Design of Dissolution Apparatus for the Flow-through Cell Method Based on the Low Pulsation Peristaltic Pump

Objective: Due to quality of generic formulations depends on available information of reference drug products the aim of this work was to perform an in vitro dissolution study of two doses of propranolol-HCl and ranitidine-HCl reference tablets using USP basket or paddle apparatus and flow-through cell method. Methods: Two doses of propranolol-HCl (10-mg and 80-mg) and ranitidine-HCl (150-mg and 300-mg) of Mexican reference products were used. Dissolution profiles of propranolol-HCl were obtained with USP basket apparatus at 100 rpm and 1000 ml of 1% hydrochloric acid. Profiles of ranitidine-HCl were determined with USP paddle apparatus at 50 rpm and 900 ml of distilled water. All formulations were also studied with the flow-through cell method using laminar flow at 16 ml/min. Dissolution profiles were compared by model-independent (f2 similarity factor, mean dissolution time and dissolution efficiency) and model-dependent methods (dissolution data adjusted to some mathematical equations). Time data, derived from these adjustments, as t50%, t63.25%, and t85% were used to compare dissolution profiles. Results: With all approaches used and being high solubility drugs significant differences were found between low and high doses and between USP dissolution apparatuses (*P<0.05). Conclusion: In vitro dissolution performance of two doses of propranolol-HCl and ranitidine-HCl was not expected. Considering the same USP dissolution apparatus, the reference tablets did not allow the simultaneous release of the used doses. The results could be of interest for pharmaceutical laboratories or health authorities that classify some drug products as a reference to be used in dissolution and bioequivalence studies.

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DISSOLUTION BEHAVIOR OF CARBAMAZEPINE SUSPENSIONS USING THE USP DISSOLUTION APPARATUS 2 AND THE FLOW-THROUGH CELL METHOD WITH SIMULATED GI FLUIDS

International Journal of Pharmacy and Pharmaceutical Sciences ◽

10.22159/ijpps.2017v9i11.21201 ◽

2017 ◽

Vol 9 (10) ◽

pp. 111

Author(s):

Jose Raul Medina ◽

Erik Aguilar ◽

Marcela Hurtado

Keyword(s):

Laminar Flow ◽

Simulated Gastric Fluid ◽

Cell Method ◽

Drug Products ◽

Flow Through ◽

Model Independent ◽

Dissolution Apparatus ◽

Usp Apparatus ◽

Usp Apparatus 2 ◽

Independent Parameters

Objective: To characterize the dissolution behaviour of carbamazepine generic suspensions using the USP Dissolution Apparatus 2 and the flow-through cell method with simulated gastrointestinal fluids as dissolution media.Methods: Tegretol® suspension and two generic formulations were tested. Dissolution studies were performed using the USP Apparatus 2 (75 rpm and 900 ml of dissolution medium) and the flow-through cell method (laminar flow at 16 ml/min). Simulated gastric fluid (SGF) (with and without pepsin) and simulated intestinal fluid (SIF) (without pancreatin) at 37.0±0.5 °C, was used as dissolution media. The quantity of dissolved carbamazepine was determined at 5 min intervals until reaching 60 min, at 285 nm. Percentage dissolved at 60 min, mean dissolution time, dissolution efficiency values (model-independent parameters), as well as t50% and t63.2% were calculated (model-dependent parameters). Values for all parameters were compared between the reference and generic formulations using one-way analysis of variance (ANOVA) following a Dunnett’s multiple comparison test. Dissolution data were also fitted to different fit models.Results: Since the first sampling time, the reference product had reached 100% of drug dissolved, which was determined using USP Apparatus 2. Nevertheless, significant differences in the three model-independent parameters of generic products were found (*P<0.05). Dissolution data obtained with the paddle apparatus were fitted to different kinetic equations; however, using the flow-through cell method and SIF without pancreatin, the three drug products were fitted to the same kinetic model (Gompertz). With ANOVA-based comparisons and the flow-through cell method, significant differences were found in dissolution data of generic product A versus reference at all sampling times (*P<0.05). The flow-through cell method and SGF with pepsin were the best options to discriminate among dissolution profiles.Conclusion: The flow-through cell method seems to be an adequate dissolution apparatus to characterize in vitrodissolution performance of Class II drugs manufactured as suspensions. For carbamazepine suspensions, SGF and laminar flow at 16 ml/min were the most appropriate conditions to discriminate among generic formulations. Given the physicochemical characteristics of carbamazepine and the environment in which the drug products were tested, these differences could be of clinical relevance.

