This paper presents the results obtained after studying the thermal stability and decomposition kinetics of perindopril erbumine as a pure active pharmaceutical ingredient as well as a solid pharmaceutical formulation containing the same active pharmaceutical ingredient (API). Since no data were found in the literature regarding the spectroscopic description, thermal behavior, or decomposition kinetics of perindopril, our goal was the evaluation of the compatibility of this antihypertensive agent with the excipients in the tablet under ambient conditions and to study the effect of thermal treatment on the stability of perindopril erbumine. ATR-FTIR (Attenuated Total Reflectance Fourier Transform Infrared) spectroscopy, thermal analysis (thermogravimetric mass curve (TG—thermogravimetry), derivative thermogravimetric mass curve (DTG), and heat flow (HF)) and model-free kinetics were chosen as investigational tools. Since thermal behavior is a simplistic approach in evaluating the thermal stability of pharmaceuticals, in-depth kinetic studies were carried out by classical kinetic methods (Kissinger and ASTM E698) and later with the isoconversional methods of Friedman, Kissinger-Akahira-Sunose and Flynn-Wall-Ozawa. It was shown that the main thermal degradation step of perindopril erbumine is characterized by activation energy between 59 and 69 kJ/mol (depending on the method used), while for the tablet, the values were around 170 kJ/mol. The used excipients (anhydrous colloidal silica, microcrystalline cellulose, lactose, and magnesium stearate) should be used in newly-developed generic solid pharmaceutical formulations, since they contribute to an increased thermal stability of perindopril erbumine.
Purpose
Romania has a high prevalence of hypertension (45.1% in 2016). Whether this is attributable to a low rate of treatment adherence—which can aggravate the pathology and reduce patients’ quality of life (QoL)—is unknown. To address this point, the present study investigated the factors that influence short- and long-term adherence and QoL in patients with arterial hypertension using a specially designed questionnaire.
Patients and Methods
The study enrolled 289 patients at different stages of hypertension with or without comorbidities. The diagnosis of hypertension was established by the cardiologist, and treatment regimens were communicated by patients to the clinical pharmacist who administered the questionnaire, which comprised 7 domains with variable numbers of items.
Results
The majority of surveyed patients (57.43%) considered that their capacity for effort was decreased because of their hypertension, with 65.05% reporting that they were affected by symptoms associated with high blood pressure (eg, headache and dizziness). Most patients (71.28%) understood the consequences of discontinuing their medication and the severe complications of hypertension, and 69.55% indicated that they would not stop treatment if they experienced side effects. For 53.28% of patients, social activity was significantly affected by their condition. Only 47.05% of patients underwent regular mandatory medical examinations and 55.36% periodically monitored their blood pressure at home. A regression analysis revealed correlations between specific questionnaire items and patient characteristics.
Conclusion
Nonpharmacologic factors that were shown to influence patients’ adherence to treatment and QoL included the level of health education and knowledge of disease complications, self-monitoring of hypertension, and consultation with medical and pharmaceutical healthcare providers regarding hypertension and its treatment.
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