Design and development of novel bi layer fast dissolving films containing amlodipine besylate and benazepril hydrochloride for hypertensive emergencies

Abstract

Oral dissolving film delivers drug directly into the systemic circulation by dissolving or disintegrating in buccal cavity [1]. Fast dissolving films are intended to deliver drug in to direct circulation. So, it is advantageous system oral many other dosage form as it provide fast onset of action. newlineOral dissolving films are advantageous in following terms. newline1. Oral fast dissolving films are dissolved in mouth cavity by saliva without need of water so it is advantageous for patient of dysphegia. newline2. Large surface are of film allows fast release of drug. newline3 As film is unit dosage form precision in dose is achieved. newline4. Older patient having problem in swallowing large tablets can take film easily. newline5. This system provides higher bioavailability as it bypass the effect of first pass metabolism. newline6. Liquid API can be deliverd in solid dosage form by this system. newline7. It is cheaper to manufacture as compared to other dosage forms. newline8. Onset of action is very fast. newline9. Many excipients are used in film preparation that give pleasant mouth felling. newline10. As first pass metabolism is bypassed dose required to produce effect is less. newlineThere are several potent drug combination that provides better effect but as they are incompatible with each other it is not feasible to give them in fixed dose combination. This can be overcome by careful designing physically separate film. newlineAll the therapeutic films which are available in the market are available as single, monolithic films. The scope of the present research works aims at designing of bilayer or multilayer films with specific advantages as listed below: newline1. Physical separation of two or more incompatible drugs newline2. Delivery of multiple therapeutically active compounds by a single and simple dosage form. newline3. Cost effective and patient compliant dosage form. newline newline