In vitro release studies of furosemide reference tablets: influence of agitation rate, USP apparatus and dissolution media

Abstract

<p class="ADMETabstracttext">Furosemide is a diuretic drug widely used in chronic renal failure. The drug has low solubility and permeability, which cause clinical problems. Studying the in vitro release performance elucidates the rate and extent of drug dissolved from dosage forms under different conditions. Furosemide reference tablets were tested using USP Apparatuses 1 and 2 as well as the flow-through cell method (USP Apparatus 4), a dissolution apparatus that simulates the human gastrointestinal tract better than the other methods. Dissolution profiles were created with USP Apparatuses 1 and 2 at 25, 50, and 75 rpm and 900 mL of 0.1 M hydrochloric acid, acetate buffer (pH 4.5), and phosphate buffer (pH 6.8). USP Apparatus 4 with a laminar flow of 16 mL/min and 22.6 mm cells was used. Drug dissolution was quantified at 274 nm for 60 min. Mean dissolution time, dissolution efficiency, time to 50 % dissolution, and time to 80 % dissolution data were used to compare dissolution profiles. Additionally, zero-order, first-order, Higuchi, Hixson-Crowell, Makoid-Banakar, and Weibull models were used to adjust furosemide dissolution data. Between USP Apparatus 1 and 2, significant differences were observed in almost all parameters at 50 and 75 rpm (p < 0.05). A similar dissolution profile (f<sub>2</sub> > 50) with a pharmacopoeial dissolution method (USP Apparatus 2 at 50 rpm and 900 mL of phosphate buffer pH 5.8) and USP Apparatus 4 (laminar flow of 16 mL/min, 22.6 mm cells, and pH 6.8) was observed. The Weibull function was the best mathematical model to describe the in vitro release performance of furosemide in the three USP dissolution apparatuses. These results could be used to manufacture better furosemide dosage forms and decrease the negative clinical impact of current furosemide formulations.</p>

Preparation, Characterization, and Evaluation of Physcion Nanoparticles for Enhanced Oral Bioavailability: An Attempt to Improve Its Antioxidant and Anticancer Potential

“…It has been documented that if a drug possesses high DE, the drug is expected to remain in contact with the absorbing membranes for a prolonged period of time and thus exhibit high bioavailability. MTD is used to statistically determine the mean dissolution time for a drug, which provides an accurate drug release profile . Physcion NPs rapidly dissolved in distilled water with a release of >85% in 30 min.…”

“…MTD is used to statistically determine the mean dissolution time for a drug, which provides an accurate drug release profile. 43 Physcion NPs rapidly dissolved in distilled water with a release of >85% in 30 min. It showed slightly lower dissolution in 0.1 M HCl (75%) and phosphate buffer (80%).…”

Discriminative Dissolution Method Using the Open-Loop Configuration of the USP IV Apparatus to Compare Dissolution Profiles of Metoprolol Tartrate Immediate-Release Tablets: Use of Kinetic Parameters

“…The cumulative dissolution profiles of the reference and generic drugs obtained in both dissolution apparatus were adjusted to different mathematical models. Within the dependent models with a single parameter were found the first-order, second-order, Higuchi, Hixson–Crowell, and Korsmeyer–Peppas models ( Table 1 ), which were used to determine dissolution rates and the release mechanism [ 25 ]. In the case of dependent models with two parameters, the Weibull, Gompertz, and logistic models were considered.…”

An aquatic microrobot for microscale flow manipulation

“…The dissolution test is a globally necessitated test for most pharmaceutical products. Furthermore, this test is effectively acquainted in the industry as quality control to monitor the formulation 54 and manufacturing process of the dosage by critically evaluating the drug bioavailability 55 in the body. Recently in the field of medical engineering, several researchers have investigated the dissolution of doses combined with magnetic particles which are manipulated through the external magnetic field 56 , 57 .…”