Formulex 1L

Product Information

Both methods were validated per USP <1225> and deemed suitable for intended use per the results shown in the on-line resource Table S.I. Formulation Analysis - Scanning Electron Microscope Stable: All elements are present and will remain available to plants through varying conditions of usage. It has been reported that powder-based intranasal formulations may reach the blood stream faster and have better bioavailability than liquid sprays due to significantly larger deposition in the nasal mucosa [ 2, 9, 11]. Faster naloxone absorption is paramount when treating opioid overdose since this is an emergency situation with victims suffering respiratory depression for an unknown period, and at a high risk of death if not treated promptly. 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 To examine the pharmacokinetics and safety of FMXIN001, a new intranasal powder-based naloxone formulation, in comparison to Narcan® nasal liquid spray. Methods

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). With 1000+ ingredients, six food categories and evolving regulations, do you have the information and insights you need to create a market compliant nutraceutical product with a compliant formulation, valid claims and appropriate label? Hoekman J, Ray S, Aurora SK, Shrewsbury SB. The upper nasal space—a novel delivery route ideal for central nervous system drugs. US Neurology. 2020;16(1):25.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. Ryan SA, Dunne RB. Pharmacokinetic properties of intranasal and injectable formulations of naloxone for community use: a systematic review. Pain Management. 2018;8(3):231–45. The administration of nasal powder formulations has been associated with greater sensory irritation than liquid sprays and the amount of powder is recommended to be kept as low as possible, preferably about 20 mg or below [ 15]. 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. Formulex has an acidity buffer and usually requires no pH adjustment after mixing with water. One bottle covers everything the plants need, making it very versatile and easy to use. It is ideal for all soil growing plants and some say it is the ultimate fertilizer for all house plants. Formulex contains all the macro and micro nutrients your plants need for optimum growth. Many gardeners use it to start their plants off before moving onto stronger nutrients that may be more specific to the plant they are growing. Formulex has a lower NPK than other nutrients for the vegetative stage. Therefore it is more gentle on the plant which gives peace of mind that they won’t be getting nutrient burn. How to use Formulex for best results.

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 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. Rawal S, Hoffman HJ, Honda M, Huedo-Medina TB, Duffy VB. The Taste and Smell Protocol in the 2011–2014 US National Health and Nutrition Examination Survey (NHANES): Test–Retest Reliability and Validity Testing. Chem Percept. 2015;8(3):138–48. Overall, FMXIN001 displayed greater peak and total systemic exposure, with earlier onset of action (supported by greater partial exposures) for total and unconjugated naloxone when compared to the reference product, Narcan® (naloxone HCl) nasal spray 4 mg (Adapt Pharma, Inc., USA), after a single dose in healthy subjects under fasted conditions. Treatment B: Naloxone HCl, (Narcan® NASAL SPRAY) 4 mg (Adapt Pharma, Inc., USA) for one actuation in the right nostril.

Pilot and pivotal open-label, single-dose, randomized, two-period, two-treatment, two-sequence, crossover studies, evaluated the bioavailability profile of FMXIN001 compared to Narcan® reference product in a total of 56 (14 + 42) healthy adult subjects. The pivotal study population was heterogenous with a reasonable distribution across all variables, but with slight bias in favor of more female than male subjects (Table I), which was not considered to impact the study conclusions. Bioavailability of Dry Powder and Liquid Naloxone Intranasal Spray Formulex can be used for new product development as well as life cycle management of existing products to ensure continued compliance. 4 reasons you should use Formulex for your formulation compliance? Formulex has a buffered pH, meaning that it prevents large variations in acidity level and will remain stable. There’s usually no need to adjust its pH before use! I take it you've used half strength bloom for foliar feeds, starting off clones and feeding seedlings and the reults have not been good? Nasal powder formulations are generally simple compositions with or without excipients, which allow for the administration of larger drug doses and enhance drug diffusion and absorption across the mucosa, improving bioavailability compared to nasal liquids [ 1]. Addition of lactose excipient, for example, to the formulation increases the fluid volume on the nasal mucosal surface by increasing the osmotic pressure, which can improve absorption of some drugs [ 2]. Excipients may also confer better stability and longer shelf-life as compared to the fluid nasal sprays.