Accelerated Stability Assessment of Extemporaneously Compounded Amiloride Nasal Spray.

Amiloride is a U.S. Food and Drug Administration-approved diuretic agent used to treat hypertension and congestive heart failure. Recent human and animal studies have suggested that amiloride may also have a role in treating anxiety through its acid-sensing ion channel antagonism. Intranasal administration of amiloride nasal spray via an extemporaneously compounded preparation has the potential for rapid delivery to the site of action to achieve therapeutic outcomes in individual patients with anxiety disorders. However, these patient-specific preparations do not have the pre-formulation characterization, including chemical stability, that conventional manufactured dosage forms have. The objective of this study was to assess the estimated chemical stability of compounded amiloride nasal spray over 6 months and 12 months utilizing accelerated degradation with high heat and the Arrhenius equation. A stability-indicating highperformance liquid chromatography analytical method was employed at appropriate intervals over a 12-month period to reveal that amiloride remained chemically stable over the period tested and by extrapolation. Physical stability and compatibility with the preservative benzyl alcohol were also confirmed via visual inspection, pH monitoring, and measurement of turbidity.

Antiepileptic intranasal Amiloride loaded mucoadhesive nanoemulsion: development and safety assessment.

Current investigation aimed to develop a novel Amiloride loaded mucoadhesive nanoemulsion formulation for nose-to-brain delivery. Furthermore, nasal irritation study and histopathological examination of the nasal mucosa were also carried out to assess nonirritant nature of the nanoemulsion. The optimized formulation, surface epithelium lining and the granular cellular structure of the nasal mucosa were totally intact, whereas KCl caused major changes in the ultrastructure of mucosa. Amiloride loaded mucoadhesive nanoemulsion formulations are non toxic on nasal mucosa and can be administered by intranasal route for effective treatment of epilepsy.

Positive benefits of a pharmacist-managed hypertension clinic in Nigeria.

OBJECTIVE: The aim of this study was to determine whether the provision of further practice-based support by pharmacists will bring about improved outcomes for blood pressure (BP) control in middle-aged and elderly Nigerian hypertensive patients managed with combination diuretics (amiloride hydrochloride 5 mg+hydrochlorothiazide 50 mg) and/or methyl dopa at the primary care level. DESIGN AND SETTING: This was a 1-year prospective, randomized cohort study of the outpatients of a state comprehensive health centre in South-western Nigeria. Free primary health services including free drugs were provided for all patients. PATIENTS AND METHOD: The study population comprised 51 Nigerian patients with uncomplicated hypertension aged 45 years or more, with a 0.2-3.0-year history of hypertension, registered at the Comprehensive Health Centre, Ife between October 2002 and March 2003. They were invited into the pharmacist-managed hypertension clinic and followed for the study period. Participating pharmacists counselled for current medication, personalized goals of lifestyle modification stressing weight loss and/or increased activity, increased patient awareness by providing relevant education about hypertension and associated/related diseases, adjusted drug therapy to optimize effectiveness and minimize adverse events, utilized treatment schedules that enhanced patients' adherence to therapy, and monitored treatment outcomes between enrollment and return visits. Patient satisfaction and the number of treatment failures within 6 months post enrollment were compared with retrospective data from our earlier study involving physician-managed patients under a similar setting. RESULTS: Uncontrolled BP reduced from 92 to 36.2% by 10.15+/-5.02 days after enrollment. Treatment failures were observed at 5.9% of the total return visits (n=184) within 6 months. CONCLUSION: Pharmacist-managed hypertension clinics can improve BP control, reduce treatment failure and increase patient satisfaction.

Significant cost-saving with modification of antihypertensive therapy.

Thirty patients attending Somerset Hospital Outpatient Department, Cape Town, who were on nifedipine for hypertension or chest pain, were followed up for 6 months after alternative therapy was instituted. After the change of treatment, blood pressure control improved and no serious side-effects were encountered. Reserpine combined with a thiazide was a major component of the new regimen which reduced the monthly cost per patient from R54 to R14, a saving of 73%. If this saving was extended to 5% of the potential hypertensive patients in the RSA it would amount to R8 million per month. Although a self-assessment depression inventory was completed by 21 patients, our study does not fully evaluate the impact on quality of life. The likelihood of side-effects is, however, small--provided that the maximum daily dose of reserpine does not exceed 0.1 mg. We feel that a more considered approach is needed in the choice of antihypertensive agents.

Valoración comparativa del efecto antihipertensivo y metabólico de la combinación de hidroclorotiacida y amilorida, y de la clortalidona sola y con sales de potasio en pacientes con hipertensión arterial esencial / Antihypertesive and metabolic effect of hidrochlorothiazide-amiloride combination and chlorthalidone alone and with potassium salts in patients with essential hypertension

En 20 pacientes con hipertensión arterial esencial leve a moderada se valoró en forma comparativa el efecto antihipertensivo y metabólico de una combinación de 50 mg de hidroclorotiacida con 5 mg de amilorida con el obtenido tras la administración de clorotalidona sola y agregado sales de potasio por vía oral. Cada grupo se formó de 10 enfermos que recibieron indistintamente uno de los medicamentos durante tres meses. Al final del estudio se observó una disminución similar en la tensión arterial media en ambos grupos, con promedio de 25 mm Hg. Sin embargo, los pacientes que recibieron clorotalidona desarrollaron alcalosis y disminución sérica (4.6 + 0.1 a 3.5 + 0.1 mEg/L, p 0.01) e intraglobular de potasio (98 + 1 a 86 + 1.1 mEq/L, p 0.001). La administración oral de sales de potasio sólo originó incremento en la eliminación renal del electrólito, sin modificación del potasio en el suero o en el eritrocito. Los pacientes que recibieron hidroclorotiacida más amilorida no mostraron alteración electrolítica, lo que pone de manifiesto la eficiencia de la amilorida para prevenir esos efectos indeseables de los diuréticos tiacídicos