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-The Consumer Magazine
Brands Tested
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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.
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