You are hereNOVEL APPROACH OF BILAYERED TABLETS: AN OVERVIEW

NOVEL APPROACH OF BILAYERED TABLETS: AN OVERVIEW


Table 2: Commercially marketed bilayer tablets [19]

Product Name

Chemical Name

Developer

Glycomet®-GP2Forte

Metformin hydrochloride, Glimepiride

USV Limited

ALPRAX PLUS

Sertraline, Alprazolam

Torrent Pharmaceutcals Ltd.

DIAMICRON®XRMEX500

Gliclazide, Metformin hydrochloride

Sedia® Pharmaceuticals (India) Pvt. Ltd.

Newcold Plus

Levocetrizine             hydrochloride,          Phenylpropanolamine, Paracetamol

Piramol Healthcare Ltd.

TRIOMUNE 30

Nevirapine, Lamivudine, Stavudine

Cipla Ltd.

DIUCONTIN-K®20/250

Furosemide, Potassium chloride

T.C. Health Care Pvt. Ltd.

Tribet-1

Glimepiride,            Pioglitazone               hydrochloride,          Metformin                  hydrochloride

Abbott Healthcare Pvt. Ltd.

PIOKIND®-M15

Pioglitazone, metformine hydrochloride

Psychotropics India Ltd.

Revelol®-Am 25/5

Metoprolol succinate, Amlodipine besilate

Ipca Laboratories Ltd.

EVALUATION OF SUSTAIN RELEASE BILAYER TABLET [6, 19, 26]

1.      Tablet Thickness and Size
Thickness and diameter of tablets were important foruniformity of tablet size. Thickness and diameter was measuredusing venire caliper.

2.      Tablet Hardness
The resistance of tablets to shipping or breakage underconditions of storage, transportation and handling before usagedepends on its hardness. The hardness of tablet of each formulationwas measured by Monsanto hardness tester. The hardness wasmeasured in kg/cm2.

3.      Friability
Friability is the measure of tablet strength. Electrolab EF- 2 friabilator (USP) was used for testing the friability using the following procedure. Twenty tablets were weighed accurately and placed in the tumbling apparatus that revolves at 25 rpm dropping the tablets through a distance of six inches with each revolution. After 4 min, the tablets were weighed and the percentage loss in tablet weight was determined.

% loss = [(Initial wt. of tablets – Final wt. of tablets)/ Initial wt. of tablets] ×100

4.      Uniformity of weight
Twenty tablets were selected at random and the average weight was calculated. Weight Variation was calculated and was compared with I. P. standards.

5.      Dissolution Studies
Bilayer tablets were subjected to in vitro drug release studies in simulated gastric and intestinal fluids to assess their ability in providing the desired controlled drug delivery. Drug release studies were carried out using USP dissolution test apparatus I at 100 rpm, 37±0.5°C, and pH 1.2 buffer (900 ml) (i.e. 0.1 N HCl) for 2 hours, since the average gastric emptying time is about 2 hours. The dissolution medium was replaced with pH 6.8 phosphate buffer (900ml) and experiment continued for another 10 hours. At different time intervals, 5ml of the samples were withdrawn and replaced with 5ml of drug-free dissolution medium. The samples withdrawn were analyzed by UV spectrophotometer using multi component mode of analysis.

CONCLUSION AND DISCUSSION
Bilayer tablet is suitable for sequential release of two drugs in combination, separate two incompatible substances and also for sustained release tablet in which one Layer is immediate release as initial dose and second layer is maintenance dose. Compression Force-controlled presses are clearly limited when a quality bi-layer tablet needs to be produced in conjunction with accurate weight control of both layers. Low pre-compression forces are necessary to secure interlayer bonding. But at low forces, the compression force control system is not sufficiently sensitive and therefore lacks in accuracy. The use of higher compression forces may rapidly result in separation and hardness problems when compressing bi-layer tablets. Such problems become even more apparent when the tableting speed is high or increased.

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19.    Sanjay D, Sanhati SR, Amitava G, Bhaskar M. Bilayer Table Technology: A Suitable Approach for Bimodal Release and Co-administration of Drug(s) Through Oral Route. Available on: www.apjtb.com/press/2012/B189.doc.
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