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Packaging and Labeling Control
Published in Graham P. Bunn, Good Manufacturing Practices for Pharmaceuticals, 2019
The established name of the drug, if it contains a single active ingredient; if a combination drug, the established name of each active ingredient. If a compendial drug, the label must express the quantity of each therapeutically active ingredient contained in each dosage unit, for example, Aspirin Tablets, 325 mg., (USP—General Notices), and the quantity or proportion of any ingredient, whether active or not, as required by Section 502(e).
Designing and evaluation of dermal targeted combinatorial nanostructured lipid carrier gel loaded with curcumin and resveratrol for accelerating cutaneous wound healing
Published in Particulate Science and Technology, 2023
Ajay Singh, Mohammad Kashif Iqubal, Saurabh Mittal, Farheen Fatima Qizilbash, Ali Sartaz, Shobhit Kumar, Javed Ali, Sanjula Baboota
Combination drug therapy involves use of two or more drugs in a fixed-dose ratio, which have been shown synergistically increased efficacy. This approach has been increasingly utilized in drug development to overcome problems with pharmaceuticals that have a small therapeutic window or restricted efficacy. CUR and RSV have been found to act on multiple key regulators related to antioxidant in the cells and can potentially produce a synergistic effect. In addition to alleviating and reversing tissue oxidative injury, RSV and CUR works synergistically to increase antioxidant defense by scavenging free radicals. CUR and RSV benefit from each other’s antioxidant abilities, and both substances are protected by each other in this way (Coradini et al. 2014; AlBasher et al. 2020). In a study RSV and CUR relieved and synergistically reversed the Fipronil -induced tissue oxidative injury, probably by improving the antioxidant defenses via their free radical scavenging activity and restored the antioxidant enzymes including glutathione and superoxide dismutase (AlBasher et al. 2020). In comparison to monotherapy, Zaky et al. found that combined CUR and RSV showed greater activity in reducing aluminum-induced neuroinflammation in rats. This was partially attributed to the increased antioxidant activity (decreased total lipid peroxidation, restored glutathione, glutathione S-transferase, and superoxide dismutase) (Zaky et al. 2017). There is evidence that CUR and RSV work together synergistically to have anticancer effects (Malhotra, Nair, and Dhawan 2010, 2012; Liu et al. 2015; Mohapatra et al. 2015; García-Quiroz et al. 2019; Gavrilas et al. 2019; Guo et al. 2020). Many studies have also looked into the combined antioxidant properties of CUR and RSV. Zhou and associate established the synergy of CUR and RSV combination in protecting human endothelial EAhy926 cells against H2O2-induced oxidative stress (Zhou et al. 2021a).