Atorvastatin Calcium 10mg and Fenofibrate 160mg Tablets

  

Generic Name	Atorvastatin Calcium 10mg and Fenofibrate 160mg Tablets
Composition	Each film coated tablet contains: Atorvastatin Calcium Equivalent to Atorvastatin 10mg Fenofibrate 160mg Colour:  Yellow Oxide of Iron
Shelf Life	24 Months
Standard Batch Size	1 Lakh Tablets

 

MANUFACTURING  FORMULA: 

 

Sl. No.	Name of the material	Std.	Qty Required / Batch (kg)
	Dry Mixing
1	Atorvastatin Calcium	I.P.	1.120
2	Fenofibrate	I.P.	16.000
3	Starch	I.P.	5.000
4	Lactose	I.P.	7.500
5	Microcrystalline cellulose Powder	I.P.	17.500
6	Sodium Lauryl Sulphate	I.P.	0.075
	Granulation
7	Polyvinyl Pyrolidone K30	I.P	0.500
8	Isopropyl Alcohol	I.P	8.000
	Lubrication
9	Talc	I.P	0.350
10	Magnesium stearate	I.P	0.250
11	Sodium Starch Glycolate	I.P	1.000
12	Colloidal Silicon Dioxide	I.P.	0.250
13	Starch	I.P.	0.455
Total weight			50.000 kg

* - Starch Qty may vary based on drying loss. 

FOR FILM COATING:

Sl. No.	Ingredients	Specs	Qty Required / Batch (kg)
1	Hydroxypropyl Methyl Cellulose (HPMC E-15)	IP	1.200
2	Iso Propyl Alcohol	IP	14.400
3	Methylene Chloride	USP	23.400
4	Talc	IP	0.325
5	Titanium Dioxide	IP	0.255
6	Castor Oil	IP	0.415
7	PEG 6000	IP	0.180
8	Yellow Oxide of Iron	I.H.S	0.120