PubMed · 4064215
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L S Wan, P W Heng. 1985. Liquid penetration into tablets containing surfactants.. https://doi.org/10.1248/cpb.33.2569
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The main objective of this research is to investigate the principles underlying the dissolution process, study the phenomena of drug release in laminar flow, and better understand the effect of hydrodynamic condition on drug dissolution, in order to predict drug dissolution from a solid dosage form. Two drug models were selected, theophylline (Class I) and naproxen (Class II), and were formulated into conventional tablets containing 105 mg theophylline or 300 mg naproxen using wet granulation method. Additionally theophylline (105 mg) and naproxen (300 mg) matrices containing 30% hydroxypropylmethylcellulose (HPMC) polymer were prepared by direct compression and tested for dissolution using both USP II and IV dissolution apparatus. Tablets were tested for dissolution (USP IV) using different cell diameter, flow rate, and different position of the tablet inside the cell. In general, the drug dissolution at a given time is a direct function of the flow rate, increasing the flow rate increases drug release. The use of a small cell resulted in faster drug dissolution and higher Reynold's Number than using a large cell. Tablet position in the cell, also has an effect on drug dissolution, inserting the tablet in a horizontal position inside the cell gave faster dissolution than a vertical position. The hydrodynamic conditions did not affect the drug dissolution from HPMC controlled release tablets indicating that the drug dissolution is controlled by the matrix. An equation to predict drug dissolution from conventional tablets was established: Sh=-21.36+10.58Re(1/2) where R2=0.98. This study demonstrated that hydrodynamic conditions, and type of dissolution testing apparatus used have an effect on dissolution rate, mass transfer rate, and film thickness underlying dissolution process.
The purpose of this study was to investigate the effect of the agitation force and mechanical destructive force on the drug dissolution of a tablet in the paddle rotation dissolution test and in the disintegration test. The agitation in the paddle method and the mechanical destructive force in the disintegration test were considered to be conclusive factors for drug dissolution. The dissolution rate of planar-constant-release tablets increased with increasing paddle rotation speed and increased with increasing distance from the center of the vessel bottom. Separately, the fluid resistance (agitation force) in the vessel was measured using a modified paddle method apparatus equipped with a fluid resistance sensor. The fluid resistance was 0.03 x 10(-3) N/(64 mm(2)) when the paddle rotation speed was 50 rpm at a position 4 mm away from the center. A considerable position-dependent change in agitation force intensity was seen with the fluid resistance sensor. The impulsive force (mechanical destructive force) in the disintegration test apparatus was measured using a modified basket-rack assembly with a strain gauge transducer. The fluid resistance was measured using the basket-rack assembly with a different sensor probe and amplifier. The impulsive force applied by the auxiliary disk was 0.31 N and the fluid resistance at the bottom of the basket-rack assembly was 1.66 x 10(-3) N/(64 mm(2)).
The performance of principal component analysis (PCA) for the evaluation of dissolution profiles is examined and compared with other methods such as the similarity factor and the calculation of the area under the curve. Both simulated and real data from the pharmaceutical industry are used. The PCA scores plots of the dissolution curves provide information about the between- and within-batch variations. Differences in level or shape can be observed in the first two principal components (PCs). Irrelevant irregularities, which have a strong influence on the similarity factor, are neglected in PC1/PC2. To detect outliers in a set of dissolution curves, PCA was preferred above Hotelling's T2 test. In general, PCA is found to be a useful technique to examine dissolution data visually, but however, it does not contain criteria to decide if batches are similar or not. This can be done by combining PCA with the resampling with replacement or bootstrap method to construct confidence limits.