Ketorolac Tromethamine 10 mg Tablet | Formulation & Manufacturing Process

Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain. Specifically it is recommended for moderate to severe pain. Recommended duration of treatment is less than six days, and in Switzerland not more than two days. It is used by mouth, by nose, by injection into a vein or muscle, and as eye drops. Effects begin within an hour and last for up to eight hours.

Ketorolac was patented in 1976 and approved for medical use in 1989. It is available as a generic medication. In 2020, it was the 249th most commonly prescribed medication in the United States, with more than 1 million prescriptions.

Due to a series of deaths due to gastrointestinal bleeding and kidney failure, ketorolac as a pain medication was removed from the German market in 1993. When ketorolac was introduced into Germany, it was often misused as an opioid replacement in pain therapy because its side effects were perceived as much less severe, it did not produce any dependence, and a dose was effective for 7–8 hours compared to morphine with 3–4 hours. As a very potent prostaglandin inhibitor, ketorolac diminishes the kidney’s defenses against vasoconstriction-related effects, e.g. during blood loss or high endogenous catecholamine levels.

There are several dosage forms and strengths available with Ketorolac Tromethamine. The most common of which is Ketorolac Tromethamine 10 mg Tablet.

Each film-coated tablet contains Ketorolac Tromethamine USP 10 mg. The formulation & manufacturing process of Ketorolac Tromethamine 10 mg Tablet is as below:

Formulation:

Each tablet contains:

SN	COMPOSITION	SPECIFICATION		QUANTITY	FUNCTION
Active Ingredient(s):
1	Ketorolac Tromethamine	USP		10.200 mg
Excipient(s):
2	Microcrystalline Cellulose 101	BP		40.000 mg
3	Sodium Starch Glycolate	BP		10.000 mg
4	Purified Talc	BP		3.000 mg
5	Magnesium Stearate	BP		2.000 mg
For DC Granules:
6	Lactose Monohydrate	BP		78.266 mg
7	Microcrystalline Cellulose 101	BP		53.800 mg
8	Polyvinylpyrrolidone K-30	BP		2.933 mg
Coating Material(s):
8	Hydroxypropyl Methylcellulose	BP	6.000 mg
9	Polyethylene Glycol 6000	BP	1.000 mg
10	Propylene Glycol	BP	0.700 mg
11	Purified Talc	BP	1.000 mg
12	Titanium Dioxide	BP	1.000 mg
13	* Carnauba Wax	BP	0.250 mg
14	* Chloroform	BP	2.000 mg
15	* Purified Water	BP	81.820 mg
* Will not appear in the final product
** 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 a 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 and coating will be carried out by Auto coater. Tablets will be blistered by the Blister machine.