Ondansetron is a serotonin 5HT3 antagonist; anti-emetic drug. Bitter taste of the ondansetron is a major problem in ensuring patient compliance. The study was designed to formulate tasteless complexes of ondansetron with ion exchange resin and evaluate molecular properties of drug complex. The drug-loading process was carried out using various resins and was optimized using different drug:resin ratio and pH. Resinates were characterized by infrared spectroscopy, thermal analysis, and X-ray powder diffraction (XRPD). Indion 234 gave the best loading efficiency at drug resin ratio of 1:1.5. pH had no effect on drug loading. XRPD studies revealed that drug is in amorphous state in complex. The Infrared studies revealed complexation of secondary amine group of drug with carboxylic functional group of resin. Taste evaluation by using semiquantitative method found resonates as tasteless and agreeable. The release of drug from resinates in simulated gastric fluid was complete in 30 min. Thus, ion exchange resinates offer an effective tool for masking of bitterness and improve drug release.
This case report documents 20 patients suffering from uncontrolled type 2 diabetes mellitus, presenting complaints of fluctuating blood glucose levels. The parameters like fasting and postprandial blood glucose, HbA1c and C- peptide levels of patients were evaluated. These patients were then advised an adjuvant therapy of Gplife advanced diabetic support tablets along with their daily insulin injections. After 60 days of treatment, the therapy was discontinued, and patients were subjected to continuous glucose monitoring for 8 days and time in range (TIR) percentage was calculated. Also, the fasting and postprandial blood glucose, HbA1c and C-peptide levels were estimated. The average TIR percentage was found to be 93.2%, whereas the time above range (TAR) and time below range (TBR) was 6.8 % and 0 % respectively, which indicates that the patients had a negligible incidence of hyper and hypoglycemia after 60 days of treatment. There was a significant decrease by 61 % in HbA1c levels, 40.05 % in fasting blood glucose levels and 34.29 % in postprandial blood glucose levels (p<0.001). C-peptide levels increased by 1.38 folds after 60 days of treatment. Also, there were no evidence of diabetic comorbidities. Thus, indicating a marked improvement in the diabetic condition and overall quality of life in patients.
Type I or Type II diabetes, once recognized as juvenile diabetes or insulin-dependent diabetes, is a chronic illness in which the pancreas produces slight or no insulin. Insulin-dependent diabetes is a syndrome of glucose homeostasis considered by autoimmune destruction of the insulin-producing pancreatic Beta-cell that gradually leads to insulin deficiency. As there is no perfect treatment for management, Gplife has thought of and developed a product that is found to be effective in the management of insulin-dependent diabetes. After 60 days of evaluation of cases, it is observed that fasting blood glucose was reduced by 62.25%, postprandial glucose levels were reduced by 62.37%, HBA1C levels were reduced by 39.57%, C Peptide levels were increased by 26.67%, also the external insulin injection requirement of the patient’s decreased by 88.57%. This case study gives an overview of the current understanding of the disease and the efficacy of advance diabetic support products in insulin-dependent diabetes. It is evident that the said product further helps to reduce insulin and OHA doses for the management of insulin-dependent diabetes. It is suggested that the advance diabetes support product should be further extensively used as a monotherapy or adjunctive therapy for the regulation, or management or control of insulin-dependent diabetes.
In the current scenario, people have often adopted a sedentary lifestyle with a large amount of fast-food consumption, a lack of a balanced and nutritious diet, etc., which is drastically hampering their gut health. So there is an emerging need for a promising and safe medication for gastrointestinal illnesses that promotes improvement of overall gut health. The present clinical trial aims at generating evidence around the safety and effectiveness of incorporating a phytoconstituents-based product in the management of digestive ailments. This clinical trial was a randomized, double-blind, placebo-controlled trial involving 60 patients with selfdescribed gastrointestinal symptoms, divided equally into two parallel groups. Herbal formulation and placebo treatment were given as 1 tablet twice a day after meals for 3 months. Response to treatment was evaluated from the baseline to the end of the study on the basis of changes in symptom scores for various clinical symptoms like epigastric pain, heartburn, nausea, constipation, etc. Also, the safety and tolerability of the drug were evaluated by monitoring adverse events and hematological, lipid, liver, and renal function tests at baseline and the end of the study. 100% of patients got relief from symptoms like epigastric discomfort, belching, flatulence, fullness of the stomach, abdominal distension, hyperacidity, bloating, and postprandial fullness in 14 days of treatment with herbal formulation. 100% of patients got relief from heartburn, nausea, and vomiting in 7 days of treatment with herbal formulation. Also, 100% of patients got relief from constipation after 90 days of treatment of herbal formulation. There was reduction in rescue medication for 90% of subjects after 90 days of treatment of herbal formulation. While there was no evidence of fluctuation in liver function test, renal function test and lipid profile indicating systemic safety. Therefore, indicating improvement in overall health and quality of life of patients with gastrointestinal discomfort as compared to the placebo treatment.
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