The consistency evaluation of the quality and efficacy of the generic drug requires that the generic drug and the reference preparation have the same quality attributes and clinical efficacy. In the consistency evaluation of the generic drug, effective methods are adopted to accurately evaluate the drug’s in vivo and in vitro correlation (IVIVC) Is an important question. Among them, the in vitro dissolution test is an important method to evaluate the quality of drugs and their correlations in vivo and in vitro. This method is an effective alternative method for researching and evaluating the bioavailability of drugs in vivo using in vitro tests.
In vivo and in vitro correlation (IVIVC) refers to the relationship between the biological properties generated by the preparation or the parameters derived from the biological properties (such as tmax, Cmax or AUC) and the physical and chemical properties of the same preparation (such as in vitro release behavior). Reasonable quantitative relationship. Dissolution rate refers to the speed and extent of the dissolution of a drug from a solid preparation such as a tablet or capsule in a prescribed solvent. It is a simple in vitro test method that simulates the disintegration and dissolution of a drug in the body. There is a certain correlation between the degrees, which has attracted wide attention.
For example, researchers have established a method for determining the dissolution of sodium ferulate tablets, which lays the foundation for the consistency evaluation of the dissolution of sodium ferulate tablets in vivo and in vitro. The researchers used the high-performance liquid method to evaluate the in vitro dissolution of 5 batches of sodium ferulate tablets from two manufacturers in 3 dissolution media, and drew the in vitro dissolution curve diagram [1]. The f2 similarity factor method was used to compare the similarity of dissolution curves, and the model-dependent method was used as a supplement to evaluate the consistency of dissolution in vitro. Results The dissolution effect of sodium ferulate tablets in water, pH 4.5 acetate buffer and pH 6.8 phosphate buffer was ideal. The study found that the method used in the research is stable and reliable, which can provide a theoretical reference for the consistency evaluation of sodium ferulate tablets.
The dissolution rate of the drug can comprehensively and reliably reflect the quality of the tablet, which is an important means to ensure and measure whether the quality of the solid oral preparation production process is reasonable and stable. For drug quality control, in vitro dissolution test can not only be used as a means of drug quality control, but also help formulate drug standards. Different crystal forms of the same drug may have significant differences in appearance, solubility, melting point, dissolution, bioavailability, etc., thus affecting the stability, bioavailability and efficacy of the drug. This phenomenon is manifested in oral solid preparations. It is especially obvious. Medicilon provides research and development services for pharmaceutical preparations. According to the characteristics of the dosage form, combined with the physical and chemical properties and stability of the drug, the production conditions and equipment are considered, process research is carried out, the preparation process of laboratory samples is initially determined, and the corresponding process control is established index.
When evaluating the quality of drugs, measuring the dissolution rate of the drug helps to detect the difference between the drugs produced by different manufacturers. For example, a researcher has established a method for the dissolution of vitamin B2 in multivitamin B tablets, and compares the dissolution profiles of different samples [2]. Using HPLC method, using a CACell PAK C18 column (4.6 mm×250 mm, 5μm), using a solution containing 2 mmol/L heptane sulfonate and 50 mmol/L ammonium dihydrogen phosphate-acetonitrile (85:15) Mobile phase; Flow rate: 1.0 mL/min; Column temperature: 35; Detection wavelength: 267 nm; The dissolution test takes vitamin B2 as the investigation object, adopts the paddle method, uses 600 mL of water as the dissolution medium, and rotates at 75 r/min. The HPLC dissolution determination method established by the researcher is simple and convenient, with good specificity, precision and accuracy. The dissolution method can better reflect the differences between samples from different manufacturers. Some manufacturers should improve the production process and strengthen the product Dissolution studies to improve the effectiveness of drugs.
At present, dissolution testing has been increasingly used in drug research and development, production control, and supervision of marketed products. With the increasing application scope of dissolution, how to appropriately use this quality index in drug development and drug supervision requires continuous exploration.
[1] Consistency evaluation of in vitro dissolution behavior of sodium ferulate tablets[J].
[2] Study on the determination method of vitamin B2 dissolution in multivitamin B tablets [J].
