Developing dissolution testing methodologies for extended-release oral dosage forms with supersaturating properties. Case example: Solid dispersion matrix of indomethacin

Tajiri, Tomokazu; Morita, Shigeaki; Sakamoto, Ryosaku; Mimura, Hisashi; Ozaki, Yukihiro; Reppas, Christos; Kitamura, Satoshi

doi:10.1016/j.ijpharm.2015.05.054

Cited by 11 publications

(3 citation statements)

References 33 publications

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“…Thus the NFs hold great potential in the reduction of drug resistance for many infectious diseases. The versatility in the forms of hydrogels that have been manufactured such as a particle form (nanogels), 165 inhalable form, 166 liquid injectable form (intravenous and subcutaneous), 167 as a patch for scaffolds 168 and in an oral dosages form 169 makes them perfect candidates to be exploited for chemotherapy and drug resistance in infectious diseases. For tuberculosis, the nanotechnology based systems allow increased transcytosis in the gut lumen M cells which enhances the intracellular uptake in the lining epithelium, and improved uptake in the Peyer's patch.…”

Section: Future Prospectives and Challengesmentioning

confidence: 99%

Recent trends on hydrogel based drug delivery systems for infectious diseases

et al. 2016

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For centuries, the rapid spread and cure of infectious diseases have been a major concern to the progress and survival of humans. These diseases are the global burden and the prominent cause for the worldwide deaths and disability. Nanomedicine has emerged as the most excellent tool to eradicate and halt their spread. Various nanoformulations (NFs) using advanced nanotechnology are in demand. Recently, hydrogel and nanogel based drug delivery devices poses new prospects to simulate the natural intelligence of various biological systems. Owing to their unique porous interpenetrating network design, hydrophobic drug incorporation and stimulus sensitivity hydrogels owe excellent potential as targeted drug delivery system. Present review is an attempt to highlight the recent trends of hydrogel based drug delivery systems for the delivery of therapeutic agents and diagnostics for the major infectious diseases including Acquired immune deficiency syndrome (AIDS), Malaria, Tuberculosis, Influenza and Ebola. Future prospective and challenges are also briefed.

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Section: Future Prospectives and Challengesmentioning

confidence: 99%

Recent trends on hydrogel based drug delivery systems for infectious diseases

et al. 2016

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“…This configuration is especially suitable for dissolution tests of low dosage strength drugs, in which a small volume of medium is usually required to achieve adequate concentration. The open-loop configuration offers infinite sink conditions, which is often preferred for controlled-release dosage forms and poorly soluble drugs (2). In open-loop configuration, the flow-through cell apparatus enables a medium change during the drug dissolution process, simulating the in vivo environment with relevant pH changes.…”

Section: Introductionmentioning

confidence: 99%

“…In open-loop configuration, the flow-through cell apparatus enables a medium change during the drug dissolution process, simulating the in vivo environment with relevant pH changes. This is particularly suitable for the dissolution test of pH-sensitive drugs, such as targeted dosage forms and targeted drug release systems (2)(3)(4). Equipped with various types of cells, the flow-through cell apparatus also demonstrates great superiority in the dissolution tests of new and special dosage forms, including but not limited to liposome, nanoparticles, microsphere, powders, granules, suspensions, soft capsules, implants, suppositories, microspheres, oilbased agents, and gels (5).…”

Section: Introductionmentioning

confidence: 99%

Application of Salicylic Acid Tablets in the Performance Verification Test for the Flow-Through Cell Apparatus

Chen,

Qiu,

Zhou

et al. 2024

Dissolut. Technol.

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The flow-through cell is the preferred apparatus for dissolution testing of controlled-release dosage forms, poorly soluble drugs, and many special dosage forms, such as suspensions, soft capsules, implants, microspheres, and liposomes. Although the flow-through cell apparatus has been included in pharmacopoeias for years, there is no official performance verification test (PVT) method. In this study, salicylic acid tablets were used to develop a PVT for the flow-through cell apparatus. Using the same erosion and zero-order release mechanism as the basket and paddle apparatus, the salicylic acid tablet proved to be a good potential reference standard in PVT for the flow-through cell apparatus. In phase I, four parameters were systematically investigated for their influence on dissolution of salicylic acid using the design of experiment (DoE) method. The tablet loading pattern was the most important parameter influencing dissolution; flow rate and cell inner diameter (ID) also had a significant impact. Temperature had a negligible effect on dissolution. In phase II, dissolution tests were conducted by four different analysts on different flow-through cell apparatus (i.e., four collaborators) in two test facilities for repeatability and reproducibility assessments and to determine preliminary acceptance criteria for the PVT. The experimental condition for phase II was tablets placed on the tablet holder with glass beads, cell ID of 12 mm, flow rate of 16 mL/min, and temperature of 37 °C, and sample collected at 90 minutes. Reproducibility of the PVT was confirmed with data from a fifth collaborator.

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