Discriminative Dissolution Method for Benzoyl Metronidazole Oral Suspension

Silva, Aline Santos da; Silva, Carlos Eduardo da Rosa; Paula, Fávero Reisdorfer; Silva, Fabiana Ernestina Barcellos Da

doi:10.1208/s12249-015-0407-9

Cited by 14 publications

(13 citation statements)

References 22 publications

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“…The dissolution of Class IV drugs is dependent on nature of the drug (acid or basic), its solubility, and formulation factors. Consequently, drugs with this class may have problems with dissolution, which can restrict in vivo absorption [2].…”

Section: Dissolution Profilesmentioning

confidence: 99%

“…All β values were<1, which indicates a parabolic curve with initial inflection. The dissolution conditions used were 900 ml of SGF without pepsin, a USP paddle apparatus at 50 rpm, and 90 min of testing [2].…”

Section: Model-dependent Comparisonsmentioning

confidence: 99%

“…As no official dissolution test has been defined for benzoyl metronidazole suspensions and since this is an immediate-release dosage form, some researchers have suggested a Q value ≥ 80% and a dissolution time ≥ 60 min are adequate dissolution criteria [2].…”

Section: Model-dependent Comparisonsmentioning

confidence: 99%

“…Benzoyl metronidazole is an antiparasitic and antibacterial agent [2,3]. According to the Biopharmaceutics Classification System, carbamazepine is a Class II drug owing to its low solubility/high permeability; metronidazole is a Class I drug owing to its high solubility/high permeability [4].…”

Section: Introductionmentioning

confidence: 99%

“…Differences in dissolution profiles were found by both groups. Others have studied the in vivo release of carbamazepine using different dissolution medium and agitation rates [2]. The optimal conditions were used of a USP paddle apparatus at 50 rpm with SGF without pepsin as the dissolution medium.…”

Section: Introductionmentioning

confidence: 99%

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In Vitro Release Studies of Carbamazepine Tablets and Benzoyl Metronidazole Suspensions Using the Flow-Through Cell Apparatus and Simulated Gastrointestinal Fluids

2017

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Objective: To characterize the in vitro release of carbamazepine tablets and benzoyl metronidazole suspensions using the flow-through cell apparatus and simulated gastrointestinal fluids.Methods: Tegretol ® tablets, Flagyl ® suspension, and generic formulations of each were tested. Release studies were performed using an automated flow-through cell apparatus. Simulated gastric fluid (with and without pepsin) and simulated intestinal fluid (without pancreatin) at 16 ml/min and fasted state simulated intestinal fluid at 8 ml/min, all at 37.0±0.5 °C, were used as dissolution media. The quantity of dissolved carbamazepine and benzoyl metronidazole was determined at 5-min intervals until 60 min at 285 and 278 nm, respectively. Percentage dissolved at 60 min, mean dissolution time, dissolution efficiency values, and t10%, t25%, t50% and t63.2% were calculated. Mean values for all parameters were compared between the reference and generic formulations using Studentʼs t-test. Dissolution data were fitted to different kinetic models.Results: Simulated gastric fluid without pepsin showed no discriminative capability for carbamazepine tablets. Significant differences were observed between the reference and generic formulations for almost all parameters (*P<0.05). In some cases, the logistic model best described the in vitro release of both drugs. Conclusion:Using an apparatus and media that best simulates the gastrointestinal environment, we identified differences in the rate and extent of dissolution of both drugs that could help to optimise the design of interchangeable formulations. Based on the physicochemical characteristics of carbamazepine and benzoyl metronidazole and the conditions in which the formulations were tested, these differences could be of clinical relevance.

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Section: Dissolution Profilesmentioning

confidence: 99%

Section: Model-dependent Comparisonsmentioning

confidence: 99%

Section: Model-dependent Comparisonsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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In Vitro Release Studies of Carbamazepine Tablets and Benzoyl Metronidazole Suspensions Using the Flow-Through Cell Apparatus and Simulated Gastrointestinal Fluids

2017

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Creating Tunable Collagen Matrices – An Approach Inspired by In Vivo Collagen Synthesis and Self-Assembly

Joshi

2021

Collagen Biografts for Tunable Drug Delivery

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Patient-friendly extemporaneous formulation of bisoprolol: application to stability and bioavailability studies

El-Masry

Helmy

et al. 2022

Drug Deliv. and Transl. Res.

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BackgroundCommunity and hospital pharmacists are always face the challenge to prepare oral liquid extemporaneous formulations to t the needs of a speci c patient population when commercial forms or the required strength are unavailable. AimThis study was performed to prepare a stable patient-friendly oral liquid extemporaneous formulations of bisoprolol. MethodEight different extemporaneous formulations were prepared using various suspending agent(s). The in vitro dissolution of all extemporaneous formulations was examined. A comprehensive accelerated stability study was carried out to evaluate the adequate beyond-use date of the most optimized extemporaneous formulation. A validated UPLC method was used for the analysis and quanti cation of bisoprolol in the accelerated stability and bioavailability studies. A group of eight healthy volunteers was enrolled in a two-way cross-over experimental design to study the bioavailability of the most optimized extemporaneous formulation. The pharmacokinetic parameters of bisoprolol were estimated. ResultsExtemporaneous suspension contain 0.5% w/v xanthan gum was easily prepared with a simple, natural, safe, sugar free excipients. It achieved the best dissolution behavior among other extemporaneous suspensions. It was an easily pourable viscous suspension with no sedimentation. At least 98% of the initial concentration of bisoprolol remained throughout the 6-month study period in the selected suspension regardless of the storage conditions. There was no perceptible change in color, odor or taste, and no noticeable microbial growth was observed in any sample. The selected formulation was bioequivalent to the commercial tablet in terms of the rate and extent of absorption. ConclusionThis research may be of great help during development of appropriate extemporaneous formulation of bisoprolol fumarate. The simple preparation method could be utilized to draw up a Standard Operating Procedure (SOP) easy to use by different types of pharmacy settings.

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Discriminative Dissolution Method for Benzoyl Metronidazole Oral Suspension

Cited by 14 publications

References 22 publications

In Vitro Release Studies of Carbamazepine Tablets and Benzoyl Metronidazole Suspensions Using the Flow-Through Cell Apparatus and Simulated Gastrointestinal Fluids

In Vitro Release Studies of Carbamazepine Tablets and Benzoyl Metronidazole Suspensions Using the Flow-Through Cell Apparatus and Simulated Gastrointestinal Fluids

Creating Tunable Collagen Matrices – An Approach Inspired by In Vivo Collagen Synthesis and Self-Assembly

Patient-friendly extemporaneous formulation of bisoprolol: application to stability and bioavailability studies

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