This article studies the compatibility of amlodipine besylate in its solid formulations with various drug excipients. The various factors affecting amlodipine besylate stability were studied using high-performance liquid chromatography (HPLC). It has been found that binary 1:1 mixtures of amlodipine besylate and an excipient are stable at 65 degrees C and 40 degrees C/75% RH. Further investigations were conducted to study the stability of amlodipine besylate in multicomponent mixtures, including mixtures with actual formulations. The study reveals that mixtures of lactose, magnesium stearate, and water induce some instability on amlodipine besylate. The major degradation product confirmed by HPLC-mass spectrometry is amlodipine besylate glycosyl. This is in conformity with the well-known Maillard reaction between primary amines and lactose. Thus, lactose-free amlodipine formulations are recommended from the safety, quality, efficacy, and process cost points of view.
Download full-text PDF |
Source |
---|---|
http://dx.doi.org/10.1081/pdt-120027414 | DOI Listing |
Spec Care Dentist
January 2025
Paediatric Dentistry, The University of Western Australia, Dental School, Perth, Australia.
Introduction: Aplastic anemia (AA) is a rare condition that frequently manifests with pancytopenia. Management of severe disease is through either allogenic stem cell transplantation or immunosuppressive therapy with supportive care. Drug-induced gingival overgrowth (DIGO) is a potential complication of a number of medications, including cyclosporine and amlodipine.
View Article and Find Full Text PDFPerspect Clin Res
August 2024
Department of Nephrology, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India.
Background: Pharmacotherapy of chronic kidney disease (CKD) consists of prescribing myriad of drugs such as antihypertensives, antidiabetics, and phosphate binders to delay disease progression and control the comorbidities, resulting in inherent variability in prescriptions. In addition, tendency to self-medicate may further aggravate the condition. Hence, the present study was planned to assess self-medication practices and variability in prescription patterns in CKD patients.
View Article and Find Full Text PDFJ Clin Med
January 2025
Department of Internal Medicine, Division of Cardiology, Kangdong Sacred Heart Hospital, Seoul 05355, Republic of Korea.
This study assessed the therapeutic effectiveness of a single-pill combination (SPC) of olmesartan/amlodipine plus rosuvastatin for blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) in patients with hypertension and dyslipidemia. Adult patients with hypertension and dyslipidemia who were decided to be treated with the study drug were eligible. The primary endpoint was the proportion of patients who achieved BP, LDL-C and both BP and LDL-C treatment goals at weeks 24-48.
View Article and Find Full Text PDFFront Pharmacol
January 2025
Department of Cardiology, Affiliated Changshu Hospital of Nantong University, Changshu, China.
Objective: This study aims to analyze the adverse drug events (ADEs) associated with tolvaptan in the Food and Drug Administration Adverse Event Reporting System database from the fourth quarter of 2009 to the second quarter of 2024.
Methods: After standardizing the data, various signal detection techniques, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network, and Multi-Item Gamma Poisson Shrinker, were employed for analysis.
Results: Among the 7,486 ADE reports where tolvaptan was the primary suspected drug, a total of 196 preferred terms were identified, spanning 24 different system organ classes.
Front Pharmacol
January 2025
School of Pharmacy, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Objective: There is a lack of studies investigating the safety of combination regimens specifically for cardiovascular and cerebrovascular diseases. This study aimed to evaluate the safety of combination drugs for cardiovascular and cerebrovascular diseases using real-world data.
Methods: We analyzed adverse drug reaction data received by the Hubei Adverse Drug Reaction Center from the first quarter of 2014 to the fourth quarter of 2022.
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!