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Printed: 23, March 2015

Bi-layer tablet is appropriate for consecutive relieve two drugs together, separate two incompatible substances, and for sustained release tablet by which one layer as immediate release layer as initial dose and 2nd layer as maintenance dose. The primary reason in extended relieve any bi-layer tablet formulation should be to separate physically or chemically incompatible ingredients and to produce repeat action or prolonged action of tablet. The goal of present work ended up being create a robust formulation of bi-layer tablets of Metoprolol Succinate extended release by using methocel as polymer and Hydrochlorothiazide immediate release by using mix-carmilose-sodium as super disintegrant.

Bilayer tablet formulation thesis proposal After granulation done the lube

Metoprolol Succinate can be utilized inside the treating of hypertension, angina pectoris and heart failure in doses not the same as 25 mg to 200 mg. Hydrochlorothiazide could be a first line diuretic drug within the thiazide class which inhibits the reabsorption of sodium, potassium ions within the nephron within the kidney and fosters antihypertensive effect. A whole amount of five formulations are really showed up at optimize and make a robust and stable formulation. Wet-granulation process was requested your formulation of both layers along with the final tablets were evaluated for the thickness, weight variation, hardness, friability, disintegration time, dissolution study. One of the all formulations F5 was taken as enhanced formula because of its dissolution along with other physical parameters within the condition specifications.

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Keywords: Metoprolol Succinate. Hydrochlorothiazide, Bi-layered tablet, in vitro dissolution.

The scenario of prescription delivery is quickly altering. Conventional pharmaceutical dosage forms are more and more being substituted with new drug delivery systems. These new drug delivery systems have become edge over conventional ones in relation to many biopharmaceutical parameters, a specific drug delivery technique is mixture of immediate release and extended-release drug delivery system.

Bilayer tablet formulation thesis proposal of dose

Bi-layer tablet is appropriate for consecutive relieve two drugs together, separate two incompatible substances, and for by which one layer as immediate release layer as initial dose and 2nd layer as maintenance dose. Combination therapy have various advantages over monotherapy for example problem of dose dependent undesirable effects were minimized. This mixture of immediate release and extended-release drug delivery technique is for your utmost safety, raise the effectiveness, reduce the dose frequency and lastly lead to improved patient compliance.1

Metoprolol Succinate is unquestionably an antihypertensive (cardio selective b-blocker) based in the treating of hypertension, angina pectoris and heart failure in doses not the same as 25 mg to 200 mg. It’s a water soluble drug with bioavailability of 40-60 % and plasma half-existence 3-7 hrs. Hence, conventional tablet is inadequate to own therapeutic plasma concentration for longer period of time along with a dosage regime of two occasions or 3 occasions daily is needed.2 Hydrochlorothiazide could be a first line diuretic drug within the thiazide class that functions inhibiting the reabsorption of sodium, potassium ions within the nephron within the kidney. This reduces the quantity of the bloodstream stream, decreasing bloodstream stream go back to the center and so cardiac output by other mechanisms. Medicines getting extended half-existence (7-14hr) does not requires frequent dosing making Hydrochlorothiazide a perfect candidate by having an immediate release formulation, is known as to reduce peripheral vascular resistance and fosters antihypertensive effect.2

Using two drugs in same formulation shows synergism effect to lessen hypertension. The merchandise in the study ended up being formulate the bi-layered tablets of Metoprolol Succinate extended release and Hydrochlorothiazide immediate release by using methocel (K4M and K100M) as polymer in extended release layer and blend-carmilose-sodium as super disintegrant in immediate release layer. Metoprolol succinate could be a quickly and completely absorbed drug but plasma level achieved is extremely variable after dental administration. Besides in addition, it’s relatively short elimination half-existence (3 to 7 hrs) then metoprolol succinate a perfect candidate by having an extended release formulation.2

MATERIALS AND METHOD:

Metoprolol Succinate and Hydrochlorothiazide was introduced on by Alkem Laboratories Limited, Taloja, Navi Mumbai. Also Povidone k-30, Starch, Lactose monohydrate was acquired from same laboratories. A number of other materials like Methocel (K4M and K100M), DCP Anhydrous, Brilliant blue, Mix-carmilose-sodium(Ac-Di-Sol), Xanthan gum, Sodium Stearyl Fumarate, Colloidal Anhydrous Silica(Aerosil-200). Purified Talc and Magnesium stearate used was of analytical grade and purchased in commercial sources.

Preparation of bi-layer tablets:

Metoprolol Succinate and Hydrochlorothiazide bi-layer tablets were produced by wet granulation process using the formula succumbed the table-1. Load the sifted Metoprolol Succinate, lactose monohydrate. methocel (K4M and K100M), xanthan gum within the rapid mixing granulator after which add binding agent that was formerly prepared. After granulation done the lube with remaining ingredients. Then created granules are uncovered for compression in bi-layer machine (Kanbert). Similarly granulation of Hydrochlorothiazide layer is created by sifting materials while using sieve individually. Then binding representative is produced by dissolving starch in specified quantity of purified water. Load the sifted Hydrochlorothiazide, lactose monohydrate, DCP anhydrous, brilliant blue within the rapid mixing granulator. adding binding agent that’s formerly prepared. After granulation done the lube with remaining ingredients and uncovered for compression in bi-layer machine that was particularly designed and produced for creating quality bi-layer tablets. Metoprolol Succinate layer blend was pre-compressed with low hardness and Hydrochlorothiazide layer blend was compressed when it comes to this, up until the preferred hardness was achieved. Fractional laser treatments is known as Bi-layered technology.

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