Furosemide Tablet 10 Mg

Furosemide Tablet 10 mg is an oral tablet containing Furosemide, with a dosage of 10 milligrams per tablet. Furosemide belongs to the Loop Diuretic class of potent diuretics, which increases urine excretion by inhibiting the reabsorption of sodium and chlorine in the Loop of Henle in the kidneys, thereby helping the body eliminate excess water and salt. The main mechanism of action of furosemide lies in its physiological effects on the kidneys. In the ascending segment of the Henry's loop, furosemide blocks the sodium potassium chloride co transporter (NKCC2), reducing the reabsorption of sodium and chloride. Due to the reduced reabsorption of sodium and chlorine, more water is retained in urine, thereby increasing urine output. By increasing urine excretion, furosemide can reduce blood volume in the body, thereby lowering blood pressure. For edema caused by heart failure, cirrhosis or kidney disease, furosemide can help alleviate symptoms by reducing fluid retention in the body.

 

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Furosemide, as a highly effective diuretic, belongs to the category of loop diuretics and its chemical name is 4-chloro-N-furfuryl-5-sulfamoylantranilic acid. This drug exerts a potent diuretic effect by inhibiting the reabsorption of sodium and chloride ions by the renal tubules, increasing the excretion of electrolytes and water. Since its first synthesis in the 1960s, Furosemide has become a commonly used medication worldwide for the treatment of edematous diseases such as heart failure, cirrhosis ascites, nephrotic syndrome, and hypertension. In the manufacturing field, the large-scale production of Furosemide Tablet 10 Mg requires strict adherence to Good Manufacturing Practice (GMP) to ensure the safety, efficacy, and quality control of each batch of products. The production process covers multiple links such as raw material synthesis, formulation processing, packaging, and quality control, involving interdisciplinary technologies such as chemical synthesis, formulation engineering, and analytical chemistry.

Raw materials and active ingredients

 

The core active ingredient of Furosemide Tablets 10 mg is Furosemide, whose chemical name is 4-chloro-N-furanmethyl-5-sulfonylbenzoic acid, molecular formula is C ₁ ₂ H ₁ ₁ ClN ₂ O ₅ S, and molecular weight is 330.75 g/mol. Furosemide is a white to slightly yellow crystalline powder that is almost insoluble in water, but soluble in dilute alkaline solutions (such as sodium hydroxide solution). This characteristic requires adjustment of solubility through excipients in the formulation process.

 

Raw material source: The synthesis of furosemide usually starts with 4,6-dichlorobenzoic acid-3-sulfonyl chloride, which is reacted with ammonia to generate an intermediate, and then condensed with 6-furanomethylamine to obtain it. The world's major producing countries include China, India, the United States, Brazil, etc. Among them, companies such as Shandong Boshan Pharmaceutical Co., Ltd. in China and Aurobindo Pharma Ltd in India provide raw materials for the international market.

Composition of excipients and preparations

 

The formulation of Furosemide Tablets 10 mg needs to balance drug stability, compressibility, and bioavailability. Typical excipients include:
Fillers: lactose, microcrystalline cellulose (MCC) - adjust tablet weight and volume to ensure uniformity of content.
Adhesive: PVP, starch - promotes particle formation and prevents fragmentation.
Disinfectant: Crosslinked carboxymethyl cellulose sodium (CCNa), low substituted hydroxypropyl cellulose (L-HPC) - accelerates the disintegration of tablets in the gastrointestinal tract and promotes drug release.

 

Lubricants: Magnesium stearate, talcum powder - reduces friction between particles and molds during the tablet pressing process to prevent sticking and impact.
Flow aid: Silica (colloidal silica) - improves particle flowability and ensures tablet pressing efficiency.
Special process requirements: Furosemide is sensitive to light, and a light blocking agent (such as titanium dioxide) may be added to the formulation, and a light shielding packaging material (such as aluminum foil blister) may be used.

The production of Furosemide Tablet 10 mg follows GMP (Good Manufacturing Practice), and the typical process flow is as follows:

1

 

Raw material pretreatment

The raw material of furosemide needs to be wet ground or air flow crushed to achieve the target particle size (usually D90<100 μ m) to improve the dissolution rate. Sift the auxiliary materials (such as 80 mesh sieve) to remove lumps or foreign objects.

2

 

Mixing and granulation

Dry mixing: Pre mix furosemide with some fillers (such as lactose) in a high-speed mixer for 10-15 minutes to ensure even distribution of the main drug.
Wet granulation: Add a binder solution (such as PVP ethanol solution), use a granulation mechanism to form soft materials, and sieve (such as a 16 mesh sieve) to obtain wet particles.
Drying: Wet particles are dried in a fluidized bed dryer at 50-60 ℃ until the moisture content is less than 3%, and then sieved into whole particles (such as a 20 mesh sieve).

3

 

Total mixing and tablet pressing

Dry particles are mixed with residual excipients (disintegrants, lubricants) in a three-dimensional mixer for a total of 15-20 minutes.
Control the weight difference (± 5%), hardness (40-80 N), and brittleness (<1%) of the tablets by rotating the tablet press.

4

 

Coating (optional)

To mask bitterness or improve appearance, film coating (such as hydroxypropyl methylcellulose coating solution) can be applied to control weight gain by 2-4%.

5

 

Packaging and Quality Inspection

Tablets are packaged in blister packs or bottles, sealed, and subjected to tests for content uniformity, dissolution rate (such as paddle method with a 30 minute dissolution rate of ≥ 80%), microbial limit, etc.
The finished product must comply with USP (United States Pharmacopeia) or EP (European Pharmacopoeia) standards.

Modern Furosemide Tablet 10 mg production uses highly automated equipment, such as:

1. Wet granulation machines, such as GEA Collette Gral or Diosna P-series, achieve precise spraying and granulation of adhesives.
2. Fluidized bed dryer: such as Glatt GPCG series, controls drying temperature and airflow velocity to prevent particle overheating.
3. High speed tablet press: such as Fette 3090 or Korsch XL series, equipped with an online weighing system (IWPC) for real-time monitoring of tablet weight.
4. 3D printing technology: Some companies are exploring 3D printing customized tablets to control drug release rate by adjusting layer thickness and porosity.

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