DESCRIPTION
FIELD OF THE INVENTION
The present invention is related to the pharmaceutical composition for the treatment of inflammation and fever with fewer gastric side effects in children.
BACKGROUND OF THE INVENTION
WO 1997/006801 relates to a composition exempt of paracetamol containing fenamic acid derivative in association with codeine. The invention also covers the use thereof in the manufacture of a medicament having central analgesic activity.
WO 2010/116127 described a respiratory disorder therapy for administration twice daily or less comprising a therapeutically effective amount of cetirizine, or a pharmaceutically acceptable derivative thereof, and a therapeutically effective amount of mefenamic acid, or a pharmaceutically acceptable derivative thereof.
EP 1200088 Bl relates to a stable, solid pharmaceutical composition comprising as active ingredients paracetamol and drotaverine hydrochloride in a mixture with one or more organic acid or potassium sorbate as stabilizers, one or more usually used pharmaceutical auxiliary materials and optionally additional active ingredient. As additional active ingredient codein phosphate may be used.
WO 2009/083759 relates to an oral pharmaceutical suspension comprising paracetamol and ibuprofen. The invention also relates to a method of treating perioperative or postoperative pain by administering to a subject a therapeutically effective amount of

oral pharmaceutical suspension comprising paracetamol and Ibuprofen.
Mefenamic acid can cause gastric mucosal damage which may result in ulceration and/or bleeding. These gastric effects have been attributed to inhibition of the synthesis of prostaglandins produced by COX-1. Other factors possibly involved in NSAIA-induced gastropathy include local irritation, promotion of acid back-diffusion into gastric mucosa, uncoupling of oxidative phsphorylation, and enterohepatic recirculation of the drugs.
Mefenamic acid may also cause diarrhea, dizziness, stomach upset, gas and constipation.
OBJECTIVES OF THE INVENTION
The object of the present invention is to provide a pharmaceutical formulation comprising an antipyretics and NSAID.
Yet another object of the present invention is to provide the pharmaceutical formulation comprising paracetamol and mefenamic acid.
Yet another object of the present invention is to provide the formulation used to treat pain, inflammation and fever.
Yet another object of the present invention is to provide the pharmaceutical formulation having lesser side effects by adding substances or the mixture of substances used to treat the side
effects.
Yet another object of the present invention is to provide a safe and effective formulation for the treatment of pain and inflammation in children.
SUMMARY OF THE INVENTION

The present invention is related to a pharmaceutical formulation comprising antipyretic drug, an NSAID and a substance that reduces the gastric side effects occurring due to the NSAID. The antipyretic used in the above combination is paracetamol, mefenamic acid is the NSAID and the agent that reduces the gastric side effects may be simethicone or dimethicone or Dill oil or Methyl poly siloxane (MPS) or the combination of the above.
DETAILED DESCRIPTION OF THE INVENTION
Mefenamic acid is a non-steroidal anti-inflammatory drug used to treat pain, including menstrual pain. Mefenamic acid decreases inflammation (swelling) and uterine contractions by a still unknown mechanism. However it is thought to be related to the inhibition of prostaglandin synthesis. There is also evidence that supports the use of mefenamic acid for perimenstrual migraine headache prophylaxis, with treatment starting 2 days prior to the onset of flow or 1 day prior to the expected onset of the headache and continuing for the duration of menstruation.
Since hepatic metabolism plays a significant role in mefenamic acid elimination, patients with known liver deficiency may be prescribed lower doses. Kidney deficiency may also cause accumulation of the drug and its metabolites in the excretory system. Therefore patients suffering from renal conditions should not be prescribed mefenamic acid.
Mefenamic acid can cause gastric mucosal damage which may result in ulceration and/or bleeding. These gastric effects have been attributed to inhibition of the synthesis of prostaglandins produced by COX-1. Other factors possibly involved in NSAIA-induced gastropathy include local irritation, promotion of acid back-diffusion into gastric mucosa, uncoupling of oxidative phsphorylation, and enterohepatic recirculation of the drugs.

