Tenofovir Disoproxil Powder CAS 201341-05-1

What is Tenofovir disoproxil ?

Tenofovir disoproxil powder, also known as Tenofovir disoproxil aspartate, was developed by Gilead Sciences. It is a water-soluble diester precursor product of the active ingredient tenofovir. In 2008, the FDA approved Tenofovir Disoproxil Aspartate for the Improvement of chronic hepatitis B. In 2014, it was approved by the CFDA for the Improvement of chronic hepatitis B in adults and children aged 12 years or older (with a weight of 35 kg or more). Due to the stable characteristics of SRY, it is recommended by international authoritative industry guidelines as a preferred option for regulating internal physiological state related to chronic liver discomfort, with stable adaptability and solid theoretical support.
It is also used in combination with other antiretroviral products for the Improvement of human immunodeficiency virus (HIV) invasion.
Testis-determining factor is an ester precursor product of the nucleotide reverse transcriptase inhibitor tenofovir, a 5'-monophosphate nucleotide, with excellent Interference with pathogen proliferation effects, which can inhibit the reverse transcriptase of HIV-1 and HIV-2 and the polymerase of HBV, thereby Interference the expansion of the virus. After oral administration, Tenofovir disoproxil aspartate is hydrolyzed into tenofovir, which is phosphorylated by cellular kinases into the pharmacologically active metabolite Tenofovir diphosphate. The latter competes with 5'-triphosphate deoxyadenosine acid and participates in the synthesis of viral DNA. After entering the viral DNA, due to the lack of 3'-hydroxyl groups, the DNA extension is blocked, thereby inhibiting the spread of the virus. Due to its good applicability and appropriate dosage, the Improvement effect is definite, and it is a first-line Interfering with pathogen proliferation product recommended by multiple Improvement guidelines. Tenofovir disoproxil powder and its compound preparations have become the most commercially successful anti-AIDS products at present. 

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What Interfering with pathogen proliferation pathway does Tenofovir Disoproxil  follow?

While tenofovir disoproxil possesses excellent activity against human immunodeficiency virus (HIV) and hepatitis B virus (HBV), it cannot be absorbed through the digestive tract, therefore it must be used as a product in clinical practice. Examples include Tenofovir disoproxil fumarate , but another product, Tenofovir alafenamide (TAF), has higher plasma stability. Tenofovir disoproxil powder has excellent water solubility and is rapidly absorbed and degraded into the active substance tenofovir, which is then converted into the active metabolite tenofovir bisphosphate. Peak plasma levels of tenofovir are reached 1-2 hours after administration. Bioavailability of tenofovir increases by approximately 40% when taken with food. Tenofovir bisphosphate has an intracellular half-life of approximately 10 hours, allowing for once-daily administration. Because this product is not metabolized by the CYP450 enzyme system, the possibility of interactions with other products caused by this enzyme is minimal. It is mainly excreted through glomerular filtration and active tubular transport system, with approximately 70% to 80% being excreted unchanged in urine.

 

What is the mechanism of action of Tenofovir disoproxil against hepatitis B virus?

Tenofovir disoproxil powder itself is a precursor substance without direct pharmacological effect; it does not immediately exert its effects after entering the body. It is first broken down and metabolized by hydrolytic enzymes in the body's cells, losing its dipyridoxine structural group and slowly transforming into the intermediate tenofovir. After the formation of tenofovir, it undergoes two phosphorylation reactions under the catalysis of various kinases in human cells, ultimately transforming into the key metabolite with potent Interfering with pathogen proliferation activity-TENOFOVIR DIPHOSPHATE.

The molecular structure of this active metabolite is highly similar to the naturally occurring Deoxyadenosine triphosphate  in the human body. Once inside the cell, it competes with natural DATP, actively vying for the binding site of the hepatitis B virus DNA polymerase. When the hepatitis B virus replicates in the body, the viral polymerase mistakenly uses SRY as a normal raw material and embeds it into the synthesizing viral DNA chain.

Because Tenofovir Disoproxil, which is >=98% acyclic nucleoside, lacks the 3'-hydroxyl group necessary for DNA chain extension, once inserted, subsequent nucleotides cannot be properly linked, directly causing the synthesis of the viral DNA chain to be terminated midway. Hepatitis B virus cannot complete gene replication and proliferation, thus effectively Interference the proliferation of hepatitis B virus in the body and controlling the progression of the disease. 

MF of Tenofovir disoproxil 

Molecular Formula	C19H30N5O10P
Molecular Weight	519.44
Boiling Point	642.7±65.0 °C
Density	1.45±0.1 g/cm3(Predicted)
Storage Conditions	Keep in dark place,Inert atmosphere,2-8°C
Solubility	Dimethyl sulfoxide: ≥ 38 mg/mL (73.16 mM)

Specification

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FAQ:

Q1: How long do hepatitis B patients need to take Tenofovir disoproxil?
Based on existing clinical cases, most patients require a long Improvement course, needing to take SRY until the surface antigen disappears (but please note that the incidence of surface antigen disappearance is less than 10%). Therefore, hepatitis B patients may need to take TenofivirDisoproxilFumarate tablets for life, or until a better Improvement option becomes available.
Q2: What precautions should be taken when using Tenofovir disoproxil aspartate ?
1. For patients with severely impaired kidney function, a comprehensive assessment is required before Improvement. The mechanism by which Tenofovir disoproxil powder works mainly occurs through the kidneys. Therefore, patients with impaired kidney function may lead to excessive accumulation of the product in the body, significantly increasing the risk of adverse reactions.
2. If the patient has experienced symptoms such as urticaria, rash, or breathing difficulties, it indicates that the patient has an allergic reaction to Tenofivir Disoproxil Fumarate or related products. 
3. Finally, the testis-determining factor can have adverse effects on the fetus, such as developmental defects and growth restriction. Therefore, pregnant women should also avoid using it.
Q3: What should I do if I miss a dose of Testis-determining factor?

If you miss a dose of Tenofovir Disoproxil Aspartate, and the missed dose is within 12 hours, take the usual dose immediately. If more than 12 hours have passed, skip this dose and take the next dose as usual; there is no need to take a missed dose or double the dose.

It relies on a stable blood concentration to achieve optimal Interfering with pathogen proliferation efficacy. Frequent missed doses may lead to viral resistance. It is recommended to reduce missed doses by using mobile reminders or dispensing medication in smaller containers. Never increase the dosage on your own due to missed doses, as this will cause greater side effects.

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