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The Importance of Particle Size Analysis in Preformulation Studies

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The size of the particles is called particle size. The particle size of the API is closely related to the homogeneity of the preparation process in terms of mixing, the accuracy of dosage, and compressibility, and it has an impact on the solubility, duration of action, site of action, stability, and safety of the drug formulation. And the particle size control of drugs has an important influence on drug effectiveness, strength, and security. Therefore, particle size is an essential object of study in preformulation studies for innovative medicines. Preformulation research is a vital link in drug development, directly affecting the subsequent development process and final application of drugs. Preformulation research aims to determine the pros and cons of potential drug molecules at the initial research stage and to screen candidates for drug molecules, involving the synthesis of new drug molecules, biological activity screening, pharmacokinetics, toxicology, safety evaluation, etc...

Exploring the Role of Preclinical Toxicology Tests in Vaccine Development

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  The vaccine is a generic term for various biological products containing antigenic substances that induce specific active immunity in humans. In preclinical studies of vaccine, it is crucial to examine the safety of vaccines by performing preclinical safety evaluations with relevant animals. Drug safety evaluation in preclinical studies of new medicines refers to the use of greater than clinical doses or more prolonged than clinical dosing times to administer drugs to animals to discover and evaluate the potential toxic effects on the animal organism, the manifestations of toxicity, and the reversibility of target organ damage. This study helps to find toxic doses, detect harmful effects, determine safe dose ranges, search for unhealthy target organs, and assess the reversibility of toxicity. The difficulty of drug safety evaluation in vaccines is that the vaccine does not directly exert preventive or therapeutic effects but acts by inducing the immune system to produce antibo...

Accelerating New Drug Development: The Role of Radioisotope Labeling

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  In drug development, Radioisotope labeling has become a powerful tool. It provides a means to track the fate of drugs in the body and helps researchers to better understand the metabolic processes and potential toxicity of new compounds. So, scientists can design more effective and safer drugs, reducing the risk of adverse effects and increasing the likelihood of success in clinical trials. Isotopes are atoms of the same chemical element with different masses due to the presence of different neutron numbers in the nucleus, and there are light and heavy isotopes; based on physical properties, isotopes can also be classified into two forms: radioactive and stable. Radioisotope labeling technology is a very useful tool in the process of new  drug development , and Medicilon offers radioisotope services. Based on physical properties, isotopes can be classified into two forms: radioactive and stable. Radioactive isotopes (e.g. 3H, 14C) undergo their decay process and radiate radi...

Why is it important to check for bacterial endotoxins in drug development?

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  Impurities that need to be controlled may be generated during the production and standard storage of drugs according to established processes, and these impurities may impact the activity and safety of the drug itself. They may also cause adverse reactions in the clinical use of the drug. Therefore, impurity analysis is crucial in pharmaceutical research to drug development . Bacterial endotoxin is a process-related impurity, one of the headache impurities in the purification of proteins, nucleic acids, polysaccharides, and other biological macromolecules, which are widely present in reagent consumables and samples. It is a significant source of contamination in biomedical tests and pharmaceutical products, and the inspection of bacterial endotoxin has become one of the critical testing items for drug quality control. Bacterial endotoxin is a complex formed by lipopolysaccharide of the cell wall of Gram-negative bacteria, and a variety of trace proteins, which are released with...

Salt formation: an effective means to improve the physical and chemical properties of drug molecules and enhance the druggability of drugs

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  In drug development, drug forming research , including pharmacodynamics, pharmacokinetics, and early safety evaluation of drugs, is required to determine whether the active compound has the potential to be developed into a pill. The drug-forming properties of drugs are also an essential part of the drug-forming evaluation, and salt formation is one of the effective means to improve the physicochemical properties of drug molecules and enhance drug-forming properties.   Many drugs are salts of organic acids or bases. The salt formation can make some oily organic acids or organic bases solid, which is conducive to preparing concrete dosage forms. Moreover, the salt formation of drugs increases the water solubility, which is conducive to preparing some aqueous dosage forms, such as water injection and oral liquid. The salt formation process is often a purification process, which removes the impurities mixed in the drug that cannot become salt, etc. So what are the benefits o...
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  Veratrum alkaloids are a class of natural compounds found in plants of the Veratrum genus.Historically, Veratrum  has been used as a source of medicines and insecticide. Their toxicity was noted in sneezing powders made from pulverized roots of these plants. Inhalation or ingestion has resulted in several signs and symptoms, including hypotension or bradyarrhythmia.  Pharmacological and toxicological studies on Veratrum alkaloids have revealed pharmacological effects such as lowering blood pressure, strengthening the heart, anti-thrombotic, improving blood-brain circulation, and antiparasitic infection. However, it has been found to have both reproductive and genotoxic effects and significant toxic effects on the human digestive and respiratory systems, so it should not be used indiscriminately. Mechanism of Toxicity [1] The veratrum alkaloids, which are chemically similar to steroids, include protoveratrine, veratridine, and Jervine. These agents were introduced...

What's the role of Mini-pig animal models in drug development?

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 The development of various human diseases is highly complex. For drug developers to study human pathogenesis and pathological changes and observe and evaluate the efficacy of drugs, it is necessary to construct models that mimic human diseases, such as organoid or animal models, to explore the nature of human diseases and evaluate the effectiveness of new drugs. In vitro, ex vivo, or rodent models are generally used in the early stage of drug discovery . As new drug candidates progress from discovery to preclinical development and scale-up drug preparation, large animal models such as Minipigs, dogs, and monkeys are gradually adopted. The porcine model is one of the large animal models used in many laboratories and drug research sites. The size and characteristics of pigs vary by species. Minipigs were first used in medical research in Europe before being introduced to the United States in the 1980s. Minipigs are a commonly used animal model for pharmaceutical research. Minipigs a...