Mefenamic acid is known to cause an upset stomach, therefore it is recommended to take prescribed doses together with food or milk. Other known mild side effects of mefenamic acid include headaches, nervousness and vomiting. Serious side effects may include ■ diarrhea, hematemesis (vomiting blood), haematuria (blood in urine), blurred vision, skin rash, itching and swelling, sore throat and fever.
Paracetamol is an antipyretic that can reduce fever by affecting the part of the brain known as the hypothalamus that regulates the temperature of the body. This is why paracetamol is included in many cough, cold and flu medications. Specifically, paracetamol has been given to children after they have been given vaccinations in order to prevent them developing post-immunisation pyrexia, or fever.
Paracetamol can be used by patients for whom NSAIDs are contraindicated, including those with asthma or peptic ulcers. Because there are few interactions with other medications, paracetamol can be taken by people with sensitivity to aspirin. Cholestyramine, which lowers high cholesterol, may reduce the rate at which paracetamol is absorbed by the gut, while Metoclopramide and Domperidone, which are used to relieve the symptoms of stomach disorders, may have the opposite effect and should be used with caution. Paracetamol has shown no propensity to be addictive, even in people who use it frequently. Long-term or regular use of paracetamol may, however, increase the anticoagulant activity of warfarin or similar anticoagulant medicines so caution may be required in these instances.
Simethicone is an oral anti-foaming agent used to reduce bloating, discomfort and pain caused by excess gas in the stomach or intestinal tract. It is a mixture of polydimethylsiloxane and silica gel. Simethicone is an anti-foaming agent that decreases the surface tension of gas bubbles, causing them to combine into

larger bubbles in the stomach that can be passed more easily by burping. Simethicone does not reduce or prevent the formation of gas in the digestive tract, rather, it increases the rate at which it exits the body. However, simethicone can relieve pain caused by gas in the intestines by decreasing foaming which then allows for passing of flatus. Simethicone is not absorbed by the body into the bloodstream, and is therefore considered relatively safe, with sources reporting the worst side effects as bloating, constipation, diarrhea, gas and heartburn. While sold as a treatment for colic, randomised controlled trials have not borne this claim out.
Dill Oil can efficiently handle gas trouble. It does not only help remove gas from intestine, but also stops further gas formation. Moreover, it gives the gases a safe downward passage by relaxing the muscles in the abdominal region. Digestive: Dill seeds have been in use as a remedy to facilitate digestion. This digestive property of Dill seeds comes from its essential oils. Dill oil promotes digestion by stimulating the secretion of digestive juices like gastric juices, acids and bile in the stomach. Its aroma also stimulates the salivary glands and thus aids in the primary digestion of the food in the mouth. Lastly, it stimulates the peristaltic movement of the intestines and helps the ingested food to advance through them, thereby facilitating digestion again.
The other substance that can be used is Dimethitrone or Methyl poly siloxane (MPS).
The present invention relates to a pharmaceutical formulation comprising Mefenamic acid and Paracetamol with certain other ingredients. Mefenamic acid causes gastric irritation and formation of gas in the children. Thus, the novelty of this invention provides an effective composition comprising mefenamic acid and paracetamol without these side effects.
To avoid these side effects, the ingredients used can be Simethicone, Dimethicone, or Dill oil or Methyl poly siloxane (MPS) either alone or in combination.
The formulation is preferably oral formulation, more preferably liquid oral formulation, even more preferably a suspension.
Paracetamol is in the range of 115 mg to 175 mg preferably 125 mg per 5 ml while Mefenamic acid is in the range of 35 mg to 75 mg preferably 50 mg per 5 ml of the suspension.

CLAIMS
1) A pharmaceutical formulation comprising at least an antipyretic, at least an NSAID and the substances used to treat the gastric disorders with other excipients.
2) The antipyretic as claimed in 1, used is paracetamol and the NSAID claimed in 1 is mefenamic acid.
3) The substances used to treat gastric disorders as claimed in 1 can be Simethicone, dimethicone, or dill oil or MPS either alone or in combination or more preferably a combination of Simethicone and dill oil can be used.
4) The formulation as claimed in 1 may be oral formulation, more preferably liquid oral formulation, even more preferably a suspension.
5) Paracetamol as claimed in claim 2, is in the range of 115 mg to 175 mg preferably 125 mg while Mefenamic acid as claimed in claim 2 is in the range of 35 mg to 75 mg preferably 50 mg per 5 ml of the suspension.
6) Simethicone as claimed in claim 3 is in the range of 25 mg -75 mg per 5 ml more preferably 50 mg per 5 ml, Dimethicone as claimed in claim 3 is in the range of 25 mg -75 mg per 5 ml more preferably 50 mg per 5 ml, MPS as claimed in claim 3 is in the range of 25 mg - 75 mg per 5 ml more preferably 50 mg per 5 ml and Dill Oil as claimed in claim 3 is in the range of 0.25 mg - 2 mg per 5 ml more preferably 1 mg per 5 ml,
7) Excipients as claimed in 1 can be pharmaceutically acceptable excipients comprises one or more of suspending

or viscosity increasing agents, sweeteners, buffering agents, preservatives, wetting agents, flavoring agents, solvents.