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Abstract:  The amlodipine besylate tablet is one of the most highly prescribed medicines to manage hypertension in the geriatric population. However, the difficulty of swallowing tablets due to problems like dysphagia, fear of choking, and odynophagia has been identified as one of the contributing factors to non-compliance among geriatrics. Due to the swallowing factor among geriatrics, this study was conducted to compare two compounding methods of orally disintegrating films, namely solvent casting and spray casting, to produce an orally disintegrating film containing amlodipine besylate. Different polymers were used to develop the orally disintegrating films, and the formulations were subjected to validation tests such as thickness, folding endurance, tensile strength, percentage of elongation, Young’s modulus, disintegration, and dissolution. Chemicals like hydroxypropyl methylcellulose, carboxymethyl cellulose, glycerin, mannitol, sodium lauryl sulfate, citric acid, peppermint oil, and a coloring agent were used to formulate the orally disintegrating films. In addition, orally disintegrating films were prepared using the solvent casting and the spraying method. An increase in the polymer’s concentration resulted in the formation of a greater mechanical strength. After a comparison between the hydroxypropyl methylcellulose and the carboxymethyl cellulose as film-forming agents, it was discovered that hydroxypropyl methylcellulose had greater mechanical film properties than carboxymethyl cellulose, except for the folding endurance. Moreover, hydroxypropyl methylcellulose was shown to have a better disintegration time, which was in the range of 30 minutes to 90 minutes, with a drug release of 95% to 100%, while carboxymethyl cellulose disintegrated at 6 minutes to 15 minutes with a drug release of 60% to 75%. On the other hand, both the solvent casting and spraying methods produced an evenly matched orally disintegrating film quality. Orally disintegrating films containing amlodipine besylate were developed and characterized. It was concluded that these orally disintegrating films have a great potential in the market and a profound ability in the reduction of geriatric non-compliance to antihypertensive drugs.

Related Keywords: Mohamad Fariz Haiqal Ruslan, B. Pharm (Hons), Ashok Kumar Janakiraman, PhD, Long Chiau Ming, B. Pharm (Hons), M. Clin. Pharm, A.B.M. Helal Uddin, PhD (Pharmaceutical Chemistry), Zaidul Islam Sarker, PhD, Liew Kai Bin, B. Pharm (Hons), MSc, PhD, solvent casting method, spray casting method, amlodipine besylate, calcium channel blocker, hypertension, high blood pressure, angina, chest pain, coronary artery disease, elderly, orally disintegrating films, hydroxypropyl methylcellulose, carboxymethyl cellulose, drug release, hydrophilic polymers, disintegration time, dissolution profile

Related Categories: EXCIPIENTS, PEER-REVIEWED, TECHNOLOGY, CARDIOLOGY, DOSAGE FORMS/DRUG CARRIERS

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