Dissolution Profile Consideration in Pharmaceutical Product Development

Mehtani, Disha; Seth, Ankit; Sharma, Piyoosh; Maheshwari, Rahul; Abed, Sara Nidal; Deb, Pran Kishore; Chougule, Mahavir B.; Tekade, Rakesh K.

doi:10.1016/b978-0-12-814423-7.00009-5

Cited by 8 publications

(10 citation statements)

References 111 publications

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“…Product is required. An In vivo bioequivalence research is not necessary if the similarity factor (f2) shows that the products' dissolving profiles before and after the alteration are comparable " [14]" .…”

Section: Surrogate Of Bioequivalence Study At Post Approval Changes O...mentioning

confidence: 99%

Comparative dissolution profiling of generic and standard drug under BCS Based Biowaiver conditions

Sayali Adinath Wagh,

Shubham Chandrakant Gadge,

Sayali Ulhas Vishe

et al. 2024

World J. Bio. Pharm. Health Sci.

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As specified by regulatory bodies, the current study intends to investigate the dissolving characteristics of a generic medicine product and its matching standard reference medication under Biowaiver settings. Through this comprehensive analysis, we validate the suitability of the generic drug for Biowaiver considerations. Consequently, it may potentially serve as a cost-effective alternative with therapeutic equivalence to the standard reference drug. These findings emphasize the significance of dissolution profiling in supporting the assessment of pharmaceutical quality and regulatory decision-making. This review paper also provides an overview of methodologies and statistical techniques used to compare dissolution profiles, which is a critical aspect of pharmaceutical quality assessment. The study investigates various approaches, including model-independent and model-dependent methods, in line with regulatory guidelines for evaluating whether the dissolution profiles are equivalent or comparable. We discuss the significance of choosing suitable metrics and acceptability criteria, and the effects of process and formulation modifications on dissolving profiles. The study's findings show that dissolving profiles are similar, suggesting that the generic drug's formulation satisfies the requirements to be eligible for Biowaiver. Therefore, it possesses potential for substitution with the standard drug under appropriate circumstances.

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Section: Surrogate Of Bioequivalence Study At Post Approval Changes O...mentioning

confidence: 99%

Comparative dissolution profiling of generic and standard drug under BCS Based Biowaiver conditions

Sayali Adinath Wagh,

Shubham Chandrakant Gadge,

Sayali Ulhas Vishe

et al. 2024

World J. Bio. Pharm. Health Sci.

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“…The preparation of well-dissolved and homogenous solutions is of great importance in a wide range of scientific and industrial applications such as pharmaceuticals, food processing, and wet appliance . The dissolution process involves the interactions of the solute with the solvent molecules and the motion of the solute molecules into the bulk solution .…”

Section: Introductionmentioning

confidence: 99%

“…The dissolution process involves the interactions of the solute with the solvent molecules and the motion of the solute molecules into the bulk solution . For the case of solid particles, the dissolution mechanism typically consists of several steps such as disintegration, disaggregation, and relocation of solute molecules in the solution, while the dissolution occurs directly for the liquid formulation . The dissolution mechanism is generally controlled by diffusion and/or kinetics, which are affected by major parameters such as temperature, pressure, solute concentration, and solvent composition …”

Section: Introductionmentioning

confidence: 99%

Detergent Dissolution Intensification via Energy-Efficient Hydrodynamic Cavitation Reactors

et al. 2023

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In this study, we explored the potential of hydrodynamic cavitation (HC) for use in dissolution of liquid and powder detergents. For this, microfluidic and polyether ether ketone (PEEK) tube HC reactors with different configurations were employed, and the results from the reactors were compared with a magnetic stirrer, as well as a tergotometer. According to our results PEEK tube HC reactors present the best performance for dissolution of liquid and powder detergents. In the case of liquid detergent, for the same level of initial concentration and comparable final dissolution, the PEEK tube consumed 16.7 and 70% of the energy and time of a tergotometer and 16.7 and 14.8% of that of a magnetic stirrer, respectively. In the case of powder detergent, the PEEK tube used 12% less power than a tergotometer and 81.2% less power than a magnetic stirrer. Additionally, the time required to dissolve the detergent was reduced significantly from 1200 s in the tergotometer and 1800 s in the magnetic stirrer to just 50 s in the PEEK tube. These results suggest that HC could significantly improve the dissolution rate of liquid and powder detergents and energy consumption in washing machines.

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“…This tool is widely used during the development of pharmaceutical products for the approval of generic drugs, and in addition, they play a fundamental role in the decision-making of regulatory entities since biowaivers can be obtained and demonstrate similarity despite post-approval changes to the drug [ 2 ]. However, to achieve the above, it is important to develop dissolution methods that are sufficiently discriminatory and robust so as not to overestimate results, and then, the selection of the dissolution apparatus, the agitation rate or work flow, the dissolution medium, and the analytical methodology are some of the critical factors to consider during their development [ 3 ].…”

Section: Introductionmentioning

confidence: 99%

Discriminative Dissolution Method Using the Open-Loop Configuration of the USP IV Apparatus to Compare Dissolution Profiles of Metoprolol Tartrate Immediate-Release Tablets: Use of Kinetic Parameters

Solis-Cruz,

Hernandez-Patlan,

Morales Hipólito

et al. 2023

Pharmaceutics

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The use of the USP IV apparatus (flow-through cell) has gained acceptance in recent years due to its versatility and ability to discriminate due to its hydrodynamic conditions. Therefore, the objective of the present study was to develop a discriminative dissolution method in the USP IV apparatus using the open-loop configuration, as well as to propose a method to compare non-cumulative dissolution profiles obtained in the open-loop configuration considering kinetic parameters and validate its predictive power through its comparison with independent and dependent methods using five commercial immediate-release tablet drugs (one reference drug and four generic drugs) of metoprolol tartrate as a model drug. The comparison of the non-accumulated dissolution profiles consisted of determining the geometric ratio of Cmax, AUC0∞, AUC0Cmax, and Tmax (kinetic parameters) of the generic/reference drugs, whereby generic drugs “C” and “D” presented the highest probability of similarity since their 90% confidence intervals were included, or they were very close to the acceptance interval (80.00–125.00%). These results were consistent with the f2, bootstrap f2, and dissolution efficiency approaches (independent models). In conclusion, the proposed comparison method can be an important tool to establish similarity in dissolution profiles and to facilitate the development/selection of new formulations and positively ensure bioequivalence in clinical studies.

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Dissolution Profile Consideration in Pharmaceutical Product Development

Cited by 8 publications

References 111 publications

Comparative dissolution profiling of generic and standard drug under BCS Based Biowaiver conditions

Comparative dissolution profiling of generic and standard drug under BCS Based Biowaiver conditions

Detergent Dissolution Intensification via Energy-Efficient Hydrodynamic Cavitation Reactors

Discriminative Dissolution Method Using the Open-Loop Configuration of the USP IV Apparatus to Compare Dissolution Profiles of Metoprolol Tartrate Immediate-Release Tablets: Use of Kinetic Parameters

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