&lt;p&gt;Physicochemical properties and drug-release mechanisms of dual-release bilayer tablet containing mirabegron and fesoterodine fumarate&lt;/p&gt;

Lee, Honggoo; Park, Yun Sang; Jeong, Jin-Hyuk; Kwon, Yong-Bin; Shin, Dae Hwan; Kim, Ju‐Young; Rhee, Yun-Seok; Park, Eun-Seok; Kim, Dong-Wook; Park, Chun‐Woong

doi:10.2147/dddt.s212520

Cited by 14 publications

(5 citation statements)

References 31 publications

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“…For ATR-FTIR imaging, the analyzed samples must be placed on an internal reflectance element, and measurements are usually taken at the interface between the analyzed sample and the medium. This method has been used to investigate the influence of pH and/or ionic strength on drug release from a hydrophilic polymer matrix system [ 76 , 77 ], to study the drug release from multi-layer and/or multi-drug tablets [ 78 , 79 ], as well as thin films [ 80 ]. In addition, ATR-FTIR imaging was coupled with DEM to model the release of nicotinamide from HPMC matrix tablets [ 81 ].…”

Section: Drug Release Modelingmentioning

confidence: 99%

Model-Informed Drug Development: In Silico Assessment of Drug Bioperformance following Oral and Percutaneous Administration

Djuris,

Cvijic,

Djekic

2024

Pharmaceuticals

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The pharmaceutical industry has faced significant changes in recent years, primarily influenced by regulatory standards, market competition, and the need to accelerate drug development. Model-informed drug development (MIDD) leverages quantitative computational models to facilitate decision-making processes. This approach sheds light on the complex interplay between the influence of a drug’s performance and the resulting clinical outcomes. This comprehensive review aims to explain the mechanisms that control the dissolution and/or release of drugs and their subsequent permeation through biological membranes. Furthermore, the importance of simulating these processes through a variety of in silico models is emphasized. Advanced compartmental absorption models provide an analytical framework to understand the kinetics of transit, dissolution, and absorption associated with orally administered drugs. In contrast, for topical and transdermal drug delivery systems, the prediction of drug permeation is predominantly based on quantitative structure–permeation relationships and molecular dynamics simulations. This review describes a variety of modeling strategies, ranging from mechanistic to empirical equations, and highlights the growing importance of state-of-the-art tools such as artificial intelligence, as well as advanced imaging and spectroscopic techniques.

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Section: Drug Release Modelingmentioning

confidence: 99%

Model-Informed Drug Development: In Silico Assessment of Drug Bioperformance following Oral and Percutaneous Administration

Djuris,

Cvijic,

Djekic

2024

Pharmaceuticals

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“…It was found that only at relatively high flow rates did the dissolution profile resemble that of zero-order release formulations, attributed to the erosion of the gel layer [64]. In a more recent study by Lee et al, the dissolution behaviour of Fesoterodine fumarate (Fst) and Mirabegron (Mrb) was studied in a bilayer tablet where extended release was desired for both APIs [88]. Several techniques were implemented to characterize the dissolution behaviour of the two drugs in the bilayer tablet, including camera imaging, SEM, swelling and erosion studies, USP dissolution testing and ATR-FTIR spectroscopic imaging.…”

Section: Multi-layer and Multi-drug Tabletsmentioning

confidence: 99%

“…This resulted in a decreased dissolution profile as compared to the dissolution profile of the monolayer tablet. The use of ATR-FTIR spectroscopic imaging in this study revealed the amount of drug transfer from one layer to the other and vice versa in a dual-release bilayer-tablet system [ 88 ]. This paper demonstrates that, with more complex drug delivery systems under development, chemical imaging will become essential in the characterisation of the drug release mechanisms underlying dissolution profiles obtained via USP standard testing.…”

