Delving into the Latest Updates on Aspirin/Magnesium Carbonate/Dihydroxyaluminum Aminoacetate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Asphanate, Aspirin/Dihydroxyaluminium Aminoacetate/Heavy Magnesium Carbonate, Bufferin

+ [17]

Target

COX x NMDA receptor

Mechanism

COX inhibitors(Cyclooxygenases inhibitors), NMDA receptor antagonists(Glutamate [NMDA] receptor antagonists)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesNervous System Diseases+ [6]

Active Indication

Common ColdHeadacheNeuralgia+ [13]

Inactive Indication-

Originator Organization

Nichi-Iko Pharmaceutical Co., Ltd.

Active Organization

Nichi-Iko Gifu Plant Co., Ltd.

Lion Corp.

Eisai Co., Ltd.

+ [4]

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

JP (22 Sep 2000),

Angina, StableAngina, UnstableBrain Infarction+ [2]

Regulation-

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Structure

Molecular FormulaC12H16AlMgNO11

InChIKeyKBSUEWXOYXVBHN-UHFFFAOYSA-K

CAS Registry53664-49-6

主要目的：以持证商为 Lion Corporation 的铝镁匹林片（Ⅱ）（商品名：BUFFERIN Combination Tab. A81，规格：每片含阿司匹林 81mg，重质碳酸镁 22mg，甘羟铝 11mg）为参比制剂，以湖南金圃医药科技有限公司研发的铝镁匹林片（Ⅱ）（规格：每片含阿司匹林 81mg，重质碳酸镁22mg，甘羟铝 11mg）为受试制剂，评价两种制剂在中国健康受试者中空腹和餐后状态下的生物等效性。次要目的：评价受试制剂与参比制剂在中国健康受试者中的安全性。

[Translation]

Primary objective: To evaluate the bioequivalence of the two preparations in the fasting and fed state in healthy Chinese subjects, using the aluminum magnesium aspirin tablets (II) (trade name: BUFFERIN Combination Tab. A81, specification: each tablet contains 81 mg aspirin, 22 mg heavy magnesium carbonate, 11 mg aluminum glycolate) from Lion Corporation as the reference preparation and the aluminum magnesium aspirin tablets (II) (specification: each tablet contains 81 mg aspirin, 22 mg heavy magnesium carbonate, 11 mg aluminum glycolate) developed by Hunan Jinpu Pharmaceutical Technology Co., Ltd. as the test preparation. Secondary objective: To evaluate the safety of the test preparation and the reference preparation in healthy Chinese subjects.

Start Date11 Oct 2024

Sponsor / Collaborator

Hunan Jinpu Pharmaceutical Technology Co., Ltd.

CTR20243019 / Active, not recruitingNot Applicable

健康受试者在空腹及餐后状态下单次口服铝镁匹林片（Ⅱ）的人体生物等效性试验

[Translation] Bioequivalence study of a single oral dose of aluminum magnesium aspirin tablets (Ⅱ) in healthy subjects under fasting and fed conditions

主要目的：以浙江华海药业股份有限公司研发生产的铝镁匹林片（Ⅱ）为受试制剂（T），以Lion Corporation持证生产的铝镁匹林片（Ⅱ）（商品名：BUFFERIN Combination Tab. A81）为参比制剂（R），评估健康受试者在空腹及餐后状态下单次口服受试制剂和参比制剂的药代动力学特征，评价两制剂的人体生物等效性。次要目的：考察健康受试者口服受试制剂和参比制剂后的安全性。

[Translation]

Primary objective: To evaluate the pharmacokinetic characteristics of the test and reference preparations after a single oral administration in healthy subjects in the fasting and postprandial state, and to evaluate the bioequivalence of the two preparations in humans. Secondary objective: To investigate the safety of the test and reference preparations after oral administration in healthy subjects.

Start Date29 Aug 2024

Sponsor / Collaborator

Zhejiang Huahai Pharmaceutical Co., Ltd.

