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Related Concept Videos

Oral Drug Delivery Systems: Continuous-Release Systems01:26

Oral Drug Delivery Systems: Continuous-Release Systems

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Continuous-release drug delivery systems offer a strategic approach to maintaining therapeutic drug levels over extended periods following oral administration. By modulating the release rate of active pharmaceutical ingredients, these systems minimize fluctuations in plasma concentrations, which enhances clinical efficacy and reduces the need for frequent dosing. Such characteristics make them particularly advantageous in managing chronic diseases where patient adherence and stable drug...
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Modified-Release Drug Delivery Systems: Drug Release Characteristics01:22

Modified-Release Drug Delivery Systems: Drug Release Characteristics

176
Drug release from modified-release dosage forms is designed to achieve specific therapeutic effects by controlling the rate and extent of drug release. The classification of these drug release systems is based on key pharmacokinetic assumptions: drug disposition follows first-order kinetics, drug release is the rate-limiting step in absorption, and the released drug is rapidly and completely absorbed.There are four major models of drug release patterns. The first model is the slow zero-order...
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Modified-Release Drug Delivery Systems: Overview01:19

Modified-Release Drug Delivery Systems: Overview

152
Modified-release dosage forms are designed to address the limitations of drugs with short biological half-lives. These forms maintain stable therapeutic drug concentrations over extended periods, reducing the need for frequent dosing. A consistent drug level helps minimize peak-trough fluctuations, which can reduce adverse effects, lower the risk of drug resistance, and improve overall treatment effectiveness.One common type of modified-release form is the extended-release (ER) formulation. ER...
152
Modified-Release Drug Delivery Systems: Bioavailability01:30

Modified-Release Drug Delivery Systems: Bioavailability

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Modified-release (MR) dosage forms are designed to extend drug release over time, thereby maintaining stable plasma concentrations and reducing dosing frequency. However, their bioavailability is typically below 100% due to incomplete drug release and presystemic metabolism, and limitations in drug permeability across the gastrointestinal epithelium, all of which can restrict the fraction of the drug reaching systemic circulation. Consequently, studying the in vivo bioavailability of MR...
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Modified-Release Drug Delivery Systems: Rate-Programmed II01:19

Modified-Release Drug Delivery Systems: Rate-Programmed II

85
Rate-programmed drug delivery systems release drugs in a controlled manner to maintain therapeutic levels. Three main designs include reservoir, matrix, and hybrid systems.Reservoir systems consist of a drug core enclosed within a membrane that controls drug release. In non-swelling reservoir systems, polymers like ethyl cellulose or polymethacrylates are used. These do not hydrate in aqueous media and control release through membrane thickness, porosity, or insolubility. This type includes...
85
Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions01:15

Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions

71
PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure...
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Formation of Dispersible Taohong Siwu Tablets
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Mathematical Model-Based Accelerated Development of Extended-release Metformin Hydrochloride Tablet Formulation.

W Chen1, D Desai2, D Good1

  • 1Drug Product Science and Technology, Bristol-Myers Squibb Co., P.O. Box 191, New Brunswick, New Jersey, 08903-0191, USA.

AAPS Pharmscitech
|January 6, 2016
PubMed
Summary
This summary is machine-generated.

A computational fluid dynamic model accurately predicted metformin release from extended-release tablets. This simulation approach ensured consistent drug release across different tablet strengths, confirmed by clinical studies.

Keywords:
CFDGastroPlusHPMCdiffusionmathematical modelscale-upsurface areavolume

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Area of Science:

  • Pharmaceutical Sciences
  • Pharmacokinetics
  • Computational Modeling

Background:

  • Extended-release metformin formulations require precise control over drug release kinetics.
  • Tablet geometry significantly influences drug release from matrix systems.
  • Predictive modeling can optimize formulation development and reduce clinical testing burden.

Purpose of the Study:

  • To develop and validate a computational fluid dynamic (CFD) model for predicting metformin release from HPMC matrix tablets.
  • To utilize a surface area/volume (SA/V) approach for designing high-dose (1000 mg) metformin tablets with equivalent release profiles.
  • To predict clinical exposure of the new 1000 mg Met XR tablet using a pharmacokinetic absorption model and validate with bioequivalence data.

Main Methods:

  • Development of a CFD model incorporating drug substance properties, formulation composition, and tablet geometry.
  • Application of the SA/V approach to design 1000 mg Met XR tablet geometry for equivalent release.
  • Construction of a pharmacokinetic absorption model in GastroPlus™ using in vitro dissolution and physicochemical data.
  • Comparison of simulated in vitro release and in vivo pharmacokinetic profiles with experimental data.

Main Results:

  • CFD simulations successfully predicted metformin release kinetics, maintaining similar dissolution behavior across different tablet geometries via constant SA/V ratio.
  • Experimental dissolution profiles of high-strength tablets matched simulated release.
  • The pharmacokinetic absorption model accurately predicted equivalent human exposure across all Met XR strengths.
  • Clinical bioequivalence study confirmed the predicted equivalent in vivo exposure.

Conclusions:

  • CFD modeling is a reliable tool for predicting metformin release from HPMC matrix extended-release tablets.
  • The SA/V approach effectively ensures consistent drug release kinetics across varying tablet strengths and geometries.
  • Integrated in vitro-in silico modeling accurately predicts in vivo performance, supporting efficient drug development and bioequivalence assessment.