Search results for " FORMS"
showing 10 items of 199 documents
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid.
2018
This work presents a review of literature and experimental data relevant to the possibility of waiving pharmacokinetic bioequivalence studies in human volunteers for approval of immediate-release solid oral pharmaceutical forms containing folic acid as the single active pharmaceutical ingredient. For dosage forms containing 5 mg folic acid, the highest dose strength on the World Health Organization Essential Medicines List, the dose/solubility ratio calculated from solubility studies was higher than 250 mL, corresponding to a classification as "not highly soluble." Small, physiological doses of folic acid (≤320 μg) seem to be absorbed completely via active transport, but permeability data f…
Computational Fluid Dynamics Simulation of Hydrodynamics and Stresses in the PhEur/USP Disintegration Tester Under Fed and Fasted Fluid Characteristi…
2015
ABSTRACT: Disintegration of oral solid dosage forms is a prerequisite for drug dissolution and absorption and is to a large extent dependent on the pressures and hydrodynamic conditions in the solution that the dosage form is exposed to. In this work, the hydrodynamics in the PhEur/USP disintegration tester were investigated using computational fluid dynamics (CFD). Particle image velocimetry was used to validate the CFD predictions. The CFD simulations were performed with different Newtonian and non-Newtonian fluids, representing fasted and fed states. The results indicate that the current design and operating conditions of the disintegration test device, given by the pharmacopoeias, are n…
New insights into black bodies
2012
Planck's law describes the radiation of black bodies. The study of its properties is of special interest, as black bodies are a good description for the behavior of many phenomena. In this work a new mathematical study of Planck's law is performed and new properties of this old acquaintance are obtained. As a result, the exact form for the locus in a color-color diagrams has been deduced, and an analytical formula to determine with precision the black body temperature of an object from any pair of measurements has been developed. Thus, using two images of the same field obtained with different filters, one can compute a fast estimation of black body temperatures for every pixel in the image…
Formulation predictive dissolution (fPD) testing to advance oral drug product development: an introduction to the US FDA funded ‘21st Century BA/BE’ …
2018
Over the past decade, formulation predictive dissolution (fPD) testing has gained increasing attention. Another mindset is pushed forward where scientists in our field are more confident to explore the in vivo behavior of an oral drug product by performing predictive in vitro dissolution studies. Similarly, there is an increasing interest in the application of modern computational fluid dynamics (CFD) frameworks and high-performance computing platforms to study the local processes underlying absorption within the gastrointestinal (GI) tract. In that way, CFD and computing platforms both can inform future PBPK-based in silico frameworks and determine the GI-motility-driven hydrodynamic impac…
Oral biopharmaceutics tools – Time for a new initiative – An introduction to the IMI project OrBiTo
2013
OrBiTo is a new European project within the IMI programme in the area of oral biopharmaceutics tools that includes world leading scientists from nine European universities, one regulatory agency, one non-profit research organization, four SMEs together with scientists from twelve pharmaceutical companies. The OrBiTo project will address key gaps in our knowledge of gastrointestinal (GI) drug absorption and deliver a framework for rational application of predictive biopharmaceutics tools for oral drug delivery. This will be achieved through novel prospective investigations to define new methodologies as well as refinement of existing tools. Extensive validation of novel and existing biopharm…
Democratic values in the aesthetics of classic American pragmatism
2011
Abstract In the present paper an interpretation of the political dimension of pragmatic aesthetic reflection is proposed. The interconnection between politics and aesthetics in three classic American pragmatists: William James (1842–1910), John Dewey (1859–1952), and George Herbert Mead (1863–1931) is evoked. The author claims that by emphasizing the role of democratic values in philosophy and life, the classic American pragmatists encroach upon the field of the arts and aesthetics. Their emphasis put upon individual activity, free expression of thoughts, plurality of the forms of expression, and acceptance of criticism as a tool helping create better solutions in human cooperation can easi…
In vitro models for the prediction of in vivo performance of oral dosage forms: Recent progress from partnership through the IMI OrBiTo collaboration
2019
The availability of in vitro tools that are constructed on the basis of a detailed knowledge of key aspects of gastrointestinal (GI) physiology and their impact on formulation performance and subsequent drug release behaviour is fundamental to the success and efficiency of oral drug product development. Over the last six years, the development and optimization of improved, biorelevant in vitro tools has been a cornerstone of the IMI OrBiTo (Oral Biopharmaceutics Tools) project. By bringing together key industry and academic partners, and by linking tool development and optimization to human studies to understand behaviour at the formulation/GI tract interface, the collaboration has enabled …
Modular Calabi-Yau threefolds of level eight
2005
In the studies on the modularity conjecture for rigid Calabi-Yau threefolds several examples with the unique level 8 cusp form were constructed. According to the Tate Conjecture correspondences inducing isomorphisms on the middle cohomologies should exist between these varieties. In the paper we construct several examples of such correspondences. In the constructions elliptic fibrations play a crucial role. In fact we show that all but three examples are in some sense built upon two modular curves from the Beauville list.
Representation Theorems for Indefinite Quadratic Forms Revisited
2010
The first and second representation theorems for sign-indefinite, not necessarily semi-bounded quadratic forms are revisited. New straightforward proofs of these theorems are given. A number of necessary and sufficient conditions ensuring the second representation theorem to hold is proved. A new simple and explicit example of a self-adjoint operator for which the second representation theorem does not hold is also provided.
The Fatou coordinate for parabolic Dulac germs
2017
We study the class of parabolic Dulac germs of hyperbolic polycycles. For such germs we give a constructive proof of the existence of a unique Fatou coordinate, admitting an asymptotic expansion in the power-iterated log scale.