Kane, Michael Publications
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Item Current Understanding of Sodium N-(8-[2-Hydroxylbenzoyl] Amino) Caprylate (SNAC) as an Absorption Enhancer: The Oral Semaglutide Experience.(Clinical Diabetes, 2024-01) Solis-Herrera, Carolina; Kane, Michael P; Triplitt, CurtisOral administration of peptide therapeutics faces challenges because of the distinct environment of the gastrointestinal tract. An oral formulation of semaglutide, a glucagon-like peptide 1 receptor agonist, was approved by the U.S. Food and Drug Administration in 2019 as a peptide therapy for the treatment of type 2 diabetes. Oral semaglutide uses sodium N-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC) technology to enhance the absorption of semaglutide in the stomach and protect it from degradation by gastric enzymes. This article presents a summary of studies investigating SNAC technology as an absorption enhancer for a number of molecules and, in particular, explores how SNAC, once coformulated with oral semaglutide, facilitates increased absorption and bioavailability. Practical advice and dispensing information for pharmacists is also provided.Item Measurement of free fraction, total concentration and protein binding for testosterone, triiodothyronine and thyroxine.(Bioanalysis, 10/17/2023) Klock, Emily*; Kane, Michael P; Musteata, Florin MMeasuring the total and free concentrations of hormones is useful, but the technology to do this simultaneously is lacking. A new method offers the ability to measure these parameters concurrently for testosterone, thyroxine and triiodothyronine. The free concentrations showed significant correlations with patients' vital statistics. Overall, 67% of correlations for total concentration showed that the new and classical methods had equal accuracy, or that comprehensive ultrafiltration was more accurate. The protein binding term was found to correlate significantly with the patients' luteinizing hormone, prostate-specific antigen and height. Comprehensive ultrafiltration for measuring the total concentration, free concentration and protein binding term uses less sample and is much faster than measuring these parameters with three separate methods.Item Comparison of liquid-liquid extraction, microextraction and ultrafiltration for measuring free concentrations of testosterone and phenytoin.(Bioanalysis, 1/17/2022) Cibotaru, Dorina*; Celestin, Marie N*; Kane, Michael P; Musteata, Florin MThe purpose of the study was to find methods suitable for measuring the free concentrations of testosterone and phenytoin. Sample solutions of the compounds in buffer and human albumin were processed using liquid-liquid extraction, microextraction and ultrafiltration and analyzed by LC-MS/MS. Liquid-liquid extraction with dibutyl phthalate provided complete extraction from buffer solutions and partial extraction from albumin samples. Spintip C18 devices provided exhaustive extraction from buffer and albumin samples. Spintip C8 devices offered complete extraction from buffer and approximately 50% recovery from albumin samples. Centrifree ultrafiltration devices showed high recovery of free concentrations from all the samples, while Amicon and Nanosep devices provided partial recovery. Spintip C8 and Centrifree devices proved useful for measuring free concentrations.Item Implementation of an anabolic therapy program and follow-up of patients prescribed abaloparatide: real-world results of a pharmacist-led osteoporosis clinic(Current Trends in Endocrinology, 2022) Kane, Michael P; Arceri, Veronica R ++; Quinn, Hugh B ++; Telese, Mallory ++; Racz, Michael J; Busch, Robert SUtilizing anabolic osteoporosis therapies presents with challenges, including patient acceptance of injections, addressing medication safety concerns, and achieving medication access. We developed a pharmacist-run clinic to ensure the safe and effective use of these therapies. Primary endpoints were comparison of dual energy X-ray absorptiometry (DXA) T-scores and bone mineral density (BMD) values of the total hip, femoral neck, spine, and wrist at baseline, after abaloparatide therapy, and following 1 year of follow-on antiresorptive therapy. The secondary endpoint was the number of documented fractures during the evaluation period. 146 patients were referred for abaloparatide treatment. Ninety-one patients initiated treatment: average age was 66.7 (± 7.7) years, 56% had a history of osteoporotic fracture, baseline T-Scores of the femoral neck and spine were -2.5 (± 0.7), and -2.4 (± 1.3), respectfully. Mean length of therapy was 12 ± 2 months (range 9-18 months). T-scores and BMD significantly improved at all sites except for a significant decrease in T-score at the 1/3 radius. After 1 year of follow-on anti-resorptive treatment, T-scores and BMD significantly increased at the total hip and at the lumbar spine compared to post-abaloparatide, with nonsignificant changes in the femoral neck and 1/3 radius. There was one reported fracture. Eighteen patients (19.8%) discontinued therapy due to adverse drug reactions and there was a 72.5% medication persistence rate. Abaloparatide is effective in increasing BMD and T-scores and in preventing osteoporosis-related fractures. While significant barriers to anabolic osteoporosis treatment remain, involvement of a pharmacist-led clinic may increase medication persistence.Item The Occurrence and Burden of Hypophosphatasia in an Ambulatory Care Endocrinology Practice.(Endocrine Practice, 7/21/2021) Quinn, Hugh B ++; Busch, Robert S; Kane, Michael POBJECTIVE: Hypophosphatasia (HPP) is an inherited disease resulting from loss-of-function mutations in the ALPL gene encoding tissue-nonspecific alkaline phosphatase. The presentation and severity of the disease are highly variable, ranging from perinatal onset with high mortality rates to adult identification with low mortality rates and symptoms ranging from minimal to severe. Moderate forms of HPP typically manifest during middle age and are often undiagnosed. The objective of this study was to determine the occurrence and burden of HPP in an ambulatory care endocrinology practice. METHODS: Potential subjects were identified with a computerized text search of patient electronic medical records. Search terms included serum alkaline phosphatase (ALP) levels of