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Critical Reviews™ in Therapeutic Drug Carrier Systems

Publication de 6  numéros par an

ISSN Imprimer: 0743-4863

ISSN En ligne: 2162-660X

The Impact Factor measures the average number of citations received in a particular year by papers published in the journal during the two preceding years. 2017 Journal Citation Reports (Clarivate Analytics, 2018) IF: 2.7 To calculate the five year Impact Factor, citations are counted in 2017 to the previous five years and divided by the source items published in the previous five years. 2017 Journal Citation Reports (Clarivate Analytics, 2018) 5-Year IF: 3.6 The Immediacy Index is the average number of times an article is cited in the year it is published. The journal Immediacy Index indicates how quickly articles in a journal are cited. Immediacy Index: 0.8 The Eigenfactor score, developed by Jevin West and Carl Bergstrom at the University of Washington, is a rating of the total importance of a scientific journal. Journals are rated according to the number of incoming citations, with citations from highly ranked journals weighted to make a larger contribution to the eigenfactor than those from poorly ranked journals. Eigenfactor: 0.00023 The Journal Citation Indicator (JCI) is a single measurement of the field-normalized citation impact of journals in the Web of Science Core Collection across disciplines. The key words here are that the metric is normalized and cross-disciplinary. JCI: 0.39 SJR: 0.42 SNIP: 0.89 CiteScore™:: 5.5 H-Index: 79

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Dissolution Criticality in Developing Solid Oral Formulations: From Inception to Perception

Volume 30, Numéro 6, 2013, pp. 495-534
DOI: 10.1615/CritRevTherDrugCarrierSyst.2013007795
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RÉSUMÉ

Currently, dissolution testing has become a vital tool for accessing product performance, especially in the hierarchy of solid oral dosage forms. With advances in complicated, expensive, and sophisticated analytical instruments, characterization of formulations has become easier, but simple dissolution assembly is gradually gaining momentum from industrial environs as well as regulatory agencies. As such, simple dissolution testing involves many complexities which must be properly understood to reach correct conclusions. The appropriate selection of multiple parameters (e.g., apparatus, medium, agitation, etc.) involved in dissolution testing and understanding their impact on analysis require thorough subject knowledge. In the words of regulatory provisions, in vitro dissolution testing can become a surrogate for expensive and tedious bioequivalence studies in special cases (i.e., when a biowaiver is recommended). As a consequence, reduced human testing as well as lower product development cost ultimately benefit patients and society. Therefore, the dissolution science has recently become one of the keys for success for formulation scientists, especially generic manufacturers. While designing dissolution methodologies, generic manufacturers need to follow the respective regulatory guidelines at the product development stage; concomitant data are required for the approval process. This comprehensive review is an earnest attempt to acquaint readers with the history, contemporary practices, and relevant issues regarding dissolution which may become a guiding tool for overcoming challenges and opening better prospects in product development.

CITÉ PAR
  1. Kulinowski Piotr, Hudy Wiktor, Mendyk Aleksander, Juszczyk Ewelina, Węglarz Władysław P., Jachowicz Renata, Dorożyński Przemysław, The Relationship Between the Evolution of an Internal Structure and Drug Dissolution from Controlled-Release Matrix Tablets, AAPS PharmSciTech, 17, 3, 2016. Crossref

  2. Patadia Riddhish, Vora Chintan, Mittal Karan, Mashru Rajashree, Investigating effects of hydroxypropyl methylcellulose (HPMC) molecular weight grades on lag time of press-coated ethylcellulose tablets, Pharmaceutical Development and Technology, 2015. Crossref

  3. Patadia Riddhish, Vora Chintan, Mittal Karan, Mashru Rajashree C., Quality by Design Empowered Development and Optimisation of Time-Controlled Pulsatile Release Platform Formulation Employing Compression Coating Technology, AAPS PharmSciTech, 18, 4, 2017. Crossref

  4. Shrivas Meera, Khunt Dignesh, Shrivas Meenakshee, Choudhari Manisha, Rathod Rajeshwari, Misra Manju, Advances in In Vivo Predictive Dissolution Testing of Solid Oral Formulations: How Closer to In Vivo Performance?, Journal of Pharmaceutical Innovation, 15, 3, 2020. Crossref

  5. Pareek Suresh, Omray Ashok, Koli Akshay R., InstaSpheres TA (Tartaric acid) as functional starter core for extended release formulations, Journal of Drug Delivery Science and Technology, 54, 2019. Crossref

  6. Gupta Aashu, Maheshwari Rahul, Kuche Kaushik, Hutcheon Gillian A., Tekade Rakesh K., Regulatory assessment for controlled drug delivery products, in Drug Delivery Systems, 2019. Crossref

  7. Mrad Mohamed Azouz, Csorba Kristóf, Galata Dorián László, Nagy Zsombor Kristóf, Nagy Brigitta, Spectroscopy-Based Prediction of In Vitro Dissolution Profile Using Artificial Neural Networks, in Artificial Intelligence and Soft Computing, 12854, 2021. Crossref

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