Indacaterol 110 mcg + Glycopyrronium 50 mcg Inhalation Capsule | Formulation & Manufacturing Process

Indacaterol + Glycopyrronium is a fixed-dose combination medication for inhalation consisting of the following two active ingredients: Indacaterol maleate – an ultra-long-acting beta-adrenoceptor agonist (ultra-LABA) and Glycopyrronium bromide (glycopyrrolate) – a muscarinic anticholinergic.

Indacaterol + Glycopyrronium is used as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

The drug is marketed by Novartis under the trade names Ultibro Breezhaler and Utibron Neohaler in Europe and the United States, respectively. In 2016, Novartis licensed its U.S. commercial rights for Seebri Neohaler and Utibron Neohaler to Sunovion Pharmaceuticals.

There are several dosage forms and strengths available with Indacaterol + Glycopyrronium. The most common of which is Indacaterol 110 mcg + Glycopyrronium 50 mcg Inhalation Capsule.

Each inhalation capsule contains Indacaterol 110 mcg as Indacaterol Maleate INN & Glycopyrronium 50 mcg as Glycopyrronium Bromide BP. The formulation & manufacturing process of Indacaterol 110 mcg + Glycopyrronium 50 mcg Inhalation Capsule is as below:

Formulation:

Each capsule contains:

SN	COMPOSITION	SPECIFICATION	QUANTITY	FUNCTION
Active Ingredient:
1	Indacaterol Maleate	INN	115.00 mcg (Equivalent to 110 mcg Indacaterol)
2	Glycopyrronium Bromide	BP	52.00 mcg (Equivalent to 50 mcg Glycopyrronium)
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.