Salmeterol 50 mcg + Fluticasone Propionate 500 mcg Inhalation Capsule | Formulation & Manufacturing Process

Fluticasone + Salmeterol is a fixed-dose combination medication containing fluticasone propionate and salmeterol. It is used in the management of asthma and chronic obstructive pulmonary disease (COPD). It is used by inhaling the medication into the lungs.

The combination was approved for medical use in the United States in 2000. A generic version was approved in the United States in 2019. In 2020, it was the 56th most commonly prescribed medication in the United States, with more than 11 million prescriptions.

There are several dosage forms and strengths available with Salmeterol + Fluticasone Propionate. One of the most common of which is Salmeterol 50 mcg + Fluticasone Propionate 500 mcg Inhalation Capsule.

Each inhalation capsule contains Salmeterol 50 mcg, as Salmeterol Xinafoate BP and Fluticasone Propionate BP 500 mcg. The formulation & manufacturing process of Salmeterol 50 mcg + Fluticasone Propionate 500 mcg Inhalation Capsule is as below:

Formulation:

Each capsule contains:

SN	COMPOSITION	SPECIFICATION	QUANTITY	FUNCTION
Active Ingredient:
1	Salmeterol Xinafoate	BP	52.00 mcg (Equivalent to 50 mcg Salmeterol)
2	Fluticasone Propionate	BP	500.00 mcg
Excipients:
3	Empty Hard Gelatin Capsule Shell (Size # 3)	Pharma Grade	1.00 Pcs
4	Lactose Monohydrate	BP	12.00 mg
** The formulation varies from Man to Man, Machine to Machine, Method to Method, and Materials to Materials.

Manufacturing Process:

Carry out the following steps as per the cGMP instructions for manufacturing this product. Check that the area and all the process equipment are free from any traces of previous products. Perform the whole operation in a clean area.

1. Weigh accurately the required ingredients and record accordingly.
2. Fill the powder with an auto capsule-filling machine.
3. After getting approval from the QC department, the blister packaging is done.