Factors Influencing the Dissolution of Solid Dosage Forms (Part I)
In theory, in vivo drug testing is the most important and reliable basis for evaluating drugs. However, in the development of oral solid dosage forms, the method of measuring bioavailability is used to screen and evaluate each new prescription and process, which is time-consuming and costly. money. Although the results of in vivo and in vitro tests may not be completely consistent, they have certain relevance. Because the in vitro dissolution test is simple and feasible, it can be regarded as a cost-effective quality test and control method. The determination of in vitro dissolution rate can provide an important basis for the formulation of preparations and process screening, and avoid blindness in the research and development of solid preparations.
Medicilon provides R&D and production 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 indicators.
Solid dosage forms are generally more stable than aqueous solutions, but chemical reactions occur when drugs are in the solid state. The reaction mechanism is generally more complex than that in the solution state, and there are more factors that affect the reaction rate. The compatibility between drugs and drugs, the compatibility of drugs and excipients, and the interaction between the components may lead to the degradation of Solid dosage forms. Medicilon has rich experience in the research and application of innovative drugs and generic drugs. It provides one-stop and systematic formulation R&D services covering innovative drugs and generic drugs to meet the needs of customers at different stages of development and is committed to solid dosage forms. , Semi-solid preparations, liquid preparations and innovative preparations, etc. to provide contract research and development services. At the same time, Medicilon has rich R&D experience in sustained and controlled release formulations, microparticle formulations, and protein and peptide pharmaceutical formulations, and many mature products have been handed over to customers.
Through the determination of dissolution, the pros and cons of new dosage forms can be compared, the influence of excipients, carriers and diluents on drug dissolution and its principles can be investigated, and the varieties, dosages and best prescriptions of excipients can be screened scientifically. Therefore, investigating the influence of different technologies and processes on drug dissolution is of great significance to the design of new processes.
The main factors affecting the absorption of the active ingredients in solid dosage forms in the body include the disintegration time of the preparation, the size of the drug particles, the solubility of the drug itself and the structure of the drug powder, etc., and these factors are closely related to the dosage form, the prescription and the preparation process. Correlation, that is to say, the dosage form, formulation prescription and process are directly related to the dissolution of the drug.
