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Fenbendazole pills are a broad-spectrum benzimidazole deworming drug mainly used for deworming animals. It is commonly found in the veterinary field and has not been approved for the treatment of human diseases. Its component is Fenbendazole, with the molecular formula C15H13N3O2S. It is a white or off-white powder, odorless and tasteless. It is soluble in dimethyl sulfoxide, slightly soluble in methanol, insoluble in water, and soluble in glacial acetic acid.
Fenbendazole mainly acts on worms by binding to tubulin and disrupting the balance of tubulin and microtubules, thereby interfering with the energy metabolism and microtubule structure of parasites, inhibiting their growth and reproduction, and ultimately leading to the death of the worms.
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Additional information of chemical compound:
Fenbendazole Pills COA
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Information on Raw Materials and Auxiliary Materials
The manufacturing of fenbendazole pills first requires pharmaceutically grade fenbendazole raw materials, whose chemical name is methyl 5-phenylthiobenzimidazole-2-carbamate, CAS number is 43210-67-9, molecular formula is C15H13N3O2S, and molecular weight is 299.34 or 299.35. The active pharmaceutical ingredient of fenbendazole is usually a white or off-white powder, odorless and tasteless, insoluble in water, but soluble in dimethyl sulfoxide and glacial acetic acid. During the formulation process, some excipients are also needed, such as solvents (such as triethanolamine), emulsifiers (such as Tween -80), fillers (such as silica, starch), binders (such as starch slurry), lubricants (such as magnesium stearate), etc. The selection and usage amount of these excipients will be adjusted according to the specific formulation process and product quality requirements.
Production Process Flow
The production process of fenbendazole tablets usually includes the following steps:
Accurately weigh the fenbendazole raw material and the required excipients according to the prescription ratio, and place them respectively in clean containers for later use.
Put the raw material of fenbendazole and some excipients (such as starch, silica, etc.) into the mixer and mix them evenly.
Soft materials are made by adding adhesives (such as starch slurry).
The soft materials are made into wet pellets through a swing pellet machine.
Place the wet particles in a hot air circulation oven for drying, and control the drying temperature and time to ensure that the moisture content in the particles meets the requirements.
The dried granules are granulated by a granulator to obtain uniformly sized granules.
Mix the granulated granules evenly with the remaining auxiliary materials (such as magnesium stearate) and lubricants in the mixer.
The mixed granules are pressed into tablets through a tablet press.
The pressed tablets are packaged in inner packaging (such as aluminum-plastic composite film packaging) and outer packaging (such as paper box packaging).
The packaged tablets are subject to quality inspection. Those that pass the inspection are stored in the warehouse.
Production Equipment and Quality Control
Production equipment
Dissolution tank: It is used for dissolving fenbendazole raw materials and preparing adhesives.
Mixer: It is used for mixing raw materials and auxiliary materials.
Swing granulator: It is used to turn soft materials into wet granules.
Hot air circulation oven: Used for drying wet particles.
Granulator: Used for granulating and drying the granules.
Tablet press: It is used to press granules into tablets.
Packaging machine: Used for the inner and outer packaging of tablets.
Quality Control
Raw material quality control: Conduct quality inspections on the active pharmaceutical ingredients and excipients of fenbendazole to ensure they meet quality standards.
Intermediate product control: During the steps of mixing and granulation, drying and granulation, and total mixing and tablet pressing, quality inspections of intermediate products are carried out, such as the particle size distribution and moisture content of the particles.
Finished product quality control: Conduct quality inspections on packaged tablets, including appearance, content uniformity, dissolution rate, microbial limit and other indicators. Only tablets that meet the quality standards can be released from the factory.
Precautions during the Manufacturing Process
Environmental control
The production of fenbendazole tablets should be carried out in a clean environment to avoid microbial contamination. The production workshop should be regularly cleaned and disinfected, and the operators should wear clean work clothes and gloves.
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Equipment cleaning and maintenance
Production equipment should be regularly cleaned and maintained to ensure its normal operation and product quality. Equipment cleaning should follow the corresponding cleaning procedures to avoid cross-contamination.
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Process parameter control
During the production process, all process parameters such as mixing time, drying temperature and time, and tablet pressing pressure should be strictly controlled to ensure the stability and consistency of product quality.
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Records and traceability
Detailed records should be kept during the production process, including raw material usage records, production operation records, quality inspection records, etc. These records should be properly kept for traceability and investigation when necessary.
