Search Results for: Solid Dosage Form

Key Points Of This Chapter   The selection of the process is based on the characteristics of the API and the properties of the excipients, which must be comprehensively considered through reasonable evaluation methods. When there are many influencing factors, in order to find CQAs more quickly and effectively, it is necessary to conduct DoE […]

This article introduces several sterilization methods for sterile medicines: moist heat sterilization, dry heat sterilization, radiation sterilization, ethylene oxide sterilization and sterilization filtration, and studies the sterilization principles and effects of various sterilization methods. Factors, advantages and disadvantages, and products suitable for sterilization, etc., and through the sterilization method of solution dosage form products and

The sterility test of microspheres for injection should focus on both “outside sterility” and “inside sterility”, and the difficulty of detection is “inside sterility”, that is, the sterility test inside the microsphere. On the basis of investigating the production process of microspheres for injection, this study selected representative varieties, simulated the dissolution process of microspheres

Part 1 – Origin of Stability Test Placement Conditions   According to the concept proposed by W.Grimm (DrugsMade in Germany, 28:196-202, 1985 and 29:39-47. 1986), the world is divided into 4 climate zones according to the annual climate conditions.   Climate zone Ⅰ: temperate zone 21°C/45%RH Climate Zone Ⅱ: Subtropical 25°C/60%RH Climate zone Ⅲ: dry

After decades of research and development efforts, the biopharmaceutical industry has achieved rapid development, but oral biologics technology is still far away from everyone’s vision. Today, biologics are often administered in a healthcare facility (by IV, or subcutaneously), rather than by the patient at home.   The term “biopharmaceuticals” is generally understood as complex macromolecules,

Objective: To provide a reference for the detection of seal integrity in injection consistency evaluation.   Methods: Based on literature research and combined with practical work experience, the relevant research on the existing injection packaging seal integrity detection technology was systematically summarized.   RESULTS AND CONCLUSION: At present, our country is still in the initial

It often takes a long time for a new drug to go from research and development to clinical trials to approval for marketing. In the case of Gleevec (a leukemia drug), the whole process took about 50 years. Therefore, traditional drug development and production techniques are in urgent need of change. In 2015, the world’s

Biopharmaceutical engineering requires practitioners to integrate knowledge systems and technologies in pharmacy, biochemistry, and medicine, and the technical threshold is relatively high. Practitioners in the biopharmaceutical industry need to be proficient in biological knowledge and apply innovative biotechnology to process biological raw materials to produce biological drugs. The biopharmaceutical industry is currently in short supply

Part 1 Question Formulation   At present, China’s pharmaceutical factories are developing vigorously. However, with the construction of a large number of pharmaceutical factories, some problems have been exposed in the preliminary design of pharmaceutical workshops, most of which are due to the lack of consideration in the specific layout design process. week, improper design,

In the process of drug production, the amount of raw materials used in feeding exceeds 100% of the feeding amount required by the formula, which is called excessive feeding. Generally speaking, in the process of drug application and registration, the prescription dosage in the application materials is not allowed If adjustments are made, the value