This multicenter, open-label, single crossover study examined 195 patients taking an immediate-release diltiazem tablet as chronic stable angina therapy to determine if apparently logical methods of converting them to an extended-release, once-daily formulation were effective. Patients were converted from the immediate-release (Phase I) to an extended-release (Phase II) formulation of diltiazem on a mg-for-mg basis or, when a similar dose was not available, to the next higher 120 mg dose. Weekly angina occurrences and nitroglycerin use, exercise testing at the end of each phase, and ambulatory electrocardiographic monitoring (AEM) during the week prior to the exercise study were evaluated. There was a statistically significant decrease in angina frequency and nitroglycerin consumption during Phase II. In the exercise studies, there was an insignificant increase in time to 1 mm ST-segment depression and total exercise time associated with a statistically significantly lower end-exercise blood pressure and heart rate in Phase II. In those patients who had ischemia during either phase on AEM, total ischemic duration and ischemic episodes were insignificantly lower in Phase II. All observations were similar in the subgroup of patients who were converted mg-for-mg. Adverse reactions were equal. Thus, in converting patients from an immediate- to an extended-release diltiazem formulation for the treatment of symptomatic coronary artery disease, it is reasonable to convert directly to the same or, if not available, the next higher available dose of the extended-release preparation.
Download full-text PDF |
Source |
---|---|
http://dx.doi.org/10.1002/clc.4960170905 | DOI Listing |
Int J Pharm
January 2023
Division of Product Quality and Research, Office of Testing and Research, Center for Drug Evaluation and Research, Food and Drug Administration, MD, United States; Currently at Eli Lilly and Company, United States.
Abuse of opioid drug products is a national health crisis in the US. To deter abuse, a number of drug products with abuse-deterrent (AD) properties have been approved by the US Food and Drug Administration (FDA). For abuse deterrence, it is critical to maintain the AD properties during the product shelf life.
View Article and Find Full Text PDFTurk J Pharm Sci
October 2022
University of Greenwich, Department of Engineering and Science, London, United Kingdom.
Objectives: The aim of the investigation was to prepare sustained release (SR) pellets of diltiazem hydrochloride employing almond gum and gelucire. The study was performed to explore the suitability of almond gum in the preparation of pellets of diltiazem hydrochloride without the use of microcrystalline cellulose and role and effectiveness of hydrophobic gelucire (43/01) in controlling the drug release.
Materials And Methods: Pellets were prepared by extrusion-spheronization of the blend previously obtained by incorporation of the drug in a mixture of melted gelucire 43/01 and almond gum.
AAPS PharmSciTech
July 2022
Industrial Pharmacy Laboratory, Medicinal and Pharmaceutical Chemistry Department, Pharmaceutical and Drug Industries Research Institute, National Research Centre (Affiliation ID: 10014618), 33 EL Bohouth St. (Former EL Tahrir St.), P.O. 12622, Dokki, Giza, Egypt.
The present study evaluated the effect of different configuration setups of the Flow-Through Cell (USP IV) dissolution tester in developing in vitro-in vivo correlation (IVIVC). A Biopharmaceutics Classification System (BCS) Class I Diltiazem (DTZ), formulated in extended-release (ER) gel-matrix system, was employed for this purpose. The study also assessed the validity and predictability of IVIVC employing both deconvolution- and convolution-based approaches.
View Article and Find Full Text PDFDiabetes Res Clin Pract
December 2020
Bausch Health, 2150 Boul. St-Elzéar, Laval, QC H7L 4A8, Canada. Electronic address:
Aims: The CV-CARE registry provides RWE in Canadian routine clinical practice.
Methods: CV-CARE is a multi-site, observational, prospective Canadian registry enrolling patients initiating treatment with metformin hydrochloride extended-release (MetER) for T2D; colesevelam (C) for HCh; and azilsartan (AZI), azilsartan/chlorthalidone (AZI/CHL) or diltiazem extended-release (TXC) for HTN. Patient characteristics/assessment were performed at baseline and 12 ± 6 months.
Turk J Pharm Sci
September 2019
Department of Pharmaceutics and Pharmaceutical Nanotechnology, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Objectives: The aim of this investigation was to develop an extended release formulation of diltiazem hydrochloride (DL) for once- and twice-daily administration, based on Eudragit (Eud) RL and RS microspheres using emulsion solvent evaporation.
Materials And Methods: Formulations with different drug-polymer concentrations were produced and characterized in terms of yield, encapsulation efficiency (EE), particle size, and surface morphology. The drug release and thermal behavior of the microspheres were also investigated.
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!