Section: Advances In Ftir Spectroscopic Imaging For Tablet Dissolutio...mentioning

confidence: 99%

Advances in ATR-FTIR Spectroscopic Imaging for the Analysis of Tablet Dissolution and Drug Release

van Haaren,

De Bock,

Kazarian

2023

Molecules

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One of the major challenges in the development of effective pharmaceutical formulations for oral administration is the poor solubility of active pharmaceutical ingredients. For this reason, the dissolution process and drug release from solid oral dosage forms, such as tablets, is usually thoroughly studied in order to understand the dissolution behaviour under various conditions and optimize the formulation accordingly. Standard dissolution tests used in the pharmaceutical industry provide information on the amount of drug released over time; however, these do not allow for a detailed analysis of the underlying chemical and physical mechanisms of tablet dissolution. FTIR spectroscopic imaging, by contrast, does offer the ability to study these processes with high spatial and chemical specificity. As such, the method allows us to see the chemical and physical processes which occur inside the tablet as it dissolves. In this review, the power of ATR-FTIR spectroscopic imaging is demonstrated by presenting a number of successful applications of this chemical imaging technique to dissolution and drug release studies for a range of different pharmaceutical formulations and study conditions. Understanding these processes is essential for the development of effective oral dosage forms and optimization of pharmaceutical formulations.

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“…They prepared and investigated the release behaviour of each drug in the bilayer tablet. 9 A previous study found that either the formulation was not targeted to the desired region, or if it was targeted, there was a deficiency in prolonging release. Hence, the present study aimed to develop a suitable delivery system that would allow Fesoterodine to be absorbed well through the intestinal region and prolong its release with the help of a pH dependant minitablet in the capsule system.…”

Section: Introductionmentioning

confidence: 99%

Formulation and evaluation of pH activated dosage form as minitablets in capsule for delivery of fesoterodine

Syed¹,

Rathi²,

Gawale³

et al. 2022

Journal of Taibah University Medical Sciences

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Objectives In the present study, an attempt is made to develop novel multifunctional sustained-release minitablets in a capsule system by film coating Fesoterodine for the treatment of urinary incontinence (increased urinating frequency). Methodology The direct compression technique was used to formulate the minitablets, and coating was applied using hydroxypropyl methylcellulose (HPMC) phthalate. The pre-formulation study was performed using tools like differential scanning calorimetry (DSC), infrared spectroscopy (IR) and post-formulation parameters such as hardness, thickness, weight variation, uniformity, and drug release. Drug release kinetics were studied for the formulations F1–F11. Results All the pre- and post-formulation parameters were found to be within the limits. F1 and F2 result in burst release of the drug within 30 minutes. For the F3, F4, and F5 formulations, HPMC phthalate-coated minitablets show almost 100% drug release in 3, 4, and 5 hours, respectively. F6, F7, and F8 (2.5%, 5%, and 10% formaldehyde-coated minitablets, respectively) show drug releases in the small intestine, and the release was prolonged for 24 hours, whereas F9, F10, and F11 (2.5%, 5%, and 10% glutaraldehyde-coated minitablets, respectively) release in the small intestine, but drug release takes more than 20 hours. Conclusion Film-coated minitablets were satisfactorily developed in terms of various post-compression parameters like hardness, thickness, friability, weight variation, and content uniformity. IR and DSC studies revealed no significant drug excipient interactions. HPMC phthalate-coated minitablets released in the buffer, and it was supposed that the drug releases in the intestine, which leads to better absorption and follows Korsmeyer-Peppas release kinetics.

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<p>Physicochemical properties and drug-release mechanisms of dual-release bilayer tablet containing mirabegron and fesoterodine fumarate</p>

Cited by 14 publications

References 31 publications

Model-Informed Drug Development: In Silico Assessment of Drug Bioperformance following Oral and Percutaneous Administration

Model-Informed Drug Development: In Silico Assessment of Drug Bioperformance following Oral and Percutaneous Administration

Advances in ATR-FTIR Spectroscopic Imaging for the Analysis of Tablet Dissolution and Drug Release

Formulation and evaluation of pH activated dosage form as minitablets in capsule for delivery of fesoterodine

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