Speciality Pharmaceuticals And Active Pharmaceutical Ingredients Biology Essay

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We have the same drive for growth that marked our early days. Sun Pharma came into existence as a startup with just 5 products in 1983. In the time since, we have crossed several milestones to emerge as a leading pharma company in India, a rank that we have now been at for more than 5 years. (IMS-ORG Retail Store Audit, March 2006)

We have reached leadership in each of the therapy areas that we operate in, and are rated among the leading companies by key customers. Strengthening market share and keeping this customer focus remains a high priority area for the company.

In the post 1996 years, we have used a combination of internal growth and acquisitions to drive growth; important mergers were those of the US, Detroit based Caraco Pharm Labsand that of the plant at Halol which is now UKMHRA and USFDA approved.

Under a recent corporate development, the areas related to new molecular entities and drug delivery systems are proposed to be demerged into a separate company

What is Acidity

Stomach acidity or hyperacidity conditions are a common problem. Ask the person sitting right beside you in a bus if he had experienced bouts of acidity attacks. Chances are great that he or she would answer you with a big YES. Why is this so?

Our stomach produces acid to digest the food that we eat. This is a regular and natural process. Whenever we eat, cells within the lining of the stomach pump acid to liquefy your sumptuous dinner, from mash potatoes to a slab of steak.

Problem occurs when these cells produce large amount of acid, more than your stomach needs. When this happens, you will suffer from stomach acidity. You would know if you were suffering from stomach acidity if you feel a burning sensation just above the stomach, or right below (the hollow part) your breastbone. This is the most classic sign of acidity. Other people experience acid regurgitation. This happens when you are lying horizontal on your bed. You may have a sour taste in your mouth, which resembles the taste of an orange puree that had gone stale. Acid regurgitation oftentimes results to heartburn, or that pain near the heart area.

Drug - Pantocid 20

Pantocid is a drug that is used as an Antacid. The molecular weight of pantoprazole sodium is 405.5. Pantoprazole is a

substituted benzimidazole which inhibits basal and stimulated gastric secretion.

Pantoprazole sodium is a white to off-white amorphous hygroscopic powder.

Solubility is low at neutral pH and increases with increasing pH

Criteria

Tpp

Statement of the essential attributes of a clinically and commercially successful product, which can form the basis for commercial evaluation and guide Discovery and Development activities.

PHARMACOLOGICAL ACTION

Site and mechanism of action

Pantoprazole is a proton pump inhibitor, i.e. it inhibits specifically and dose-proportionally H+, K+- ATPase, the enzyme, which is responsible for gastric acid secretion in the parietal cells of the stomach.

Pantoprazole is a substituted benzimidazole, which accumulates in the acidic compartment of the parietal cells after absorption. In the parietal cell it is protonated and chemically re-arranged tot the active inhibitor, a cyclic sulphonamide, which binds to the H+, K+-ATPase, thus inhibiting the proton pump and causing suppression of stimulated and basal gastric acid secretion after single and multiple intravenous and oral pantoprazole dosing. Because pantoprazole acts distal to the receptor level, it can influence gastric acid secretion irrespective of the nature of the stimulus.

Pantoprazole exerts its full effect in a strongly acidic environment (pH<3) and remains mostly inactive at higher pH values, which explains its selectivity for the acid secreting parietal cells of the stomach.

Therefore, the complete pharmacological and therapeutic effect for pantoprazole can only be achieved in the acid-secreting parietal cells. By means of a feedback mechanism this effect is diminished at the same rate as acid secretion is inhibited.

Effect on gastric acid secretion

Although pantoprazole has a half-life of approximately 1 hour, the antisecretory effect increases during repeated once daily administration, demonstrating that the duration of action markedly exceeds the serum elimination half-life.

Pharmacokinetics

Absorption and distribution

Pantoprazole is unstable in acid and is administered orally in the form of an enteric-coated tablet.

Absorption takes place in the small intestine. On average, the maximum serum/plasma concentrations are approximately 2 to 3 micrograms/mL about 2½ hours after administration of 40 mg pantoprazole daily, as a single or multiple dose in healthy volunteers. The absolute systemic bioavailability of pantoprazole from single and multiple oral doses of pantoprazole is approximately 77%.

Following intravenous administration of pantoprazole, serum/plasma concentrations decline biexponentially. The terminal half-life (t½) is about 1 hour. The total serum clearance is approximately 0,1 L/h/kg and the volume of distribution is about 0,15 L/kg respectively.

The plasma kinetics for pantoprazole after both oral and intravenous administration are linear over the dose range 10 to 80 mg.

Metabolism

Pantoprazole is almost exclusively metabolised in the liver. The main metabolite is desmethylpantoprazole, which is conjugated with sulphate.

Elimination

Renal elimination represents the most important route of excretion (approximately 80%) for the metabolites of pantoprazole. The balance is excreted with the faeces. The half-life of the main metabolite is approximately 1½ hours, which is slightly longer than that of pantoprazole.

Pharmacokinetic profile in patients with impaired liver or renal function

For patients with mild to moderately severe hepatic cirrhosis the elimination half-life values increase from 1 hour to between 7 to 9 hours. The AUC values increase by a factor of 6 to 8, while the maximum serum concentration only increases by a factor of 1,5 in comparison with healthy subjects.

In patients with renal impairment the half-life of the main metabolite is moderately increased but there is no accumulation at therapeutic doses. The half-life of pantoprazole in patients with renal impairment is comparable to the half-life of pantoprazole in healthy subjects. Pantoprazole is poorly dialysed.

A slight increase in AUC and Cmax occurs in elderly volunteers compared with younger people.

CONTRA-INDICATIONS

Hypersensitivity to pantoprazole.

Safety and efficacy in children has not been established.

Severely impaired liver function. (See 'Special precautions').

INTERACTIONS

Concomitant intake of food has no influence on the bioavailability.

PANTOCID 40 may reduce or increase the absorption of medicines whose bioavailability is pH-dependent, e.g. ketoconazole.

The active ingredient of PANTOCID 40 is metabolised in the liver via the cytochrome P450 enzyme system. An interaction of PANTOCID 40 with other drugs or compounds which are metabolised using the same enzyme system cannot be excluded.

No clinically significant interactions were, however, observed in specific tests with a number of such drugs or compounds, namely antipyrine, caffeine, carbamazepine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline, warfarin and oral contraceptives.

Precautions

Nursing Mothers

Darifenacin is excreted into the milk of rats. It is not known whether darifenacin is excreted into human milk

and therefore caution should be exercised before ENABLEX is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of ENABLEX in pediatric patients have not been established.

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