“Introduction of New

Generic”

Presented by- Farzana Sultana BPH 04806682 Snjida Akhtar BPH 04806719 Nadia Islam BPH 04806696 Tahmina BPH 04806703 Raziya Sultana Riza BPH 04806709 Sushoma Akter BPH 04806679 Nishat Akter BPH 04806711 Md. Rocknur Alam BPH 04806692 Md. Jewel Vuiya BPH 04806706 Md. Jobaer Alam BPH 04806704 Sheikh Md. Nazmus Sakib BPH 04806686

Generic: Omeprazole 20mg + Ketorolac Tromethamine 10mg

Brand Name: Keto Plus

Pharmacology of generic :

Ketorolac is a acetic acid derivative related to the carboxylic acid group of NSAIDs. Ketorolac is an anti-inflammatory agent with analgesic and antipyretic properties . It also used to treat osteoarthritis and control acute pain.

Omeprazole is a PPI used to inhibit the secretion of excess HCL from the parietal cell of stomach.

Tablet type : Bilayer tabletOmeprazole - immediate release layerKetorolac Tromethamine - sustained release layer

Why omeprazole is in immediate release layer and Ketorolac Tromethamine is in sustained release layer ?

After administration of omeprazole it takes minimum 5 minutes to enter into the MEC level and Ketorolac Tromethamine takes minimum 15 minutes to reach MEC level.It is advised to take omeprazole at lest 15-20 minutes before the administration of Ketorolac Tromethamine

Due to maintain this phenomenon omeprazole is in immediate release layer and Ketorolac Tromethamine is in sustained release layer.

Reasons of combination:Ketorolac tromethamine is a potent NSAID drug but it produce some severe adverse reaction inside the body, because ketorolac is acidic in nature. Stomach produce strong HCl acid from the parietal cell of the stomach.So acetic nature of ketorolac and secreted HCl produce severe side effects inside the body.Such as GIT irritation,peptic ulcer,perforation,renal failure etc.

Following the above side effects of ketorolac can be minimize by combining ketorolac with omeprazole.

Comparative studies with other combinations :Onset of actionKetorolac+Omeprazole Naproxen+Omeprazole Diclofenac+Omeprazol

EfficacyKetorolac+Omeprazole Naproxen+Omeprazole Diclofenac+Omeprazol

Side effectsDiclofenac+Omeprazole Naproxen+Omeprazole Ketorolac+Omeprazole