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Ketorolac tromethamine nasal spray and preparation method thereof

A technology of ketorolac tromethamine and nasal spray, applied in aerosol delivery, anti-inflammatory agents, pharmaceutical formulations, etc., can solve the problems of injection pain, toxicity, perforation, etc., and achieve high bioavailability, effective Effects that act quickly and avoid damage

Inactive Publication Date: 2014-03-26
NANJING KANGLAIFU MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] The main toxic and side effects target organs of ketorolac are the gastrointestinal tract and kidneys. Oral administration of tablets can easily cause ulcers, bleeding and even perforation between the pylorus and the upper end of the duodenum
The injection prescription contains organic solvents such as ethanol, which has certain toxicity.
The clinical use of injections is inconvenient, injection pain, patient tolerance, poor compliance
In addition, ketorolac tromethamine is often combined with morphine to enhance the analgesic effect, but ethanol has a certain impact on the metabolism of morphine, which increases the probability of adverse reactions, so the use of traditional injections in clinical practice increases the risk of adverse reactions

Method used

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  • Ketorolac tromethamine nasal spray and preparation method thereof
  • Ketorolac tromethamine nasal spray and preparation method thereof
  • Ketorolac tromethamine nasal spray and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] A: Spray composition

[0047] Ketorolac Tromethamine 1800g

[0048] Potassium phosphate (K 3 P0 4 ) 445g

[0049] Potassium dihydrogen phosphate (KH 2 PO 4 ) 41g

[0050] Sodium Hydroxide (NaOH) or Salt (HCl) q.s.

[0051] Add Water For Injection to: 60L

[0052] B: Preparation method

[0053] 1) Add phosphate to an appropriate amount of water for injection, stir until dissolved, and prepare a phosphate solution; add ketorolac tromethamine or its salt to an appropriate amount of water for injection and stir until dissolved to obtain a ketorolac tromethamine solution : Take sodium hydroxide or hydrochloric acid and prepare lye or acid solution with appropriate amount of water for injection, and set aside.

[0054] 2) Take the above-mentioned lye or acid solution and adjust the pH value of the phosphate buffer solution to 7.2±0.1

[0055] 3) Add the buffer prepared in 2) to the ketorolac tromethamine solution in 1), and mix well:

[0056] 4> Take the aforementi...

Embodiment 2

[0059] A: Spray composition

[0060] Ketorolac Tromethamine 600g

[0061] Disodium hydrogen phosphate (Na 2 HPO 4 .12H 2 O) 215g

[0062] Potassium dihydrogen phosphate (KH 2 P0 4 ) 41g

[0063] Trishydroxymethylaminomethane (Tromethamine) or salt (HCl) q.s.

[0064] Add Water For Injection to: 60L

[0065] B: Preparation method

[0066] 1) Add phosphate to an appropriate amount of water for injection, stir until dissolved, and prepare a phosphate solution: take ketorolac tromethamine or its salt, add appropriate amount of water for injection and stir until dissolved to obtain ketorolac tromethamine Solution; take sodium hydroxide or hydrochloric acid and prepare it with suitable water for injection to make lye or acid solution, and set aside.

[0067] 2) Take the above-mentioned lye or acid solution and adjust the pH value of the phosphate buffer solution to 7.4±0.1

[0068] 3) Add the buffer prepared in 2) to the ketorolac tromethamine solution in 1), and mix well...

Embodiment 3

[0072] A: Spray composition

[0073] Ketorolac Tromethamine 3000g

[0074] Potassium phosphate (K 3 PO 4 ) 261g

[0075] Potassium dihydrogen phosphate (KH 2 PO 4 ) 300g

[0076] Sodium Hydroxide (NaOH) or Salt (HCl) q.s.

[0077] Add Water For Injection to: 60L

[0078] B: Preparation method

[0079] 1) Add phosphate to an appropriate amount of water for injection, stir until dissolved, and prepare a phosphate solution; take ketorolac tromethamine or its salt, add appropriate amount of water for injection and stir until dissolved to obtain ketorolac tromethamine Solution; take sodium hydroxide or hydrochloric acid and prepare lye or acid solution with appropriate amount of water for injection, and set aside.

[0080] 2) Take the above-mentioned lye or acid solution and adjust the pH value of the phosphate buffer solution to 7.5±0.1

[0081] 3) Add the buffer prepared in 2) to the ketorolac tromethamine solution in 1), and mix well:

[0082] 4> Take the aforemention...

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Abstract

The invention belongs to the field of pharmaceutical preparations, and in particular designs a non-steroid anti-inflammatory drug ketorolac tromethamine nasal delivery system. Compared with conventional troches and injections, the nasal spray provided by the invention provides convenient, efficient and quick-acting analgesic selection for patients with moderately severe pains. Meanwhile, the invention provides a formula of the ketorolac tromethamine nasal spray and a preparation method thereof, so that the stability of the spray product is greatly improved compared with that of conventional injections, and the nasal spray is good in stability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations. Specifically, the invention designs a nasal administration system for non-steroidal anti-inflammatory drug ketorolac tromethamine. Background technique [0002] Ketorolac Tromethamine is a non-steroidal anti-inflammatory drug. Clinically, it is mainly used for pain relief of moderate and severe pain such as postoperative, fracture, sprain, toothache and cancerous pain. It is a cyclooxygenase inhibitor, which can selectively block the cyclooxygenase of arachidonic acid and the production of prostaglandins, so as to exert excellent analgesic, anti-inflammatory and antipyretic effects. It does not directly act on opioid receptors, so it has no tendency to become addicted, and has no adverse reactions to the central nervous system or narcotic analgesics. [0003] The main toxic and side effects target organs of ketorolac are the gastrointestinal tract and kidneys. Oral administration of t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/12A61K31/407A61K47/12A61K47/02A61P29/00
Inventor 程一林马建国周玉琢王北沈文
Owner NANJING KANGLAIFU MEDICAL TECH
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