Fexofenadine is an antihistamine pharmaceutical drug used in the treatment of allergy symptoms, such as hay fever and urticaria. Therapeutically, fexofenadine is a selective peripheral H1 blocker. It is classified as a second-generation antihistamine because it is less able to pass the blood–brain barrier and cause sedation, compared to first-generation antihistamines.
It was patented in 1979 and came into medical use in 1996. It is on the World Health Organization’s List of Essential Medicines. Fexofenadine has been manufactured in generic form since 2011. In 2020, it was the 255th most commonly prescribed medication in the United States, with more than 1 million prescriptions.
There are several dosage forms and strengths available with Fexofenadine. The most common of which is Fexofenadine Hydrochloride 30 mg/5 ml Suspension.
Each 5 ml suspension contains Fexofenadine Hydrochloride USP 30 mg. The formulation & manufacturing process of Fexofenadine Hydrochloride 30 mg/5 ml Suspension is as below:
Formulation:
Each 5 ml suspension Contains:
SN | COMPOSITION | SPECIFICATION | QUANTITY | FUNCTION |
Active Ingredient(s): | ||||
1 | Fexofenadine Hydrochloride | USP | 30.00 mg | Active |
Excipient(s): | ||||
2 | Sucralose | BP | 10.40 mg | Sweetening agent |
3 | Glycerin | BP | 500.00 mg | Solvent |
4 | Sorbitol Solution 70% | BP | 1,000.00 mg | Solvent |
5 | Methyl Paraben Sodium | BP | 10.00 mg | Antimicrobial preservatives |
6 | Propyl Paraben Sodium | BP | 1.00 mg | Antimicrobial preservatives |
7 | Microcrystalline Cellulose and Carboxymethylcellulose Sodium RC 591 | USP | 37.50 mg | Suspending agent |
8 | Colloidal Silicon Dioxide-200 | BP | 10.00 mg | Anticaking agent |
9 | Citric Acid Monohydrate | BP | 24.00 mg | Buffering agent |
10 | Sodium Citrate Dihydrate | BP | 20.00 mg | Buffering agent |
11 | Sodium Carboxy Methyl Cellulose | BP | 11.00 mg | Suspending agent |
12 | Polysorbate 80 | BP | 2.50 mg | Solubilizing agent agent |
13 | Strawberry Flavor Liquid | Pharma Grade | 12.00 mg | Flavor |
14 | Purified Water | BP | Quantity Sufficient | Solvent |
Manufacturing Process:
- Soaked Sodium Carboxy Methyl Cellulose for at least 1 hour in slightly hot water.
- Soaked Fexofenadine Hydrochloride for at least 2 hours in Sorbitol 70%.
- Dissolve Colloidal Silicon Dioxide-200 & Microcrystalline Cellulose and Carboxymethylcellulose Sodium RC 591 for at least 1 hour.
- Dissolve sucralose and transfer into final charging vat. Then transfer Glycerin into the final charging vat.
- Add Colloidal Silicon Dioxide -200 and Microcrystalline Cellulose and Carboxymethylcellulose Sodium RC 591 with continuous stirring. Add Buffer solution.
- Add Sodium Carboxy Methyl Cellulose solution and Fexofenadine Hydrochloride. Then add Polysorbate 80 and Strawberry Flavor Liquid.
- After final mixing inform QA to collect sample for QC test.