Quality by design based development and optimization of novel gastroretentive floating osmotic capsules of clopidogrel bisulfate

Shah, Harshil P.; Prajapati, Shailesh T.

doi:10.1007/s40005-018-0405-5

Cited by 20 publications

(13 citation statements)

References 42 publications

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“…In many cases, modified drug release is beneficial for improving drug efficacy and patient compliance or prolonging the duration of action [ 42 ]. Therefore, tablet film coating with various polymers is actively pursued to achieve modified drug release by controlling the rate and/or sites of drug release.…”

Section: Pharmaceutical Application Of Film Coatingmentioning

confidence: 99%

Pharmaceutical Application of Tablet Film Coating

et al. 2020

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Tablet film coating is a common but critical process providing various functionalities to tablets, thereby meeting diverse clinical needs and increasing the value of oral solid dosage forms. Tablet film coating is a technology-driven process and the evolution of coated dosage forms relies on advancements in coating technology, equipment, analytical techniques, and coating materials. Although multiple coating techniques are developed for solvent-based or solvent-free coating processes, each method has advantages and disadvantages that may require continuous technical refinement. In the film coating process, intra- and inter-batch coating uniformity of tablets is critical to ensure the quality of the final product, especially for active film coating containing active pharmaceutical ingredients in the coating layer. In addition to experimental evaluation, computational modeling is also actively pursued to predict the influence of operation parameters on the quality of the final product and optimize process variables of tablet film coating. The concerted efforts of experiments and computational modeling can save time and cost in optimizing the tablet coating process. This review provides a brief overview of tablet film coating technology and modeling approaches with a focus on recent advancements in pharmaceutical applications.

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Section: Pharmaceutical Application Of Film Coatingmentioning

confidence: 99%

Pharmaceutical Application of Tablet Film Coating

et al. 2020

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“…Optimization was executed by two-level, three-factor (2 3 ) full factorial design using Design Expert 11 software. Independent variables (HPMC K100M, Carbopol 934P, and Ethylcellulose (EC)) and dependent variables (Floating time, percentage cumulative drug release at 2 h, 12 h, and t50%) were selected for optimization based on risk assessment of data (8) .…”

Section: Design Of Experiments (Doe)mentioning

confidence: 99%

“…USP Type-II (Paddle) apparatus, 0.1 N Hydrochloric acid (HCl) as a dissolution medium at 75 rpm at 37°C ± 0.5°C were the maintained parameters. At the regular time intervals (1,2,3,4,5,6,8,12) h, the samples were withdrawn by using a syringe fixed with a pre-filter and replaced with fresh 0.1 N Hydrochloric acid (HCl) media. Cumulative percentage drug release was analyzed at 284 nm (Domperidone) and 260nm (Famotidine) by the developed HPLC technique (14) .…”

Section: In Vitro Dissolution Studiesmentioning

confidence: 99%

Design and Characterization of Combinational Domperidone-Famotidine Floating Drug Delivery System - In vitro and In vivo studies

Chidurala

J²

2021

Ars Pharm

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Introduction: The drawbacks assosiated with oral administration of drugscan be controlled or minimized by gastro retentive formulations that remain buoyant within the stomach for an extended time by providing prolonged gastric retention and releasethe drug in an exceedingly extended manner thereby improving bioavailability. The current research was to develop and optimize Domperidone and Famotidine floating tablets with extended release by Quality by Design approach. Method: Based on QTPP (Quality Target Product Profile), CQAs (Critical Quality Attributes)wereidentified. Risk analysis by the evaluation of formulation and process parameters showed that optimizing the levels of polymers could reduce high risk to achieve the target profile. A 23factor experimental design with midpoints was selected for statistical analysis and optimization. Results: HPMC K100 and Carbopol 934P had a positive effect while ethyl cellulose demonstrated a negative effect on the selected responses. Drug release kinetics followed the first-order release with Higuchi diffusion and Fickian diffusion. Optimized formula satisfying all the required parameters was selected and evaluated. The predicted response values were in close agreement with experimental response values. Abdominal X-ray imaging after oral administration of the tablets on a healthy rabbit’s stomach confirmed the extended floating behavior with shorter lag time. In vivo, pharmacokinetic studies in rabbits revealed that the optimized formulation exhibited prolonged drug release with enhanced Cmax, tmax, AUCo-t, and t1/2 of an optimized product when compared to the marketed product. Conclusions: It has been concluded that the application of Quality by Design in the formulation and optimization reduced the number of trials to produce a cost-effective formula.

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“…However, modeling approaches of mosapride have not yet been performed in animals and humans. Pharmacokinetic modeling enables better interpretation of experimental data and assists the rational design of future drug delivery systems (Kim, Shin, & Shin, 2018; Li, Al‐Jamal, Kostarelos, & Reineke, 2010; Shah & Prajapati, 2019). The aim of this study was to investigate the PK properties of mosapride following intravenous (1 mg single dose) and oral (5 mg dose once a day for 5 days) administration in beagle dogs.…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetic analysis of mosapride following intravenous and oral administration in beagle dogs

Kim

Baek

2020

Vet Pharm & Therapeutics

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The aim of this study was to investigate the pharmacokinetic properties of mosapride after intravenous and oral administration to beagle dogs. To obtain the advanced pharmacokinetic parameters of mosapride, both noncompartmental analysis and pharmacokinetic modeling were performed. Twenty beagle dogs were randomly sorted into intravenous (1 mg single administration of mosapride) and oral (5 mg once a day administration of mosapride) groups. Blood samples were collected according to the reported schedule for pharmacokinetics. The plasma concentration of mosapride was analyzed using liquid chromatography–tandem mass spectrometry. According to the pharmacokinetic analysis, the absorption rate of mosapride was 3.14 ± 1.14 hr−1 and oral bioavailability of mosapride was approximately 1%. The one‐compartment model well described the pharmacokinetics of mosapride after both intravenous and oral administration to dogs. These findings will help facilitate the determination of the optimal dose regimen of mosapride for dogs with gastrointestinal disorder.

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Quality by design based development and optimization of novel gastroretentive floating osmotic capsules of clopidogrel bisulfate

Cited by 20 publications

References 42 publications

Pharmaceutical Application of Tablet Film Coating

Pharmaceutical Application of Tablet Film Coating

Design and Characterization of Combinational Domperidone-Famotidine Floating Drug Delivery System - In vitro and In vivo studies

Pharmacokinetic analysis of mosapride following intravenous and oral administration in beagle dogs

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