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Release studies were performed in pH 1.2 and 6.8 whereas time-lapsed X-ray microfocus Computed Tomography (4D-CT), was employed to visualize volumetric and morphological changes of the formulations during the dissolution procedure.
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A description of the dissolution procedure can be seen in Puppolo et al. (2017).
The dissolution studies were conducted according to the dissolution procedure recommended for single-entity products in 900 mL of 0.1 N HCl (75 rpm).
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The dissolution process appears auto-catalytic.
In vivo BE studies for higher strengths may not be necessary based on (1) clinical safety and/or efficacy data on the proposed dose and the need for the higher strength, (2) linearity of pharmacokinetics over the therapeutic dose range, and (3) the same dissolution procedures being used for all strengths and similar dissolution results obtained.
As already mentioned above, the groundbreaking innovation that brought DNP into the realm of in vitro and in vivo biological MR was the addition of a dissolution procedure for producing HP liquid-state imaging agents at physiological temperatures.
A. Capozzi and T.C. optimized the solid sample extraction and ex situ dissolution procedure and performed the in vitro13C hyperpolarized MRS measurements.
The optimization of a microwave dissolution procedure for potentially toxic elements in a contaminated soil sample has been evaluated using a central composite design approach.
Methods for estimating the content of ground granulated blast furnace slag (GGBFS), fly ash and other pozzolanas in hardened concrete were investigated including a selective dissolution procedure, a method based on scanning electron microscopy (SEM) combined with image analysis and a XRF method.
The technique combines the solid-state methods of dynamic nuclear polarization (DNP) (Bailey et al, 1981) with a rapid dissolution procedure to produce stable injectable solutions (in vivo stability of approximately 60 s) (Golman et al, 2006a; Malloy et al, 1987).
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