Innovative prolonged-release oral alkalising formulation allowing sustained urine pH increase with twice daily administration: randomised trial in healthy adults
| Autor: | C Roussel-Maupetit, L A Granier, M A Manso-Silván, F Guillaumin, C Guittet, F Vandenhende |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Adult
Male 0301 basic medicine Evening Potassium Compounds Urology Potassium Administration Oral chemistry.chemical_element lcsh:Medicine Urine Pharmacology Placebo Article Drug Administration Schedule Potassium bicarbonate 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine Double-Blind Method Potassium Citrate Humans Medicine Dosing lcsh:Science Morning Multidisciplinary Drug discovery business.industry lcsh:R Hydrogen-Ion Concentration Middle Aged Bicarbonates Drug Combinations 030104 developmental biology Tolerability chemistry Nephrology Delayed-Action Preparations Female lcsh:Q Antacids business 030217 neurology & neurosurgery |
| Zdroj: | Scientific Reports, Vol 10, Iss 1, Pp 1-11 (2020) Scientific Reports |
| ISSN: | 2045-2322 |
| Popis: | A multi-particulate fixed-dose combination product, consisting of a combination of two alkalising salts formulated as prolonged-release granules, ADV7103, was developed to obtain a sustained and prolonged alkalising effect. The specific release of both types of granules was shown in vitro through their dissolution profiles, which indicated that potassium citrate was released within the first 2–3 h and potassium bicarbonate up to 10–12 h after administration. The long-lasting coverage of ADV7103 was confirmed through a randomised, placebo-controlled, double-blind, two-period study, measuring its effect on urine pH in healthy adults (n = 16) at doses of alkalising agent ranging between 0.98 and 2.88 meq/kg/day. A significant increase of urine pH with a positive dose–response in healthy adult subjects was shown. Urine pH above 7 was maintained during 24 h with a dosing equivalent to 1.44 meq/kg twice a day, while urine pH was below 6 most of the time with placebo. The effect observed was non-saturating within the range of doses evaluated and the formulation presented a good safety profile. ADV7103 provided an effective prolonged release of alkalising salts to cover a 12-h effect with adequate tolerability and could afford a twice a day (morning and evening) dosing in patients requiring long-term treatment. |
| Databáze: | OpenAIRE |
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