Table 7.

Functions of excipients in reference listed drug (RLD) and developed generic product.

Reference listed drug	Proposed developing generic drug	Function
Microcrystalline cellulose, NF	Lactose monohydrate, NF	Filler
Mannitol, USP		Filler
Hydroxypropyl methylcellulose, USP	Mono- and diglycerides, NF	Rate controlling polymer
Ethylcellulose, NF		Polymer
Colloidal silicon dioxide, NF	Colloidal silicon dioxide, NF	Glidant
Magnesium stearate	Magnisium stearate	Lubricant
Hydrogenated castor oil, NF	Talc	Lubricant
Povidone		Solubilizer
Yellow iron oxide		Colourant