Results 271 to 280 of about 1,965,906 (302)
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Dissolution Profiles for Multisized Prednisolone Acetate Suspensions
Journal of Pharmaceutical Sciences, 1977Particle-size measurements and in vitro dissolution characteristics of commercial and formulated suspensions of prednisolone acetate were determined using a resistance particle counter and a spinning filter apparatus, respectively. Significant differences in dissolution rates were noted for the commercial suspensions.
S A, Howard, J W, Mauger, L, Phusanti
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Disintegration/dissolution profiles of copies of Fosamax (alendronate)
Current Medical Research and Opinion, 2003Poor quality has been reported for some generics and other copies of original products. We performed a pilot study to compare the disintegration/dissolution profiles of FOSAMAX (alendronate) 70 mg tablets with those of copies of FOSAMAX that were manufactured outside the United States.We used the standard United States Pharmacopeia (USP) disintegration
S, Epstein +7 more
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ASSESSMENT OF SIMILARITY BETWEEN DISSOLUTION PROFILES*
Journal of Biopharmaceutical Statistics, 2000In vitro dissolution equivalence has been assessed through profile comparison between the test and reference formulations for postapproval changes. Functions of the absolute mean difference and average squared mean differences were two of the often-used criteria to evaluate distance or similarity between general profiles.
M C, Ma, B B, Wang, J P, Liu, Y, Tsong
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Guidelines on Dissolution Profile Comparison
Drug Information Journal, 2001This article presents a short review on guidelines for dissolution profile testing, particu-larly focusing on the recommendations regarding statistical methods for assessing profile similarity. In this context, the guidelines on in vitro/in vivo correlations and on granting biowaivers are outlined briefly. The comparison of two dissolution profiles can
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Pharmaceutical Research, 2014
The aim of this study was to investigate influencing factors on the dissolution test for powders for pulmonary delivery with USP apparatus 2 (paddle apparatus).We investigated the influence of dose collection method, membrane holder type and the presence of surfactants on the dissolution process. Furthermore, we modeled the in vitro dissolution process
Sabine, May +5 more
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The aim of this study was to investigate influencing factors on the dissolution test for powders for pulmonary delivery with USP apparatus 2 (paddle apparatus).We investigated the influence of dose collection method, membrane holder type and the presence of surfactants on the dissolution process. Furthermore, we modeled the in vitro dissolution process
Sabine, May +5 more
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Journal of Pharmaceutical Sciences, 2003
Dissolution profiles are classified in accordance with the shape of fractional dissolution rate function. This function is constant in time for the classical first-order model and, in this case, the dissolution is described by a monoexponential function.
Petr, Lánský, Michael, Weiss
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Dissolution profiles are classified in accordance with the shape of fractional dissolution rate function. This function is constant in time for the classical first-order model and, in this case, the dissolution is described by a monoexponential function.
Petr, Lánský, Michael, Weiss
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Mathematical expression of tablet dissolution profiles
International Journal of Pharmaceutics, 1983Abstract The process of tablet dissolution may adequately be expressed in terms of two consecutive stages, the first having a time-dependent rate, and the second being a simple first-order process. By utilizing tables of first and second differences, the rate constants of these processes may easily be determined from dissolution profiles.
J.R. Leary, S.D. Ross
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Journal of Pharmaceutical Sciences, 1997
The objectives of this work were to apply several profile comparison approaches to dissolution data of four different but bioequivalent metoprolol tartrate tablet formulations to (1) identify the advantages and disadvantages of each approach, (2) quantify the metric for comparing dissolution profiles of each method, (3) determine metric limits that are
J E, Polli +3 more
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The objectives of this work were to apply several profile comparison approaches to dissolution data of four different but bioequivalent metoprolol tartrate tablet formulations to (1) identify the advantages and disadvantages of each approach, (2) quantify the metric for comparing dissolution profiles of each method, (3) determine metric limits that are
J E, Polli +3 more
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Equivalence analyses of dissolution profiles with the Mahalanobis distance
Biometrical Journal, 2018AbstractFor some postapproval changes, the manufacturer has to demonstrate that the dissolution profile of the drug product before the change is statistically equivalent to the dissolution profile after the change. Guidelines suggest the so‐called similarity factor f2 as standard approach for the equivalence analysis. f2 is a statistically questionable
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in Vitro Dissolution Profile Comparison and IVIVR
1997USP1 describes the in-vivo/in-vitro correlation as the “establishment of a rational relationship between a biological property, or a parameter derived from a biological property produced by a dosage form and a physicochemical property or characteristic of the same dosage form”.
Pradeep Sathe, Yi Tsong, Vinod P. Shah
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