Chen Q, Larochelle MR, Weaver DT, Lietz AP, Mueller PP, Mercaldo S, et al. Prevention of prescription opioid misuse and projected overdose deaths in the United States. JAMA Netw Open. 2019;2(2):e187621. Significantly greater partial exposure (AUC) is evident from our PK data for very early time points: 0–4 min, 0–10 min and 10–30 min, although the Tmax values were not significantly different. In the presented studies healthy volunteers were not exposed to opioids due to ethical reasons and hence pharmacodynamics of naloxone was not determined. Nevertheless, more rapid naloxone onset, as evident by the early higher exposure, could improve overdose outcomes in an emergency real-world situation, when time is of the essence. This sets your garden up for life: plants will take in nutrients more easily, and you can watch their yields increase. Djupesland PG. Nasal drug delivery devices: characteristics and performance in a clinical perspective—a review. Drug Deliv and Transl Res. 2013;3(1):42–62. We compared the pharmacokinetics and safety of FMXIN001 versus Narcan® in two clinical trials: a pilot study with 14 healthy adults and a pivotal trial in 42 healthy adults (NCT04713709). The studies were open-label, single-dose, randomized, two-period, two-treatment, two-sequence crossover studies to assess the pharmacokinetics and safety of FMXIN001 versus Narcan® nasal spray. Results

The manufacture of FMXIN001 is based on a modified spray drying process using a Mini Spray Dryer B-290 (Büchi Labortechnik AG.). Briefly, Naloxone hydrochloride dihydrate (3.0 g) was dissolved in an ethanol-water mixture (50:50) with stirring. The clear and homogeneous solution of naloxone hydrochloride is spray-dried using the Mini Spray-Dryer and mixed with lactose monohydrate to yield a product with a final homogeneous level of 20% w/w naloxone hydrochloride dihydrate. The final composition is then introduced into a disposable unit dose device, Aptar Pharma (France), to provide a precise dose of 4 mg naloxone hydrochloride dihydrate upon single intranasal administration. Plant sizes are shown as the grow pot diameter x the total height of the plant. This means the diameter of the grow pot at the top of rim x the total height of the plant including the grow pot. It therefore includes the plant roots etc as well as the height or length of the plant.Hydroculture plants are measured the same way as soil plants, however the grow pots are sized by diameter plus their standardised heights, which allows a water meter to be fitted. For example: an 18/19 grow pot has an 18cm diameter at the rim and is 19cm tall. Trenkel M, Scherließ R. Nasal powder formulations: in-vitro characterisation of the impact of powders on nasal residence time and sensory effects. Pharmaceutics. 2021;13(3):385. Hydroculture plants - These require a hydro kit for assembly, this includes a waterproof pot liner with a base wide enough to accommodate the hydroculture grow pot. The size tip provided for each hydroculture plant provides a recommended size for the external diameter of the decorative pots that will accommodate the specified waterproof liner.

Please note: plant heights are approximate and are provided for indicative purposes only. Plants suitable for hanging may be depicted in a hanging grow pot, the actual grow pot used to ship the plant might not include these attachments. Formulex enables formulators (manufacturers, brand owners, regulatory and R&D teams) to create & validate formula along with micro and macro nutrients, validate product claims and build automated label templates online. FMXIN001 naloxone powder was manufactured and loaded into the Aptar Unit dose powder devices, by Formulex Pharma Innovations (Israel). Optimization of Excipient AmountFORMULEX is stable. All elements are present and will remain available to plants through varying conditions of usage. 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.

In case of a food product disapproval by FSSAI due to regulatory non-compliance, you all want to know What are the approved ingredients as per the respective food categories? What are their permissible consumption limits? Which ingredient or product claim is not a valid one? What are the correct food labelling information? FORMULEX is meticulously formulated to express a pH of 6 when made up with tapwater. Hydroponic growers no longer need to worry about pH.Le Guellec S, Le Pennec D, Gatier S, Leclerc L, Cabrera M, Pourchez J, et al. Validation of anatomical models to study aerosol deposition in human nasal cavities. Pharm Res. 2014;31(1):228–37. 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]. In taller planters they allow for the soil to be contained to an appropriate depth for the plant, without needing to fill the entire vessel with soil. This ensures the root system is surrounded in optimum moisture content rather than it draining to the bottom beyond the roots. The related substances were analyzed by the dedicated method, which was also validated. The same HPLC system was used. An ACQUITY UPLC CSH C18 2.1 × 150 mm column with 1.7-μm particle size was applied. The solution A was prepared from Sodium 1-octanesulfonate buffer pH 2.0, Mobile phase A and B were prepared from Solution A/THF/ACN at different ratios. The gradient program (min/%B) was set as 0/9%, 13/ 30%, 13.1/0%, 24/100%, 24.1/9% and 27/9%. The injection volume was 2.0 μL. The column temperature was set at 35°C and the PDA detection was at 229 nm. The Aptar Unit Dose Powder Device has a maximum fill volume of 130 mm 3 allowing to load a fill weight of 10–80 mg of the powder. A fill weight of 20 mg was selected, therefore, to prevent possible aggregation and to keep the sensory irritation as low as possible. Lactose monohydrate is the only excipient in the formulation and its amount was established as 16 mg in the device. Formulation Analysis - HPLC