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. 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

X-ray diffraction (XRD) pattern images of naloxone HCl raw material, lactose monohydrate or naloxone microspheres mixed with lactose monohydrate (batch PNLX070729) are shown in the on-line resource Fig. S1. Naloxone HCl peaks are not observed in the XRD pattern for naloxone microspheres, with the peaks determined due to lactose monohydrate, consistent with an amorphous microsphere structure. Following storage for 6 months, the amorphous microsphere structure is maintained, as judged by XRD, shown in on-line resource Fig. S2. Dry-Powder Deposition In Vitro Nasal Cast Study 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.

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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.

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.Djupesland PG, Messina JC, Mahmoud RA. Role of nasal casts for in vitro evaluation of nasal drug delivery and quantitative evaluation of various nasal casts. Ther Deliv. 2020;11(8):485–95. 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. Descriptive statistics from the pivotal study of naloxone treatments A and B for plasma unconjugated naloxone PK variables are summarized in Table II and further detailed in the on-line resource Table S.III. Conclusions from PK Statistical Analysis

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. Cady R. A novel intranasal breath-powered delivery system for sumatriptan: a review of technology and clinical application of the investigational product AVP-825 in the treatment of migraine. Expert Opin Drug Deliv. 2015;12(9):1565–77.NARCAN® prescribing information (2015). Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208411lbl.pdf Complete: designed for hydroponic applications where every nutrient element must be supplied in solution. FDA Draft Guidance: Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA (2013). Retrieved from https://www.fda.gov/files/drugs/published/Bioequivalence-Studies-With-Pharmacokinetic-Endpoints-for-Drugs-Submitted-Under-an-Abbreviated-New-Drug-Application.pdf