Aqueous Polymer Dispersion Coating Used for Osmotic Pump Tablets: Membrane Property Investigation and IVIVC Evaluation

Cheng, Lizhen; Gai, Xiumei; Wen, Haoyang; Liu, Dandan; Tang, Xin; Wang, Yanyan; Wang, Tuanjie; Pan, Weisan; Yang, Xinggang

doi:10.1208/s12249-017-0837-7

Cited by 7 publications

(3 citation statements)

References 44 publications

(45 reference statements)

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“…For the analysis dog plasma sample (50 µL) was added to 400 µL of acetonitrile in a 1.5 ml centrifuge tube and vortex for 1 min. The internal standard (50 µL) was added, vortex, and centrifuged at 10,000 rpm for 5 min, and the supernatant was placed for auto-sampling for LC-MS [29].…”

Section: An Analytical Methods For In Vivo Estimation Of Trospium Chloridementioning

confidence: 99%

Development, optimization and pharmacokinetic evaluation of biphasic extended-release osmotic drug delivery system of trospium chloride for promising application in treatment of overactive bladder

Gundu

Pekamwar

Shelke³

et al. 2021

Futur J Pharm Sci

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Background The research was aimed with an approach to formulate biphasic extended-release system of trospium chloride resulting in controlled release of drug up to 24 h with prospects of better control on urinary frequency, efficacy, tolerability, and improved patient compliance. The push–pull osmotic pump (PPOP) bi-layered tablet of trospium chloride (60 mg) was developed with the use of immediate-release polymers in the pull layer (30 mg drug) and polyethylene oxide in the push layer (remaining 30 mg drug). The tablet was formulated by compression after non-aqueous granulation, seal coating, and semipermeable coating. The tablet prepared was laser drilled to create an orifice for drug release. Results Comparative in vitro dissolution and in vivo pharmacokinetic analysis of available marketed formulations demonstrated the complete drug release within 16–18 h; hence the developed biphasic extended-release system has its great importance as it provides zero-order release up to 24 h. Conclusions The developed biphasic extended-release drug delivery system of trospium chloride provides the drug release for 24 h with effective plasma concentration in comparison with the available marketed formulation. Extended release of drug from the developed formulation provides scope for its promising application in the treatment of overactive bladder (OAB).

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Section: An Analytical Methods For In Vivo Estimation Of Trospium Chloridementioning

confidence: 99%

Development, optimization and pharmacokinetic evaluation of biphasic extended-release osmotic drug delivery system of trospium chloride for promising application in treatment of overactive bladder

Gundu

Pekamwar

Shelke³

et al. 2021

Futur J Pharm Sci

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“…The rationale for this test is based on the recognition that the solubilized drug, instead of the precipitated one, is available for absorption. Hence, an IVIVC may be achieved using this in vitro release/dispersion test 86 , 87 , 88 , 89 . Inspired by a level A IVIVC for a cyclosporine SMEDDS, a biowaiver extension for a poorly water-soluble drug was claimed using a SMEDDS formulation 84 .…”

Section: In Vitro Release/dispersion and Ivivcmentioning

confidence: 99%

In vitro and in vivo correlation for lipid-based formulations: Current status and future perspectives

Huang

Qin

Chen

et al. 2021

Acta Pharmaceutica Sinica B

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Lipid-based formulations (LBFs) have demonstrated a great potential in enhancing the oral absorption of poorly water-soluble drugs. However, construction of in vitro and in vivo correlations (IVIVCs) for LBFs is quite challenging, owing to a complex in vivo processing of these formulations. In this paper, we start with a brief introduction on the gastrointestinal digestion of lipid/LBFs and its relation to enhanced oral drug absorption; based on the concept of IVIVCs, the current status of in vitro models to establish IVIVCs for LBFs is reviewed, while future perspectives in this field are discussed. In vitro tests, which facilitate the understanding and prediction of the in vivo performance of solid dosage forms, frequently fail to mimic the in vivo processing of LBFs, leading to inconsistent results. In vitro digestion models, which more closely simulate gastrointestinal physiology, are a more promising option. Despite some successes in IVIVC modeling, the accuracy and consistency of these models are yet to be validated, particularly for human data. A reliable IVIVC model can not only reduce the risk, time, and cost of formulation development but can also contribute to the formulation design and optimization, thus promoting the clinical translation of LBFs.

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“…Numerous case studies have reported the usage of Wagner-Nelson or Loo-Riegelman approaches, therefore academia seems to follow the trend set by industry and regulators. Cheng et al for example, in two separate studies investigated the ionic-driven osmotic pump tablets consisting of theophylline or propranolol as model drugs (7,8). The IVIVCs were established in the two-stage modeling by the Wager-Nelson method between an in vitro dissolution test and in vivo plasma drug concentrations obtained in an animal study.…”

Section: Deconvolutionmentioning

confidence: 99%

In Vitro-In Vivo Correlation (IVIVC): From Current Achievements Towards the Future

Tuszyński¹,

Szlęk²,

Polak³

et al. 2018

Dissolution Technol.

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Conventional in vitro-in vivo correlation (IVIVC) based on compendial dissolution testing faces many obstacles, among which are problems in establishing meaningful correlation for immediate release dosage forms, lack of intravenous data in cases of many drugs without a possibility to obtain a unit impulse response, and well-known difficulties to build an IVIVC model for BCS III and BCS IV class drugs. Three major elements are obligatory for IVIVC development: in vitro dissolution data, in vivo pharmacokinetic profile, and modeling tools. Dissolution testing and modeling approaches are under heavy development to create predictive IVIVIC/IVIVR models. Application of noncompendial dissolution methods, biorelevant media, and equipment simulating the human gastrointestinal tract, together with sophisticated multivariate statistical methods and mechanistic approaches, are nominated to be the future of IVIVC.

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Aqueous Polymer Dispersion Coating Used for Osmotic Pump Tablets: Membrane Property Investigation and IVIVC Evaluation

Cited by 7 publications

References 44 publications

Development, optimization and pharmacokinetic evaluation of biphasic extended-release osmotic drug delivery system of trospium chloride for promising application in treatment of overactive bladder

Development, optimization and pharmacokinetic evaluation of biphasic extended-release osmotic drug delivery system of trospium chloride for promising application in treatment of overactive bladder

In vitro and in vivo correlation for lipid-based formulations: Current status and future perspectives

In Vitro-In Vivo Correlation (IVIVC): From Current Achievements Towards the Future

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