Ketotifen 1 mg Tablet | Formulation & Manufacturing Process

Ketotifen is an antihistamine medication and a mast cell stabilizer commonly used to treat allergic conditions such as conjunctivitis, asthma, and urticaria (hives). Ketotifen is available in ophthalmic (eye drops or drug-eluting contact lenses) and oral (tablets or syrup) forms: the ophthalmic form relieves eye itchiness and irritation associated with seasonal allergies, while the oral form helps prevent systemic conditions such as asthma attacks and allergic reactions. In addition to treating allergies, ketotifen has shown efficacy in managing systemic mast cell diseases such as mastocytosis and mast cell activation syndrome (MCAS), which involve abnormal accumulation or activation of mast cells throughout the body. Ketotifen is also used for other allergic-type conditions like atopic dermatitis (eczema) and food allergies.

Research on ketotifen continues to explore its impact on appetite regulation and effectiveness against specific medical conditions like irritable bowel syndrome. Despite inconclusive evidence regarding its efficacy in asthma treatment compared to other medications like Montelukast, long-term administration of oral ketotifen has shown positive outcomes in reducing corticosteroid use while improving clinical symptoms related to asthma management.

There are several dosage forms and strengths available with Ketotifen. The most common of which is Ketotifen 1 mg Tablet.

Each tablet contains Ketotifen 1 mg as Ketotifen Fumarate BP. The formulation & manufacturing process of Ketotifen 1 mg Tablet is as below:

Formulation:

Each tablet contains:

SN	NAME OF INGREDIENT(S)	SPECIFICATION	QUANTITY	FUNCTION
Active Ingredient(s)
1	Ketotifen Fumarate	BP	1.408 mg (equivalent to Ketotifen 1 mg)
Excipient(s)
2	Polyvinylpyrrolidone K-30	BP	2.000 mg
3	Lactose Monohydrate	BP	92.967 mg
4	Microcrystalline Cellulose-101	BP	60.000 mg
5	Crospovidone	BP	8.750 mg
6	Sodium Starch Glycolate	BP	7.000 mg
7	Purified Talc	BP	1.750 mg
8	Magnesium Stearate	BP	0.875 mg
9	Lemon Yellow Color	Pharma Grade	0.250 mg

** The formulation varies from Man to Man, Machine to Machine, Method to Method, and Materials to Materials.

Manufacturing Process:

The process consists of sieving the active ingredient & excipients through the Vibration Shifter and granules preparation by rapid mixture/granulator & blending that is followed by a Drum Blender. Tablets will be compressed by the tablet compression machine. Tablets will be blistered by the Blister machine.