用于老年医学的含盐酸美金刚口腔崩解片的配制和表征。

Q4 Medicine International journal of pharmaceutical compounding Pub Date : 2023-11-01
Hanifah Mohd Rofiq, Hiu Ching Phang, Ashok Kumar Janakiraman, Yik-Ling Chew, Abm Helal Uddin, Zaidul Islam Sarker, Siew-Keah Lee, Kai Bin Liew
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引用次数: 0

摘要

盐酸美金刚通常用于治疗阿尔茨海默病和血管性痴呆。然而,这种药物只有片剂,老年患者很难吞咽。对于那些被诊断为阿尔茨海默氏症的患者来说,这个问题尤其棘手。因此,本研究旨在使用不同类型和浓度的聚合物,开发含有盐酸美金刚的口腔崩解膜,并确定其特性。利用溶剂浇注法,开发了 12 种配方,其中涉及对聚合物类型和浓度的操作。随后,选择了六种配方进行表征测试。这些测试评估了薄膜的拉伸强度、杨氏模量、百分比伸长率、耐折度、崩解和溶解时间、含量均匀性、水分损失和吸湿性。分别加入了不同浓度的聚乙烯醇、羟丙基甲基纤维素、聚乙烯吡咯烷酮和拉鲁兰胶等聚合物。研究发现,只有羟丙基甲基纤维素和聚乙烯醇配方可制成可接受的口腔崩解膜。配方 E(羟丙基甲基纤维素 50 毫克/膜)表现出最佳的机械强度、快速崩解和溶解性以及出色的含量均匀性,被认定为最佳配方。虽然聚乙烯醇显示出更高的机械强度,但羟丙基甲基纤维素薄膜更能满足口腔崩解薄膜的最佳特性。研究表明,机械强度随聚乙烯醇薄膜中聚合物浓度的增加而成正比增加。然而,对于羟丙基甲基纤维素薄膜来说,只有当羟丙基甲基纤维素的浓度从 40 毫克/膜增加到 50 毫克/膜时,机械强度才会增加,但当羟丙基甲基纤维素的浓度为 60 毫克/膜时,机械强度则会降低。总之,含盐酸美金刚的口腔崩解薄膜经过开发、表征和推理,具有很大的市场潜力,可提高老年痴呆症患者的用药依从性。
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Compounding and Characterization of Oral Disintegrating Films Containing Memantine Hydrochloride for Geriatrics.

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.

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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.
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