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Fast Melt Tablet (FMT) is a newer type of orally disintegrating tablet using the advantage of cocoa butter that melts at body temperature to achieve fast melting effect when the tablet is placed in oral cavity. However, oral disintegrating dosage form must have good palatability so that patients can accept it. The objective of this study is to taste mask a previously developed FMT containing memantine hydrochloride using artificial sweetener namely aspartame and acesulfame K and conduct a palatability study. Six formulations were developed and each sweetener was used at three level (10mg, 20mg and 30mg) to taste mask memantine hydrochloride in FMT. Formulation T7 was selected as the best taste masked formulation. Aspartame 30mg is sufficient to cover the bitter taste of memantine hydrochloride. A taste masked memantine hydrochloride FMT containing 30mg of aspartame was successfully developed. This formulation has hardness of 17.31 (0.18) Newton, 0.51 (0.02) g weight, 6.18 (0.42) mm thickness and in-vitro melting time of 31.16 (1.23) seconds. This novel dosage form has the potential to be commercialized as a patient friendly dosage form to treat Alzheimer's disease., (Copyright© by International Journal of Pharmaceutical Compounding, Inc.)

Geriatric patients have difficulty to comply to their medication regimen due to complicated medication administration schedule, dysphagia, reduced ability to swallow tablets and dementia. This is particularly more challenging among the Alzheimer Disease's patients. Therefore, a model drug, memantine hydrochloride has been formulated into an orally disintegrating film (ODF) for easier consumption. However, bitter taste of memantine hydrochloride needs to be solved first if the drug is formulated into an ODF. The objective of this study is to taste mask memantine hydrochloride ODF and conduct a palatability study to evaluate the palatability of the dosage form. Memantine hydrochloride ODF was prepared using solvent casting method followed by freeze drying. The polymeric base consisted of Guar gum, PEG 400 and wheat starch in solvent water, with varying amounts of Aspartame or Acesulfame K for taste masking. The freeze-dried memantine hydrochloride ODFs were evaluated for tensile strength, in-vitro disintegration time, average thickness, dissolution, memantine hydrochloride content, and palatability. Formulation M7 was selected as the best taste masked formulation. Aspartame 30 mg is sufficient to cover the bitter taste of memantine hydrochloride in ODF form. A taste masked memantine hydrochloride ODF of dimensions 20 x 20 mm containing 30mg of aspartame was successfully developed. This formulation has average values for tensile strength 0.03 (0.01) kPa, folding endurance 351.92 (4.82) flips, thickness 0.94 (0.02) mm, and disintegration time 34.15 (2.16) seconds., (Copyright© by International Journal of Pharmaceutical Compounding, Inc.)

Orally disintegrating tablets, which were originally developed in the pharmaceutical field to improve the compliance of patients who had difficulty swallowing tablets, have become a preferable choice in solid dosage forms since it brings advantages to the patients and consumers in the healthcare system. Among the advantages of this novel dosage form are a faster onset of action, improved bioavailability, and the ease of administration as it can be taken without water. However, there are still some limitations of orally disintegrating tablets that need to be overcome, including a lack of mechanical strength, an unpleasant taste of the drug in the mouth, and a stability issue due to its hygroscopicity nature. This objective of this study was to identify the composition of co-processed excipients comprising of mannitol, microcrystalline cellulose, xylitol, and crospovidone or croscarmellose sodium in order to formulate orally disintegrating tablets containing memantine hydrochloride. This study was carried out in two stages. Firstly, orally disintegrating tablets containing memantine hydrochloride with 6 different formulations, which differed in the percentage of crospovidone or croscarmellose sodium, were formulated and manufactured. Secondly, the orally disintegrating tablets obtained were evaluated through pre- and post-compression tests based on the standard for orally disintegrating tablets. Formulation 3, which consisted of 10% xylitol, 10% mannitol, 72% microcrystalline cellulose, and 8% crospovidone, was chosen as the optimum formulation for the co-processed excipient since it was the fastest disintegration process among all the formulations in the study. In addition, Formulation 3 also showed the acceptable and satisfying results in other evaluation tests such as - weight variation test, hardness test, and friability test. The co-processed excipient comprising of 10% xylitol, 10% mannitol, 72% microcrystalline cellulose, and 8% crospovidone, which is characterized by improved functionalities such as a fast disintegration process, plays a crucial role in the application of orally disintegrating tablets., (Copyright© by International Journal of Pharmaceutical Compounding, Inc.)

Memantine hydrochloride is commonly prescribed for Alzheimer's disease and vascular dementia. However, the drug is only available in tablet form, a dosage form which is difficult for geriatrics to swallow. This problem is especially difficult for those patients diagnosed with Alzheimer's. This study was therefore aimed to develop and characterize an oral disintegrating film containing memantine hydrochloride using different types and concentrations of polymers. Using the solvent casting method, twelve formulations were developed, which involved manipulations on the type and concentration of the polymer. Afterwards, six formulations were selected to undergo characterization tests. These tests evaluated the films' tensile strength, Young's Modulus, percent elongation, folding endurance, disintegration and dissolution time, content uniformity, moisture loss, and moisture uptake. Polymers such as polyvinyl alcohol, hydroxypropyl methylcellulose, polyvinyl pyrrolidone, and pullulan gum were respectively incorporated at different concentrations. The study found that only hydroxypropyl methylcellulose and polyvinyl alcohol formulations developed into acceptable oral disintegrating films. Formulation E (hydroxypropyl methylcellulose 50-mg/film), which exhibited optimal mechanical strength, fast disintegration and dissolution, and excellent content uniformity, was identified as the best formula. Although polyvinyl alcohol showed higher mechanical strength, hydroxypropyl methylcellulose films were better at fulfilling the optimal characteristics of an oral disintegrating film. The study showed that the mechanical strength increased proportionally to the polymer concentration in the polyvinyl alcohol film. However, for the hydroxypropyl methylcellulose film, the mechanical strength increased only when hydroxypropyl methylcellulose's concentration was increased from a 40-mg/film to a 50-mg/film but decreased with a 60-mg/film. To summarize, orally disintegrating films containing memantine hydrochloride was developed, characterized, and reasoned to have high potential to be marketed and to increase medication compliance among geriatrics suffering from Alzheimer's disease., (Copyright© by International Journal of Pharmaceutical Compounding, Inc.)

Co-processed excipients were prepared by incorporating one excipient into the particle structure of another and a combination of two or more compendia or noncompendia excipients to physically modify their properties, which cannot be achievable by simple physical mixing. The co-processed multicomponent-based excipients were introduced to achieve better characteristics and tableting properties. This objective of this study was to develop and evaluate a co-processed excipient for amlodipine orally disintegrating tablets to simplify the compounding process. The co-processed excipients were prepared by wet granulation with 5% of polyvinylpyrrolidone and croscarmellose sodium, five different percentages of microcrystalline cellulose, and lactose monohydrate. After sieving and drying, the co-processed excipients were evaluated for flowability and compressibility. The co-processed excipients were mixed with the amlodipine powder and magnesium stearate and compressed into tablets. The amlodipine tablets were evaluated for weight variation, content uniformity, thickness, hardness, friability, disintegration, and dissolution tests. Formulation 4 was chosen as the optimum formulation because the results showed this formulation had the excellent flowability and compressibility of a co-processed excipient. It showed uniformity of weight, content, thickness, and hardness, weight loss less than 1%, fast disintegration time, and dissolution results. The developed co-processed excipient can be used by the pharmaceutical industry in the future to compound amlodipine orally disintegrating tablets in a fast and economical way., (Copyright© by International Journal of Pharmaceutical Compounding, Inc.)