Formulation and Stability Studies of Fast Disintegrating Tablets of Amlodipine Besylate

Abstract

Introduction: Among tablets, fast dissolving technology has gained considerable popularity due to their rapid onset of action. Amlodipine besylate (ADB) is a longacting calcium channel blocker that is used in the treatment of angina and hypertension which are life-threatening conditions and require immediate relief. Currently, no fast dissolving tablet dosage form of ADB is commercially available. Methods: A total of seven fast disintegrating tablets of Amlodipine besylate (ADB) have been prepared by direct compression method employing various excipients (Disintegrants and binders) in different concentrations. Pre-compression and post-compression studies were performed along with the storage in the stability chambers under real (30±2ºC / 65±5% RH) and accelerated conditions (40±2ºC / 75±5% RH) for six months. The assay of ADB was performed using a validated UV spectrometric method at 361 nm. Results: The release of ADB from tablets has been found to be very fast with almost more than 85% drug released within 15 min. The release of drug from all the tablet formulations followed Higuchi model. Conclusion: The use of sodium bicarbonate as super disintegrant has greatly promoted the rapid release of the active drug. The binder has been shown to affect the tensile strength of the tablets. The stability studies for six months in aluminum blister packaging indicated no significant change in concentration in the majority of the formulations. This study provides basic groundwork related to the formulation of fast disintegrating tablets of ADB.

Photostability study of amlodipine besylate tablets packed in primary packaging

“…Comparing these results with the results obtained in our study, it can be concluded that the excipients and primary packaging play a significant role in the photoprotection of amlodipine besylate. The impact of primary packaging (Alu/Alu blister) was observed on the stability of amlodipine besylate in rapidly disintegrating tablets for 6 months under real (30 °C, 65% of relative humidity) and stress (40 °C, 75% of relative humidity) conditions [19]. In both cases, the decrease in the content of amlodipine besylate was lower than 5%.…”

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“…Dropping height should be 6 inches on each rotation. The friability each batch was determined calculated using the following formula 15 :…”

A Rapid HPLC Method for the Concurrent Determination of Several Antihypertensive Drugs from Binary and Ternary Formulations

“…Telmisartan, olmesartan, and irbesartan are available on the market in combination with amlodipine and hydrochlorothiazide (Figure 1), manufactured by the same or different pharmaceutical industries [4]. Different analytical methods such as spectrophotometric [11][12][13][14][15][16][17][18], derivative spectrofluorimetric [19], HPLC [20][21][22][23][24][25][26][27], electrophoresis [28], and HPTLC [29] were reported for the concurrent determination of sartans, amlodipine, or hydrochlorothiazide from formulations and biological fluids. The literature has also reported a few analytical methods for the concurrent determination of ternary mixtures of sartans, amlodipine, and hydrochlorothiazide [30][31][32][33][34].…”