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Environmental Protection and Sustainable Development
During the manufacturing process of fenbendazole pills, attention should also be paid to environmental protection and sustainable development issues. For example, environmentally friendly solvents and excipients can be adopted to reduce the impact on the environment. Optimize the production process to improve the utilization rate of raw materials and the efficiency of energy utilization; Strengthen the treatment and recycling of waste, etc.
Method for Content Determination
High Performance liquid Chromatography (HPLC)
High performance liquid chromatography is the main method for determining the content of fenbendazole tablets, which has the advantages of high sensitivity, good accuracy and high separation efficiency.
Sample pretreatment
Extraction: Take an appropriate amount of fenbendazole tablets, grind them finely, accurately weigh a certain amount, place it in a volumetric flask, add methanol or other solvents, ultrasonically treat to dissolve fenbendazole, dilute to the mark with the solvent, shake well, filter, and take the filtrate as the test solution.
Preparation of reference substance solution: Accurately weigh an appropriate amount of fenbendazole reference substance, dissolve it in a solvent and dilute it to prepare a reference substance solution of a certain concentration.
Chromatographic conditions
Chromatographic column: Commonly used C18 reversed-phase chromatographic columns, such as AgI1ENTZorBAx SB-C18 (250mm×4.6mm, 3.5μm) or chromatographic columns of equivalent performance.
Mobile phase: Generally, a methanol-water system is adopted. The proportion can be adjusted according to the actual situation, such as methanol -0.5% (w/v) sodium dihydrogen phosphate solution (containing 0.313% (w/v) sodium hexanesulfate, adjusting the pH value to 3.5 with phosphoric acid) (40:60), etc.
Detection wavelength: It is usually around 290nm. There are also reports of using wavelengths such as 294nm and 280nm for detection. The specific wavelength can be selected based on the ultraviolet absorption characteristics of the drug.
Flow rate: Generally 1.0ml per minute.
Column temperature: Commonly set at 25℃ or 30℃.
Determination method
Accurately measure a certain volume of the test solution and the reference solution respectively, inject them into the liquid chromatograph, and record the chromatogram.
The content of fenbendazole in the test sample was calculated by the peak area according to the external standard method.
Ultraviolet-visible spectrophotometry
Ultraviolet-visible spectrophotometry can also be used for the content determination of fenbendazole tablets, and the operation is relatively simple.
Sample pretreatment
Take an appropriate amount of fenbendazole tablets, grind them finely, accurately weigh a certain amount, place it in a volumetric flask, add methanol or other solvents, ultrasonically treat to dissolve fenbendazole, dilute to the mark with the solvent, shake well, filter, and take the filtrate as the test solution.
Accurately measure an appropriate amount of the filtrate and further dilute it with a solvent to prepare a solution of a certain concentration.
Determination method
Using the solvent as the blank, the absorbance of the test solution is determined at the specified wavelength (such as 294nm±2nm).
The content of fenbendazole in the test sample was calculated based on the absorption coefficient (E) of C15H13N3O2S.
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Methods for substance Inspection
The relevant substances in fenbendazole pills mainly include impurity A, impurity B, etc. These impurities may affect the quality and safety of the drug, so they need to be inspected and controlled.
High performance liquid chromatography
Sample pretreatment: Sample pretreatment methods in the determination of the same content, preparing the test solution.
Preparation of the control solution: Accurately measure an appropriate amount of the test solution and dilute it with a solvent to prepare a control solution of a certain concentration.
Chromatographic conditions: Similar to content determination, but the proportion of the mobile phase, detection wavelength and other conditions can be adjusted according to the characteristics of the relevant substances to improve the resolution of the relevant substances from the main components.
Determination method: Precisely measure a certain volume of the test solution and the reference solution respectively, inject them into the liquid chromatograph, and record the chromatogram until the retention time of the main component peak is twice or three times. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not exceed 0.5% of the main peak area of the reference solution, and the sum of the areas of all impurity peaks shall not exceed twice the main peak area of the reference solution.
Method for Dissolution Determination
Dissolution rate refers to the speed and extent to which a drug dissolves from a preparation under specified conditions, and it is one of the important indicators for evaluating the quality of tablets.
Dissolution medium
Commonly used dissolution media include hydrochloric acid solution (9→1000), phosphate buffer solution (pH6.8), etc. The appropriate dissolution medium can be selected based on the dissolution characteristics of the drug and the absorption environment in the body.
Dissolution method
Generally, the basket method or the paddle method is adopted, and the rotational speed is usually 50 or 100 revolutions per minute.
Determination method
Take an appropriate amount of fenbendazole tablets and place them in the basket or dissolution cup of the dissolution tester. Add the specified volume of dissolution medium and conduct the dissolution test at a temperature of 37℃±0.5℃.
