Tanaka A. Optimization of nasal drug absorption from powder formulations: the feasibility of controlling drug absorption by the use of pharmaceutical excipients. Yakugaku Zasshi. 2018;138(12):1467–72.

Formulex is a complete, balanced and stabilised nutrient solution formulated with all the macro and micro nutrients required for optimal plant growth. Formulex signifies a breakthrough in plant nutrition because: Treatment B: Naloxone HCl, (Narcan® NASAL SPRAY) 4 mg (Adapt Pharma, Inc., USA) for one actuation in the right nostril. Dunne RB. Prescribing naloxone for opioid overdose intervention. Pain Management. 2018;8(3):197–208. 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. 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.

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Treatment A: Naloxone Intranasal Spray 4 mg (FMXIN001 4 mg microspheres powder, nasal spray, containing 16 mg lactose as an excipient) (Nasus Pharma, Israel). Intranasal administration was using the Unit Dose Powder Device (Aptar Pharma, France) for one actuation in the right nostril.

Formula compliance- Formulex offers the users the ability to create, maintain, assess product formulas, and formulations for regulatory compliance. The user can select multiple ingredients to create formulas, add daily consumption, view the acceptability of the ingredient use levels and combinations. Formulex automatically performs the necessary calculations for RDA analysis, permitted range, permitted level according to the FSSR guidelines Liu G, Zong G, Doty RL, Sun Q. Prevalence and risk factors of taste and smell impairment in a nationwide representative sample of the US population: a cross-sectional study. BMJ Open. 2016;6(11):e013246. Particle engineering with lactose excipient is well known in the field of dry powder inhalation to the lungs (see for example, [ 25, 26]). Its application specifically for intranasal delivery is, however, less common. The FMXIN001 unique Microspheres Powder formulation is comprised of uniform microspheres (10-30 μm) together with much larger lactose carrier particles (Fig. 1) which enables deposition beyond the nasal valve, but the particle size precludes distribution into the airways or lungs. Upon intranasal delivery with the Aptar device the smaller naloxone microspheres may collide with the larger lactose particles to increase their distribution to the upper mucosa, as was found by in vitro deposition experiment using a nasal cast (Fig. 3). As well as serving as a carrier, the lactose serves as a disaggregating agent which may aid in maintaining the amorphous nature of naloxone microspheres, likely contributing to the product’s physical stability, expressed in particle size distribution (PSD), delivered doses uniformity and aerodynamic PSD. Disaggregation is important to keep the powder flowability and the carrier capacity of the lactose is helpful in assuring the full dosage of the powder is sprayed from the device. The administration of the study drug was generally well-tolerated by the healthy subjects who participated in this study. Overall, 9 mild TEAEs affecting 4 subjects (28.6% of subjects dosed) were reported during the conduct of the study (21.4% following treatment A and 21.4% following treatment B), all of which had a possible relationship to the investigational medicinal product (IMP), and were not related to the study device. No local irritation in the nasal cavity was observed or reported by the subjects. No SAEs were reported during the conduct of this study and none of the AEs had a significant impact on the safety of the subjects or on the integrity of the study results. Pivotal Study DemographicsBiocidal, ultrasonic and general purpose cleaners. Degreasers for theremoval of grease, grime, oils and tar for engines, machinery, tanks, chassis, concrete floors etc. 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 Tiozzo Fasiolo L, Manniello MD, Tratta E, Buttini F, Rossi A, Sonvico F, et al. Opportunity and challenges of nasal powders: drug formulation and delivery. Eur J Pharm Sci. 2018;113:2–17. 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. Complete: designed for hydroponic applications where every nutrient element must be supplied in solution.