It is said that erectile dysfunction (ED) is mainly seen in men aged over 40. However, recent studies have shown that young men, aged between 20 and 29, are experiencing the same problem. In fact, 8% of young men experience erectile dysfunction due to diverse health conditions and lifestyle (source). Sildenafil and Tadalafil drugs are used to treat ED. The quality of the Sildenafil and Tadalafil API affects the effectiveness of the drug. In this blog, we will discuss an overview of how we create these APIs in our state-of-the-art facility.
Sildenafil Citrate (Viagra API)
Sildenafil citrate tablets are made using the Sildenafil API, known for its phosphodiesterase type 5 (PDE5) inhibiting properties. Its role is to relax the muscles and increase blood flow. Therefore, they have been widely used in the treatment of ED and certain cardiovascular diseases.
General Process Steps of Sildenafil Citrate API Production
The following is the general process we use to create APIs for the Sildenafil Citrate tablet.
Step 1: Synthesis of the core structure
The process starts with the creation and synthesis of Sildenafil Citrate. It is synthesized by the condensation of the key intermediates such as 2-ethoxybenzoyl chloride and piperazine. Our experts use our in-house high-quality intermediates to create a stable and efficient structure.
Step 2: Formation of sildenafil base
We formulate the sildenafil base through a multi-step reaction process. Our experts conduct this procedure under highly controlled temperature and pH to ensure that the efficacy and safety of the API are not compromised.
Step 3: Salt formation
The citrate form keeps the API pharmacokinetics, and it is essential to create oral drugs. For this, the Sildenafil base is reacted with citric acid to form Sildenafil Citrate. Now, we have the Sildenafil Citrate API that will go through the final steps of API formation.
Step 4: Purification
Chemox Pharma is known for its GMP adherence and custom pharmacopeial standards APIs. Therefore, Sildenafil Citrate undergoes crystallization and filtration to remove impurities and create a pure, efficient, and high-quality API.
Step 5: Drying
The purified Sildenafil Citrate API goes through controlled drying in our WHO-GMP facility to create a fine API powder.
Step 6: Quality Testing & Packing
We understand that the quality of the API affects the efficacy of the sildenafil citrate tablet. Therefore, our batches are thoroughly checked using our highly controlled and advanced QC tests (such as HPLC, IR, assay, and residual solvents analysis) to ensure that they meet the regulatory standards. Once approved, they are packed using GMP-grade packing for shipping.
Tadalafil (Cialis API)
Tadalafil Tablets are used for patients with ED. Cialis tablets with tadalafil relax the muscles to improve blood circulation. While it’s widely used to treat erectile dysfunction, the Tadalafil drug is also used for Pulmonary Arterial Hypertension (PAH) and Benign Prostatic Hyperplasia (BPH).
General Process Steps of Tadalafil API Production
The following are the steps to create an API for the Tadalafil tablet.
Step 1: The tadalafil synthesis
We start the process with D-Tryptophan intermediate, a chiral amino acid. It is a crucial building block in tadalafil synthesis. We use our in-house intermediates to ensure safety and meet the desired quality standard.
Step 2: Cyclization
The next step is to create the tricyclic structure with the cyclization process. We achieve this with various and controlled catalytic conditions.
Step 3: Amide bond formation
To create the Tadalafil API base, our team adds piperonyl and methyl groups. All these processes happen in our highly controlled, WHO-GMP-approved facility in Dahej.
Step 4: Purification
The Tadalafil API base is recrystallized to remove the impurities and achieve the desired purity to meet the regulatory standards to produce the Tadalafil drug.
Step 5: Drying
Our experts use vacuum drying to create a stable Tadalafil API for drug creation. Our experts adhere to GMP standards to ensure the API has the best efficacy and is safe.
Step 6: QC & Packing
Our Tadalafil APIs undergo comprehensive quality testing to ensure that each batch has the same quality, efficacy, and meets the quality standards. After quality assurance, the API undergoes cleanroom packaging to ensure that it reaches you without any damage.
Chemox Pharma is a trusted pharmaceutical API supplier known for its WHO-GMP-approved R&D and production facility, quality control, and custom packaging. We can help you create a custom API based on your pharmacopeia standards to meet the regulatory requirements. Whether you need intermediates or APIs, we are here to create custom quality. Contact us now with your queries or schedule a consultation call.
Conclusion
Sildenafil and Tadalafil drugs are used for the treatment of erectile dysfunction. The Sildenafil and Cialis API are used to create Viagra and Tadalafil tablets, respectively. In this blog, we discussed how we make these APIs in our WHO-GMP-approved facility. The process is slightly different due to citrate formation in Sildenafil and Anide Bond formation in Tadalafil APIs. You can customize the quality of the drug to meet the desired regulatory standard. Contact Chemox Pharma with your queries now!
FAQ
What is the use of Tadalafil and Sildenafil Citrate APIs?
The Tadalafil and Sildenafil Citrate API are used to create Viagra and Cialis tablets. These medicines are used to treat erectile dysfunction as they relax the muscles and regulate blood flow.
Which is more powerful, Sildenafil or Tadalafil?
Sildenafil (Viagra) and Tadalafil (Cialis) are both used for the treatment of erectile dysfunction. While Viagra is popular and takes effect in 30-60 minutes, its impact lasts for about 4-6 hours. On the other hand, Tadalafil takes a little longer to take effect, but its impact lasts for 36 hours. Both are effective, safe, and widely used. You should consult a specialist to determine which is better for you.
Is Tadalafil the same as Viagra?
No. Both Tadalafil and Viagra are used to treat erectile dysfunction, but they are different regarding their APIs, molecular structure, and effects. Tadalafil API is used to create Cialis Tablets, which have effects for 36 hours. Sildenafil Citrate API is used to create Viagra, which has an impact for 4-6 hours.
Can I take Tadalafil and Sildenafil together?
While both are used for ED, they have different structures and shouldn’t be consumed together.
