DDDPlus (Dose Disintegration and Dissolution Plus) is an advanced technology computer program that models and simulates the in vitro dissolution of active pharmaceutical ingredients (API) and formulation excipients dosed as powders, tablets, capsules, and swellable or non-swellable polymer matrices under various experimental conditions.
Details
DDDPlus (Dose Disintegration and Dissolution Plus) is an advanced technology computer program that models and simulates the in vitro dissolution of active pharmaceutical ingredients (API) and formulation excipients dosed as powders, tablets, capsules, and swellable or non-swellable polymer matrices under various experimental conditions.
Dissolution rate is a critical parameter of pharmaceutical dosage forms because the API needs to be dissolved before it can be absorbed. In vitro dissolution testing is important to screen formulations during development and to ensure batch-to-batch quality control during production. Throughout the world, more than 40 years of research have been devoted to characterizing the biopharmaceutical properties of drugs. Several guidelines have been published and all pharmacopoeias include a description of dissolution testing.
During drug development, in vitro dissolution testing is an important tool for evaluating candidate formulations and for understanding possible risks related to specific gastrointestinal factors, potential for dose dumping, food effects on bioavailability, and interaction with excipients. Today, dissolution studies are the most frequently used tools in the development, characterization, and utilization process of both immediate and controlled-release formulations.
Dissolution, in the simplest sense, can be defined as the sequence by which a solid solute enters into a solution in the presence of a solvent. We can define the dissolution rate as the amount of ingredient in a solid dosage form dissolved in unit time under particular conditions.
A DDDPlus simulation is essentially the numerical integration of a set of differential equations that coordinate well-characterized physical actions that occur during dissolution, including but not limited to changes in particle size distributions for both active and excipient ingredients, as well as changes in microclimate (surface) and medium bulk pH as formulation constituents dissolve.
DDDPlus allows you to select from one of 5 mathematical models and 5 dosage forms used to describe the dissolution of a single ingredient. The mathematical models for the in vitro dissolution simulation account for the effects of:
Outputs are displayed with immediate on-screen text and graphics for single simulations, and can be saved to Microsoft Excel-compatible tab-delimited ASCII text files for both single and multiple simulations. Extended analyses through Parameter Sensitivity Analyses and Virtual Trials provide insight into the probable behaviors of formulations under varying conditions and can guide experimental efforts to focus precious resources where they will do the most good.
Dissolution rate is a critical parameter of pharmaceutical dosage forms because the API needs to be dissolved before it can be absorbed. In vitro dissolution testing is important to screen formulations during development and to ensure batch-to-batch quality control during production. Throughout the world, more than 40 years of research have been devoted to characterizing the biopharmaceutical properties of drugs. Several guidelines have been published and all pharmacopoeias include a description of dissolution testing.
During drug development, in vitro dissolution testing is an important tool for evaluating candidate formulations and for understanding possible risks related to specific gastrointestinal factors, potential for dose dumping, food effects on bioavailability, and interaction with excipients. Today, dissolution studies are the most frequently used tools in the development, characterization, and utilization process of both immediate and controlled-release formulations.
Dissolution, in the simplest sense, can be defined as the sequence by which a solid solute enters into a solution in the presence of a solvent. We can define the dissolution rate as the amount of ingredient in a solid dosage form dissolved in unit time under particular conditions.
A DDDPlus simulation is essentially the numerical integration of a set of differential equations that coordinate well-characterized physical actions that occur during dissolution, including but not limited to changes in particle size distributions for both active and excipient ingredients, as well as changes in microclimate (surface) and medium bulk pH as formulation constituents dissolve.
DDDPlus allows you to select from one of 5 mathematical models and 5 dosage forms used to describe the dissolution of a single ingredient. The mathematical models for the in vitro dissolution simulation account for the effects of:
- Physicochemical properties of the formulation ingredients under study: pKa's, solubility, diffusion coefficient, and density.
- Manufacturing properties for immediate release dosage forms.
- Particle size distribution for each of the formulation ingredients.
- Different flow patterns and fluid velocities for each experimental apparatus.
- Interactions between the active ingredient and formulation excipients.
- Microclimate pH-dependence of solubility and dissolution/precipitation.
- Micelle-facilitated dissolution through the incorporation of surfactants in the media.
- In spite of its sophistication, DDDPlus is relatively easy for someone with a background in formulation and chemistry to learn and use. DDDPlus incorporates an intuitive and modern graphical user interface that enables rapid and smooth transition from setting up inputs to evaluating results.
Outputs are displayed with immediate on-screen text and graphics for single simulations, and can be saved to Microsoft Excel-compatible tab-delimited ASCII text files for both single and multiple simulations. Extended analyses through Parameter Sensitivity Analyses and Virtual Trials provide insight into the probable behaviors of formulations under varying conditions and can guide experimental efforts to focus precious resources where they will do the most good.
Software Link: DDDPlus - Drug design software
