fit the internal dimensions of the pot and can be trimmed down to size to create an unobtrusive barrier for the plant and soil to be potted into, whilst protecting the pot from unsightly calcium or fertiliser deposits from the soil.