Alverine 60mg capsules

Abstract Colonoscopy is the standard procedure for screening, and surveillance of colorectal cancer, including the treatment for colonic lesions. Colonic spasm is an important problem from colonoscopy that affects both surgeons and patients. The spasm also might be the cause of longer cecal intubation time, difficulty of the procedure, and increased pain. Previous reports indicated that antispasmodic agents can decrease such symptoms. Therefore, we conducted this study to investigate the cecal intubation time of antispasmodic agents. A single blinded randomized controlled trial was conducted from 01/11/2020 to 31/08/2021. One hundred four patients were allocated to antispasmodic agent group and control group, in 1:1 ratio. The efficacy of median (range) cecal intubation time showed similar results of 5 (2, 14) and 5 (2, 15) minutes with no statistically significant difference. The mean scores of all domains i.e., pain, spasm, cleanliness, and difficulty were better in the antispasmodic agent group about 2.6 (1.4), 1.8 (0.8), 2.4 (0.9), and 2.0 (0.9), respectively, than control group but there were spasm and cleanliness showed statistically significant difference. Moreover, the satisfaction scores showed better efficacy in decreased spasm, decreased difficulty, and increased cleanliness than control group. Prescribing of antispasmodic drugs before colonoscopy might be the choice of treatment for the patients. The antispasmodic drugs will be beneficial to both of the patient and the doctor.

Abstract licence: CC BY 4.0

The study compares the active substance alverine citrate from three commercial sources in order to demonstrate polymorphic forms using the XRPD, SEM, and ATR-FTIR techniques. Based on the solubility tests of alverine citrate, a hard capsule was prepared with the highest possible dose of the active substance. The release profiles of alverine citrate and its stability were also investigated. XRPD and ATR-FTIR analysis shows that all alverine citrate samples (despite differences in the synthesis process) are in the same polymorphic Form I. Scanning electron micrographs of alverine citrate from each manufacturer show differences in morphology (texture). The solubility studies confirmed the complete solubility of the highest dose of alverine citrate in media with a pH of 1.2-6.8. The release studies show that the release of the active substance, regardless of the manufacturer type, meets the immediate release requirement. Accelerated stability studies confirm the stability of the alverine citrate from selected manufacturers. As a result, the manufacturer of the final medicinal product may allow their inter-changeability during production without compromising the safety or efficacy of the medicinal product.

Abstract licence: CC BY-NC 4.0

The irritable bowel syndrome (IBS) is one of the most prevalent functional gastrointestinal disorders. However, at most, one-third of IBS patients are satisfied with the results of their treatment. A combination of pharmaceuticals or multi-target drugs should be used for the treatment to be effective due to the complexity of IBS pathophysiology. The Russian Expert Panel in gastroenterology, including functional gastrointestinal disorders, currently considered to be disorders of gut-brain interaction, at its open session has discussed the possibilities to increase the efficacy of treatment of patients with IBS with a multitargeted agent alverine citrate combined with simethicone registered under the trade name of Meteospasmyl® (Mayoly Pharma, France) and adopted the respective resolution. Based on the results of multiple experimental and clinical studies, the experts declared that the combination of alverine citrate with simethicone relieves pain through the alleviation of its main mechanisms (spasms, flatulence, visceral hypersensitivity, and inflammation), and normalizes bowel movements demonstrating the normokinetic (eukinetic) properties. All clinical effects of the combination of alverine citrate and simethicone are prolonged. Alverine citrate combined with simethicone improves patients’ quality of life, including their psychological well-being. Due to the efficacy and good safety profile, it is possible to use the combination of alverine citrate and simethicone as on-demand and ex juvantibus treatment. The combination of alverine citrate and simethicone is a single selective antispasmodic that allows for a simultaneous solution of two clinical challenges: to rid the patient of abdominal pains and to properly prepare the patient for instrumental examinations (colonoscopy, abdominal ultrasound, and radiological examination), due to a high simethicone dose and spasmolytic properties of alverine citrate. In addition, Meteospasmyl® is a single antispasmodic, which has demonstrated high efficacy and safety in a clinical study of its combination with a probiotic (Probiolog® IBS), containing the strains (Lactobacillus plantarum CECT 7484, Lactobacillus plantarum CECT 7485, and Pediococcus acidilactici CECT 7483) acting on all IBS pathogenesis steps. This is extremely important, considering the proven role of gut dysbiosis in IBS pathophysiology.