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A Fully Automated Sequential-Injection Analyser for Dual Electrogenerated Chemiluminescence/Amperometric Detection

Journal of Automated Methods and Management in Chemistry ◽

10.1155/jammc/2006/67571 ◽

2006 ◽

Vol 2006 ◽

pp. 1-9 ◽

Cited By ~ 3

Author(s):

Anastasios Economou ◽

Maria Nika

Keyword(s):

Thin Layer ◽

Optical Flow ◽

Amperometric Detection ◽

Electrogenerated Chemiluminescence ◽

Sequential Injection Analysis ◽

Peristaltic Pump ◽

Sequential Injection ◽

Experimental Sequence ◽

Flow Through ◽

The Individual

This work describes the development of a dedicated, fully automated sequential-injection analysis (SIA) apparatus suitable for simultaneous electrogenerated chemiluminescence (ECL) and amperometric detection. The instrument is composed of a peristaltic pump, a multiposition selection valve, a home-made potentiostat, a thin-layer electrochemical/optical flow-through cell, and a light detector. Control of the experimental sequence and simultaneous data acquisition of the light and the current intensities were performed in LabVIEW6.1. The CL reagents and the sample were first aspirated as distinct zones into the holding coil of the analyser and, then, delivered to the cell; during their travel, the individual zones mixed and the ECL reaction was initiated as soon as the mixed regents reached the cell. The utility of the analyser was demonstrated for the detection of oxalate andH2O2based on their ECL reactions withRu(bpy)32and luminol, respectively.

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Flow through diffusion cell method: A novel approach to studyin vitro enzymatic degradation of a starch-based ternary semi-interpenetrating network for gastrointestinal drug delivery

Journal of Applied Polymer Science ◽

10.1002/app.22897 ◽

2006 ◽

Vol 100 (4) ◽

pp. 2975-2984 ◽

Cited By ~ 3

Author(s):

S. K. Bajpai ◽

Sutanjay Saxena

Keyword(s):

Drug Delivery ◽

Enzymatic Degradation ◽

Diffusion Cell ◽

Interpenetrating Network ◽

Cell Method ◽

Novel Approach ◽

Flow Through ◽

Through Diffusion

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Novel Application of MRI Technique Combined with Flow-Through Cell Dissolution Apparatus as Supportive Discriminatory Test for Evaluation of Controlled Release Formulations

AAPS PharmSciTech ◽

10.1208/s12249-010-9418-8 ◽

2010 ◽

Vol 11 (2) ◽

pp. 588-597 ◽

Cited By ~ 13

Author(s):

Przemyslaw P. Dorożyński ◽

Piotr Kulinowski ◽

Aleksander Mendyk ◽

Anna Młynarczyk ◽

Renata Jachowicz

Keyword(s):

Controlled Release ◽

Controlled Release Formulations ◽

Flow Through ◽

Dissolution Apparatus

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Development of a vessel-simulating flow-through cell method for the in vitro evaluation of release and distribution from drug-eluting stents

Journal of Controlled Release ◽

10.1016/j.jconrel.2008.05.012 ◽

2008 ◽

Vol 130 (1) ◽

pp. 2-8 ◽

Cited By ~ 32

Author(s):

Anne Neubert ◽

Katrin Sternberg ◽

Stefan Nagel ◽

Claus Harder ◽

Klaus-Peter Schmitz ◽

...

Keyword(s):

Drug Eluting Stents ◽

In Vitro Evaluation ◽

Cell Method ◽

Drug Eluting ◽

Flow Through

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Instrumentation of Flow-Through USP IV Dissolution Apparatus to Assess Poorly Soluble Basic Drug Products: a Technical Note

AAPS PharmSciTech ◽

10.1208/s12249-015-0444-4 ◽

2015 ◽

Vol 17 (5) ◽

pp. 1261-1266 ◽

Cited By ~ 3

Author(s):

Alice Paprskářová ◽

Petra Možná ◽

Enoche F. Oga ◽

Abdelbary Elhissi ◽

Mohamed A. Alhnan

Keyword(s):

Technical Note ◽

Basic Drug ◽

Drug Products ◽

Poorly Soluble ◽

Flow Through ◽

Dissolution Apparatus

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Design of Manifold for Nanofluid Flow in Microchannel

Volume 8: Heat Transfer, Fluid Flows, and Thermal Systems, Parts A and B ◽

10.1115/imece2007-42720 ◽

2007 ◽

Cited By ~ 1

Author(s):

Manish Senta ◽

A. G. Agwu Nnanna

Keyword(s):

Flow Distribution ◽

Peristaltic Pump ◽

Flow Uniformity ◽

Flow Loop ◽

Nanofluid Flow ◽

Pressure Transducers ◽

Design And Optimization ◽

Inlet Flow Rate ◽

Uniform Flow Distribution ◽

Flow Through

This paper presents a study of nanofluid flow through microchannel. Its focus is on the design and optimization of microchannel assembly with emphasis on the design of manifold or jacket. The test setup consists of ninety-nine 120μm×120μm×20mm channels, nanofluid flow loop, heat source, thermal sensors and pressure transducers. Flow of nanofluid through the channels is regulated using a peristaltic pump. Numerical iterations were performed to study the effect of inlet and exit flow locations and shape of the jacket on uniform distribution of nanofluid in the channels. Based on the numerical results, it is recommended that for uniform flow distribution in the microchannel, a trapezoidal shaped jacket should be used. The results obtained from this work provided an insight on the variation of the flow patterns within the channel. It reveals that flow uniformity among the channels largely depends on the shape of the manifolds, length and location of inlet and outlets, and the inlet flow rate.

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