Method for Determining In Vivo Tablet Disintegration

Steinberg, Wallace H.; Frey, Gunther H.; Masci, Joseph N.; Hutchins, Hastings H.

doi:10.1002/jps.2600540518

Cited by 28 publications

(4 citation statements)

References 3 publications

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“…Similar reports have been made by one of the authors for studying the performance of colon targeted drug delivery system using pH sensitive and biodegradable system [17]. The main purpose of this study is to track the movement, integrity, and disintegration of the tablet in the GIT.…”

Section: Methodsmentioning

confidence: 64%

Optimisation andIn VivoEvaluation of Pectin Based Drug Delivery System Containing Curcumin for Colon

Butte¹,

Momin²,

Deshmukh

2014

International Journal of Biomaterials

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The higher incidences of side effects of existing drugs have shifted researchers and clinicians to explore the dietary phytoconstituents for its therapeutic potentials. The present study is based on compression coated curcumin tablet for the colon. Curcumin has anti-inflammatory and antioxidant properties. Curcumin presents a bioavailability problem due to poor solubility. An inclusion complex was formed with hydroxypropyl-β-cyclodextrin to enhance the solubility. In this study, the core tablet of curcumin inclusion complex was compressed between the layers of polymer blend of pectin and Eudragit S100. The 32 full factorial design was utilised for optimization of the formulation. The polymer ratio (X1) and coat thickness (X2) presented significant effects on the selected responses, i.e., percent drug release after 4 hours (Y240) and difference in percent drug release between 4th and 6th hour (Y diff) in presence of pectinase enzyme. The results revealed that higher coat weight (600 mg) and higher level of pectin ratio (70% w/w) protected the curcumin tablet till ascending colon. The in vivo studies by roentgenography method using human volunteers supported these observations. Hence, it can be concluded that the combination of pectin and Eudrgit S100 makes the system biodegradable and pH dependent for targeting the drug to the colon.

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Section: Methodsmentioning

confidence: 64%

Optimisation andIn VivoEvaluation of Pectin Based Drug Delivery System Containing Curcumin for Colon

Butte¹,

Momin²,

Deshmukh

2014

International Journal of Biomaterials

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“…Very early, attempts to characterize tablet movement were done, using Xrays (9,10) or the so-called Jo-Jo technique (the tablet is attached with a band, swallowed, and withdrawn from the stomach to measure in vivo disintegration) (11). The radioelemetry method employs a pH-sensitive radiotransmitting reusable capsule whose signal is used to determine the position of the capsule in the abdomen (12).…”

Section: Electronic Supplementary Materialsmentioning

confidence: 99%

Meta-analysis of Magnetic Marker Monitoring Data to Characterize the Movement of Single Unit Dosage Forms Though the Gastrointestinal Tract Under Fed and Fasting Conditions

2015

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“…If possible, models for capsule opening and tablet disintegration should be fitted to in vitro data and applied to in vivo data . It is also known that in vivo capsule opening, or in vivo tablet disintegration, , takes longer than the time observed during USP disintegration testing and would impact gastric residence in vivo …”

Section: Discussionmentioning

confidence: 99%

“…If possible, models for capsule opening and tablet disintegration should be fitted to in vitro data and applied to in vivo data. 110 It is also known that in vivo capsule opening, 111 or in vivo tablet disintegration, 112,113 takes longer than the time observed during USP disintegration testing and would impact gastric residence in vivo. 114 Method Artif icial Ef fects: In addition to the intrinsic properties of the drug substance and drug product described above, the in vitro dissolution performance may be affected by artificial effects in the in vitro dissolution setup, which may not necessarily have relevance for in vivo dissolution.…”

Section: Q4: Which Are the Factors To Be Considered When Modeling Dis...mentioning

confidence: 99%

Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report

Pepin,

Arora,

Borges

et al. 2024

Mol. Pharmaceutics

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This Article shares the proceedings from the August 29th, 2023 (day 1) workshop "Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives". The focus of the day was on model parametrization; regulatory authorities from Canada, the USA, Sweden, Belgium, and Norway presented their views on PBBM case studies submitted by industry members of the IQ consortium. The presentations shared key questions raised by regulators during the mock exercise, regarding the PBBM input parameters and their justification. These presentations also shed light on the regulatory assessment processes, content, and format requirements for future PBBM regulatory submissions. In addition, the day 1 breakout presentations and discussions gave the opportunity to share best practices around key questions faced by scientists when parametrizing PBBMs. Key questions included measurement and integration of drug substance solubility for crystalline vs amorphous drugs; impact of excipients on apparent drug solubility/supersaturation; modeling of acid−base reactions at the surface of the dissolving drug; choice of dissolution methods according to the formulation and drug properties with a view to predict the in vivo performance; mechanistic modeling of in vitro product dissolution data to predict in vivo dissolution for various patient populations/species; best practices for characterization of drug precipitation from simple or complex formulations and integration of the data in PBBM; incorporation of drug permeability into PBBM for various routes of uptake and prediction of permeability along the GI tract.

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Method for Determining In Vivo Tablet Disintegration

Cited by 28 publications

References 3 publications

Optimisation andIn VivoEvaluation of Pectin Based Drug Delivery System Containing Curcumin for Colon

Optimisation andIn VivoEvaluation of Pectin Based Drug Delivery System Containing Curcumin for Colon

Meta-analysis of Magnetic Marker Monitoring Data to Characterize the Movement of Single Unit Dosage Forms Though the Gastrointestinal Tract Under Fed and Fasting Conditions

Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report

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