This in vitro study evaluated the therapeutic equivalence of two multisource (generic) formulations of 100-mg phenytoin as immediate-release tablets available in the Peruvian pharmaceutical market, compared with the reference medicine, to establish interchangeability. The mean weight, hardness, and content of active substance were evaluated, prior to analyzing the dissolution profile. USP dissolution apparatus 2 (paddle) was used at 75 rpm with 900 mL of dissolution medium at 37 ± 0.5 °C at pH levels of 1.2, 4.5, and 6.8. The generic and reference formulations had similar weight or drug content, but hardness values were significantly different (p = 0.029). At pH 1.2, the generic products were considered therapeutically equivalent to the reference product based on similarity factor (f 2 ) and dissolution efficiency values; however, at pH 4.5 and 6.8, there were differences in dissolution performance based on f 2 values below the acceptable range.

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Ziziphus jujuba Mills, 'annab' in Iran, 'ber' in India or 'pomme sourette' in France, is a species whose fruit (known warmly as 'the fruits of life' in China) has been consumed for centuries for its nutritional value. The food industry used it as a food additive and flavoring. The dry seeds, the crude leaves and the stem bark are still used in ethnopharmacology to treat digestive disorders and gastric ulcers as antitussive, laxative and hypotensive drugs; even now, it is used in China to treat children who suffer from typhoid fever, furuncle and ecthyma. In Taiwan, the dry seeds for the variety spinosa (Suan Zao Ren) are the second most commonly prescribed and used phytomedicine for insomnia. Its popularity and production have increased worldwide in recent years, especially in Europe. The European Pharmacopoeia Commission has been unable to elaborate upon the EP monograph on Ziziphi spinosae semen as was planned. The EMA has not made its recommendations yet. Is it still a gap in the scientific knowledge? Or is difficult for traditional Chinese medicinal herbs to fulfill the style and quality parameters that are required? Copyright © 2017 John Wiley & Sons, Ltd.

Despite the wide variety of pharmacological activities described for the Marrubium vulgare L. herb, amazingly, only one clinical trial can be found in scientific literature. It was designed for the evaluation of its antidiabetic activity. Worse, the outcomes of this trial were contradictory to what previous in vivo mice assays had concluded. Therefore, should Marrubium vulgare be ruled out due to its lack of therapeutic potential in diabetes? The authors suggest a reevaluation of the clinical trial methodology to establish valid and final results.

Background There is scarce evidence on fourth doses of SARS-CoV-2 vaccines in chronic kidney disease (CKD) patients. We have evaluated the humoral response and effectivity of the fourth dose in the CKD spectrum: non-dialysis CKD (ND-CKD), hemodialysis (HD), peritoneal dialysis (PD) and kidney transplant (KT) recipients. Methods This is a prespecified analysis of the prospective, observational, multicentric SENCOVAC study. In patients with CKD who had received a complete initial vaccination and one or two boosters and had anti-Spike antibody determinations 6 and 12 months after the initial vaccination, we analyzed factors associated to persistent negative humoral response and to higher anti-Spike antibody titers as well as the efficacy of vaccination on COVID-19 severity. Results Of 2186 patients (18% KT, 8% PD, 69% HD and 5% ND-CKD), 30% had received a fourth dose. The fourth dose increased anti-Spike antibody titers in HD (P = 0.001) and ND-CKD (P = 0.014) patients and seroconverted 72% of previously negative patients. Higher anti-Spike antibody titers at 12 months were independently associated to repeated exposure to antigen (fourth dose, previous breakthrough infections), previous anti-Spike antibody titers and not being a KT. Breakthrough COVID-19 was registered in 137 (6%) patients, of whom 5% required admission. Admitted patients had prior titers below 620 UI/ml and median values were lower (P = 0.020) than in non-admitted patients. Conclusions A fourth vaccine dose increased anti-Spike antibody titers or seroconverted many CKD patients, but those with the highest need for a vaccine booster (i.e. those with lower pre-booster antibody titers or KT recipients) derived the least benefit in terms of antibody titers. Admission for breakthrough COVID-19 was associated with low anti-Spike antibody titers.

Cardiovascular factors are one of the main causes of morbidity and mortality in patients with chronic kidney disease. Bone mineral metabolism disorders and inflammation are pathological conditions that involve increased cardiovascular risk in chronic kidney disease. The cardiovascular risk involvement of bone mineral metabolism classical biochemical parameters such as phosphorus, calcium, vitamin D and PTH is well known. The newest markers, FGF23 and klotho, could also be implicated in cardiovascular disease.