Samples are taken at the specified time points (such as 15 minutes, 30 minutes, 45 minutes, 60 minutes, etc.), filtered through a 0.8μm microporous filter membrane, and the filtrate is taken as the test solution.
The concentration of fenbendazole in the test solution was determined by high performance liquid chromatography or ultraviolet-visible spectrophotometry, and the dissolution amount of each tablet was calculated.
Identification Methods
Ultraviolet-visible spectrophotometry
Sample pretreatment
Take an appropriate amount of fenbendazole tablets, grind them finely, accurately weigh a certain amount, place it in a volumetric flask, add methanol or other solvents, ultrasonically treat to dissolve fenbendazole, dilute to the mark with the solvent, shake well, filter, and take the filtrate as the test solution.
Determination method
The absorbance of the test solution was determined at the specified wavelengths (such as 218nm±2nm and 294nm±2nm) using the solvent as the blank. Fenbendazole should have maximum absorption at these wavelengths.
Chemical reaction method
React with sodium hydroxide solution
Take about 25mg of this product, add 5ml of water, and drop in sodium hydroxide solution until it dissolves just. Then add 1 to 2 drops of copper sulfate solution, and a green precipitate will be formed immediately.
React with the p-dimethylaminobenzaldehyde test solution
Take 25mg of this product, place it in a test tube, add 2.5ml of ethanol to dissolve it, and then drop 2ml of p-dimethylaminobenzaldehyde solution along the tube wall. It immediately shows green and gradually turns dark red.
Other Analytical Methods
Determination method of drying weight loss
Take this product and dry it at 105℃ for 3 hours. The weight loss shall not exceed 1.0% to check the content of moisture or other volatile substances in the medicine.
Determination method of incineration residue
Take an appropriate amount of this product and conduct the test as per the method. The remaining residue must not exceed a certain limit (such as 0.1%) to check for inorganic impurities in the medicine.
Heavy metal inspection method
Take the residue left under the incineration residue section and check it in accordance with the law. The content of heavy metals should not exceed 20 parts per million to ensure the safety of the drug.
The history of Fenbendazole tablets is a clear and winding timeline, which began with rational scientific exploration, flourished in the widespread recognition of animal husbandry, and ultimately unexpectedly slipped into the gray area of human health.
In 1944, researchers first synthesized the core structure of benzimidazole, but its biological activity has not been fully understood.
1961: A critical turning point occurred. Scientists from Merck have discovered and launched Thiabendazole, the first commercially successful benzimidazole insecticide in history. Its success is like the sound of a starting gun, declaring to the global pharmaceutical industry that benzimidazole is an infinite potential 'pharmacophore treasure trove'. It confirms the feasibility of efficient and selective deworming by inhibiting the polymerization of microtubule proteins in parasites, paving the way for the development of all similar drugs in the future and setting a benchmark.
In the late 1960s, chemists initiated a systematic medicinal chemistry project in the laboratory of Hoechst AG in Germany. They adopted the classic "structure-activity relationship" strategy to modify and replace various chemical groups at the 2nd and 5th positions of the benzimidazole parent nucleus, synthesizing hundreds of derivatives.
Around 1970, a compound with the code name HOE 881V performed exceptionally well in both in vitro and in vivo screening among numerous candidate molecules. Its chemical structure was determined to be methyl [5- (phenylthio) -1H-benzimidazol-2-yl] carbamate - which later became fenbendazole.
1971-1973: Hearst Corporation applied for patent protection for fenbendazole in major global markets (including the United States and Europe), laying the legal groundwork for its commercialization.
In 1974, fenbendazole was first approved for marketing in Germany, mainly used for controlling gastrointestinal nematodes in livestock such as cattle and sheep. Its debut immediately caught the attention of the industry.
1975 and beyond: Fenbendazole rapidly entered the global market. It has been proven to be highly effective against adults, larvae, and even eggs of various parasites, and extremely safe for host animals. Its broad-spectrum, high efficiency, and low toxicity characteristics quickly made it one of the preferred deworming drugs in animal husbandry and companion animal medicine.
Throughout the 1980s, during the patent period of fenbendazole, Hearst Corporation enjoyed the dividends of market monopoly. To meet different needs, the company has developed various dosage forms, among which oral tablets have become one of the most classic and common dosage forms due to their accurate dosage and convenient feeding, especially suitable for individualized administration in animals such as dogs, cats, and horses. During this period, fenbendazole firmly established its position as the "gold standard" in the benzimidazole drug family.
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