CTR20240251 / CompletedNot Applicable

铝镁匹林片（II）人体生物等效性预试验

[Translation] Preliminary study on bioequivalence of aluminum-magnesium aspirin tablets (II) in humans

本研究旨在研究空腹和餐后状态下单次口服华润双鹤利民药业（济南）有限公司提供的受试制剂T铝镁匹林片（II）（规格：每片含阿司匹林81 mg，重质碳酸镁22 mg，甘羟铝11 mg）及Lion Corporation持证的参比制剂R铝镁匹林片（II）（商品名：BUFFERIN Combination Tab. A81；规格：每片含阿司匹林81mg，重质碳酸镁22mg，甘羟铝11mg）的药代动力学特征，

[Translation]

The aim of this study was to investigate the pharmacokinetic characteristics of a single oral dose of the test preparation T Aluminum Magnesium Aspirin Tablets (II) (Specification: each tablet contains 81 mg aspirin, 22 mg heavy magnesium carbonate, and 11 mg aluminum glycolate) provided by China Resources Double Crane Limin Pharmaceutical (Jinan) Co., Ltd. and the reference preparation R Aluminum Magnesium Aspirin Tablets (II) (trade name: BUFFERIN Combination Tab. A81; Specification: each tablet contains 81 mg aspirin, 22 mg heavy magnesium carbonate, and 11 mg aluminum glycolate) certified by Lion Corporation in the fasting and fed state.

Start Date25 Jan 2024

Sponsor / Collaborator

China Resources Double-Crane Pharmaceutical (Jinan) Co., Ltd.

100 Clinical Results associated with Aspirin/Magnesium Carbonate/Dihydroxyaluminum Aminoacetate

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100 Translational Medicine associated with Aspirin/Magnesium Carbonate/Dihydroxyaluminum Aminoacetate

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100 Patents (Medical) associated with Aspirin/Magnesium Carbonate/Dihydroxyaluminum Aminoacetate

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23

Literatures (Medical) associated with Aspirin/Magnesium Carbonate/Dihydroxyaluminum Aminoacetate

01 Jun 2024·Therapeutic Drug Monitoring

Unveiling the Rare Presentation of Acetylsalicylate Overdose: Grand Round

Article

Author: Hasegawa, Eiju ; Okada, Ichiro ; Kohara, Saeko ; Hishikawa, Tsuyoshi ; Kyan, Ryoko ; Kamijo, Yoshito

Background:This case report highlights a rare occurrence of aspirin overdose presenting only as severe coagulopathy.Case presentation:An 85-year-old woman was admitted to the hospital with multiple lumbar vertebral compression fractures causing severe back pain. The patient had self-medicated with excessive consumption of Bufferin A containing 330 mg of aspirin. On arrival, she showed no typical symptoms of salicylate toxicity, such as nausea, vomiting, hyperventilation, tinnitus, or hearing loss. However, blood work revealed a significant decrease in vitamin K–dependent coagulation factors leading to coagulopathy. The administration of 20-mg menatetrenone (vitamin K) resulted in rapid improvement in coagulation abnormalities. The patient's blood salicylate level was later determined to be 42.7 mg/dL.Discussion:Acute salicylate poisoning is known to cause coagulopathy because of the inhibition of vitamin K–dependent coagulation factors. However, this case is unique because it demonstrates coagulopathy as the sole manifestation of aspirin toxicity without any other symptoms.Conclusions:This case highlights the importance of considering the possibility of aspirin toxicity in patients with coagulopathy, especially those who are regularly consuming aspirin.

30 Oct 2017·Optics ExpressQ2 · PHYSICS & ASTROPHYSICS

Comprehensive study of solid pharmaceutical tablets in visible, near infrared (NIR), and longwave infrared (LWIR) spectral regions using a rapid simultaneous ultraviolet/visible/NIR (UVN) + LWIR laser-induced breakdown spectroscopy linear arrays detection system and a fast acousto-optic tunable filter NIR spectrometer

Q2 · PHYSICS & ASTROPHYSICS

ArticleOA

Author: Swaminathan, Siva R. ; Hommerich, Uwe ; Jin, Feng ; Ramer, Evan D. ; Yang, Clayton S. C. ; Patel, Sita ; Trivedi, Sudhir B. ; Samuels, Alan C. ; Brown, Ei E.