Abstract licence: CC BY-NC 4.0

Graphene oxide (GO)–lipid hybrid nanostructures represent a promising class of multifunctional platforms for drug delivery and fluorescence-guided cellular imaging. In this study, we developed a graphene oxide-supported lipid bilayer system composed of rhodamine-labeled phosphatidylcholine (POPC-Rhod) for the delivery of the repurposed antispasmodic drug alverine citrate (ALV) to neuroblastoma cells. The hybrid nanostructures were assembled using two drug-loading strategies and characterized by UV–Vis spectroscopy, fluorescence analysis, dynamic light scattering, and atomic force microscopy to evaluate molecular interactions, vesicle size distribution, and nanomechanical properties. In vitro studies were performed using human neuroblastoma SH-SY5Y cells and their retinoic acid-differentiated neuronal-like counterparts. Confocal microscopy confirmed efficient cellular uptake of the fluorescent lipid–graphene hybrids, while viability and mitochondrial reactive oxygen species assays revealed differentiation-dependent cellular responses. ALV-loaded hybrids induced cytotoxic effects in proliferating neuroblastoma cells, whereas differentiated neuron-like cells exhibited greater tolerance and, at moderate concentrations, preserved viability despite increased oxidative stress. These findings demonstrate that graphene oxide–lipid hybrids can act as fluorescence-traceable drug delivery platforms and highlight the potential of alverine as a candidate for repurposing in neural cancer models. The system presented here provides a proof-of-concept framework for the development of multifunctional nanocarriers integrating therapeutic delivery with imaging capabilities.

Abstract licence: CC BY 4.0

Abdominal pain is the cardinal symptom of irritable bowel syndrome (IBS) and the primary determinant of disease burden and healthcare utilization. Despite its diagnostic centrality and high prevalence across all IBS subtypes, effective management remains a clinical challenge. This narrative review explores the pathophysiological mechanisms underlying IBS-related pain, emphasizing the role of visceral hypersensitivity, altered brain–gut communication, and luminal factors such as gas and distension. We examine current guideline recommendations, real-world treatment patterns, and evidence supporting both pharmacological and non-pharmacological interventions. Particular focus is placed on the fixed-dose combination of alverine citrate/simeticone, which targets both motor and sensory pathways. Mechanistic studies demonstrate its smooth muscle relaxant, antinociceptive, and anti-inflammatory actions. Clinical trials support its efficacy in reducing pain, improving quality of life, and lowering healthcare resource use. Despite these advances, several unmet needs remain, including subtype-specific treatment strategies, mechanistic biomarkers, and broader access to integrated care. The review concludes with a call for more personalized, mechanism-based approaches to pain management in IBS, with alverine citrate/simeticone offering a pragmatic option within this evolving therapeutic framework.

Abstract licence: CC BY 4.0

Study Overall Design: This trial is a prospective, multi-center, single-arm, exploratory clinical study. Subjects who meet the inclusion criteria and do not meet the exclusion criteria will receive Compound Alverine Citrate Capsules (Lejiansu; specification: each capsule contains 60 mg of Alverine Citrate and 300 mg of Simethicone; produced by Laboratoires Mayoly Spindler, France) after signing the informed consent form. The dosage is 180 mg/day (1 capsule orally three times a day) for a treatment period of 24 weeks. Apart from the baseline period, efficacy will be evaluated at the end of the 24-week treatment period. Safety assessments will be conducted throughout the trial. The safety evaluation will be performed according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 by the National Cancer Institute. Study Population: Patients with cirrhotic portal hypertension Intervention: Compound Alverine Citrate Capsules (Lejiansu; each capsule contains 60 mg of Alverine Citrate and 300 mg of Simethicone; manufactured by the French company UCB Pharma), 180 mg/day (1 capsule orally, 3 times a day), taken continuously for 24 weeks. Study Objectives: To evaluate the safety and efficacy of Compound Alverine Citrate Capsules in treating portal hypertension in patients with cirrhosis. Study Endpoints Primary Endpoints 1. Safety Assessment: Incidence of adverse events, serious adverse events, and adverse events leading to discontinuation of treatment (evaluated according to CTCAE version 5.0). 2. Efficacy Assessment: The response rate at 24 weeks of treatment, defined as a reduction in HVPG by ≥ 10% from baseline or a reduction to below 12 mmHg. Secondary Endpoints 1. HVPG Changes: The absolute value and percentage change in HVPG from baseline after 24 weeks of treatment. 2. Decompensation Events: Incidence of cirrhosis decompensation events during treatment, including esophageal/gastric variceal bleeding and re-bleeding, new or worsening ascites, spontaneous bacterial peritonitis, overt hepatic encephalopathy, and acute kidney injury/hepatorenal syndrome. 3. 12-Week Response Rate: The treatment response rate at 12 weeks. 4. Mortality and Transplantation: Rates of death, liver transplantation, and liver disease-related mortality during the treatment period. Exploratory Endpoints 1. Cardiac Function: Changes in cardiac function from baseline after 24 weeks of treatment. 2. Liver and Spleen Stiffness: Changes in liver and spleen stiffness from baseline after 24 weeks of treatment. 3. Esophageal Varices: Status of esophageal varices after 24 weeks of treatment. Sample Size Calculation: This trial is a single-arm, exploratory clinical study, and plans to enroll 30 subjects. Conditions: Hypertension, Portal. Interventions: Alverine.

Source: ClinicalTrials.gov (public domain)