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:


Each tablet contains:

Active Ingredient(s):
1Ketorolac TromethamineUSP10.200 mg 
2Microcrystalline Cellulose 101BP40.000 mg 
3Sodium Starch GlycolateBP10.000 mg 
4Purified TalcBP3.000 mg 
5Magnesium StearateBP2.000 mg 
For DC Granules:
6Lactose MonohydrateBP78.266 mg 
7Microcrystalline Cellulose 101BP53.800 mg 
8Polyvinylpyrrolidone K-30BP2.933 mg 
Coating Material(s):
8Hydroxypropyl MethylcelluloseBP6.000 mg 
9Polyethylene Glycol 6000BP1.000 mg 
10Propylene GlycolBP0.700 mg 
11Purified TalcBP1.000 mg 
12Titanium DioxideBP1.000 mg 
13* Carnauba WaxBP0.250 mg 
14* ChloroformBP2.000 mg 
15* Purified WaterBP81.820 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.

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