Taste Masking Study of Orally Disintegrating Film (ODF) Formulations Containing Memantine Hydrochloride.

Q4 Medicine International journal of pharmaceutical compounding Pub Date : 2024-09-01
Ganesan Gobal, Hiu Ching Phang, Zhi Qi Ng, Ying Hui Loke, Yik Ling Chew, Abm Helal Uddin, Siew-Keah Lee, Vijayakumar Lakshminarayanan, Kai Bin Liew, Shamima Abdul Rahman
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Abstract

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.

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含盐酸美金刚的口腔崩解膜(ODF)制剂的掩味研究
由于用药程序复杂、吞咽困难、吞咽药片能力下降和痴呆症等原因,老年病患者很难按疗程服药。这对阿尔茨海默病患者来说尤其具有挑战性。因此,我们将盐酸美金刚配制成口腔崩解片(ODF),以方便患者服用。然而,如果将盐酸美金刚配制成口腔崩解片,首先需要解决盐酸美金刚的苦味问题。本研究的目的是掩盖盐酸美金刚口腔崩解膜的味道,并进行适口性研究,以评估该剂型的适口性。盐酸美金刚 ODF 采用溶剂浇注法制备,然后进行冷冻干燥。聚合物基质由瓜尔胶、PEG 400 和小麦淀粉在溶剂水中组成,并添加了不同量的阿斯巴甜或安赛蜜 K 以掩盖味道。对冻干盐酸美金刚脂 ODF 的拉伸强度、体外崩解时间、平均厚度、溶解度、盐酸美金刚脂含量和适口性进行了评估。制剂 M7 被选为口感最佳的掩味制剂。阿斯巴甜 30 毫克足以掩盖 ODF 形式盐酸美金刚的苦味。成功研制出了含有 30 毫克阿斯巴甜的遮味盐酸美金刚 ODF,尺寸为 20 x 20 毫米。该制剂的拉伸强度平均值为 0.03 (0.01) 千帕,耐折度为 351.92 (4.82) 次,厚度为 0.94 (0.02) 毫米,崩解时间为 34.15 (2.16) 秒。
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来源期刊
CiteScore
0.40
自引率
0.00%
发文量
62
期刊介绍: The International Journal of Pharmaceutical Compounding (IJPC) is a bi-monthly, scientific and professional journal emphasizing quality pharmaceutical compounding. IJPC is the only publication that covers pharmaceutical compounding topics relevant and necessary to empower pharmacists to meet the needs of today"s patients. No other publication features hands-on, how-to compounding techniques or the information that contemporary pharmacists need to provide individualized care.
期刊最新文献
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