Sucheta Dalal :20 Brands of Anti-Diabetic Tablets Tested: All found effective
Sucheta Dalal

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20 Brands of Anti-Diabetic Tablets Tested: All found effective  

April 27, 2006

About 33 million people in India suffer from diabetes and another one million do not know they have a condition. Most diabetics use anti-diabetic tablets to maintain their glucose level. Insight’s in-house lab tested 20 brands of these tablets and found that all brands compiled with the standards.

 

20 Brands of Anti-Diabetic Tablets Tested:

All Found Effective

 

INSIGHT — The Consumer Magazine (May-June 2006) has published the test findings of its in-house comparative product testing laboratory on 20 brands of anti-diabetic tablets.

 

Nearly 33 million people in India suffer from diabetes and another one million do not know they have the condition. Apart from diet and exercise, many patients have to take insulin injections or anti-diabetic tablets. Most diabetics use anti-diabetic tablets to keep their blood glucose under control. So we decided to test these life-saving drugs.

 

It would be a relief for diabetics to know that all the brands tested complied with the standards.

 

Two Kinds of Drugs

 

We selected two kinds of anti-diabetic oral drugs — sulphonylurea and biguanide. Sulphonylureas work by stimulating the pancreas to release more insulin. Non-obese patients with Type 2 diabetes (non-insulin dependent diabetes) are usually prescribed sulphonylureas. Biguanides work by increasing insulin sensitivity and glucose utilisation and reducing the amount of glucose produced by the liver. Obese patients with Type 2 diabetes are usually prescribed biguanides.

 

We tested four generic drugs, which are glibenclamide, glipizide, gliclazide and metformin. Out of these, metformin is a biguanide and the other three are sulphonylureas.

 

Standards

 

The glibenclamide and metformin tablets were tested as per the Indian Pharmacopoeia (IP). Glipizide and gliclazide tablets were tested as per the British Pharmacopoeia (BP) since tests for them were not specified in the IP.

 

Parameters

 

All the tablets were tested for four basic parameters — identification, assay, uniformity of weight and disintegration. We also tested glibenclamide for uniformity of content and metformin tablets for dissolution as specified. Though the test for uniformity of content was not specified for glipizide and gliclazide, we extended the test for these drugs in the interests of the consumers.

 

All brands passed all the tests.

 

Identification

This test is done to identify the active ingredient in the drug.

 

Assay

The test for assay is done to find out the actual amount of active ingredient present in the tablet and whether it is the same as what is labelled. This is carried out on a net quantity of randomly selected 20 tablets.

 

Uniformity Of Weight

This test is done to check the individual variation of the weight from the average weight of the dosage unit. This also gives an idea of the uniformity of distribution of the material before the preparation of the tablets.

 

Disintegration

A tablet needs to break down into small particles or disintegrate so that it is ready for absorption within a specific time period. This test checks whether a tablet disintegrates within a fixed time limit.

 

Uniformity Of Content

This test determines whether the actual amount of active ingredient is present in a single dose, i.e. a single tablet.

 

Dissolution

The dissolution test measures the actual release of the drug from the tablet into the gastro-intestinal fluid which is an essential step in drug availability to the body.

 

Price

As all the brands complied with the standards, a major criterion for preferring one brand to another is the price. Glibenclamide tablets cost between Rs. 5.50 and 8.00 for ten tablets. Metformin tablets cost between Rs. 7.20 and 13.10 for ten tablets whereas glipizide tablets cost around Rs. 4.65 to 6.65 for ten tablets. The gliclazide tablets were the costliest at between Rs. 29 and 63.70 for ten tablets.

 

The variation in the price, apart from profit margin, could be due to the additives used in making the tablet such as for coating, binding, disintegration, dissolution and for increasing bulk. The additives also influence the efficiency of the tablets.

 

Labelling Information

All the brands carried the following labelling information — name and address of the manufacturer, label claim of active ingredient, quantity, batch number, date of manufacture, date of expiry, manufacturer’s licence number, price, storage conditions and cautionary information.

 

Side-effects

A common side-effect of sulphonylureas is hypoglycaemia, or low blood glucose level. Common side-effects of biguanides include abdominal discomfort, diarrhoea, nausea or vomiting, loss of appetite, and metallic taste.

 

Area of Action

The Indian Pharmacopoeia (IP) should provide standards for glipizide and gliclazide tablets since they are widely used.

 

Feature

Read our feature on the types of diabetes, symptoms, risk factors, complications and treatment. Our feature also highlights the dangers of hypoglycaemia, diet tips for diabetics and the discovery of inhaled insulin.

 

As a policy, the test results are conveyed to all the manufacturers for their views and comments. All manufacturers receive the results of their own product only. Details of the Test Report have been published in the May-June 2006 issue of Insight.

 

Date: 24/04/2006                                Pritee Shah

Place: Ahmedabad                           Editor - Insight

 

Brands Tested

 

We tested five brands of each type of generic drug, all of which are national brands. The glibenclamide tablets tested were Daonil, Diabetnil, Euglucon, Glyboral and Glinil which had 5 mg strength. Glycomet, Gluformin, Walaphage, Glyciphage and Obimet were metformin tablets and were of 500 mg. The glipizide tablets of 5 mg were Glynase, Diaglip, Glide, Glucotrol and Glibetic and the gliclazide tablets of 80 mg were Glycigon, Reclide, Glizid, Dianorm and Diamicron.


-- Sucheta Dalal



 



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