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Antihistamines, Decongestants, and Expectorants during Pregnancy
Published in “Bert” Bertis Britt Little, Drugs and Pregnancy, 2022
Bromodiphenhydramine and carbinoxamine have not been studied during human pregnancy. Experimental animal teratology studies of bromodiphenhydramine are published. Malformations were not increased in frequency in one animal study of carbinoxamine (Maruyama and Yoshida, 1968). The Hungarian Birth Defects study of a large case-control sample (23,757 cases; 39,877 controls) found that the frequency of birth defects was not increased among 2640 infants whose mothers took dimenhydrate during embryogenesis (Czeizel and Vargha, 2005). The frequency of congenital anomalies was not increased in one animal study of dimenhydrinate exposure during embryogenesis (McColl et al., 1965).
Development and optimization of levodopa and benzylhydrazine orally disintegrating tablets by direct compression and response surface methodology
Published in Drug Development and Industrial Pharmacy, 2020
Yuanyuan Zhang, Zewen Li, Hui Tang, Wenjie Ren, Xin Gao, Yangjian Sun, Qiu Xiang Zhao, Fanye Wang, Junhong Liu
Figure 4 displays the dissolution profiles of the ODT formulation containing levodopa and benzylhydrazine, cumulative release of benzylhydrazine was more than 90% at 3 min, while that of levodopa was about 90% at 20 min. Such cumulative release fulfilled the requirement of Chinese Pharmacopeia [23]. Cumulative release is also one of the most important properties for ODTs. Yıldız et al. [38] conducted an in vitro drug dissolution study of the mirtazapine ODTs, cumulative release of mirtazapine was more than 85% at 5 min. Cumulative release of carbinoxamine maleate was about 90% at 5 min in another in vitro drug dissolution test [21]. The ofloxacin ODTs showed about 90% of drug release within 5 min and the bitter taste was masked by forming complex [39]. Therefore, the cumulative release of the L/B ODTS prepared by direct compression method in this study is good and acceptable on the basis of the General Principles of the Chinese Pharmacopeia.
A novel and discriminative method of in vitro disintegration time for preparation and optimization of taste-masked orally disintegrating tablets of carbinoxamine maleate
Published in Drug Development and Industrial Pharmacy, 2018
Yali Liu, Peng Li, Rong Qian, Tianyu Sun, Fangzhi Fang, Zonghua Wang, Xue Ke, Bohui Xu
Carbinoxamine maleate, a white crystalline powder, is the first-generation antihistamine H1-receptor blocking agent of ethanolamine class [1]. It is also a pediatric drug with high solubility in water and terrible bitter taste. In 1954, the common tablet of carbinoxamine maleate (CAM), called Clistin, was approved by new drug application (NDA), but soon removed from the market [2]. It is crucial for pediatric drugs to enhance compliance of patients who have difficulties to swallow tablets and endure bitter taste [3,4]. To overcome the swallowing problem, there is a new drug delivery dosage form known as ODTs, which can be dissolved easily with saliva in mouth [5,6]. Furthermore, children are more sensitive to bitter taste substances than adults, so that ion exchange resins (IERs) were used to mask bitter taste for better compliance to children [7,8].