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

2015 ◽  
Vol 17 (5) ◽  
pp. 1261-1266 ◽  
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

scholarly journals A Novel Multicompartment Dissolution Apparatus for Evaluation of Floating Dosage Form Containing Poorly Soluble Weakly Basic Drug

2006 ◽  
Vol 13 (1) ◽  
pp. 14-19 ◽  
Author(s):  
Dr. Rajesh K. Parikh ◽  
Dhaivat C. Parikh ◽  
Renish R. Delvadia ◽  
Sanjay M. Patel
Keyword(s):  
Dosage Form ◽  
Basic Drug ◽  
Poorly Soluble ◽  
Dissolution Apparatus

scholarly journals INFLUENCE OF DOSE AND USP DISSOLUTION APPARATUS IN THE RELEASE PERFORMANCE OF REFERENCE TABLETS: PROPRANOLOL-HCl AND RANITIDINE-HCl CASES

2019 ◽  
pp. 164-170
Author(s):  
JOSE RAUL MEDINA-LOPEZ ◽  
LUIS ANTONIO CEDILLO-DIAZ ◽  
MARCELA HURTADO
Keyword(s):  
In Vitro Dissolution ◽  
Dissolution Time ◽  
Reference Drug ◽  
Cell Method ◽  
Drug Products ◽  
Propranolol Hcl ◽  
Flow Through ◽  
Dissolution Apparatus ◽  
Paddle Apparatus

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.

Dissolution testing of a poorly soluble compound using the flow-through cell dissolution apparatus

2002 ◽  
Vol 236 (1-2) ◽  
pp. 135-143 ◽  
Author(s):  
Shobha N Bhattachar ◽  
James A Wesley ◽  
Ann Fioritto ◽  
Peter J Martin ◽  
Suresh R Babu
Keyword(s):  
Dissolution Testing ◽  
Soluble Compound ◽  
Poorly Soluble ◽  
Flow Through ◽  
Dissolution Apparatus

scholarly journals DISSOLUTION PERFORMANCE OF MELOXICAM FORMULATIONS UNDER HYDRODYNAMICS OF USP PADDLE APPARATUS AND FLOW-THROUGH CELL METHOD

2019 ◽  
pp. 182-188
Author(s):  
OSE RAUL MEDINA-LOPEZ ◽  
JOSE ANGEL OROZCO-JUAREZ ◽  
MARCELA HURTADO
Keyword(s):  
In Vitro Dissolution ◽  
Dissolution Time ◽  
Weibull Function ◽  
Cell Method ◽  
Drug Products ◽  
Poorly Soluble ◽  
Flow Through ◽  
Dissolution Efficiency ◽  
Paddle Apparatus

Objective: To study the in vitro dissolution performance of four generic formulations of the poorly soluble drug meloxicam and the reference under hydrodynamic environments generated by flow-through cell method and USP paddle apparatus (pharmacopeial test). Methods: Dissolution method was validated according to ICH guidelines. Dissolution profiles were carried out with an automated flow-through cell apparatus (laminar flow at 16 ml/min with 22.6 mm cells) and USP paddle apparatus at 75 rpm. Phosphate buffer pH 7.5 at 37.0±0.5 °C was used as dissolution medium. Spectrophotometric determination of drug at 362 nm was carried out during 30 min. Dissolution profiles were compared with model-dependent and-independent methods. Results: Practically, all generic formulations showed significant differences with the percentage of drug dissolved at 30 min, mean dissolution time and dissolution efficiency, when USP paddle apparatus was used (*P<0.05), while only two generic formulations were different to reference using flow-through cell method. After adjustment to different mathematical equations, Weibull function was the best model to describe meloxicam dissolution performance and significant differences were found with all drug products when USP paddle apparatus was used, while only one formulation was different with flow-through cell method. Conclusion: The study reveals the need to look for better dissolution schemes for meloxicam tablets since USP paddle apparatus may not reflect properly the in vitro dissolution performance of meloxicam generic formulations and reference.

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

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. 

Technical Note: Design of a Flow-Through Electrical Conductivity Probe

2009 ◽  
Vol 25 (3) ◽  
pp. 373-376
Author(s):  
C. W. Walker ◽  
J. E. Watson ◽  
R. S. Thomas
Keyword(s):  
Electrical Conductivity ◽  
Technical Note ◽  
Conductivity Probe ◽  
Flow Through

Pool-orifice and pool-orifice-weir fishways

1989 ◽  
Vol 16 (5) ◽  
pp. 774-777 ◽  
Author(s):  
N. Rajaratnam ◽  
C. Katopodis ◽  
A. Mainali
Keyword(s):  
Open Channel ◽  
Open Channel Flow ◽  
Technical Note ◽  
Total Flow ◽  
Total Flow Rate ◽  
Vertical Slot ◽  
Flow Hydraulics ◽  
Orifice Flow ◽  
Flow Through ◽  
Submerged Orifice

This technical note presents a method of analyzing the flow in pool-orifice fishways by dividing it into vertical slot and submerged orifice flow regimes. For a pool-orifice-weir fishway, with flow through the orifice as well as over the weir, a method has been suggested for predicting the total flow rate in the fishway. Experimental observations are presented in support of these methods. Key words: open-channel flow, hydraulics, fishways, turbulent flow.

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