This is the first report of a simultaneous ultraviolet/visible/NIR and longwave infrared laser-induced breakdown spectroscopy (UVN + LWIR LIBS) measurement. In our attempt to study the feasibility of combining the newly developed rapid LWIR LIBS linear array detection system to existing rapid analytical techniques for a wide range of chemical analysis applications, two different solid pharmaceutical tablets, Tylenol arthritis pain and Bufferin, were studied using both a recently designed simultaneous UVN + LWIR LIBS detection system and a fast AOTF NIR (1200 to 2200 nm) spectrometer. Every simultaneous UVN + LWIR LIBS emission spectrum in this work was initiated by one single laser pulse-induced micro-plasma in the ambient air atmosphere. Distinct atomic and molecular LIBS emission signatures of the target compounds measured simultaneously in UVN (200 to 1100 nm) and LWIR (5.6 to 10 µm) spectral regions are readily detected and identified without the need to employ complex data processing. In depth profiling studies of these two pharmaceutical tablets without any sample preparation, one can easily monitor the transition of the dominant LWIR emission signatures from coating ingredients gradually to the pharmaceutical ingredients underneath the coating. The observed LWIR LIBS emission signatures provide complementary molecular information to the UVN LIBS signatures, thus adding robustness to identification procedures. LIBS techniques are more surface specific while NIR spectroscopy has the capability to probe more bulk materials with its greater penetration depth. Both UVN + LWIR LIBS and NIR absorption spectroscopy have shown the capabilities of acquiring useful target analyte spectral signatures in comparable short time scales. The addition of a rapid LWIR spectroscopic probe to these widely used optical analytical methods, such as NIR spectroscopy and UVN LIBS, may greatly enhance the capability and accuracy of the combined system for a comprehensive analysis.

01 Feb 2011·International Journal of Pharmaceutics

Corrigendum to “The most appropriate storage method in unit-dose package and correlation between color change and decomposition rate of aspirin tablets”

Article

Author: Yamazaki, Noriko ; Ishii, Fumiyoshi ; Shimokawa, Ken-Ichi ; Taya, Kumiko

The most appropriate method to preserve Bufferin 81-mg tablets dispensed for unit-dose packaging in the hospital pharmacy was examined. The surface color change of the tablets was investigated over time by spectrophotometry, and the decomposition rate of aspirin was measured by high-performance liquid chromatography (HPLC). To overcome these, it was found that we can effectively prevent color changes and preserve the quality by maintaining the humidity as 55% or less, storage with drying agent in a plastic or aluminum pack. It was revealed that the color changes became greater and the decomposition rate became higher as time passed. Color changes markedly affect the patients' compliance, and are found to be a very important factor. It was considered that the clarity of the correlation between the color change and decomposition rate may contribute to a decrease in the number of tablets discarded before the expiration date.

100 Deals associated with Aspirin/Magnesium Carbonate/Dihydroxyaluminum Aminoacetate

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R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Neuralgia	JP	Eisai Co., Ltd.	19 Jun 2009
Rheumatic Fever	JP	Eisai Co., Ltd.	19 Jun 2009
Rheumatoid Arthritis	JP	Eisai Co., Ltd.	19 Jun 2009
Mucocutaneous Lymph Node Syndrome	JP	Nakakita Pharmaceutical Co., Ltd.	01 Oct 2005
Angina Pectoris	JP	Nichi-Iko Gifu Plant Co., Ltd.	01 Nov 2000
Brain Ischemia	JP	Nichi-Iko Gifu Plant Co., Ltd.	01 Nov 2000
Myocardial Infarction	JP	Nichi-Iko Gifu Plant Co., Ltd.	01 Nov 2000
Thrombosis	JP	Nichi-Iko Gifu Plant Co., Ltd.	01 Nov 2000
Angina, Stable	JP	Takeda Pharmaceutical Co., Ltd.	22 Sep 2000
Angina, Stable	JP	Nichi-Iko Pharmaceutical Co., Ltd.	22 Sep 2000
Angina, Unstable	JP	Nichi-Iko Pharmaceutical Co., Ltd.	22 Sep 2000
Angina, Unstable	JP	Takeda Pharmaceutical Co., Ltd.	22 Sep 2000
Brain Infarction	JP	Takeda Pharmaceutical Co., Ltd.	22 Sep 2000
Brain Infarction	JP	Nichi-Iko Pharmaceutical Co., Ltd.	22 Sep 2000
Ischemic Attack, Transient	JP	Takeda Pharmaceutical Co., Ltd.	22 Sep 2000
Ischemic Attack, Transient	JP	Nichi-Iko Pharmaceutical Co., Ltd.	22 Sep 2000
Thromboembolism	JP	Nichi-Iko Pharmaceutical Co., Ltd.	22 Sep 2000
Thromboembolism	JP	Takeda Pharmaceutical Co., Ltd.	22 Sep 2000
Thromboembolism	JP	Shiono Chemical Co. Ltd.	22 Sep 2000