Comparison of Flow-Through Cell and Paddle Methods for Testing Vaginal Tablets Containing a Poorly Water-Soluble Drug

Szymańska, Emilia; Winnicka, Katarzyna

doi:10.4314/tjpr.v12i1.7

Cited by 11 publications

(11 citation statements)

References 13 publications

(16 reference statements)

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“…The flow-through cell method (USP Apparatus 4) is an alternative dissolution equipment [10,11]. Its advantages over USP Apparatuses 1 and 2 have been widely demonstrated, especially for the study of in vitro dissolution behaviour of poorly water-soluble drugs [12,13]. The flow-through cell apparatus permits continuous extraction of the drug, simulating absorption into the systemic circulation and generating an intermittent flow of the dissolution medium into the cell where the dosage form is placed [14].…”

Section: Introductionmentioning

confidence: 99%

Dissolution Behavior of Carbamazepine Suspensions Using the Usp Dissolution Apparatus 2 and the Flow-Through Cell Method With Simulated Gi Fluids

Medina

Aguilar

Hurtado

2017

Int J Pharm Pharm Sci

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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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Section: Introductionmentioning

confidence: 99%

Dissolution Behavior of Carbamazepine Suspensions Using the Usp Dissolution Apparatus 2 and the Flow-Through Cell Method With Simulated Gi Fluids

Medina

Aguilar

Hurtado

2017

Int J Pharm Pharm Sci

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“…Samples of 2 mL were withdrawn at the predetermined time intervals (0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 7 h), filtered through 0.45 µm cellulose acetate paper filters, diluted with methanol and analysed using the HPLC method. [21][22][23] Withdrawn samples were replaced with equal volumes of the fresh medium. Sink conditions were maintained throughout the experiment.…”

Section: Scanning Electron Microscope (Sem) Analysismentioning

confidence: 99%

Vaginal Chitosan Tablets with Clotrimazole—Design and Evaluation of Mucoadhesive Properties Using Porcine Vaginal Mucosa, Mucin and Gelatine

et al. 2014

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Topical administration of clotrimazole represents the common use therapy in the antimycotic genitourinary tract treatment. Due to the fast self-cleaning action of the vagina, commercially available vaginal dosage forms with clotrimazole cannot assure prolonged contact time with mucosa, therefore the main objective of this study was to develop a dosage form for vaginal administration of clotrimazole using chitosan-a biodegradable and biocompatible derivative of chitin. Tablets mucoadhesive properties were examined using texture analyser under the presence of porcine vaginal mucosa and two different models of adhesive layersmucin gel and gelatine discs. In addition, friability, hardness, swelling behaviour, residence time, surface morphology of the performed tablets, the in vitro release profile of clotrimazole and clotrimazole release kinetics were determined. The release of clotrimazole from formulations with 25 or 40% of chitosan (F2 and F3) followed non Fickian diffusion through chitosan-gel layer and was retarded up to 6 h. Additionally, tablets F2 showed the best results in terms of mucoadhesive properties and appeared to be a good alternative to commercially available antimycotic vaginal dosage forms.

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“…Its advantages over the USP Apparatus 2 have been widely demonstrated, especially for the study of the in vitro dissolution performance of poorly water-soluble drugs [10,11]. The flow-through cell method permits continuous extraction of the drug, simulating absorption into the systemic circulation, generating an intermittent flow of the dissolution medium into the cell where the dosage form is placed [12].…”

Section: Introductionmentioning

confidence: 99%

Comparison of the Usp Apparatus 2 and 4 for Testing the in Vitro Release Performance of Ibuprofen Generic Suspensions

2017

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Objective: The aim of this study was the comparison of the in vitro release performance of ibuprofen generic suspensions and reference, based on the hydrodynamic environment generated by the flow-through cell method (USP Apparatus 4). Results were compared with those obtained by the use of the USP Apparatus 2. Methods:The Advil ® suspension (2 g/100 ml) and two generic formulations with the same dose were tested. Dissolution studies were carried out using a USP Apparatus 4 Sotax CE6 with 22.6 mm cells, laminar flow at 16 ml/min, and pH 7.2 phosphate buffer at 37.0±0.5 °C as dissolution medium. Ibuprofen was quantified spectrophotometrically at 222 nm. The in vitro release of the three drug products were studied using the USP Apparatus 2. The dissolution profiles of generic products were compared with the reference by model-independent, model-dependent, and analysis of variance (ANOVA)-based comparisons. Results:The dissolution profile of the generic product A was similar to the dissolution profile of reference, only with the use of the USP Apparatus 4. The f2 similarity factor was>50 and no significant differences were found with dissolution efficiency data (*P>0.05). Similar results were found with the comparison of t50% and t63.2% values. Similar dissolution profiles between generic product A and reference were also found with ANOVAbased comparisons. Conclusion:The flow-through cell method was adequate for study the in vitro release of ibuprofen suspensions. It is necessary to evaluate the in vivo performance of the drug products used in order to estimate the predictability of the proposed methodology.

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Comparison of Flow-Through Cell and Paddle Methods for Testing Vaginal Tablets Containing a Poorly Water-Soluble Drug

Cited by 11 publications

References 13 publications

Dissolution Behavior of Carbamazepine Suspensions Using the Usp Dissolution Apparatus 2 and the Flow-Through Cell Method With Simulated Gi Fluids

Dissolution Behavior of Carbamazepine Suspensions Using the Usp Dissolution Apparatus 2 and the Flow-Through Cell Method With Simulated Gi Fluids

Vaginal Chitosan Tablets with Clotrimazole—Design and Evaluation of Mucoadhesive Properties Using Porcine Vaginal Mucosa, Mucin and Gelatine

Comparison of the Usp Apparatus 2 and 4 for Testing the in Vitro Release Performance of Ibuprofen Generic Suspensions

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